Non-confidential version CHEMICAL SAFETY REPORT i
CHEMICAL SAFETY REPORT
Substance Name: 1,2-dichloroethane
EC Number: 203-458-1
CAS Number: 107-06-2
Applicant(s):
Grupa LOTOS S.A.
Use applied for:
Use as an extraction solvent in the de-waxing of petroleum vacuum distillates and de-
asphalted oil and de-oiling of slack wax for the production of base oils and paraffinic waxes
EC number:
203-458-1
1,2-dichloroethane CAS number:
107-06-2
Non-confidential version CHEMICAL SAFETY REPORT 17
9. EXPOSURE ASSESSMENT.
9.0. Introduction.
Grupa LOTOS has one European refinery site (Gdansk, Poland) using EDC as solvent in the de-
waxing and de-oiling process.
The aim of the Lube Oil Complex which one of the part is 1300 De-waxing Unit is to obtain lube oil
basestocks (“base oils”) from crude oil vacuum distillate units by separating them according to
viscosity and boiling point specifications. One undesirable characteristic of these basestocks is the
presence of paraffin wax (high molecular weight hydrocarbons) which is responsible for poor flow
properties at ambient temperatures. The paraffin wax is removed in the de-waxing process in order to
obtain a finished oil with good pour point properties.
Grupa LOTOS uses a mixture of EDC and DCM to dilute the waxy raffinate in conjunction with
refrigeration to crystallize out the wax which is then filtered, i.e. in three main steps: crystallization,
filtration and solvent recovery. Through this de-waxing process, Grupa LOTOS generates three
grades of base oils and three grades of slack waxes.
De-waxing may be followed by a de-oiling stage, also taking place at the 1300 Unit. In the case of
de-oiling, slack wax (rather than vacuum distillate) is used as feedstock in the production line and
EDC-DCM is still used as a solvent. For the de-oiling of the slack wax, the process temperature is
raised and other operating parameters of the line are adjusted to allow a similar process of dilution,
crystallization, filtration and solvent recovery. This process generates hard paraffin waxes (in two
grades) and foot oils.
9.0.1. Process description.
In the de-waxing and de-oiling process EDC exists as the mixture together with the second chemical
compound, Dichloromethane (DCM). Only such mixture is considered as the solvent. The ratio of the
components is 30-50%EDC & 50-70%DCM. The mixture of EDC-DCM dissolves the oil in the feed
and splits the feed into the oil and wax. The solvent dewaxing process involves the removal of
naturally occurring waxes from feed by means of suitable solvent. Dewaxing is carried out in
presence of a solvent mixture consisting of EDC-DCM because the former is a wax anti-solvent
favouring the crystallization of wax necessary to obtain the desired pour point and the latter an oil
solvent which ensures complete solubility of the oil at the filtering temperature without excessive
dissolution of the wax. Summing up, the ECD is an anti-solvent of a wax while DCM completely
dissolves an oil at the filtration temperature without impact on the wax solubility. These selective
properties of the solvent components are the main characteristics of the solvent used. EDC exists
inside the unit in the circulation loop.
For EDC the de-waxing and de-oiling process can be divided into 5 main steps (see figure 1):
Feed and EDC (solvent) mixing; first dilution.
Cooling of the feed/solvent mixture.
Filtration of the dewaxed oil; second dilution.
Distillation of the solvent from the products and process water.
Drying of the solvent. The dried solvent is re-used (recirculated) in the process.
EC number:
203-458-1
1,2-dichloroethane CAS number:
107-06-2
Non-confidential version CHEMICAL SAFETY REPORT 18
Figure 1 – Process overview.
First dilution, pure solvent
Second dilution, pure solvent
Feed
Oil (deparafinate)+ solvent
Wax + solvent
Solvent-water
Solvent-water
Solvent-water
Solvent-water
Solvent-waterSolvent-waterSolvent-water
Solvent-water
Solvent-water
Solvent-water
Solvent-water
Solvent-w
ater
Solvent-w
ater
Solvent-w
ater
Solvent-w
ater
Pure S
olvent
Pure S
olvent
Pure S
olvent
Pure Solvent
Battery of the scraper chillers and coolers
Battery of the rotary drum
filters S1A-H
deparafinate+solvent
vessel V1 wa
x+
so
lve
nt
ve
ss
el V
2
distillation
columns for
wax C1 to C4
distillation
columns for
dewaxed oil
C5 to C9
Stripper water
treatment column C10
water/solvent
separation vessel
V7A-B
pure solvent
vessel V3A/BFeed and EDC
(solvent) mixing;
first dilution
Cooling down the
feed/Solvent
mixture
Filtration of the
dewaxed oil;
second dilution
Distillation of the
solvent from the
products
Distillation of the
solvent from the
process water
Drying of
the solvent
I
II
III IV
V
IV
C1
C2
C3
C4
C5
C6
C7
C8
C9
C10
V7B
V7A
V3A
V3B
Stripping st
eam
Wate
r
Wax
Dewaxed
Oil
EC number:
203-458-1
1,2-dichloroethane CAS number:
107-06-2
Non-confidential version CHEMICAL SAFETY REPORT 19
The feed (lube oil basestocks) is diluted (first dilution) to the extent required for cooling and filtration
by admitting fresh, pure solvent from vessel V3B. The mixture of feed/solvent is cooled in the battery
of the scraper chillers and coolers (up to -18°C) (see photo 1 and 2).
Photo 1 – Battery of the scraper chillers and coolers.
The cooled oil/solvent mixture is admitted to the continuously operating, gas-tight cellular drum
filters S1A-H (see photo 2).
Photo 2 – Battery of the rotary drum filters.
Each filter is designed to continuously filter the wax from the chilled solution of oil and solvent. The
filters drums are slowly rotated. The flow through the filtering medium is induced by vacuum applied
beneath the filtering medium through the filtrate piping. Wax is accumulate on the filter drum during
the pick-up or filtering portion of the cycle, and after emerging from the liquid is washed continuously
EC number:
203-458-1
1,2-dichloroethane CAS number:
107-06-2
Non-confidential version CHEMICAL SAFETY REPORT 20
by the solvent mixture. Wash solvent (second dilution) is introduced in such a manner as to provide
a continuous film of solvent over the wax cake in the washing zone. The wash solvent is drawn
through the wax cake to displace the oil solvent solution originally contained in the cake. Sprays and
drip pipes are installed in the filter for the application of this wash. The filtrate is sucked through the
filter cloth to the filtrate collector, vessel V1 (see photo 3). The crystallized paraffin is retained on the
filter cloth of the drum. The wax is releases from the drum at a point where it falls by gravity into the
wax discharging equipment. A smooth deflector blade is installed to direct the flow of wax to a spiral
scroll (screw conveyor) which moves the wax to the outlet nozzle. Next, the wax is transported via
slack wax screw conveyors to the slack wax collector, vessel V2.
Photo 3 – Vessel V1A/B, mixture of dewaxed oil and solvent.
The solvent-containing products, filtrate (deparafinate + solvent) and slack wax (wax + solvent)
obtained by filtration are freed from solvent in evaporating system with strippers. Three flash columns
and two strippers for filtrate and two flash columns and two strippers for slack wax solvent recovery
have been provided (see photo 4).
The vapours from filtrate flasher C5 and wax flasher C1 and vapours from C7 are condensed and
collected in the vessel V7B. The vapours from filtrate flasher C8 and wax flasher C3 and vapours
from C10 are condensed and collected in the vessel V7A. V7A works as separator of water from EDC
and V7B works as separator of water from DCM.
Both section V7A and V7B work full of liquid and the water is separated at the top. Water from V7
comes out of the top and is fed to the C10 water stripper where the remainder in the water solvent
is stripped and the free of solvent water is sent to the Waste Water Treatment unit.
The solvent from the V7B, containing only the solved water is pumped as the reflux to filtrate flasher
C5 where the traces of water are removed counter-currently to the rising solvent vapours by means
of seven valve trays. The dried solvent flows by gravity to the wash, pure solvent collector, vessel
V3A.
The solvent from the V7A, containing only the solved water is pumped as the reflux to filtrate flasher
C1 where the traces of water are removed counter-currently to the rising solvent vapours by means
of seven valve trays. The dried solvent flows by gravity to the wash, pure solvent collector, vessel
V3B.
The vapours from the filtrate flasher C6 are completely condensed and collected in the wash, pure
solvent collector V3A.
The vapours from the filtrate flasher C2 are completely condensed and collected in the wash, pure
EC number:
203-458-1
1,2-dichloroethane CAS number:
107-06-2
Non-confidential version CHEMICAL SAFETY REPORT 21
solvent collector V3B.
Pure solvent from the vessel V3A/B is used to first and second dilution in the de-waxing and de-oiling
process.
Photo 4 – Distillation part of the unit.
EC number:
203-458-1
1,2-dichloroethane CAS number:
107-06-2
Non-confidential version CHEMICAL SAFETY REPORT 22
9.0.2. Rigorous containment of the substance by technical means.
Production unit.
All equipment and processes from production units involving EDC are under closed systems. All of
the columns, vessels are equipped with the control systems i.e. level, pressure, temperature control
devices. The seals of the rotary equipment are mainly single but the process of replacing them with
the double-axial face seal with barrier fluid is under execution. The drained streams which contain
EDC are collected in the close drain vessel and are reprocessed in the unit. In case of emergency, the
equipment is connected to the buffer vessels T1, T2, T3, T5 located on the unit. The buffer vessels T1,
T2, T3, T5 are under filtration gas blanket.
Storage.
EDC are stored at the plant in four buffer vessels T1, T2, T3, T5 located on the unit (see photo 5).
The vessels are destined for storage of pure EDC after transportation, for storage of sent back mixture
of EDC/Dichloromethane during reduction of unit capacity or emergency situation and for
contaminated EDC with oil for further processing inside the unit. Around the vessels the protection
wall against the overflow is provided, in case of leakage.
All liquid transfer operations follow detailed written procedures to minimize the risks of accidental
leakage.
Photo 5 – buffer vessels of solvent T1, T2, T3, T5.
EC number:
203-458-1
1,2-dichloroethane CAS number:
107-06-2
Non-confidential version CHEMICAL SAFETY REPORT 23
9.0.3. Procedural and control technologies to minimise emission.
For the purpose of absorbing potential solvent vapours from the filter seals by oil a so-called ‘ECO
system’ is installed in the plant. It consists of an absorption tower, a vent gas blower and an oil cooler.
The absorber is a small column filled with a random packing.
In dewaxing and deoiling process the gaseous EDC is absorbed in the oil at the ECO System and is
recycled to the process, the drained liquid EDC, also dissolved in the oil, is collected in the closed
slop system and is recycled to the process.
All equipment is located outside building except rotary drum filters and gas compressors.
All equipment of Solvent De-waxing unit is connected to a general vent-gas balance vessel to ensure
regular pressure in the unit and to avoid releases (closed system) (see photo 6).
Photo 6 – Balance vessel of the internal gas (the close system).
EC number:
203-458-1
1,2-dichloroethane CAS number:
107-06-2
Non-confidential version CHEMICAL SAFETY REPORT 24
9.0.4. Cleaning and maintenance. General maintenance: The general maintenance of equipment is done over 3 weeks every 4 years. Before any
equipment is dismantled, the equipment is purged with solvent (DCM/EDC) until all wax is washed off. The
solvent is returned to the plant‘s feed (circulated in an enclosed system). Then the equipment is purged with
base oil in order to bind and flush out solvent completely. The base oil used for purging is returned to the plant‘s
feed (circulated in enclosed system) (see e.g. figure 2 – specific procedure for filters cleaning). The description
of the maintenance work to do as well as the specific risk management measure to follow are described in a
permit procedure. Personal Protective Equipment (PPE) is mandatory (inhalation full mask A2B2E2K2HgP3
and Chemical resistant gloves KCl 890 / Fluorocaoutchouc – see details page 20).
Non-routine maintenance (= maintenance only in case of dysfunction of equipment (e.g. pump), on average
once a month): In case of equipment dysfunction or equipment change, an operator from the plant unit is in
charge to connect secondary equipment (e.g. pump) when relevant. These actions are on/off valve actions. The
unit operators are not authorized to dismantle equipment. This task will be done by maintenance operators and
as for general maintenance, the equipment is flushed and purged. The description of the maintenance work to be
carried out, as well as the specific risk management measures to follow are described in a permit procedure.
Personal Protective Equipment is mandatory (inhalation full mask A2B2E2K2HgP3 and Chemical resistant
gloves KCl 890 / Fluorocaoutchouc – see details page 20). If no failure equipment detected, no cleaning or
maintenance is done on equipment (excepted general maintenance).
General and daily maintenance are done by Grupa LOTOS workshop operators (not same operators as in
production unit).
Figure 2 – shut down and cleaning of filters procedure.
Rotary drum filter preparation for repair procedure (with opening of the dome).
Stop the feed to the drum filter.
Wash the drum filter for 10 minutes using the solvent, than drain the filter and repeat the
action.
Blow off the solvent pipes to the drum filter using the nitrogen or air.
Blind the solvent pipes and mark the blinded location.
Fill the drum filter with the pure dewaxed oil in order to wash out the cloth filter to the main
filtrate line. Drain the rest of dewaxed oil with the small quantity of solvent to 1300V11.
Repeat the action. After that the filter is considered without the solvent.
Open the special Eco-system and start ventilation of rotary drum filter for 24 hours.
Open the dome of the filter and keep it open 12 hours for natural ventilation.
Check the oxygen and solvent vapour level.
EC number:
203-458-1
1,2-dichloroethane CAS number:
107-06-2
Non-confidential version CHEMICAL SAFETY REPORT 25
9.0.5. Organisational management measures.
The industrial site is under management system:
Health and safety: PN-N-18001.
Environmental Protection : PN-EN ISO 14001.
Quality assurance: PN-EN ISO 9001.
Procedures.
According to polish law and regulation (risk assessment on work positions), procedures are in place
to perform works under written permits including safety instructions. The good unsaved internal
practice is also applied in Lube Oil Complex. Those procedures are mainly analysed on employee
workplace safety and include:
trained, familiar with and aware of existing hazards and threats,
applying personal protection equipment,
safety exams before starting individual operations on the facilities,
responsibility for carrying out work,
safety meetings (before unusual activities if the contact with chemicals could be foreseen),
supervising works performed by contractors and their presence in the refinery,
involvement in improving safety culture (i.e. meetings once per quarter),
unit annual safety performance.
The main mandatory procedures in the 1300 De-waxing Unit are:
Permission for work on production facilities in explosive zone – GKL.48.01.00.00.
Safety Analysis – GKL.48.01.03.00.
Registry of people staying on production facilities – GKL.48.01.00.00.
Internal procedures for preparing equipment to regular repair and emergency procedure (see appendix 6 for information included in procedures).
Trained and authorised personnel
General training on risks for chemical are given each years for all operators involved in chemical
handling. Specific trainings on chemical risk handling are given regularly to all plant operators
handling EDC. All tasks involving EDC handling are done by competent and authorized operators.
(see appendix 8 for details on training process).
Figure 3 – production department trainings.
EC number:
203-458-1
1,2-dichloroethane CAS number:
107-06-2
Non-confidential version CHEMICAL SAFETY REPORT 26
9.0.6. Action plan to reduce EDC emissions.
Programme for improvements to the use of and exposure to EDC.
Background.
Grupa LOTOS has developed and is already implementing a long-term R&D plan which aims
to modernise the de-waxing/de-oiling unit and reduce EDC consumption and, consequently, worker
exposure to this SVHC substance. Part of this plan will be the intensification of exposure monitoring
which will in turn support the efforts of modernisation and exposure control improvement.
This programme is involving a diverse group of people within Grupa LOTOS, including process
engineers, maintenance engineers, lube oil block managers and investment project managers, along
with external experts. At present, 15 persons are involved. The programme also involves external
laboratories for emission monitoring, environmental and human health impact assessment (EIA
and HIA), and engineering companies analyse identification and selection of new equipment to
further reduce solvent losses.
Actions for the modernization of the plant and reduction of EDC consumption.
Grupa LOTOS has replaced dated or inefficient de-waxing and de-oiling equipment in the unit,
including: replacing parts of the rotary drum filters (shells, windows and seals); modernisation of
compressors; and, revamping of the turbo-compressor system. More actions are planned up before
the Sunset Date in 2017, as shown in table 1.
Table 1 - Planned modernisation actions of the de-waxing and de-oiling unit.
Equipment Scope of modernisation Planned Start – End
Rotary drum filters E,F,G
Replacing of the filter’s shell and windows and selection of new seals for windows. Execution of new type of filter lighting with new seal as the continuous improvement program.
New rotary drum filters
Replacing of existing rotary drum filters with new ones.
Pumps Replacing of pump seals with new double seals for those pumps relevant to EDC
Scraper chiller Replacing of scraper chiller seals with new double seals
Control valves Replacing of valves’ seals with new bellows seals
Pipelines Programme of pipelines measurement and selection of pipes in bad condition for replacement
Pipelines Replacement of identified pipes
A technical study is planned that will further assess some of these projects and more specifically:
Seals modifications in pumps, scraper coolers and scraper chillers.
Replacement of rotary filters.
It is expected that the entire process of modernisation will last an estimated 59 months; this includes
4 months for internal deliberations and decision-making and a further 55 months for delivering the
required production unit modifications. A preliminary valuation of the cost of the modernisation
programme is estimated at €10-100 million ( ).
EC number:
203-458-1
1,2-dichloroethane CAS number:
107-06-2
Non-confidential version CHEMICAL SAFETY REPORT 27
Other planned actions aimed at the reduction of EDC losses and exposure.
Engineering actions are supported by continuous organisational measures, such as reinforcing the
knowledge of the employees who directly manage EDC on the hazards and risks associated with the
substance and the information in the Safety Data Sheet (SDS). This will include the provision of
information on the classification of the substance as a SVHC and the REACH authorisation process
and requirements.
Furthermore, specific measures are planned for the improvement of awareness on exposure, the
collection of monitoring data that could be shared with the relevant authorities and the further
improvement of the controls on EDC exposure, where a need is identified.
Table 2 – Improvement plan on training.
Training At present Improvement plan
Periodic training 1 x year No changes
Discussion on research reports of
harmful factors - refresher training
on the risks associated with the use of
EDC.
2 x year No changes however note: to raise
the level of awareness about the
dangers during the EDC handling
if it is needed
Table 3 – Improvement plan on PPE.
PPE Process At present Improvement plan
Wearwork EDC unloading Antistatic + TYVEX TYCHEM
Non-routine
maintenance (small
repairs).
Antistatic + TYVEX TYCHEM
EC number:
203-458-1
1,2-dichloroethane CAS number:
107-06-2
Non-confidential version CHEMICAL SAFETY REPORT 28
Table 4 – Improvement plan on monitoring.
Place, stream Frequency Comment Frequency Comment
Process water at the inlet to sewer systemonce 2015 - 1 x week -
Oily rainwater on the border of the property
(from manhole/sump)
once 2015 - 1 x week -
Process water at the inlet to WWTPonce 2015 - 1 x week in the same days as in case of samples from
Lube Oil Compex with a certain time delay
Oily rainwater at the inlet to WWTPonce 2015 - 1 x week in the same days as in case of samples from
Lube Oil Complex with a certain time delay
Stream of treated sewage discharged
into the receiver (river M.Wisła)(process water and from time to time oily rainwater with sanitary
sewage when we have excess service water)
1 x month 1 x week
Receiver (river M.Wisła) below and above the
point of waste water discharge
1 x quarter 1 x quarter (no
changes)
in the same days as in case of samples from
WWTP with a certain time delay (it does not
concern receiver - it is separate measurement)
Improvement Plan
Marshal Office requirement
Ma
rtw
a W
isła
At present
Lu
be
Oil
Co
mp
lex
WW
TP
EC number:
203-458-1
1,2-dichloroethane CAS number:
107-06-2
Non-confidential version CHEMICAL SAFETY REPORT 29
Unloading EDC
during each
unloading (c.a. 1 x 2
years)
internal mesurement no changes
1 x year so far in 2014 and 2015 no changes at least in 2016 and 2017y
2 x year internal mesurement 2 x year (no
changes) and
also - see
comment
also after each:
- EDC unloading
- change/imrovement activity which can
result in emission reducing
- important step as filter/tank opening
before maintenance/repairing
2-3 x month according to the Annual Detail
Schedule, internal measurement
no changes -
once: 2013
once: 2014 - 2016
measurement of emission
factors according to PN-EN
15446:2008 "Niekontrolowana i
rozproszona emisja w sektorze
przemysłowym - Pomiar emisji
par wydobywających się z
nieszczelnych instalacji i
przewodów" (english version:
EN 15446:2008) - factors of EDC
emission determined in regard
to seals and flanges and than
estimated to 1300 Unit
1 x week firstly monitoring of emission points,
than sealing and then systematic
monitoring
once: 2016 imission from 1300 Unit:
detail measurement of fugitive emission
(volatile organic compounds) from 1300
Unit (specially EDC)
Around the emission point (1300 plant) and
fence of refinery from leewardbased on concentration measured around emission
point (theoretical emission calculated in the point of
emission = the middle of 1300 plant)
once: 2008
once: 2009
- 1 x 2 years immission around 1300 unit in refinery
area: 2016 and after modernisation
(after those 2 sessions additional internal
decision is needed)
Around the refinerypassive measurement of EDC concentration (gas)
and the contect of EDC in falling dust
once: 2015 - every year at least untill the modernization (than
additional internal decision is needed)
Workplace
Seals
AIR
fugi
tive
emis
sion
EC number:
203-458-1
1,2-dichloroethane CAS number:
107-06-2
Non-confidential version CHEMICAL SAFETY REPORT 30
9.0.7. Teams and employees involved in use of EDC.
The industrial site is producing in continuous process, 24/24, all year (general maintenance every 4
year, 3 weeks duration). As described above the processes using EDC are closed systems without
direct handling of EDC by operators except during sampling for quality control, raw material
unloading from rail tank, non-routine maintenance, general maintenance and laboratory quality
control. Then the exposure scenario will consist of 6 worker contributing scenarios:
WCS1 – Production process (de-waxing and de-oiling), including storage, transfers,
recycling, waste transfers (not covering sampling QC) (PROC 2). This WCS covers the
complete operators shift working in the plant production unit where EDC is used as described
above. The tasks done by operators are facility supervision, control from the room panel
control, visual control routines on unit.
There are 15 employees involved in Solvent dewaxing unit (i.e. three operating positions per
shift. Not the same operators are still working for the 1300 Unit. It means that an annual
exposure of EDC for every particular person can be less because of operators rotation
between all units of Lube Oil Complex. The value 15 operators is related to a required
operating positions).
Those employees are in 5 teams (3 operators by team). Per day (24/24): Team1 = shift 1: 6:00
to 14:00; Team2 = shift2: 14:00 to 22:00; Team3 = shift3: 22:00 to 6:00. Frequency of CS1 =
all year.
WCS2 – EDC sampling for quality control (PROC8b). This WCS covers the daily sampling in the unit
for QC.
This WCS2 is done by the same employees as in WCS1.
WCS3 – Reception of EDC from a rail tank (PROC 8b). This WCS covers the specific operation of the
rail tank EDC unloading. This operation is done every 2 years by Grupa LOTOS unloading team
operators, who are not involved in Lube Oil Complex. During an unloading road tank operation, 2
operators from unloading team are doing the tasks (sampling from manhole, connecting flexibles to rail
tank, disconnecting flexible after unload – see detailed description in chapter 9.1.4). The duration is
around 3 hours.
There are 2 employees in unloading operators team (not the same employees as in WCS1, WCS2,
WCS4, WCS5 and WCS6).
WCS4 – Non-routine maintenance and cleaning (PROC 8b). This WCS covers the specific
operation of small repairs in case of equipment dysfunction (e.g. pump) (see description in
chapter 9.1.5). This task is done only by maintenance operators (not the same employees as in
WCS1, WCS2, WCS3 and WCS6). There are 6 employees in the maintenance operator team
(same operators in WCS5).
WCS5 – General maintenance and cleaning (PROC 8b). This WCS covers the specific
operation of maintenance and cleaning of general equipment 3 weeks every 4 years (e.g.
reactors, vessels) (see description in chapter 9.1.5). This task is done only by maintenance
operators (not the same employees as in WCS1, WCS2, WCS3 and WCS6). There are 6
employees in the maintenance operator team (same operators in WCS4).
WCS6 – Laboratory quality control (PROC15). This WCS covers QC analysis in laboratory.
There are 38 employees in the laboratory. Only 1 employee involved during a WCS6
operation. The employees from WCS are not the same than employees from WCS1, WCS2,
WCS3, WCS4 and WCS5.
EC number:
203-458-1
1,2-dichloroethane CAS number:
107-06-2
Non-confidential version CHEMICAL SAFETY REPORT 31
9.0.8. Overview of uses and Exposure Scenarios.
Identifiers Market
Sector
Titles of exposure scenarios and the related contributing scenarios
ES1 – IW1 - Exposure scenario 1: Use as an extraction solvent in the de-waxing of
petroleum vacuum distillates and de-asphalted oil and de-oiling of slack
wax for the production of base oils and paraffinic waxes.
- Industrial use of processing aids in processes and products, not
becoming part of articles (ERC 4)
- WCS1: Production process including storage, transfers, recycling,
waste transfers (PROC 2).
- WCS2: EDC sampling for QC (PROC 8b).
- WCS3: Receive of EDC from rail tank (PROC 8b).
- WCS4: Non routine maintenance and cleaning (PROC 8b).
- WCS5: General maintenance and cleaning (PROC8b).
- WCS6: Laboratory QC (PROC 15).
Manufacture: M-#, Formulation: F-#, Industrial end use at site: IW-#, Professional end use: PW-#,
Consumer end use: C-#, Service life (by workers in industrial site): SL-IW-#, Service life (by
professional workers): SL-PW-#, Service life (by consumers): SL-C-#.)
9.0.9. Introduction to the assessment.
9.0.9.1. Environment.
Not applicable. Environment assessment is not subject to this CSR.
9.0.9.2. Workers.
Scope and type of assessment:
The scope of exposure assessment and type of risk characterisation required for workers are described
in the following table based on the hazard conclusions presented in the document RAC n° 33/2015/09
rev 1 final.
In June 2015 the RAC has published a reference dose response relationship for carcinogenicity of 1,2-
dichloroethane. This dose response relationship has also been used to calculate the excess risk on
cancer due to occupational exposure to 1,2-dichloroethane.
Table 5 – Excess risk calculation – workers.
Route Type of effect Type of risk
characterisation
Hazard conclusion (see RAC n° 33/2015/09 rev
1 final)
Inhalation
Systemic Long Term Semi-quantitative Excess risk = 6.0 x 10- 4 (mg/m3)-1 x concentration
(mg/m3)
Systemic Acute Not needed -
Local Long Term Not needed -
Local Acute Not needed -
Dermal Systemic Long Term Semi-quantitative Based on 50% absorption:
Excess risk = 2.1 x 10- 3 (mg/kg bw/day)-1 x dose
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Route Type of effect Type of risk
characterisation
Hazard conclusion (see RAC n° 33/2015/09 rev
1 final)
(mg/kg bw/day)
Systemic Acute Not needed -
Local Long Term Not needed -
Local Acute Not needed -
Eye Local Not needed -
Comments on assessment approach related to toxicological hazard:
1,2-dichloroethane has been included into Annex XIV of the REACH regulation (list of substances
subject to authorisation) due to its intrinsic properties (carcinogenic substance; classification as carc
1B). According to Regulation (EC) No 1907/2006, Article 62 (4)(d), the CSR supporting an
application for authorisation needs to cover only those risks arising from the intrinsic properties
specified in Annex XIV. Therefore only the human health risks related to the classification of EDC as
a carcinogenic substance are addressed in this CSR.
Inhalation exposure assessment.
Worker Contributing scenario 1 (WCS1, general production process), Worker Contributing scenario 2
(WCS2, EDC sampling for QC) and Worker Contributing scenario 6 (WCS6, laboratory QC).
For those WCS, the inhalation exposure assessment for workers has been done with measured data
approach. A specific measurement campaign has been done in 2014 and 2015 based on:
CSN EN 689, BOHS NvvA sampling strategy guidance 2011 and ECHA guidance R14, 2012
for sampling strategy.
ISO 16200 (NIOSH 1003) “Workplace air quality – Sampling and analysis of volatile organic
compounds by thermic desorption/gas chromatography” for sampling and analytical requirements
(see appendix).
The sampling strategy has been based on specific on-site plant visit by Certified Industrial
Hygienist (IOHA certification). Similar Exposure Group (SEM) exposed to EDC have been
identified in each plant and linked with the Contributing Scenarios. At least a minimum of six
samples per SEM has been required as expected in the European reference CSN EN 689. The
sample collection technique has been personal air sampling – the sampling device is directly
attached to the employee within the worker’s breathing zone. It has been required from certified
laboratory to give a clear description of all technical conditions and tasks during the sampling
duration.
The measures and analysis has been done by certified laboratory in compliance with NIOSH 1003
requirements (SOCOTEC).
Worker Contributing scenario 3 (WCS3, rail tank unloading).
There are no existing measured data for this WCS, therefore a tier 2 model ART has been used as
main approach for inhalation exposure assessment. As the frequency of this activity is very low
(one every 2 years), with closed system equipment (see description in chapter 9.1.4), trained
operators and management system in place, regular measurement for this activity is considered by
Grupa LOTOS as not relevant. Also due to low frequency, it was not possible to schedule
measures campaign in 2014 for this study.
Worker Contributing scenario 4 (WCS4, non-routine maintenance) and 5 (WCS5, general annual
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maintenance).
There are no existing measured data for those WCSs, then a tier 2 model ART has been used as
main approach for inhalation exposure assessment. Scheduled maintenance is infrequent (one
every 4 years) and is only performed after equipment and pipe in-depth flushed and purged which
considerably reduces the residual quantity of solvent present in such equipment. Moreover only
trained workers are authorised to perform maintenance activities and management system covering
this activity is set up and regular internal/external audit is performed. Therefore regular
measurement for this activity is considered by Grupa LOTOS as not relevant.
The dose response relationship for EDC, as recommended by RAC, assumes a worker life time
exposure of 8 hours per day, 5 days per week during a working life of 40 years. When calculating the
excess risk due to inhalation exposure for the contributing scenarios (as Time Weighted Average
exposure over 8 hours), correction factors has been used to recalculate the exposure on a basis of 8
hours (e.g. if a measurement has been taken on 2 hours to cover a contributing scenario with a result
concentration of C1 (mg/m3), the exposure based on 8 hours will be: Exp1 (mg/m3) = C1*2/8). Such
factors considering less-than-shift duration of activities will be used in WCS3, WCS4, WCS5 and
WCS6 based on the fact that after exposure duration, the operators will no longer be involved in EDC
operations or process within the WCS assessed. For WCS4 (non-routine maintenance) and WCS5
(general maintenance), as the operators are the same (maintenance operators), the combined exposure
will be done in chapter 10. It is also the case for WCS1 and WCS2 (same operators from general
production).
The frequency of an activity is also taken into account for excess risk calculation. E.g for an activity
with a frequency of once each 6 months, the exposure result will be multiplied by a factor of
1/(5*4*6) (5 (five days/ week) multiplied by 4 (4 weeks/ month) multiplied by 6 (1 activity each 6
month)). As explained in the introduction of chapter 9.0.6 “Teams and employees involved in use of
EDC”, except for WCS1 and 2, and for WCS4 and 5, employees from a WCS are not working in
other WCSs.
When respiratory equipment is used during the task, an efficiency of 95% will be used to calculate the
real exposure. The 95% efficiency can be justified by the use of full mask with filters
A2B2E2K2HgP3 conforming with EN141 and EN 14387 (see appendix 7 for technical specifications
of PPE). Specific PPE is proposed and validated by EHS service. The PPE is available in the store-
room. The material is inspected once a year. The PPE availability is controlled by chief operator.
Audits are done to ensure good behaviour / PPE. The inhalation protective equipment (full mask) is
single use. After each use, the mask equipment is cleaned and tested by fire department. The
A2B2E2K2HgP3 filter is change after each use (the efficiency values are based on British Standards
Institution, London, 1997, American National Standards Institute, New York, 1992 and ART TNO
report 2009).
Calculation of exposure taking into account PPE:
PPE is worn during throughout the task : C real = C 33 * Effic.(0.05) PPE is worn partially during the task : C real = (C PPE * T PPE * Effic + C noPPE * T noPPE) / (TPPE
+ TnoPPE) C PPE and TPPE mean concentration and duration respectively when PPE used. C noPPE and TnoPPE mean concentration and duration respectively when no PPE used.
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Table 6 – overview of dermal and inhalation PPE used per WCS.
WCS Chemical Gloves
Mask and filters Workwear
Material
Minimum
layer
thickness
Break
through
time
Type of
Mask
Type of
filters
Sampling
EDC for QC
Chemical
resistant gloves
KCl/ nitrile
1.2 mm 30-60-
protection
against
splashes
none none Antistatic
Rail tank
unloading
Chemical
resistant gloves
KCl 890 /
Fluorocaoutchouc
< 1.0 mm 30 min. full face
mask with
absorber
A2B2E2K2
HgP3 (typ
EN 141 and
EN 14387)
Antistatic +
TYVEX *
Non-routine
maintenance
Chemical
resistant gloves
KCl 890 /
Fluorocaoutchouc
< 1.0 mm 30 min. full face
mask with
absorber
A2B2E2K2
HgP3 (typ
EN 141 and
EN 14387)
Antistatic +
TYVEX *
General
maintenance
Chemical
resistant gloves
KCl 890 /
Fluorocaoutchouc
< 1.0 mm 30 min. full face
mask with
absorber
A2B2E2K2
HgP3 (typ
EN 141 and
EN 14387)
Antistatic +
TYVEX or
TYCHEM **
Laboratory
QC of EDC
Chemical
resistant gloves
KCl/ nitrile
1.2 mm 30-60-
protection
against
splashes
none none Antistatic
* improvement plant: TYCHEM work wear instead of antistatic + TYVEX
** depending on operation and equipment.
Dermal exposure assessment.
The dermal exposure assessment has been done using Riskofderm V2.0 tier2 model with a 90th
percentile result.
As for liquids, results from Riskorfderm are given in µl, EDC density factor (1.244 g/cm3 at 20°C)
will be used to get the exposure results in mg. In the case of maintenance activity where EDC is
diluted with flushed oil the density factor of 1.244 g/cm3 will be kept as worst case value (instead of
value below 1 for oil). Body weight value of 70 kg will be used to get the final result in mg/kg/d.
The real dermal exposure duration is used for duration in Riskofderm.
When dermal equipment (gloves) is used during the task, an efficiency of 95% will be used to
calculate the actual exposure. The 95% efficiency can be justified by the use of protective gloves
satisfying the specifications of EU Directive 89/686/EEC and the standard EN 374 derived from it
(see table 6 and appendix 7 for technical specifications of PPE). Also specific PPE is proposed and
validated by EHS service. The PPE are available in the store-room. The PPE availability is controlled
by chief operator. Audits are done to ensure good behaviour / PPE. Specific trainings on PPE are
given regularly to all plant operators handling EDC.
General information on risk management related to irritation classification. A qualitative assessment was carried out with respect to eyes, skin and respiratory irritation
classification (moderate hazard, H319, H335, H315) based on OC/RMMs from ECHA, part E, Table
E.3.1. When those OC/RMM are applied, the qualitative assessment concludes to safe use:
- Containment as appropriate;
- Minimise number of staff exposed;
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- Segregation of the emitting process;
- Effective contaminant extraction;
- Good standard of general ventilation;
- Minimisation of manual phases;
- Avoidance of contact with contaminated tools and objects;
- Regular cleaning of equipment and work area;
- Management/supervision in place to check that the RMMs in place are being used correctly and OCs
followed;
- Training for staff on good practice;
- Good standard of personal hygiene;
- Substance/task appropriate gloves;
- Skin coverage with appropriate barrier material based on potential for contact with the chemicals;
- Substance/task appropriate respirator;
- Optional face shield;
- Eye protection.
9.0.9.3. Consumers.
No consumer assessment has been made, as there is no consumer related use for the substance,
resulting in exposure for consumers.
9.0.9.4. Man via environment.
Scope and type of assessment
The scope of exposure assessment and type of risk characterisation required for man via environment
is based on the hazard conclusions presented in the document draft RAC n° 33/1015/09 rev 1 and is
described in the following table. The risk assessment of man via the environment is mainly based on
the potential exposure of the general population via air as well as indirect oral exposure through
consumption of drinking water and/or various crops/food potentially contaminated with EDC
following its industrial emission at Grupa LOTOS industrial facility. Local and regional risk
assessment are conducted so to ensure all potential emissions are taken into account.
Table 7 - Type of risk characterisation for man via the environment.
Route Type of effect Type of risk
characterisation
Hazard conclusion (see RAC n°33/2015/09 rev1)
Inhalation
Systemic Long Term Semi-quantitative According to the draft RAC conclusion, the excess
risk is calculated as follows:
Excess risk = exposure (µg/m3) x 3.45 10-6
Systemic Acute Not needed -
Local Long Term Not needed -
Local Acute Not needed -
Total
exposure
Systemic long term Semi quantitative The excess risk is calculated as follows:
Excess risk = exposure (µg/kg bw/d) x 1.2 x 10 -5
Systemic Acute Not needed -
Local Long Term Not needed -
Local Acute Not needed -
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9.1 Exposure scenario 1: Use as an extraction solvent in the de-waxing ofpetroleum vacuum distillates and de-asphalted oil and de-oiling of slackwax for the production of base oils and paraffinic waxes.
9.1.1. Environmental contributing scenario 1: Use as an extraction solvent in the de-waxing of petroleum vacuum distillates and de-asphalted oil and de-oiling of slack waxfor the production of base oils and paraffinic waxes.
9.1.1.1. Exposure and risks for the environment and man via the environment.
A release factor for each environmental compartment is used to determine the fraction of the tonnagethat will be released to each environmental compartment i.e. water, air, soil. The Environmental ReleaseCategory (ERC) 4 i.e. industrial use of processing aids (solvent) in process and products, not becomingpart of articles is used to determine the default parameters used for the initial release rate calculation.The release estimation may then be refined using specific on-site data as Risk Management Measures(RMM) and Operational Conditions (OC) as well as measure data of the emission in air and wastewaters if available. Specific RMM are considered in this assessment as standard practice, theireffectiveness is known and controlled on-site. These abatement techniques are defined using the CEFICRMM library and their efficiencies are defined by the EU BREF Documents if needed. The use of suchabatements is supported by the compliance to the Industrial Emissions Directive (Directive 2010/75/EUof the European Parliament and of the Council of 24 November 2010 on industrial emissions, integratedpollution prevention and control).
The on-site specific RMMs, defined with the best available technologies (BAT referenced in EU BREFDocuments), are each assigned with a quantitative measure of release reduction and are used in thequantitative assessment in association with the initial default release factors to determine the actualrelease factor when needed.
When analytical results in influent/effluents or in the air phase as close as possible from the emissionsource are available, these will be used to back calculate the removal efficiency in the air phase or inthe wastewaters.
At its industrial site of the Grupa LOTOS, EDC is used as de-oiling and de-waxing solvent at theirunique site in Poland (Grupa LOTOS S.A.; ul. Elbląska 135; 80-718 Gdańsk, Poland).
9.1.1.1.1 Conditions of use.
The conditions of use for the industrial production using EDC is indicated in the following table forassessment of the impact of the general population via the environment.
Conditions of use of EDC at Grupa LOTOS facility
Amount used, frequency and duration of use (or from service life)
• In the system there is ca. tonnes of EDC. Annual amount used in the circulation loop at asite continuous process corresponding to ca. tonnes/year.
• Annual tonnage of substance consumed at site used for risk assessment: see mass balance“chapter 9.1.1.1.3. Releases”.
• Emission day: 344 operating days every three or four years (3 weeks of annual maintenance break).For risk assessment purposes 344 operating days will be used as it represents a worst case situation.
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9.1.1.1.2. Monitoring data.Monitoring data of the concentration of EDC in waste waters out of the production plant.
The discharge in waste waters through the different units is described below.
In summary, the waste waters; the process waters (used directly in the process) and oiled rainwaters(coming from paved production areas) are discharged into the river Martwa Wisła (see below discharged points “12”) whereas the drainage waters coming from the refinery’s drainage system
Conditions and measures related to sewage treatment plant
• Onsite STP discharge to a channel (Rozwójka) discharging to the river Martwa Wisła (close to Gdańsk) directly discharging down to the sea. Because the river Martwa Wisła is a dead arm of the Vistula river discharging directly to the sea, it is estimated that the discharge is down directly to theBaltic Sea.
• Discharge rate of onsite wastewater treatment plant: in 2014 13380 m3/d (value used for riskassessment); in 2015 3116.9 m3/d
• Receiving surface water flow rate (Martwa Wisła): dilution 10 (default value)
Other conditions affecting environmental exposure
Expected for distillation solvent recovery unit (80 to 130°C), all the process phases are under ambienttemperature or low temperature (-4°C after the first dilution, -18°C after second dilution). The sealsof the rotary equipment are mainly single but the process of replacing them with the double-axial faceseal with barrier fluid is under execution. All transfers (storage tank, mixing vessels, filtration,distillation) are automatized and under panel control and alarms. In case of emergency all the unit isconnected with a secure unit tank storage. All equipment is outside building excepted rotary drumfilters.
Conditions and measures related to treatment of waste
Air treatment:
All equipment of de-waxing and de-oiling facility unit is connected to a general vent-gas balancevessel (Gasometer tank) to ensure regular pressure in the unit and to avoid direct releases.
Waste Water treatment:
After condensers and water/solvent separation vessel, waste water is treated in a stripper column. Afterthis stripper column treatment the water is sent to the general chemical waste water treatment unitplant.
- Water stripping column treatment
o Unique number for CEFIC library of RMM / OC: E13.19 (no default value defined; maximum
achievable removal efficiency 99.5%)
o BAT Reference Document ‘Common Waste Water and Waste Gas Treatment/Management
Systems in the Chemical Sector’, page 126
- On-site chemical (flocculation) and biological WWTP
o Unique number for CEFIC library of RMM / OC : E13.21 (no default value for non-
biodegradable compounds)
o BAT Reference Document ‘Common Waste Water and Waste Gas Treatment/Management
Systems in the Chemical Sector’, page 138 (efficiency based on COD measurement and
therefore not directly applicable to EDC)
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lowering the groundwater level under the production site and rain waters (from paved non production
area) are discharged into a channel called Rozwójka (discharged point “1”) which also discharged into
the river Martwa Wisła (see below):
Figure 4 - Discharge points at Grupa LOTOS Facility
The different processes are summarized below.
Figure 5 - Concentrations of 1,2-DCA and DCM (μg · L-1) at different locations in the petrochemical
plant. Sampling points 1–3 are located at the dewaxing unit, whereas points 4–9 are at the WWTP.
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Table 8 - Description of sampling points and measured water temperature.
The monitoring of the EDC concentration in the effluents is showing the following results according
to the published results):
The inlets of the waste water treatment plant contains EDC up to few hundreds µg/L as well as
samples collected in drainage waters. No EDC concentration in the discharged waters were
determined.
The analytical technique performance and the sampling events are indicated below:
Analytical method DAI-GC-ECD (see reference 1)
Limit of quantification 1 µg/L
Limit of detection 0.33 µg/L
Blank concentration < LOD
Recovery 96%
Accuracy 3.90%
Reproducibility 5%
Sample collection 9 grab
Sampling frequency and pattern Every two weeks/once a month
In addition, there is a monitoring in place organised by the plant every month showing the same
results i.e. less than LOD with the same method as above.
Reference 1: Tobiszewski M., Namieśnik J. (2011); Determination of chlorinated solvents in industrial
water and wastewater by DAI-GC-ECD; Anal. Bioanal. Chem 399: 3565-3572.
Monitoring data of the concentration of EDC potentially released in the air phase
The potential release of EDC in the air phase in the vicinity of the industrial plant may be estimated
using modelling. It is anticipated that modelling may represent a worst case situation and in general
some default assumptions are used. However in order to refine and get more accurate data of the
concentrations of EDC following its potential release in the air phase, a monitoring program was set
up. Objective was to measure the concentration of EDC both in gaseous form and in the atmospheric
deposit.
Measurement set up
The following trapping agents were used:
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Atmospheric deposit: Bergerhoff gauges samples;
Gaseous concentration: Radiello passive tubes.
The analytical method is based on GC-MS methodology (see below for reference).
Reference text
Comment
Normative reference NF X43-014
« Determination of the total
atmospheric deposition »
Bergerhoff gauges samples
HS/GC/MS EDC analyses following NF ISO
11423-1 and NF EN ISO 10301
Internal method
Passive tubes sampling.
GC/MS EDC Analysis
Radiello passive tubes
Methodology
The sampling strategy was developed jointly between Grupa LOTOS, SOCOTEC and CEHTRA and
provides three sampling areas in residential areas. These areas are represented on the map below
(numbers 1, 2 and 3).
Three locations have been chosen up taken into account the wind directions (see below the wind
roses) i.e. mainly direction East and South and West of the production plant.
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Figure 6 - Design of the air sampling devices.
Each area has been equipped with 9 Bergerhoff gauges (3 gauges by 3 times repeated trials) and 3Radiello passive tubes.
Area / point number 1 2 3Point nameGPS Location 54°20’50,01’’ N /
18°42’46,86’’ E54°21’15,24’’ N /18°44’59,70’’ E
54°20’22,27’’ N /18°44’17’’ E
Figure 7 - The different sampling points of the setting up of the Bergerhoff and Radiello samplings.
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Results
Atmospheric depositions
Point number 1 2 3Point namePoint reference PT1-E1/E2/E3 PT2-E1/E2/E3 PT3-E1/E2/E3Exposure period from 26/10/2015 14:40 27/10/2015 09:40 26/10/2015 14:00to 10/11/2015 11:00 10/11/2015 10:15 10/11/2015 09:30Exposure time (days) 14,85 14,02 14,81Exposure surface (m²) 0,00622 0,00622 0,00622Average EDC amount collected (µg) <0,267 <0,275 <0,204Average exposure (µg/m²/day) <2,9 <3,2 <2,2
* All values are below the LOQ (calculated on the basis of 1 µg/L), no peak has been detected. As theLOD is 0.33µg/L, the average exposure used for risk assessment is therefore:
Point Number 1 2 3Average exposure (µg/m2/day) < LOD (0.966) < LOD (1.066) <LOD (0.733)
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Diffusive concentrations
Point number 1 2 3Point namePoint reference PT1-E1/E2/E3 PT2-E1/E2/E3 PT3-E1/E2/E3Exposure period from 26/10/2015 14:40 27/10/2015 09:40 26/10/2015 14:00to 10/11/2015 11:00 10/11/2015 10:15 10/11/2015 09:30Exposure time (days) 14,85 14,02 14,81Average concentration (µg/m3) <1,3 <1,4 <1,3
* All values are below the LOQ, no peak has been detected. The LOD is 0.43µg/m3
Point Number 1 2 3Average concentration(µg/m3)
< LOD (0.43) < LOD (0.43) <LOD (0.43)
Conclusion.The EDC collected in Bergerhoff gauges is very low, under limit of quantification and even limit ofdetection. Considering that collected EDC might have been evaporated from the gauges, the passivetubes positioned near gauges would have adsorbed this EDC in gaseous form.As concentrations of EDC on passive tubes are also low, it confirms that no detectable EDC depositoccurs during the 2 weeks campaign.We can conclude that diffusive EDC amount emitted by unit 1300 is so low that the EDC concentrationsin plant surrounding area (in selected sampling sites) were under limit of detection.
9.1.1.1.3. Releases.
There is in place an improvement plan in order to reduce (among others) the fugitive emission in theair phase. The table below is showing the mass balance of EDC per year.
Tonnes / year CommentEDC Tonnes involved per year : In the system there is ca. tonnes
of EDC, Annual amount used in thecirculation loop at a site continuousprocess corresponding to ca.tonnes/year.
EDC Tonnes purchased in 2015:
neutralisation: Based on calculationsolubilizing and corrosion(corrosion products FeCl3 from sediments)
It is estimated value every 4 years (the lastone comes from 2013)
in water before treatment Based on measurement (Tobiszewski M.,from 2010 to 2011.)
in water after treatment Based on measurement (Tobiszewski M.,from 2010 to 2011.)
into finished products estimation
in hydrocarbons slops estimationin air - fugitive emission estimation
– unpredictable sporadic incident This is estimated value which is still underdevelopment according to IMPROVEMENTPLAN.
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• comes from sporadic defected work of:rotary equipment single seals, controlvalve seals
• leakage that comes from corrosion indrum filters and pipelines
• leak at flanges• data t/y based on the emission
measured in 2002 year concerns theemission of EDC when the 1300 Unitwas in better technical condition
Table 9 - Local release rate of EDC in the different environmental compartments following its industrialuse at Grupa LOTOS facility.
Release Release factor estimationmethod
Explanation / Justification
Water ERC based Initial release factor: 100% (ERC 4)Initial local release rate: 42.82 kg/day (14 730 kg.year-1/344operating days)Final local release factor:Emission in water equivalent to 9.27 10-3 kg/dJustification: the above release factor is calculated using EUSES2.1.2 leading to a concentration of EDC in the STP effluents of0.33 µg/L
Air ERC based Initial release factor: 100% (ERC 4)Initial local release rate: 42.82 kg/dayFinal local release factor:Equivalent Emission in the air phase: 1.55 kg/dJustification: The release factor is back calculated using EUSESbased on measured concentration of 0.43 µg/m3 i.e. the LOD ofthe measured concentration in the air phase. The release factorbased on total deposition flux during the emission episode wouldlead to a higher concentration in air, what is not observed.
Soil ERC based Initial release factor: 5% (ERC 4)Final release factor: 0Local release rate: 0 kg/day. No release of contaminated sludgeonto agricultural soils.
Following the calculation of the theoretical release factors based on measured data, the potentialcontamination of the different environmental and biological media are calculated using EUSESsoftware.
The indirect exposure of the general population is assessed on two spatial scales: locally near a pointsource of the substance, and regionally using averaged concentrations over a larger area. In the localassessment, all food products are derived from the vicinity of one point source, in the regionalassessment, all food products are taken from the regional model and certainly represent a worst casesituation. These two scenarios (local and regional scale) are considered appropriate and conservativeenough for the first approach to indicate possible concern for further evaluation if necessary.
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Exposure via the environmental compartments.
The exposure concentrations of EDC related to the potential exposure of the general population
through environment is calculated with EUSES software (version 2.1.2).
The input values related to EDC and its physicochemical properties are extracted from the registration
dossier and from literature. These are summarized below:
Table 10 - EDC-physicochemical data, environmental properties and environmental partition
coefficients used as input values in EUSES software and related environmental partition coefficients.
End points Values Reference
Molecular weight 98.96 g/mol REACH Dossier
Melting point -35.35 °C REACH Dossier
Boiling point 83.6 °C REACH Dossier
Vapour pressure at 25°C 1.02 104 Pa REACH Dossier
Octanol-water partition coefficient 1.45 (log10) REACH Dossier
Water solubility at 25°C 7.9 103 mg/L REACH Dossier
Organic carbon-water partition
coefficient
33 L/kg Chiou, C.T., L.J. Peters, and V.H. Freed. 1979. A
physical concept of soil-water equilibria for non-
ionic organic compounds. Science. 206:831-832
Henry's law constant at 25 [oC] 128 Pa.m3.mol-1 Calculation
Bioconcentration factor for fish 2 Evaluated by the report: Intermedia Transfer
Factors for Contaminants found at Hazardous
Waste Sites DCA from Risk Science Program,
Univ. California, Dec. 1994.
Rate constant for abiotic degradation
in STP
0 Default value (EDC is not classified as
biodegradable)
Rate constant for hydrolysis in surface
water (DT50; 25°C)
1000 days (default
value)
Default.
Rate constant for photolysis in surface
water (DT50)
1000 days Default.
Total rate constant for degradation in
bulk surface water (DT50)
430 days Evaluated by the report: Intermedia Transfer
Factors for Contaminants found at Hazardous
Waste Sites DCA from Risk Science Program,
Univ. California, Dec. 1994.
Rate constant for degradation in air
(DT50)
41.9 days Simulated by AOP Program v.1.92.
Rate constant for biodegradation in
soil (DT50)
110 days Evaluated by the report: Intermedia Transfer
Factors for Contaminants found at Hazardous
Waste Sites DCA from Risk Science Program,
Univ. California, Dec 1994
Total rate constant for degradation in
bulk sediment
0 Used as default.
Table 11 - Set up of parameters used for risk assessment using EUSES.
Parameters Values Comments
Fraction of EU production volume for
region
20 % -
Fraction of EU Tonnage for region
(private use)
0% -
Fraction connected to sewer systems 100% -
STP: Mode of aeration Surface -
EC number:
203-458-1
1,2-dichloroethane CAS number:
107-06-2
Non-confidential version CHEMICAL SAFETY REPORT 49
Exposure in air and surface water.
The detailed calculation outcome is indicated in Appendix 5 and a summary is given hereafter.
The exposure concentrations calculated with EUSES are reported in the following tables with the
main results. The calculated concentration in air and in surface water is indicated below:
Predicted environmental concentration of EDC (PECs) in air and surface waters
Regional PEC in air (total): 2.59 10-08 mg/m3
Annual average local concentration in air, 100 m from point source: 3.97 10-04 mg/m3
Regional PEC in surface water (total): 7.4 10-09 mg/L
Annual average local PEC in surface water (dissolved): 3.32 10-05 mg/L
Exposure via drinking water.
There is no possibility to contaminate drinking water from the two discharged points:
- the ROZWÓJKA river which flows into the Martwa Wisła and
- the MARTWA WISŁA river, which is not a regular river – its waters are salty so it cannot be used
as drinking water.
Following emission in air of EDC, the re-deposition in soil in the form of aerosol bound or gaseous
form may occur. The deposition is calculated using the software OPS (included also in the EUSES
software) subsequently in the pore water (calculated by dividing the concentration in soil by the soil
adsorption coefficient).
The concentration of the tested substance in drinking water is estimated by the maximum of the
concentration in the soil pore water following re-deposition onto soil and the concentration in surface
waters. In the present case the highest calculated concentration is calculated from the concentration of
EDC in the soil pore waters.
The resulting calculated concentrations in soil and in waters are indicated below:
Regional PEC in agricultural soil (total): 9.1 10-10 mg/kg
Local concentration in agricultural soil over 180 days: 6.67 10-05 mg/kg
Regional PEC in pore water (agricultural soils): 1.29 10-09 mg/L
Local PEC in pore water of agricultural soil: 9.61 10-05 mg/L
Local PEC in groundwater under agricultural soil: 9.61 10-05 mg/L
Local concentration in drinking water: 9.61 10-05 mg/L
Exposure via food consumption.
Assessing concentrations in food products (in this context fish, leaf crops, root crops, meat and dairy
products) is based on the estimated bio-transfer from soil and air to plants. The major
physicochemical parameter impacting the concentration into the different media is the bio-
concentration value (BCF). EDC is typically a compound with low bioaccumulation potential and
secondary poisoning is excluded. Plant products form a major part of the food products for humans
and cattle. Contamination of plants will therefore have significant influence on the exposure of
humans.
EC number:
203-458-1
1,2-dichloroethane CAS number:
107-06-2
Non-confidential version CHEMICAL SAFETY REPORT 50
Total daily intake for the general population.
The total daily intake of humans can be estimated from the daily intake rate of each medium by
summing the contribution of each medium (drinking water, milk, meat, crops etc.) and using daily
human doses.
The following results are then obtained:
Daily human doses (LOCAL)
Daily dose through intake of drinking water 2.75 10-06 [mg.kg-1.d-1]
Daily dose through intake of fish 1.01 10-07 [mg.kg-1.d-1]
Daily dose through intake of leaf crops 3.37 10-07 [mg.kg-1.d-1]
Daily dose through intake of root crops 6.69 10-07 [mg.kg-1.d-1]
Daily dose through intake of meat 1.88 10-10 [mg.kg-1.d-1]
Daily dose through intake of milk 3.51 10-09 [mg.kg-1.d-1]
Daily dose through intake of air 1.13 10-04 [mg.kg-1.d-1]
Local total daily intake for humans 1.17 10-04 [mg.kg-1.d-1]
Daily human doses (REGIONAL)
Daily dose through intake of drinking water 1.06 10-10 [mg.kg-1.d-1]
Daily dose through intake of fish 2.43 10-11 [mg.kg-1.d-1]
Daily dose through intake of leaf crops 2.20 10-11 [mg.kg-1.d-1]
Daily dose through intake of root crops 9.01 10-12 [mg.kg-1.d-1]
Daily dose through intake of meat 1.18 10-14 [mg.kg-1.d-1]
Daily dose through intake of milk 2.20 10-13 [mg.kg-1.d-1]
Daily dose through intake of air 7.40 10-09 [mg.kg-1.d-1]
Regional total daily intake for humans 7.56 10-09 [mg.kg-1.d-1]
The main fraction of the daily intake is being represented on the local scale on the exposure to
contaminated air originating mainly from direct emission in the air phase.
Based on these values, the risk assessment can then be finalized using the toxicological end points of
EDC. Exposure to the general population via the environment is considered to be of low concern, for
the local and regional assessment when: - all Life Cancer Risks (LCRs) < 10-6.
The following risk assessment outcome is then obtained.
The exposure concentrations as calculated with EUSES 2.1.2 are reported in the following table
together with the risk assessment outcome.
Table 12 - Risk assessment of the potential contamination of the general population from the
environment.
Protection target Risk characterization local Risk characterization regional
Man via
EC number:
203-458-1
1,2-dichloroethane CAS number:
107-06-2
Non-confidential version CHEMICAL SAFETY REPORT 51
Protection target Risk characterization local Risk characterization regional
Environment –
Inhalation and total
exposure
CLR exposure via air = 1.37 10-06
CLR total exposure = 1.40 10-06
CLR exposure via air = 8.94 10-11
CLR total exposure = 9.07 10-11
CLR: Cancer life risk
Conclusion
From the measurements of the measured concentration in the air phase as well as the deposit over a
two weeks campaign, it is clear that the major contributor of the potential risk towards the general
population is the potential release in the air phase from the industrial production involving EDC at the
Grupa LOTOS site. Although in the present monitoring study of concentration of EDC in the air
phase no EDC peak was observed, risk assessment based on the limit of quantification is considered
as a worst case situation and an improvement of the analytical methods in terms of detection will
improve the results of the risk characterization.
EC number:
203-458-1
1,2-dichloroethane CAS number:
107-06-2
Non-confidential version CHEMICAL SAFETY REPORT 52
9.1.2. Worker contributing scenario 1: Production process including storage, transfers,
recycling, waste transfers (PROC 2).
As described in the introduction of chapter 9.0, the processes using EDC are closed systems without
direct handling of EDC by operators except during EDC sampling for QC (not covered by WCS1 but
covered by WCS2, see next chapter).
The contributing scenario WCS1 covered all phases where EDC is used or transferred in closed
system equipment: storage tank, crystallisation vessels, filters, distillation reactors, recovered EDC
storage tanks.
9.1.2.1. Conditions of use.
Product characteristics
• 1,2-dichloroethane – liquid
Amount used, frequency and duration of use/exposure
• The industrial sites are producing in continuous process, 24/24, all year (only 3 weeks every 4 years
maintenance break). As described below the processes using EDC are closed systems without direct handling
except during QC sampling (see WCS2).
Technical and organisational conditions and measures
• All equipment and processes from production units involving EDC is under closed systems. All of the
columns, vessels are equipped with the control systems i.e. level, pressure, temperature control devices. The
seals of the rotary equipment are mainly single but the process of replacing them with the double-axial face
seal with barrier fluid are under execution. The drained streams which contain EDC are collected in the close
drain vessel and are reprocessed in the unit. In case of emergency, the equipment is connected to the buffer
vessels located on the unit. The buffer vessels are under filtration gas blanket.
• Local exhaust ventilation: none
Conditions and measures related to personal protection, hygiene and health evaluation
• Dermal Protection: No (except during sampling for QC, see WCS2 below) - see material and justification in
chapter 9.0.9.2
• Respiratory Protection: none
Other conditions affecting workers exposure
• Place of use: Indoor (good general ventilation) and outdoor
•Trained and authorized person: General training on risks for chemical are given each years for all operators
involved in chemical handling. Specific trainings on chemical risk handling are given regularly to all plant
operators handling EDC. All tasks involving EDC handling are done by competent and authorized operators.
9.1.2.2. Exposure and risks for workers.
The WCS1 (PROC2) is covering a full shift operation (8 hours). The operator functions are described
below:
Employees working in the units using EDC = 15.
i.e. three operating positions per shift. Not the same operators are still working for the 1300 Unit.
It means that an annual exposure of EDC for every particular person can be less because of
operators rotation between all units of Lube Oil Complex. The value 15 operators is related to a
required operating positions.
Description of the shifts working in the unit using EDC :Those employees are in 5 teams (3 operators by team). Per day (24/24): Team1 = shift 1: 6:00 to 14:00;
Team2 = shift2: 14:00 to 22:00; Team3 = shift3: 22:00 to 6:00. Frequency of WCS1 = all year. The
tasks done by operators are facility supervision, control from the room panel control, visual control
EC number:
203-458-1
1,2-dichloroethane CAS number:
107-06-2
Non-confidential version CHEMICAL SAFETY REPORT 53
routines on unit.
Operators from this WCS1 are not the same operators working in WCS3 (unloading road tank), WCS4
(non-routine maintenance), WCS5 (general maintenance) and WCS6 (laboratory). Operators from
WCS1 are the same operators as those working in WCS2 (sampling for QC) – see chapter 10 for
combined exposure.
Inhalation exposure assessment.
As described in chapter 9.0.9.2, a specific measurement campaign has been conducted in October
2014 and October 2015 by an external certified laboratory, SOCOTEC Industries. A total of 10
measurements (6 in 2014, 4 in 2015) have been used for exposure calculation (see details in appendix
2). The 90th percentile result is 0.37 mg/m3 (recalculate on TWA 8h).
Other existing data: measured campaigns have been done in 2009, 2010 and 2013 by internal
laboratory (1 measured point every year). The results are: 2009, <5 mg/m3; 2010, <7.1 mg/m3, 2013,
<5 mg/m3 (EDC results on TWA 8h). Grupa LOTOS conclusions on those results are: “Since EDC
concentration is below 0.1 Highest Acceptable Level (Polish regulation) there is no necessity to do
further measurements according to Polish regulations. However Grupa LOTOS does such
measurements every 2-3 years.” Due to high LoQ (technical analyses not communicated), those
results can’t be taken into account in exposure calculation.
Dermal exposure assessment.
The dermal exposure will occur only during the QC sampling task (see WCS2 below).
No dermal exposure is expected during the other tasks in WCS1 (closed system).
Table 13 - Exposure concentrations and risks for workers.
Route of
exposure and
type of effects
Exposure concentration
(Time Weighted Average 8
hour exposure)
Correction factor
for frequency
Risk characterisation
Inhalation,
systemic, long-
term
0.37 mg/m3 **
(measured data 90th percentile, see
appendix 2)
Frequency: 1*
Excess cancer risk:
2.22 E-4
Dermal,
systemic, long-
term
- -
Combined routes,
systemic, long-
term
Excess cancer risk:
2.22 E-4
* Frequency: activity takes place on daily basis; correction factor = 1.
** no RPE used by operators.
Conclusion on risk characterisation
The derived excess cancer risks for systemic, long term effects due to inhalation and dermal contact
are considered to be the lowest achievable risks, following the minimisation principle described in
conditions of use and risk management measures of this contributing scenario.
EC number:
203-458-1
1,2-dichloroethane CAS number:
107-06-2
Non-confidential version CHEMICAL SAFETY REPORT 54
9.1.3. Worker contributing scenario 2: EDC sampling from quality control (PROC 8b).
9.1.3.1. Conditions of use.
Product characteristics
• 1,2-dichloroethane – liquid
Amount used, frequency and duration of use/exposure
• amount = 250 ml of 100% EDC per sampling.
• frequency = 1 per day.
• duration < 5 minutes.
Technical and organisational conditions and measures
• Containment: closed system – closed loop sampling
• Local exhaust ventilation: none
Conditions and measures related to personal protection, hygiene and health evaluation
• Dermal Protection: Yes (chemically resistant gloves KCl/ nitrile conforming to EN374 with specific activity
training) (Dermal: 95%) – see material and justification on page 20.
• Respiratory Protection: none
Other conditions affecting workers exposure
• Place of use: Outdoor
•Trained and authorized person: General training on risks for chemical are given each year for all operators
involved in chemical handling. Specific trainings on chemical risk handling are given regularly to all plant
operators handling EDC. All tasks involving EDC handling are done by competent and authorized operators.
Photo 7 – EDC Sampling.
Operator opens valves on the inlet and outlet of sampling bottle. When pressure on manometer no
longer increase, sampling bottle is full with mixture of solvents. Operator closes valves and
disconnects the bottle from the system. He leaves the sampling bottle in the box situated on the
entrance of the production unit, from where are taken by laboratory worker (sorter) to laboratory.
__________________________________________________________________________________
EC number:
203-458-1
1,2-dichloroethane CAS number:
107-06-2
Non-confidential version CHEMICAL SAFETY REPORT 55
9.1.3.2. Exposure and risks for workers.
The WCS2 is covering a specific operation of EDC sampling for quality control. A sampling of EDC
(100%) is done for quality control purposes at a frequency of 1 per day (24h). The location is outside.
250 ml of EDC are sampled in a sample cylinder from the closed loop sampling (vent and non-return
valves, flexible hoses with quick disconnect coupling for better operator safety) (closed sampling
process, see photo 7). After filling, the sample cylinder (hermetically closed) is sent to laboratory. The
sampling duration is less than 5 minutes.
Operators from this WCS2 are not the same operators working in WCS3 (unloading road tank),
WCS4 (non-routine maintenance), WCS5 (general maintenance) and WCS6 (laboratory).
Operators from WCS2 are same operators as those working in WCS1 – see chapter 10 for combined
exposure.
Inhalation exposure assessment.
During the 2014 and 2015 campaign (see WCS1), 6 measures were done during the specific QC
sampling task (see details in appendix 2). The 90th percentile result is 0.11 mg/m3 (recalculate on
TWA 8h). No respiratory protective equipment is used during the sampling task.
Dermal exposure assessment.
The dermal exposure will occur during the QC sampling task (1 per day, duration 5 min, flask 250 ml,
closed loop sampling, outside, gloves efficiency 95%).
Justification of Riskofderm inputs (see details in appendix 4, table 4.I): the most relevant Riskofderm
existing activity to cover sampling is “filling, mixing or loading”. “Rare contact” and “Light contact”
have been chosen because the operator is not in direct contact with EDC during sampling (closed loop
sampling) and there is no potential for splashing during this operation. The use rate is 0.1 l/min which
is representative of sampling flask operation. The duration is 5 minutes. The 90th percentile result is
4.53 E-3 mg/kg/d (using PPE 95% efficiency).
Table 14. Exposure concentrations and risks for workers.
Route of
exposure and
type of effects
Exposure concentration
(Time Weighted Average 8 hour
exposure)
Correction
factor for
frequency
Risk characterisation
Inhalation,
systemic, long-
term
0.11 mg/m3 **
(measured data 90th percentile, see
appendix 2)
Frequency: 0.33*
Excess cancer risk:
2.18 E-5
Dermal,
systemic, long-
term
4.53 E-3 mg/kg/d ***
(Riskofderm, 90th percentile)
Frequency: 0.33*
Excess cancer risk:
3.15 E-6
Combined routes,
systemic, long-
term
Excess cancer risk:
2.50 E-5
* Frequency: sampling task is one each 24 hours (all year). As there are 3 shifts per 24 hours, the frequency
correction factor is 0.33.
** no RPE used by operators
*** PPE used during the full task then 95% for dermal have been used to recalculate exposure (see justification
chapter 9.0.9.2)
Inputs data and results used in Riskofderm for dermal exposure calculation: see appendix 4.
EC number:
203-458-1
1,2-dichloroethane CAS number:
107-06-2
Non-confidential version CHEMICAL SAFETY REPORT 56
Conclusion on risk characterisation
The derived excess cancer risks for systemic, long term effects due to inhalation and dermal contact
are considered to be the lowest achievable risks, following the minimisation principle described in
conditions of use and risk management measures of this contributing scenario.
EC number:
203-458-1
1,2-dichloroethane CAS number:
107-06-2
Non-confidential version CHEMICAL SAFETY REPORT 57
9.1.4. Worker contributing scenario 3: Receive of EDC from rail tank (PROC 8b).
9.1.4.1. Conditions of use.
Product characteristics
• 1,2-dichloroethane – liquid Quantitative measures
Amount used, frequency and duration of use/exposure
• Every 2 years, tonnes of EDC are unloaded from rail tank to storage tank. The
complete duration of this operation is less than 3 hour. 2 operators are doing the
work which consists of:
- opening the manhole on the top of rail tank and taking a sample with a
dedicated cane. The flask of 200 ml is hermetically sealed after sampling
and sent to laboratory – sampling duration < 5mins.
- connecting the flexibles from road tank to storage tank (previously purged
with nitrogen gas) – duration 2 mins
- Visual control during unloading (far-off road tank, >20 m) - duration <
170mins
- Disconnecting the flexibles (previously purged with nitrogen gas – no
residual EDC expected) – duration 2 mins.
Technical and organisational conditions and measures
• Containment: fixed connection and hose steel connections. Fixed connection and
hose steel connections with gas offtake at a safe point / transfer to general vent gas
treatment system – no direct emission to atmosphere.
• Assurance of leak-proofness by leak test after establishing the connection and
complete capture of the residual quantities by inert gas into the flexibles
• Local exhaust ventilation: none
Conditions and measures related to personal protection, hygiene and health evaluation
• Dermal Protection: Yes (chemically resistant gloves KCl 890 / Fluorocaoutchouc
conforming to EN374 with specific activity training) (Dermal: 95%) – see material
and justification in chapter 9.0.9.2
• Respiratory Protection: Yes, full face mask A2B2E2K2HgP3 [Effectiveness
Inhal: 95%] during sampling and connection/disconnection.
Other conditions affecting workers exposure
• Place of use: Outdoor
•Trained and authorized person: Connection and transfer is done by employees
competent, trained and authorized for EDC unloading tank operations.
EC number:
203-458-1
1,2-dichloroethane CAS number:
107-06-2
Non-confidential version CHEMICAL SAFETY REPORT 58
Photo 8 – unloading EDC flexibles.
Photo 9 – Personal Protective Equipment during unloading operations.
9.1.4.2. Exposure and risks for workers.
The WCS3 is covering a specific operation of rail tank EDC unloading. WCS3 is done by unloading
operator team (frequency once every 2 years).The task covering WCS3 is done in less than 3 hours.
After an EDC unloading rail tank operation, the operator will no longer be exposed to EDC for the 4
remaining hours of the working day (in general in charge of other chemical unloading operations).
Operators from this WCS3 are not the same operators working in WCS1, WCS2, WCS4, WCS5 and
WCS6.
Inhalation exposure assessment.
As there is no measurement data regarding WCS3, a tier 2 model assessment approach using
Advanced Reach Tool (V1.5) has been used (see all details of ART inputs in appendix 3). In ART we
have used 3 activities (equivalent to operation phases during the task) to cover the complete task of
road tank unloading:
EC number:
203-458-1
1,2-dichloroethane CAS number:
107-06-2
Non-confidential version CHEMICAL SAFETY REPORT 59
- Activity 1 = sampling of EDC on rail tank – duration 5 mins.
- Activity 2 = connection/disconnection flexibles – duration 5 mins (total duration connecting
and disconnecting)
- Activity 3 = road tank unloaded – duration 170 mins.
(No exposure period = 300 min – other tasks during the day – no EDC).
Justification of inputs used in ART model:
Activity 1. Emission source located in the breathing zone of the worker. The activity class is transfer of
falling liquid with a flow of 0.1 to 1 l/min which is relevant for bottle sampling with a cane. Splash
loading has been chosen with no localised controls and no containment (worst case). The predicted 90th
percentile exposure during the 5 mins of activity 2 is 78 mg/m3 (result without PPE efficiency). The
exposure result considering PPE efficiency 95% will be 3.9 mg/m3 for activity 1.
Activity 2. Emission source located in the breathing zone of the worker. During this phase the
operator is connecting/disconnecting a flexible hose, and so handling of a contaminated object
is a more appropriate activity class in this case. The complete surface of connection of the
flexible is between 0.1 and 0.3 m2. As the flexible hoses are purged with nitrogen gas, the
ART input “contamination <10% of surface” is relevant. No localised controls and no
containment chosen in ART (worst case). The predicted 90th percentile exposure during the 5 mins of activity 2 is 26 mg/m3 (result without PPE
efficiency). The exposure result considering PPE efficiency 95% will be 1.3 mg/m3 for activity 2.
Activity 3. During this phase, the operator is far away from the road tank (>20 m). The ART
activity class is bottom loading with a 100-1000 l/min. The general control measures “vapour
recovery systems” has been chosen as there is gas offtake at a safe point / transfer to general
vent gas treatment system – no direct emission to atmosphere. The predicted 90th percentile exposure during the 170 mins of activity 2 is 1.7 mg/m3 (result without
PPE efficiency as no inhalation PPE used for activity 3).
The predicted 90th percentile exposure for the unloading road tank (activity 1, 2 and 3) of 180 min is:
(Expo act1 x t1 + Expo act2 x t2 + Expo act3 x t3)/(t1+t2+t3) = (3.9x5 + 1.3x5 + 1.7x170) / 180 =
1.75 mg/m3.
The predicted 90th percentile 8h based exposure result from ART is 0.66 mg/m3 for WCS3.
Dermal exposure assessment.
As described above there are three main phases during the unloading operation: sampling,
connecting/disconnecting of flexible hoses and unloading. We can consider that during the unload
phase there is no dermal exposure as the operator is only doing a visual inspection. Regarding
sampling and connecting/disconnecting flexible hose phases, the tier2 model Riskofderm has been
used for dermal exposure assessment. Justification of Riskofderm inputs (see details in appendix 4): Activity 1 – sampling rail tank from manhole. The most relevant Riskofderm existing activity to cover
sampling is “filling, mixing or loading”. “More than rare contact” and “more than light contact” have
been chosen because the operator is in direct contact with the sampling cane and there is potential for
splashing during this operation. The input “significant amounts of aerosols or splashes” is also chosen.
The use rate is 0.1 l/min witch is representative of sampling flask operation. The exposure duration is 5
minutes. The 90th percentile result of activity 1 is 0.14 mg/kg/d (using PPE 95% efficiency).
Activity 2 – connection/disconnection of flexible hoses. In Riskofderm model there is no specific
activity covering connection/disconnection of flexible hoses. From the 6 existing activity (filling-
mixing-loading, wiping, dispersion with hand tool, spraying, immersion, mechanical treatment),
“filling-mixing-loading” is the most relevant. As the flexible hoses are purged with nitrogen gas before
connecting or disconnecting operation, we can consider a use rate (“product handled per min”) of 0.05
l/min as worst case (covering the potential but not expected residual EDC). “Light contact” has been
chosen as the operator is handling purged flexible hoses. “More than rare contact” has been chosen as a
worst case situation. The input “no significant amounts of aerosols or splashes” also chosen as no
EC number:
203-458-1
1,2-dichloroethane CAS number:
107-06-2
Non-confidential version CHEMICAL SAFETY REPORT 60
splashes or aerosol expected due to nitrogen purge. The dermal exposure duration is 5 minutes
(potential dermal exposure only during connecting/disconnecting flexible hoses). The 90th percentile
result of activity 2 is 8.0 E-3 mg/kg/d (using PPE 95% efficiency).
The total dermal exposure (covering activity 1, 2 and 3) is: (0.14 + 8.0E-3) = 0.15 mg/kg/d (using
PPE 95% efficiency).
Table 15. Exposure concentrations and risks for workers.
Route of
exposure and
type of effects
Exposure concentration
(Time Weighted Average 8 hour
exposure)
Correction
factor for
frequency
Risk characterisation
Inhalation,
systemic, long-
term
0.66 mg/m3 **
(tier 2 ART model, 90th
percentile)
Frequency: 0.0021*
Excess cancer risk:
8.32 E-7
Dermal,
systemic, long-
term
0.15 mg/kg/d**
(Riskofderm, 90th percentile)
Frequency: 0. 0021*
Excess cancer risk:
6.61 E-7
Combined routes,
systemic, long-
term
Excess cancer risk:
1.49 E-6
* Frequency: activity takes place every 2 years (240d); correction factor = 0.0021
** PPE used during the full task then 95% efficiency for inhalation and 95% for dermal exposures have been
used to recalculate exposure (see justification chapter 9.0.9.2)
Input data and results used in Riskofderm for dermal exposure calculation: see appendix 4.
Conclusion on risk characterisation
The derived excess cancer risks for systemic, long term effects due to inhalation and dermal contact
are considered to be the lowest achievable risks, following the minimisation principle described in
conditions of use and risk management measures of this contributing scenario.
EC number:
203-458-1
1,2-dichloroethane CAS number:
107-06-2
Non-confidential version CHEMICAL SAFETY REPORT 61
9.1.5. Worker contributing scenario 4: Non routine maintenance and cleaning (PROC
8b).
This contributing scenario addresses non-routine equipment maintenance (e.g. small repairs, pump
dismantlement, filter change). These activities in general last no more than 15 minutes. They are
typically undertaken with a frequency of once per month as maximum.
9.1.5.1. Conditions of use.
Product characteristics
• 1,2-dichloroethane – liquid
Amount used, frequency and duration of use/exposure
• The non-routine maintenance frequency is around once per month.
Technical and organisational conditions and measures
Non-routine maintenance (= maintenance only in case of dysfunction of equipment (e.g. pump), on an
average of once a month): In case of equipment dysfunction or equipment change, operator from the plant unit
is in charge of connecting secondary equipment (e.g. pump) when relevant. These actions are on/off valve
actions. The unit operators are not authorized to dismantle equipment. This task will be done by maintenance
operators and as for general maintenance, the equipment is flashed and purged. The description of the
maintenance work to be accomplished as well as the specific risk management measures to follow are
described in a permit procedure. Personal Protective Equipment is mandatory (inhalation full mask
A2B2E2K2HgP3 and Chemical resistant gloves KCl 890 / Fluorocaoutchouc - see details page 20). If no
failure equipment detected, no cleaning or maintenance is done on equipment (except general maintenance).
• Local exhaust ventilation: none
Conditions and measures related to personal protection, hygiene and health evaluation
• Dermal Protection: Yes (chemically resistant gloves KCl 890 / Fluorocaoutchouc conforming to EN374 with
specific activity training) (Dermal: 95%) – see material and justification in chapter 9.0.9.2
• Respiratory Protection: Yes, full face mask A2B2E2K2HgP3 [Effectiveness Inhal: 95%]
Other conditions affecting workers exposure
• Place of use: Indoor – good general ventilation
•Trained and authorized persons: General training on risks for chemical are given each years for all operators
involved in chemical handling. Specific trainings on chemical risk handling are given regularly to all plant
operators handling EDC. All tasks involving EDC handling are done by competent and authorized operators.
Photo 10 – example of non-routine maintenance – seal replacement.
To take control valve to non-routine maintenance (for example seal replacement), mechanics unscrew six screws
on each flange (sign with red line) of the valve. Then mechanics clean the flange surface with brush and put the
new seal and recap the flange with screws. Possibility to contact with EDC is minimized by proper preparation
of control valve by operators according to internal procedures.
__________________________________________________________________________________________
EC number:
203-458-1
1,2-dichloroethane CAS number:
107-06-2
Non-confidential version CHEMICAL SAFETY REPORT 62
9.1.5.2. Exposure and risks for workers.
The WCS4 is covering a specific operation of non-routine maintenance. WCS4 is done by
maintenance operators. The maintenance duration is 15 minutes per day. The frequency is on an
average of once a month. Maintenance operators from WCS4 are not the same operators working in
WCS1, WCS2, WCS3 and WCS6, but they are the same operators as WCS5 (combined exposure
results in chapter 10).
Inhalation exposure assessment.
As there are no existing measurement data regarding non routine maintenance operations, a tier 2
model assessment approach using Advanced Reach Tool (V1.5) has been used (see all details of ART
inputs in appendix 3): in ART we have used 1 activity (equivalent to operation phases during the task)
to cover the complete task of maintenance:
o Activity 1 = maintenance – duration 15 mins (No exposure period = 465 mins)
Justification of inputs used in ART model: the ART input “main component” (50 to
90% EDC in the residual liquid) will be used to cover situations where the equipment
cannot be fully flushed. For maintenance operation it has to be considered that
emission source is located in the breathing zone of the worker (ART input). The
relevant activity description from ART for maintenance is handling of contaminated
objects with surface 1 to 3 m2 with a contamination of 10 to 90 % of surface (e.g.
dismantlement of pump equipment). No localised controls and no containment are
relevant ART inputs for maintenance operations. The small repair tasks of CS3 take
place in the production unit which correspond to large workroom.
The predicted 90th percentile full shift (8h) exposure result from ART is 33 mg/m3 (result without PPE
efficiency). The exposure result considering PPE efficiency 95% is 1.7 mg/m3.
Dermal exposure assessment.
The tier2 model Riskofderm has been used for dermal exposure assessment.
Justification of Riskofderm inputs (see details in appendix 4): in Riskofderm model there is no
specific activity covering maintenance operations. From the 6 existing activity (filling-mixing-
loading, wiping, dispersion with hand tool, spraying, immersion, mechanical treatment), “filling-
mixing-loading” is the more relevant for maintenance purpose. Also “More than rare contact” and
“more than light contact” have been chosen because the operator is in direct contact with the inside
part of the equipment. The input “significant amounts of aerosols or splashes” also chosen. As the CS
is covering small equipment maintenance the potential residual EDC handled rate will be less than 0.1
l/min (less than 1.5 litters of residual EDC handled during the 15 min task). The exposure duration is
15 minutes. The 90th percentile result is 4.05 E-1 mg/kg/d (using PPE 95% efficiency).
Table 16. Exposure concentrations and risks for workers.
Route of
exposure and
type of effects
Exposure concentration
(Time Weighted Average 8 hour
exposure)
Correction
factor for
frequency
Risk characterisation
Inhalation,
systemic, long-
term
1.7 mg/m3 **
(tier 2 ART model, 90th percentile)
Frequency: 0.05*
Excess cancer risk:
5.10 E-5
Dermal,
systemic, long-
term
4.05 E-1 mg/kg/d **
(Riskofderm, 90th percentile))
Frequency: 0.05*
Excess cancer risk:
4.26 E-5
EC number:
203-458-1
1,2-dichloroethane CAS number:
107-06-2
Non-confidential version CHEMICAL SAFETY REPORT 63
Combined routes,
systemic, long-
term
Excess cancer risk:
9.36 E-5
* Frequency: activity takes place once per month (12/240); correction factor = 0.05
** PPE used during the full task then 95% efficiency for inhalation and 95% for dermal exposure have been
used to recalculate exposure (see justification chapter 9.0.9.2)
Input data and results used in Riskofderm for dermal exposure calculation: see appendix 4.
Conclusion on risk characterisation
The derived excess cancer risks for systemic, long term effects due to inhalation and dermal contact are
considered to be the lowest achievable risks, following the minimisation principle described in conditions of use
and risk management measures of this contributing scenario.
EC number:
203-458-1
1,2-dichloroethane CAS number:
107-06-2
Non-confidential version CHEMICAL SAFETY REPORT 64
9.1.6. Worker contributing scenario 5: General maintenance and cleaning (PROC 8b).
This contributing scenario addresses annual large maintenance activities with full plant equipment
shut down.
9.1.6.1. Conditions of use.
Product characteristics
• 1,2-dichloroethane – liquid
Amount used, frequency and duration of use/exposure
• The general maintenance duration is 3 weeks every 4 years.
Technical and organisational conditions and measures
General maintenance: The general maintenance of equipment is done over 3 weeks every 4 years. Before any
equipment dismantling, the equipment is purged with solvent (DCM/EDC) until all wax is washed off. The
solvent is returned to the plant‘s feed (circulated in enclosed system). Then the equipment is purged with base
oil in order to bind and flush out solvent completely. The base oil used for purging is returned to the plant‘s
feed (circulated in enclosed system). The description of the maintenance work to do as well as the specific risk
management measure to follow are described in a permit procedure. Personal Protective Equipment is
mandatory (inhalation full mask A2B2E2K2HgP3 and Chemical resistant gloves KCl 890 / Fluorocaoutchouc
- see details page 20).
• Local exhaust ventilation: none
Conditions and measures related to personal protection, hygiene and health evaluation
• Dermal Protection: Yes (chemically resistant gloves KCl 890 / Fluorocaoutchouc conforming to EN374 with
specific activity training) (Dermal: 95%) – see material and justification in chapter 9.0.2.2
• • Respiratory Protection: Yes, full face mask A2B2E2K2HgP3 [Effectiveness Inhal: 95%]
Other conditions affecting workers exposure
• Place of use: Indoor (good general ventilation) or outdoor
•Trained and authorized person: General training on risks for chemical are given each years for all operators
involved in chemical handling. Specific trainings on chemical risk handling are given regularly to all plant
operators handling EDC. All tasks involving EDC handling are done by competent and authorized operators.
9.1.6.2. Exposure and risks for workers
The WCS5 is covering a specific operation of general maintenance. WCS5 is done by maintenance
operators. The maintenance duration is 1 to 6 hours maximum per day (the maximum duration of 6 h
will be used in exposure assessment as worst case). The general maintenance equipment is done over
3 weeks every 4 years (equivalent to 3.8 days per year = frequency of 0.016).
Maintenance operators from WCS5 are not the same operators working in WCS1, WCS2, WCS3 and
WCS6, but they are the same operators than WCS4 (combined exposure results in chapter 10).
Inhalation exposure assessment.
As there is no existing measurement data regarding maintenance operations, a tier 2 model assessment
approach using Advanced Reach Tool (V1.5) has been used (see all details of ART inputs in appendix
3): in ART we have used 1 activity (equivalent to operation phases during the task) to cover the
complete task of maintenance:
o Activity 1 = maintenance – duration 360 mins (No exposure period = 120 mins)
Justification of inputs used in ART model: as before any dismantling, the equipment is fully
flushed and purged, the potential residual EDC will be extremely small (0.1 to 0.5 % - in the
equipment, residual % of EDC in the waste resulting from flushed and purged operation) (ART
input). For maintenance operation it has to be considered that emission source is located in the
breathing zone of the worker (ART input). The relevant activity description from ART for
EC number:
203-458-1
1,2-dichloroethane CAS number:
107-06-2
Non-confidential version CHEMICAL SAFETY REPORT 65
maintenance is handling of contaminated objects with surface > 3 m2 with a contamination of 10
to 90 % of surface (e.g. opening equipment for vessel inspection). No localised controls and no
containment are relevant ART inputs for maintenance operations. Any size workrooms ART
input has been chosen to cover all workroom size cases.
The predicted 90th percentile full shift (8h) exposure result from ART is 22 mg/m3 (result without PPE
efficiency). The exposure result considering PPE efficiency 95% is 1.10 mg/m3.
Dermal exposure assessment.
The tier2 model Riskofderm has been used for dermal exposure assessment.
Justification of Riskofderm inputs (see details in appendix 4): in Riskofderm model there is no
specific activity covering maintenance operations. From the 6 existing activity (filling-mixing-
loading, wiping, dispersion with hand tool, spraying, immersion, mechanical treatment), “filling-
mixing-loading” is the more relevant for maintenance purpose. Also “More than rare contact” and
“more than light contact” have been chosen because the operator is in direct contact with the inside
part of the equipment. The input “significant amounts of aerosols or splashes” also chosen. As the
equipment is flushed before any dismantlement or handling, we can consider a use rate (“product
handled per min”) of 0.05 l/min of EDC as relevant (covering the potential but not expected residual
EDC).
Duration used in Riskofderm: as formerly described, the full equipment is purged and flushed prior
maintenance campaign. 2 equipment are opened per shift during maintenance operation. Due to the
vapour pressure of EDC, dermal exposure could not exceed 2min per opened equipment (estimated
time for EDC to evaporate) in a worst case situation where release of EDC is present in the equipment
after purge and flush (not expected). Considering that only part of the equipment is in contact with
EDC and could lead to dermal exposure, a maximum of 4 minutes of dermal exposure per day is
considered for the assessment of WCS5 dermal exposure as a worst case duration (2min / equipment -
2 equipment opened per day max).
The 90th percentile (see justification in chapter 9.0) result is 5.70 E-2 mg/kg/d (using PPE 95%
efficiency).
Table 17. Exposure concentrations and risks for workers.
Route of
exposure and
type of effects
Exposure concentration
(Time Weighted Average 8 hour
exposure)
Correction
factor for
frequency
Risk characterisation
Inhalation,
systemic, long-
term
1.10 mg/m3 **
(tier 2 ART model, 90th percentile)
Frequency: 0.022*
Excess cancer risk:
1.45 E-5
Dermal,
systemic, long-
term
5.70 E-2 mg/kg/d **
(Riskofderm, 90th percentile))
Frequency: 0.022*
Excess cancer risk:
2.63 E-6
Combined routes,
systemic, long-
term
Excess cancer risk:
1.71 E-5
* Frequency: activity takes place 21 days every 4 years; correction factor = 0.022
** PPE used during the full task then 95% efficiency for inhalation and 95% for dermal have been used to
recalculate exposure (see justification chapter 9.0.9.2)
Inputs data and results used in Riskofderm for dermal exposure calculation: see appendix 4.
EC number:
203-458-1
1,2-dichloroethane CAS number:
107-06-2
Non-confidential version CHEMICAL SAFETY REPORT 66
Conclusion on risk characterisation
The derived excess cancer risks for systemic, long term effects due to inhalation and dermal contact are
considered to be the lowest achievable risks, following the minimisation principle described in conditions of use
and risk management measures of this contributing scenario.
EC number:
203-458-1
1,2-dichloroethane CAS number:
107-06-2
Non-confidential version CHEMICAL SAFETY REPORT 67
9.1.7. Worker contributing scenario 6: Laboratory quality control (PROC 15).
9.1.7.1. Conditions of use.
Product characteristics
• 1,2-dichloroethane – liquid
Amount used, frequency and duration of use/exposure
• The EDC sampled (see WCS2) is analysed for quality control purpose at the service laboratory. This
operation is done every day (1 sample), duration <20 mins. All handling EDC samples are done under fume
cupboard. This equipment is certified and controlled each year.
Technical and organisational conditions and measures
• Local exhaust ventilation: Yes- All handling EDC samples are done under fume cupboard. This equipment is
certified and controlled each year.
Conditions and measures related to personal protection, hygiene and health evaluation
• Dermal Protection: Yes (chemically resistant gloves KCl/ nitrile conforming to EN374 with specific activity
training) (Dermal: 95%) – see material and justification in chapter 9.0.9.2
• Respiratory Protection: No
Other conditions affecting workers exposure
• Place of use: Indoor – good general ventilation
•Trained and authorized person: General training on risks for chemical are given each years for all operators.
Specific trainings on chemical risk handling are given regularly to all laboratory operators handling EDC. All
tasks involving EDC handling are done by competent and authorized operators.
9.1.7.2. Exposure and risks for workers.
The WCS6 is covering a specific operation of laboratory quality control. This operation is done once a
day (1 sample each 24 h, < 250 ml). The complete duration is less than 20 minutes. Since 2015, the
number of analysed parameters in the laboratory has been changed. The analysis of turbidity is no
longer carried out which brings the laboratory task involving EDC to less than 20 minutes instead of
several hours before 2015. WCS6 is done by laboratory operators (38 employees in total, only 1
operator involved during a WCS6 operation).
Laboratory operators from WCS6 are not the same operators working in WCS1, WCS2, WCS3,
WCS4 and WCS5.
Inhalation exposure assessment.
During the 2014 and 2015 campaign, 6 measures have been done during the specific laboratory QC
task by an external certified laboratory, SOCOTEC Industries (see details in appendix 2). The 90th
percentile result is 0.53 mg/m3 (recalculate on TWA 8h) (no RPE used during the task).
Dermal exposure assessment.
The tier2 model Riskofderm has been used for dermal exposure assessment.
Justification of Riskofderm inputs (see details in appendix 4): the most relevant Riskofderm existing
activity to cover laboratory activity is “filling, mixing or loading”. “Rare contact” has been chosen as
the operator is not in direct contact with the substance (flask handling). “more than light contact” have
been chosen to cover the potential splashes during this operation (worst case). But as the operation is
done in laboratory, the input “significant amounts of aerosols or splashes” has not been chosen (no).
The use rate is 0.1 l/min which is representative of laboratory operation. The duration is 20 minutes.
The 90th percentile result is 0.05 mg/kg/d (using PPE 95% efficiency).
EC number:
203-458-1
1,2-dichloroethane CAS number:
107-06-2
Non-confidential version CHEMICAL SAFETY REPORT 68
Table 18. Exposure concentrations and risks for workers.
Route of
exposure and
type of effects
Exposure concentration
(Time Weighted Average 8 hour
exposure)
Correction
factor for
frequency
Risk characterisation
Inhalation,
systemic, long-
term
0.53 mg/m3 **
(measures data, 90th percentile)
Frequency*: 1 Excess cancer risk:
3.18 E-4
Dermal,
systemic, long-
term
0.05 mg/kg/d ***
(Riskofderm, 90th percentile))
Frequency*: 1 Excess cancer risk:
1.05 E-4
Combined routes,
systemic, long-
term
Excess cancer risk:
4.23 E-4
* Frequency: activity takes place on daily basis; correction factor = 1.
** no RPE used during the task
*** PPE 95% for dermal have been used to recalculate exposure (see justification chapter 9.0.2.2)
Inputs data and results used in Riskofderm for dermal exposure calculation: see appendix 4.
Conclusion on risk characterisation
The derived excess cancer risks for systemic, long term effects due to inhalation and dermal contact
are considered to be the lowest achievable risks, following the minimisation principle described in
conditions of use and risk management measures of this contributing scenario.
EC number:
203-458-1
1,2-dichloroethane CAS number:
107-06-2
Non-confidential version CHEMICAL SAFETY REPORT 69
10. RISK CHARACTERISATION RELATED TO
COMBINED EXPOSURE.
10.1. Human health
10.1.1. Workers WCS1 and WCS2.
As described in chapter 9, there is combined exposure resulting from worker activities from WCS1
“production process” and WCS2 “EDC sampling for QC” (same operators).
Route of exposure and type of effects Risk characterisation
Inhalation, systemic, long-term for WCS1 Excess cancer risk for WCS1:
2.22 E-4
Dermal, systemic, long-term for WCS1 Excess cancer risk for WCS1:
-
Combined routes, systemic, long-term for WCS1 Excess cancer risk for WCS1:
2.22 E-4
Inhalation, systemic, long-term for WCS2
Excess cancer risk for WCS2:
2.18 E-5
Dermal, systemic, long-term for WCS2 Excess cancer risk for WCS2:
3.15 E-6
Combined routes, systemic, long-term for WCS2 Excess cancer risk for WCS2:
2.50 E-5
Combined routes, systemic, long-term for
WCS1 and WCS2
Excess cancer risk for WCS1 and WCS2:
2.47 E-4
EC number:
203-458-1
1,2-dichloroethane CAS number:
107-06-2
Non-confidential version CHEMICAL SAFETY REPORT 70
10.1.2. Workers WCS4 and WCS5.
As described in chapter 9, there is combined exposure resulting from worker activities from WCS4
“non-routine maintenance and cleaning” and WCS5 “general maintenance and cleaning” (same
maintenance operators).
Route of exposure and type of effects Risk characterisation
Inhalation, systemic, long-term for WCS4 Excess cancer risk for WCS4:
5.10 E-5 Dermal, systemic, long-term for WCS4 Excess cancer risk for WCS4:
4.26 E-5
Combined routes, systemic, long-term for WCS4 Excess cancer risk for WCS4:
9.36 E-5
Inhalation, systemic, long-term for WCS5 Excess cancer risk for WCS5:
1.45 E-5 Dermal, systemic, long-term for WCS5 Excess cancer risk for WCS5:
2.63 E-6
Combined routes, systemic, long-term for WCS5 Excess cancer risk for WCS5:
1.71 E-5
Combined routes, systemic, long-term for
WCS4 and WCS5
Excess cancer risk for WCS4 and WCS5:
1.11 E-4
10.1.3. Consumer.
Not applicable, as there is no consumer related use for the substance.
EC number:
203-458-1
1,2-dichloroethane CAS number:
107-06-2
Non-confidential version CHEMICAL SAFETY REPORT 71
10.2. Environment (combined for all emission sources)
Environment
Not relevant.
Man via environment
The risk assessment of man via the environment is mainly based on the potential exposure of the
general population via air as well as indirect oral exposure through consumption of drinking water
and/or various crops/food potentially contaminated with EDC following its industrial emission at
Grupa LOTOS industrial facility. Local and regional risk assessment were conducted so to ensure
all potential emissions are taken into account. (See table below).
Regional exposure to man via environment
Route Regional exposure Risk characterisation
Inhalation 2.59 10-08 mg/m3 Excess of risk 8.94 10-11
Combined routes 7.56 10-09 mg/kg/d Excess of risk 9.07 10-11