Formol liquide fds 01122010 - Cadilhac · FORMOL Date15/05/2011; Revision 01 SDS: 2-111 page 3 of 95 P271: Use only outdoors or in a well-ventilated area

FORMOL

Date15/05/2011; Revision 01 SDS: 2-111 page 1 of 95

Safety Data Sheet

According to REACH Regulation (1907/2006/EC) and Regulation (EU) 453/2010

Date of issue: 01-12-2010 Revision: 01

SECTION 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE COMPANY/UNDERTAKING

1.1. Product identifier

Name: Formol (Formaldehyde aqueous solution)

Index number under Regulation (EC) No 1272/2008 on classification, labelling and packaging: 605-001-00-5.

CAS Number: 50-00-0

REACH Registration number: 01-2119488953-20-0038

Methanol:

Index number under Regulation (EC) No 1272/2008 on classification, labelling and packaging: 603-001-00-X

CAS Number: 67-56-1

REACH Registration number: 01-2119433307-44-0061

1.2. Relevant identified uses of the substance or mixture and uses advised against

Identified uses:

Starting product for the Chemical Industry

Uses advised against:

There are no uses advised against providing that the instructions described in this Safety Data Sheet are observed.

1.3. Details of the supplier of the safety data sheet

Manufacturer, importer o distributor: Manufacturer.

Name: ERCROS S.A.

Group: ERCROS S.A. Full address: Avda. Diagonal 595

08014 Barcelona - Spain

Telephone number: +34 934 393 009 Fax:+34 934 308 073

e-mail address for the competent person responsible for the safety data sheet: [email protected]

1.4. Emergency telephone number

Manufacturing plants:

Tortosa: Tel: +34 977 454 022 Fax: +34 977 597 101

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Almussafes: Tel:+34 961 782 250 Fax +34 961 784 055

UK National Poisons Emergency number: 0870 600 6266

SECTION 2. HAZARDS IDENTIFICATION

2.1. Classification of the substance or mixture

Classification according to Regulation (EC) No 1272/2008 on classification, labeling and packaging:

Carcinogenicity: Category 2, H351.

Acute toxicity (oral): Category 3, H301.

Acute toxicity (dermal): Category 3, H311.

Acute toxicity (inhal.): Category 3, H331.

Skin corrosion: Category 1B, H314.

Sensitisation — Skin: Category 1, H317.

Specific target organ toxicity — Single exposure: Hazard Category 3, H335.

H351: Suspected of causing cancer.

H301: Toxic if swallowed.

H311: Toxic in contact with skin.

H331: Toxic if inhaled.

H314: Causes severe skin burns and eye damage.

H317: May cause an allergic skin reaction.

H335: May cause respiratory irritation.

Classification according to Directive 67/548/EEC or 1999/45/EC:

C; R34: Causes burns.

T; R23/24/25: Toxic by inhalation, in contact with skin and if swallowed.

Xi; R43: May cause sensitisation by skin contact.

Carc. Cat.3; R40: Limited evidence of a carcinogenic effect.

2.2. Label elements

DANGER

H351: Suspected of causing cancer.

H301: Toxic if swallowed.

H311: Toxic in contact with skin.

H331: Toxic if inhaled.

H314: Causes severe skin burns and eye damage.

H317: May cause an allergic skin reaction.

H335: May cause respiratory irritation.

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P271: Use only outdoors or in a well-ventilated area.

P280: Wear protective gloves/protective clothing/eye protection/face protection.

P310: Immediately call a POISON CENTER or doctor/physician.

P301 + P330 + P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting.

P303 + P361 + P353: IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin with

water/shower.

P304 + P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.

P305 + P351 + P338: IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to

do. Continue rinsing.

P403+233 Store in a well-ventilated place. Keep container tightly closed.

2.3. Other hazards

The substance does not meet the criteria for PBT or vPvB (see section 12).

PHYSICOCHEMICAL HAZARDS:

For evaporation it can reach rapidly a harmful concentration in the air.

SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS

3.1 Mixture

Name: Formaldehyde (aqueous solution)

CAS number: 50-00-0

EC number: 200-001-8

IUPAC name: Formaldehyde

Index number under Regulation (EC) No 1272/2008 on classification, labelling and packaging: 605-001-00-5.

Composition: Index

number

under

Regulation

(EC) No

1272/2008

EC No CAS No Name Concentration Classification

according to

Directive

67/548/EEC

Classification according to

Regulation (EC) No 1272/2008

Specific

concentration

limits

605-001-00-5 200-001-8 50-00-0 Formaldehyde 25-51%

Carc. Cat. 3;

R40 T; R23/24/25

C; R34

R43

Acute Tox.–oral: Cat. 3, H301.

Acute Tox.–dermal: Cat. 3, H311.

Acute Tox.–inhal.: Cat. 3, H331.

Skin Corr. 1B, H314. Skin Sens. 1, H317.

Carc. Cat. 2, H351.

Skin Corr. 1B;

H314: C ≥25 % Skin Irrit. 2; H315:

5 % ≤ C < 25 %

Eye Irrit. 2; H319: 5 % ≤ C < 25 %

STOT SE 3; H335:

C ≥ 5 % Skin Sens. 1; H317:

C ≥ 0,2 %

603-001-00-X 200-659-6 67-56-1 Methanol < 3% F; R11 T; R23/24/25-

39/23/24/25

Flam. Liq. 2, H225 Acute Tox. 3, H331

Acute Tox. 3, H311

Acute Tox. 3, H301 STOT SE 1, H370

STOT SE 1; H370: C ≥ 10 %

STOT SE 2; H371:

3 % ≤ C < 10 %

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SECTION 4. FIRST AID MEASURES

4.1. Description of first aid measures

4.1.1. General information:

Showers and safety eye washes, for use in the event of spraying.

4.1.2. In case of inhalation:

Transfer patient to fresh air. In severe cases apply oxygen if available. Seek medical advice.

4.1.3. After skin contact:

Wash repeatedly with plenty of water. If there is irritation, seek medical advice.

4.1.4. After eye contact:

Wash plenty of water for 10-15 minutes. Seek medical advice.

4.1.5. In case of ingestion:

If patient is conscious, give him plenty of water and induce vomiting. Seek medical advice.

4.1.6. Recommended personal protective equipment for first aid responders:

If there is no fire use the equipment recommended in section 8.2.2. If there is fire, follow the recommendations of section 5.3

4.2 Most important symptoms and effects, both acute and delayed Inhalation: May irritate the mucous membranes of the respiratory tracts, cough, bronchitis and mucosity.

Skin contact: Skin dermatitis is produced as a consequence of skin sensitivity to formaldehyde and subsequent irritant action at

low formaldehyde concentration.

Eye contact: Ocular exposure to formaldehyde vapors produces irritation and lacrimation.

Ingestion: Irritation to the mucus membranes of the digestive tract. Possible loss of consciousness.

4.3. Indication of any immediate medical attention and special treatment needed

Need of immediate medical attention.

SECTION 5. FIREFIGHTING MEASURES

5.1. Extinguishing media

Suitable extinguishing media:

Water, CO2, Foam or Dry Chemical Powder.

Use water spray to cool fire-exposed containers.

Unsuitable extinguishing media:

Not applicable.

5.2. Special hazards arising from the substance or mixture

Not applicable.

5.3. Advice for firefighters

Self-breathing equipment is recommended in case of important fire, due to the risk of combustion gases (carbon monoxide) and

formaldehyde vapors.

SECTION 6. ACCIDENTAL RELEASE MEASURES

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6.1. Personal precautions, protective equipment and emergency procedures

Wear protective equipment, goggles, gloves and masks with chemical filter. Avoid ignition sources.

6.2. Environmental precautions

Prevent spilled liquid from entering the sewer and closed areas. Advise the competent authorities, treatment plant operators and

other users of downstream waters that water may be contaminated.

6.3. Methods and material for containment and cleaning up

If possible, pump the spilled liquid to suitable containers. Alternatively, cover non-transferable product with a porous, inert

material (sand, sawdust, etc.) and transfer it to a closed container. If recycling is not possible, best disposal method is total

incineration.

6.4. Reference to other sections

See protection measures in section 8.

SECTION 7. HANDLING AND STORAGE

7.1. Precautions for safe handling

The relevant regulation on protection against risk of chemical agents in the working place must be taken into account. Do not eat,

drink or smoke during handling. Use in well ventilated places, and if it is possible with a located ventilation system.

Protection against fire and explosion: Take precautionary measures against static discharges. Vapours may form explosive

mixture with air. Keep away from sources of ignition - No smoking

Provide extinguishing media at hand, as well as eye and skin washing facilities. Staff handling the product should always use

protective garments as recommended in Section 8.

7.2. Conditions for safe storage, including any incompatibilities

Recommended materials: Stainless steel is the most suitable material for storage tanks. Epoxy-resin overlaid steel and

polyethyelene containers can also be used.

Incompatible materials: Metallic container.

Storage conditions: Well-closed containers, protected from the light and in well ventilated places.

Temperature and Humidity range/limit:

Formol %(w/w) Tª mín

30 25

37 35

45 50

50 55

Special conditions: Product must be kept away from heat, sparks, open flames or other sources of ignition.

Applicable regulations: The relevant regulation on chemicals products storage must be taken into account.

7.3. Specific end use(s)

Reacts with many substances like urea, phenol, melamine and polyacetals, to form synthetic polymerized resins.

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SECTION 8. EXPOSURE CONTROLS/PERSONAL PROTECTION

8.1. Control parameters

Formaldehyde:

VLA-EC- 0.3 ppm , 0.37 mg / m3. (INSHT, Spain).

TLV-STEL 0.3 ppm , 0.37 mg / m3

. (ACGIH ).

MAK/2002 0.3 ppm , 0.37 mg / m3

Long term exposure limit (8 h): 2 ppm, 2.5 mg/ m3

WEL (UK)

Acute exposure limit (15 min.): 2 ppm, 2.5 mg/ m3 WEL (UK)

Human exposure:

For workers:

DNEL (Acute - local effects): 1 mg/m3 (inhalation)

DNEL (Long term - systemic effects): 240 mg/kg bw/day (dermal; repeated dose toxicity)

DNEL (Long term - systemic effects): 9 mg/m³ (inhalation; repeated dose toxicity)

DNEL (Long term - local effects): 37 µg/cm2 (dermal)

DNEL (Long term - local effects): 0.5 mg/m³ (inhalation)

For general population:

DNEL (Long term - systemic effects): 102 mg/kg bw/day (dermal; repeated dose toxicity)

DNEL (Long term - systemic effects): 3.2 mg/m³ (inhalation; repeated dose toxicity)

DNEL (Long term - systemic effects): 4.1 mg/kg bw/day (oral; repeated dose toxicity)

DNEL (Long term - local effects): 12 µg/cm2 (dermal)

DNEL (Long term - local effects): 0.1 mg/m³ (inhalation)

Environment:

PNEC (freshwater): 0.47 mg/L (based on statistical extrapolation and assessment factor 10).

PNEC (marine water): 0.47 mg/L (based on toxicity value 4.7 mg/L and assessment factor 10).

PNEC (water, intermittent releases): 4.7 mg/L (based on toxicity value 4.7 mg/L and assessment factor 1).

PNEC (sediment): 2.44 mg/kg dw (partition coefficient method)

PNEC (sediment, marine water): 2.44 mg/kg dw (partition coefficient method)

PNEC (soil): 0.21 mg/kg dw(partition coefficient method)

PNEC (sewage treatment plant): 0.19 mg/L (based on effect concentration EC50 (3 h): 19 mg/L and assessment factor 100).

Methanol:

VLA-ED (Valor Límite Ambiental-Exposición Diaria): 200 ppm, 266 mg / m3 (Spain)

TLV-STEL 250 ppm (ACGIH 2006).

WEL-Limit value - Eight hours: 200 ppm, 266 mg/m3 (UK)

WEL-Limit value - Short term: 250 ppm, 333 mg/m3 (UK)

For workers:

DNEL (Acute/Long term - systemic effects): 40 mg/kg bw/day (dermal; acute toxicity)

DNEL (Acute/Long term - systemic effects): 260 mg/m3 (inhalation; acute toxicity)

DNEL (Acute/Long term - local effects): 260 mg/m3 (inhalation; acute toxicity)

For general population:

DNEL (Acute/Long term - systemic effects): 8 mg/kg bw/day (dermal; acute toxicity)

DNEL (Acute/Long term - systemic effects): 50 mg/m3 (inhalation; acute toxicity)

DNEL (Acute/Long term - systemic effects): 8 mg/kg bw/day (oral; acute toxicity)

DNEL (Acute/Long term - local effects): 50 mg/m3 (inhalation; acute toxicity)

Environment:

PNEC (freshwater): 154 mg/L (based on the lowest aquatic toxicity value 96-h LC50 fish = 15400 mg/l and assessment factor

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100).

PNEC (marine water): 15.4 mg/L (based on the lowest aquatic toxicity value 96-h LC50 fish = 15400 mg/l and assessment factor

1000).

PNEC (water, intermittent releases): 1540 mg/L (based on the lowest aquatic toxicity value 96-h LC50 fish = 15400 mg/l and

assessment factor 10).

PNEC (sediment): 570.4 mg/kg dw (equilibrium partition method)

PNEC (soil): 23.5 mg/kg dw (equilibrium partition method)

PNEC (sewage treatment plant): 100 mg/L (based on the lowest effect concentration for micro-organisms toxicity IC50 > 1000

mg/L and assessment factor 10).

8.2. Exposure controls

8.2.1. Appropriate engineering controls

An assessment must be performed and organizational measures and collective and individual protective devices employed in order

to reduce exposure.

8.2.2. Individual protection measures, such as personal protective equipment

Respiratory protection:

Use protective mask provided with AB chemical filter (EN 143 et EN 14387).

Hand protection:

Use neoprene or rubber gloves (EN 374).

Eye protection:

Use safety goggles as airtight as possible (EN 166).

Skin proteciton:

Use full working clothing, EPI Category III (EN 340).

8.2.3. Environmental exposure controls

Take into account the regulations for the protection of the environment.

SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES

9.1. Information on basic physical and chemical properties

Appearance (physical state and colour): Colourless liquid free from suspended matter

Odour: Characteristic pungent.

Odour threshold: No data available.

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pH: Aprox. 4

Melting point/freezing point: No data available.

Initial boiling point and boiling range: Between 96.7 and 101.1 ºC

Flash point: 50 ºC with 15% methanol

85 ºC with 0% methanol

Flammability (solid, gas): Not applicable for liquids.

Upper/lower flammability or explosive limits:

Formaldehyde:

Lower limit 7.0 vol%

Upper limit 73 vol%

Methanol:

Lower limit 7.3 vol%

Upper limit 36 vol%

Explosive properties: There are no chemical groups associated with explosive

properties present in the molecule

Oxidising properties: The substance is incapable of reacting exothermically with

combustible materials.

Vapour pressure: 1 at 1.3 mmHg at 20 ºC

Relative density: Aprox. 1.14 g/cm3 at 20 ºC

Solubility: Soluble in acetone, alcohol, benzene, chloroform and ether

at all rates.

Water solubility: Soluble in water.

Partition coefficient: n-octanol/water:

Formaldehyde:

0.35 at 25°C

Methanol:

- 0.77

Viscosity:

η(mPA·s)= 1.28+0.039F+0.05M-0.024T

F: Concentration Formol 25% to 50%

M: Concentration Methanol 0% to 13%

T: Temperature 25ºC to 40ºC

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Vapour density: 1.03 (air=1)

Evaporation rate: No data available.

Auto-ignition temperature:

Formaldehyde:

430 °C at 1013 hPa

Methanol:

455°C at 1013 hPa

Decomposition temperature: No data available.

9.2. Other information

Organic peroxide: Not classified (based on structure)

Self-heating: Based on the available data, the classification criteria are not met.

Pyrophoric liquid/solid: Based on the available data, the classification criteria are not met.

Corrosive to metals: No data available.

Substance which in contact with water emits flammable gases: Based on the available data, the classification criteria are not

met.

SECTION 10. STABILITY AND REACTIVITY

10.1. Reactivity

Reacts with strong oxidizing agents.

10.2. Chemical stability

At the above mentioned concentrations, formaldehyde is a stable substance. Its polimerization is not dangerous. It may polymerize

at low temperatures (T<20ºC).

10.3. Possibility of hazardous reactions

May react violently with oxidizing agents.

10.4. Conditions to avoid

Storage temperatures over 50ºC, sparks and flames.

Temperatures lower than 20ºC. It may polymerize.

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10.5. Incompatible materials

Sodium hydroxide and other alkalis, acids, amines, phenols, oxygen, hydrogen peroxide, and strong oxidant agents in general.

Also reacts with copper, iron and silver salts.

10.6. Hazardous decomposition products

Combustion: carbon monoxide.

Thermal descomposition: formaldehyde gas.

SECTION 11. TOXICOLOGICAL INFORMATION

11.1. Information on toxicological effects:

11.2. acute effects (acute toxicity, irritation and corrosivity):

11.2.1. LD50 oral (lethal dose, 50%)

Formaldehyde:

460 mg/kg bw (male rat)

(Equivalent or similar to OECD 401)

Methanol:

> 1187-2769 mg/kg bw (male and female rat)

Classification based on acute toxicity data in humans.

11.2.2. LD50 dermal (lethal dose, 50%)

Formaldehyde:

The study does not need to be conducted as formaldehyde

has corrosive properties.

Methanol:

17100 mg/kg bw (rabbit) (Rowe and McCollister, 1981). Classification based on acute toxicity data in humans.

11.2.3. LC50 inhalation (lethal dose, 50%)

Formaldehyde:

1000 mg/m³ (30 min) (rat)

(Equivalent or similar to OECD 403).

Methanol:

128.2 mg/L air; 4 hours (male and female rat)

Classification based on acute toxicity data in humans.

11.2.4. Skin corrosion /irritation

Formaldehyde:

Skin corrosion Category 1B: Causes severe skin burns and

eye damage.

Corrosive (rabbit)

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Methanol:

Not irritating (rabbit).

11.2.5. Serious eye damage/irritation

Formaldehyde:

Eye damage: Category 1: Causes severe eye damage.

Methanol:

Not irritating (rabbit).

11.2.6 Specific target organ toxicity – single exposure

Formaldehyde: Concentration ≥ 5%: Category 3: May cause respiratory

irritation.

Methanol:

Category 1: It causes damage to the optic nerve and Central

Nervous System; oral, dermal exposure and inhalation.

11.3. Sensitisation:

Formaldehyde:

Respiratory sensitisation: Based on the available data, the classification criteria are not met.

Skin sensitisation: Skin sensitizing: Category 1: May cause an allergic skin reaction.

(Skin sensitization studies show positive results for mice and guinea pig tests)

Methanol:

Respiratory sensitisation: No data available.

Skin sensitisation: Not sensitizing (guinea pig) (Equivalent to similar to OECD 406).

11.4. Repeated dose toxicity:

Formaldehyde:

Specific target organ toxicity – repeated exposure: Based on the available data, the classification criteria are not met.

Oral exposure:

NOAEL: 82 mg/kg bw/day (male rat; Exposure up to 105 weeks; target organ: stomach)

NOAEL: 109 mg/kg bw/day (female rat; Exposure up to 105 weeks)


Inhalation exposure:

NOAEC: 1.2 mg/m3

Methanol:

Specific target organ toxicity – repeated exposure: Chronic studies in monkeys clearly demonstrate the potential of the

substance to cause neurological and myocardium effects, with higher exposure times than the usual daily. It is therefore

conceivable that the effects observed in these cases were more serious compared with shorter daily exposures, because the

available biological dose of methanol was much higher

Although there is a clear potential of methanol to cause negative effects on primates health, experimental animal studies do not

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provide clear evidence for classification.

Oral exposure: LOAEL subacute: 2340 mg/kg bw/day (3 days; male monkey; target organs: neurological: eyes (retina, optic

nerve); lethal dose: 100% lethality after 3 days of exposure)

Inhalation exposure: NOEC: 0.013 mg/L air (monkey; 7-29 months of exposure; target organs: heart, brain, liver)


11.5 CMR effects (carcinogenicity, mutagenicity and toxicity for reproduction):

Formaldehyde:

Carcinogenicity: Category 2: Suspected of causing cancer.


The substance presents carcinogen activity in laboratory animals. There is clear evidence obtained in chronic inhalation studies in

rats where the substance causes tumors of the nasal cavity.

Germ cell mutagenicity: Based on the available data, the classification criteria are not met.

Positive results in in vitro bacterial reverse mutation assays (equivalent or similar to OECD 471), mammalian cell gene mutation

assays (equivalent or similar to OECD 476) and mammalian chromosome aberration test (equivalent or similar to OECD 473).

Negative results in in vivo gene mutation studies (equivalent or similar to OECD 484) and chromosome aberration test (equivalent

or similar to OECD 474).

Toxicity for reproduction: Based on the available data, the classification criteria are not met.

Due to rapid metabolism of formic acid, the formaldehyde does not reach the reproductive organs.

It is not necessary to carry out a study if the substance is considered to be genotoxic and carcinogen and good risk management

measures are implemented.

Development effects have not been observed.


NOAEC (developmental toxicity): 10 ppm (rat) (highest dose tested)

NOAEC (maternal toxicity): 5 ppm (rat)

LOAEC (maternal toxicity): 10 ppm (rat) (decreased body weight and food consumption (highest dose tested))

(equivalent or similar to OECD 414)

Oral exposure:

LOAEL (maternal toxicity): 74 mg/kg bw/day (decrease in body weight gain)

NOAEL (developmental toxicity): 185 mg/kg bw/day (highest dose tested)

Reproductive toxicity, effects on or via lactation: No data available.

Methanol:

Carcinogenicity: Based on the available data, the classification criteria are not met.

Oral exposure: NOAEL: 466 — 529 mg/kg bw/day (104 weeks; male and female rat; global effects) LOAEL: 1872 — 2101 (104

weeks; male and female rat; global effects)

Inhalation exposure: There is no evidence of carcinogenic potential in rats and mice exposed to concentrations in air up to 1.3 mg/L. NOAEC: >= 1.3 mg/L air (24 months; male and female rat) (equivalent or similar to OECD 453)

Germ cell mutagenicity: Based on the available data, the classification criteria are not met.

Negative results in in vitro bacterial reverse mutation assays (OECD 471), mammalian cell gene mutation assays (equivalent or

similar to OECD 476) y and mammalian chromosome aberration test.

Negative results in in vivo studies: chromosome aberration (equivalent or similar to OECD 474).

Toxicity for reproduction: Based on the available data, the classification criteria are not met.

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NOAEC (P) = 1.3 mg/L air (male and female rat; reproductive parameter)

NOAEC (F1) = 0.13 mg/L air (male and female rat)

(equivalent or similar to OECD 416)

NOAEC (P): 2.39 mg/L air (female monkey; reproductive rate)

NOAEC (F1): 2.39 mg/L air (female monkey; offspring growth and physical development)

NOAEC = 1.33 mg/L (rat and mouse; developmental toxicity) (equivalent or similar to OECD 414)

Oral exposure: LOAEL = 5000 mg/kg bw (mice; developmental toxicity)

LOAEL = 1700 mg/kg bw (mice; maternal toxicity)

Reproductive toxicity, effects on or via lactation: Based on the available data, the classification criteria are not met.

11.6. Aspiration hazard:

There is no evidence for aspiration hazard.

SECTION 12. ECOLOGICAL INFORMATION

12.1. Toxicity

Acute toxicity to fish

LC50 (lethal concentration, 50%):

Formaldehyde:

Species: Morone saxatilis.

6.7 mg/L (96h; freshwater; static system)

(Wellborn, 1969)

Methanol:

Species: Lepomis macrochirus.

15400 mg/L (96 h; freshwater; flow-through system)

(EPA-660/3-75-009, 1975)

Chronic toxicity to fish

NOEC (no observed effect concentration):

Formaldehyde:

Species: Oryzias latipes

≥ 48 mg/L (28d ; freshwater; flow-through system; based on

mortality, target organ pathologies)

(Equivalent or similar to OECD Guideline 215)

Methanol:

Species: Oryzias latipes.

7900 - 15800 mg/L (200 h; freshwater; static system; based

on number of births)

(Gonzáles-Doncel, M. et al., 2008)

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Acute toxicity to crustaceans

EC50 (effect concentration, 50%):

Formaldehyde:

Species: Daphnia pulex.

5.8 mg/L (48 h; freshwater; static system)

(OECD 202)

Methanol:

Species: Daphnia magna.

>10000 mg/L (48 h; freshwater; static system; based on

mobility)

(DIN 38412 Teil 11)

Chronic toxicity to crustaceans

NOEC (no observed effect concentration):

Formaldehyde:

The formaldehyde is readily biodegradable so disappears

rapidly from the aquatic environment.

Methanol:

There are no studies available as they are not considered

necessary. Studies of chronic toxicity with substances

structurally related (2-Propanol and 1-Butanol) show no

reproductive effects up to 100 mg/l concentrations (NOEC

100 mg/l) and 18 mg/l respectively.

Acute toxicity to algae and other aquatic plants

EC50 (effect concentration, 50%):

Formaldehyde:

Species: Desmodesmus subspicatus

3.48 mg/L (72 h; freshwater; static system; based on

biomass)

4.89 mg/L (72 h; freshwater; static system; based on growth

rate)

(OECD 201)

Methanol:

Species: Selenastrum capricornutum (new name:

Pseudokirchnerella subcapitata)

22000 mg/L (96 h; freshwater; static system; based on

growth rate)

(OECD 201; EPA OPPTS 850.5400)

Toxicity data on soil micro- and macro-organisms and other environmentally relevant organisms, such as birds, bees and

plants

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Formaldehyde:

Species: Eisenia fetida (annelids)

LC50 (48 h; based on mortality): 1 — 10 µg/cm2

(Contact toxicity test. Roberts BL, Dorough HW, 1984)

Terrestrial plants: Lilium longiflorum.

LOEC (5 h): 440 µg/m3 (Effect parameters: pollen tube length).

EC100 (5 h): 1680 µg/m3 (Effect parameters: pollen tube length).

(Masaru N, Syozo F, Saburo K, 1976)

Methanol:

The substance has low adsorption potential, it is not bioaccumulative and it is readily biodegradable in both aerobic and anaerobic

environments. Further tests reveal that it has no harmful effects on the aquatic environment and suggest low toxicity to soil

organisms. Species: Eisenia fetida (annelids).

LC50 (48 h): > 1 mg/cm² (based on mortality).


12.2. Persistence and degradability

Readily biodegradable

Formaldehyde:

Readily biodegradable in water: 90 % degradation after 28

days (OECD 301 C and D)

Methanol:

Readily biodegradable in water based on results from

standard studies showing a percentage of degradation of

71.5 - 95% after 5 to 20 days, respectively (Price et al. 1974;

Wagner 1976). In marine water degradation was 69 - 97 %

(Price et al. 1974).

Other relevant information

Formaldehyde:

No data available.

Methanol:

Degradation time in water: 1-7 days

Degradation time in sediment: 1-7 days

Degradation time in soil: 1-7 days

Degradation time in air: 17-18 days

12.3. Bioaccumulative potential

Bioconcentration factor (BCF): experimental data:

Formaldehyde:

BCF: 0.396 (estimated). Limited experimental data.

Methanol:

Species: Cyprinus carpio.

Aquatic bioaccumulation study performed during 72 hours,

in freshwater, static system:

Highest value: BCF: 4.5 (intestine)

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Partition coefficient: n-octanol/water (log Pow):

Formaldehyde:

0.35 at 20°C

Methanol:

- 0.77

12.4. Mobility in soil

Formaldehyde:

No data available.

Methanol:

Due to his low log Kow (-0,77) value and high water solubility, it has a high mobility in soil, with trend to quickly filter (mainly

on sandy beds) and reach underground aquifers. In clay fields or with organic matter content, it can be very slightly adsorbed (<

1%).

12.5. Results of PBT (persistent, bioaccumulative and toxic) and vPvB (very persistent and very bioaccumulative)

assessment

Formaldehyde:

Persistence assessment (P):

Due to its rapid degradation, the substance is not persistent P nor very persistent vP.

Bioaccumulation assessment (B):

The bioconcentration factor is always BCF: < 1 for studied aquatic species. Bioaccumulation in organisms is not expected.

Toxicity assessment (T):

The results of aquatic toxicity studies and those carried out in mammals indicate that the substance is not toxic.

The substance does not meet the criteria to be considered PBT or vPvB.

Methanol:

Persistence assessment (P):

Based on the available data on degradation, one can conclude that the substance is neither P nor vP.

Bioaccumulation assessment (B):

Based on the available data on bioaccumulation, one can conclude that the substance is neither P nor vP.

Toxicity assessment (T):

Based on the results of aquatic toxicity studies, and those carried out in mammals, the substance is not classified as toxic T.

Considering all available data in biotic and abiotic degradation, bioaccumulation and toxicity, it may be concluded that the

substance does not meet the PBT criteria nor vPvB.

12.6. Other adverse effects

No data available.

FORMOL


SECTION 13. DISPOSAL CONSIDERATIONS

13.1. Waste treatment methods

Substance or preparation:

There are not uniform guidelines established by the European Union for the elimination of chemical residues which are of special

waste, left subject its treatment and disposal to the internal regulations of each country. Therefore, in each case, is appropriate to

contact with the competent authority, or with operators legally authorised for waste disposal.

European regulation:

- Council Decision 2001/573/EC of 23 July 2001 amending Decision 2000/532/EC as regards the list of wastes.

- Council Directive 91/156/CEE of 18 March 1991 amending Directive 75/442/EEC on waste.

- Commission Decision 2000/532/EC of 3 May 2000 replacing Decision 94/3/EC establishing a list of wastes.

Contaminated packaging:

Contaminated packaging of dangerous substances or preparations will have the same treatment to the contained products

themselves.

European regulation:

- European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste.

SECTION 14. TRANSPORT INFORMATION

14.1 ADR (road)/RID (rail)

14.1.1 UN number: 2209

14.1.2 UN proper shipping name: FORMALDEHYDE SOLUTION

14.1.3 Transport hazard Class : 8 Label: 8

14.1.4 Packing group: III

14.1.5. Environmental hazards: No.

14.2 IMDG (sea)

14.2.1 UN number: 2209


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14.2.3 Transport hazard Class : 8, Label: 8



14.3 ICAO / IATA (air)

14.3.1 UN number: 2209


14.3.3 Transport hazard Class : 8 Label:8



14.4. Special precautions for user

It is necessary to attend to the same information described in the previous epigraphs: ADR, RID, IMDG, ICAO / IATA.

14.5. Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code

Not applicable.

SECTION 15. REGULATORY INFORMATION

15.1. Safety, health and environmental regulations/legislation specific for the substance or mixture

- 96/82/CE Directive, on the control of major-accident hazards involving dangerous substances.

- 98/24/CE Council Directive, of 7 April 1998 concerning health protection for workers and safety from the risks related to

chemical agents at work.

15.2. Chemical safety assessment

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The supplier has carried out a chemical safety assessment for the substance.

SECTION 16. OTHER INFORMATION

Information sources used in the elaboration of this Safety Data Sheet:

- HANDBOOK OF REACTIVE CHEMICALS HAZARDS. BRETHERIC 4ª Ed. 1990

- DANGEROUS PROPERTIES INDUSTRIAL MATERIALS (TENTH EDITION) SAX

- HAZARDOUS CHEMICALS DATA BOOK (2nd EDITION) G.WEIS.

- IARC (International Agency for Research on Cancer).

- NIOSH (National Institute for Occupational Safety and Health).

- NTP (National Toxicology Program).

- ACGIH (American Conference of Governmental Industrial Hygienist).

- OSHA (Occupational Health and Safety Assessment)

- INSHT (Instituto Nacional de Seguridad e Higiene en el Trabajo).

Abbreviations:

N/A = not applicable

< SMALLER THAN > GREATER THAN

VLA-EC: Valor Límite Ambiental-Exposición de Corta Duración (Spain)

ED: Exposición diaria

TLV-STEL: Threshold Limit Value - Short term exposure limit

TWA: Time Weighted Average (Media ponderada en el tiempo)

WEL: workplace exposure limit (UK)

DNEL: derived no effect level

PNEC: predicted no effect concentration

Any chemical product can be handled safely if its physical and chemical properties are known, and appropriate safety measures

and clothing are employed.

The information contained in this brochure is a guide for the user and based on both reference texts and on our own experience. It

is intended to reflect the current state of the art, but shall under no circumstances compromise our liability. This information

cannot be used as a substitute for patented processes.

Users shall comply with the legal dispositions and regulations in force, particularly those relating to Health and Safety and the

Storage and Transport of Dangerous Goods.

We recommend that our clients perform the corresponding tests before using the product in new, insufficiently tested fields.

ERCROS S.A

Head office:

Avda Diagonal 595

08014 Barcelona

Tel:+34 934 393 009 –

Fax:+34 934 874 058

Factory:

Tortosa (Tarragona)

Polígono Industrial Baix Ebre

43500 Tortosa (Tarragona)

Tel: +34 977 454 022

Fax:+34 977 597 101

Factory:

Almusafes (VALENCIA)

C/Venta de Ferrer s/n

FORMOL


Polígono Industrial Norte

46440 Almusafes (VALENCIA)

Teléf.: (+34) 961 782 250

Fax: (+34) 961 784 055

FORMOL


APPENDIX I: Exposure scenarios for Formaldehyde

Section 1.- Title Manufacturing of Formaldehyde + aq. formaldehyde solutions and use as

intermediate

Systematic title based on use

descriptor

SU 3,8,9,10,12

PROC 1,2,3,4,5,6,8a,8b,9,14,15

ERC 1, 2, 3, 4, 6a, 6b, 6c, 6d, 7

Consortium use numbers covered:

1; production of formaldehyde (IU1)

8/9; use as intermediate including use as a monomer (IU2)

Section 2.- Operational conditions and risk management measures

Processes, tasks, activities covered

Use in closed process, no likelihood of exposure (PROC 1)

Use in closed, continuous process with occasional controlled exposure (PROC 2)

Use in closed batch process (synthesis / formulation) (PROC 3)

Use in batch or other process (synthesis) where opportunity for exposure arises (PROC 4)

Mixing or blending in batch processes (multistage and/or significant contact) (PROC 5)

Calendaring operations (PROC 6)

Transfer of substance or preparation (charging/discharging) from/to vessels/ large

containers at non dedicated facilities (PROC 8a)

Transfer of chemicals (charging/ discharging) from/to vessels/ large containers at dedicated

facilities (PROC 8b)

Transfer of substance or preparations into small containers (dedicated filling line including

weighing) (PROC 9)

Production of preparations or articles by tabletting, compression, extrusion, pelletisation

(PROC 14)

Use as laboratory reagent (PROC 15)

Environment characteristic

covered No environmental assessment is performed

Environmental Assessment

Method No environmental assessment is performed

Formaldehyde is not stable; therefore it is stored as formalin (30-60%). Formaldehyde has another vapour pressure than

formalin. The vapour pressure used in the exposure assessments is 100,000 Pa for pure formaldehyde. In production-transfer

activities formaldehyde is present as formalin with a vapour pressure of 1520 Pa at elevated temperature (49% formaldehyde

solution at 55 ºC) and 1400 Pa for formalin at room temperature (50 % formaldehyde solution (with 2 % of methanol)).

Number of sites using the substance (potentially required to demonstrate strictly controlled conditions of use to justify waiving of

information according to Annex XI of REACH)

2.1.- Control of workers exposure

Contributing exposure scenario 1 controlling worker exposure for PROC 1

Workers related free short title Manufacturing of formalin; general manufacture closed system

Use descriptor covered SU3, PROC 1

Processes, tasks, activities covered PROC 1: Use in closed process, no likelihood of exposure

Assessment Method Dermal exposure: ECETOC TRA v2 (with modifications)

Inhalation exposure: ART

Product characteristic

Vapour, Formaldehyde 100%. Pure formaldehyde is present within at least parts of the closed process equipment

Amounts used

Not relevant

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Frequency and duration of use/exposure

Daily, up to 480 minutes

Human factors not influenced by risk management

A breathing volume of 10 m3/d is assumed which is default for light work activity. A default value of 70 kg is assumed as body

weight for workers.

Other given operational conditions affecting workers exposure

Indoor, large industrial workrooms (300 m3)

Hot process (50-150 °C)

Technical conditions and measures at process level (source) to prevent release

High level of containment (99.9% reduction), consisting of:

• Sealed and enclosed system

• The enclosure is not opened during the activity

• The system is designed to minimize the surface area which can contact the material or pairs of valves with wash space

between them.

Technical conditions and measures to control dispersion from source towards the worker

General ventilation at least 3 air changes per hour

Organisational measures to prevent /limit releases, dispersion and exposure

No organizational measures required.

Conditions and measures related to personal protection, hygiene and health evaluation

Stringent use of protective gloves with specific worker training and management supervision to minimize exposure (reduction

factor 98%) at activities that may lead to contact with contaminated surfaces. Wear suitable eye protection if exposure to the eyes

may be possible, e.g. due to splashing, working overhead or when the face of the worker needs to be close to the source.


Workers related free short title Manufacturing of formalin; general manufacture closed system, continuous process.



PROC 2: Use in closed, continuous process with occasional controlled exposure.

PROC 2 consists of closed process activities and dedicated transfer activities including

sampling. The contributing scenario consists of a combination of these two activities.

Assessment Method* Dermal exposure: ECETOC TRA v2 (with modifications)



Closed process: Vapour, formaldehyde 100%. Pure formaldehyde is present within at least parts of the closed process equipment

Dedicated transfer: Liquid, formalin (30-60% formaldehyde in water). The finalized product (formalin) is transferred to storage or

further processing.

Amounts used

Closed process: Not relevant

Dedicated transfer: > 1000 L/min


Closed process: Daily, up to 360 minutes.

Dedicated transfer: Daily, up to 120 minutes.



weight for workers.


Dedicated transfer and closed process:


Hot process activities (50-150 °C)

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Dedicated transfer:

• Submerged loading


- Medium level of containment (99% reduction), consisting of:

• Physical containment or enclosure of the source of emission.

• The material transfer is enclosed with the receiving vessel being docked or sealed to the source vessel.

Examples include sealing heads, transfer containers and multiple o-rings. Inflatable packing head with continuous liner

ensures a seal is maintained during the transfer and the continuous plastic liner prevents direct contact with the product. The

correct type of tie off must be used.


Dedicated transfer and closed process: general ventilation at least 3 air changes per hour

Dedicated transfer: transfer system is provided with a vapour recovery system (80% reduction)


Ensure Dedicated transfer is limited to at most 120 minutes

Ensure Closed process activities are limited to at most 360 minutes



Wear suitable eye protection if exposure to the eyes may be possible, e.g. due to splashing, working overhead or when the face of

the worker needs to be close to the source.

Closed process: Stringent use of protective gloves with specific worker training and management supervision to minimize

exposure (reduction factor 98%) at activities that may lead to contact with contaminated surfaces.

Dedicated transfer: Stringent use of protective gloves with specific worker training and management supervision to minimize

exposure (reduction factor 98%).

Dedicated transfer: Use of respiratory protective equipment (90% reduction).


Workers related free short title Manufacturing of formalin; general manufacture closed batch process



PROC 3: Use in closed, continuous process with occasional controlled exposure.

PROC 3 consists of closed process activities and dedicated transfer activities including

sampling. The contributing scenario consists of a combination of these two activities.






further processing.

Amounts used




Closed process: Daily, up to 360 minutes.

Dedicated transfer: Daily, up to 120 minutes.



weight for workers.






FORMOL


Dedicated transfer:










Dedicated transfer and closed process: general ventilation at least 3 air changes per hour

Dedicated transfer: transfer system is provided with a vapour recovery system (80% reduction)


Ensure Dedicated transfer is limited to at most 120 minutes

Ensure Closed process activities are limited to at most 360 minutes


Dedicated transfer and closed process: Wear suitable eye protection if exposure to the eyes may be possible, e.g. due to splashing,

working overhead or when the face of the worker needs to be close to the source.



Dedicated transfer: Stringent use of protective gloves with specific worker training and management supervision to minimize

exposure (reduction factor 98%).



Workers related free short title Manufacturing of formalin; batch and other processes.



PROC 4: Use in batch and other processes (synthesis) with opportunity for exposure

PROC 4 consists of three types of activities:

• dedicated transfer activities

• closed process activities

• activities near open parts of the process

This contributing scenario consists of a combination of these three activities.





further processing.


Open parts of the process: Liquid, formalin (30-60% formaldehyde in water).

Amounts used



Open parts of the process: Not relevant


Dedicated transfer and open parts of the process: Daily, up to 60 min.

Closed process: Daily, up to 360 min.



weight for workers.


Dedicated transfer, closed process and open parts of the process:




FORMOL


Dedicated transfer:









Open parts of the process:

• Open surface < 0.1 m2




Dedicated transfer: transfer system is provided with a vapour recovery system (reduction 80%)

Open parts of the process: Local exhaust ventilation (fixed capturing hoods, 90% reduction) at potential emission points.


Ensure that the process activities dedicated transfer and open parts are limited to at most 60 minutes.

Ensure that the closed process activities are limited to at most 360 min.





Process activities open parts of the process and dedicated transfer: Stringent use of protective gloves with specific worker training

and management supervision to minimize exposure (reduction factor 98%).



Open parts of the processs: Use of respiratory protective equipment (95% reduction).



Workers related free short title Manufacturing of formalin; mixing and blending.



PROC 5: Mixing or blending in batch processes for formulation of preparations and articles

(multistage and/or significant contact),

PROC 5 consists of three types of activities:

• dedicated transfer activities,

• closed process activities

• activities near open parts or the process

This contributing scenario consists of a combination of these three activities.





further processing.


Open parts of the process: Liquid, formalin (30-60% formaldehyde in water).

Amounts used



Open parts of the process: Not relevant


Dedicated transfer and open parts of the process: Daily, up to 60 min.

Closed process: Daily, up to 360 min.


FORMOL



weight for workers.






Dedicated transfer:









Open parts of the process:

• Open surface < 0.1 m2




Dedicated transfer: transfer system is provided with a vapour recovery system (reduction 80%)

Open parts of the process: Local exhaust ventilation (fixed capturing hoods, 90% reduction) at potential emission points.


Ensure that the process activities dedicated transfer and open parts are limited to at most 60 minutes.

Ensure that the closed process activities are limited to at most 360 min.





Process activities open parts of the process and dedicated transfer: Stringent use of protective gloves with specific worker training

and management supervision to minimize exposure (reduction factor 98%).



Open parts of the processs: Use of respiratory protective equipment (95% reduction).



Workers related free short title Manufacture of formalin; use of formalin in calendaring operations


Processes, tasks, activities covered PROC 6: calendaring operations

Assessment Method* ECETOC TRA v2 (with modifications) is used for both inhalation and dermal exposure

because it is not possible to assess evaporation from solids by use of ART


Liquid, formalin (30%-60% formaldehyde in water)

Amounts used

Not relevant


Up to 4 hours, daily exposure



weight for workers.


Industrial setting, indoor

FORMOL



Not relevant.


Local exhaust ventilation (90% efficacy).


Not relevant



factor 98%). Use of respiratory protective equipment (90% reduction). Wear suitable eye protection if exposure to the eyes may be

possible, e.g. due to splashing, working overhead or when the face of the worker needs to be close to the source.

Contributing exposure scenario 7a controlling worker exposure for PROC 8a

Workers related free short title Manufacturing of formalin (30-60% formaldehyde); transfer into large containers

(non-dedicated filling).

Use descriptor covered SU3, PROC 8a

Processes, tasks, activities covered PROC 8a: Transfer of substance or preparation from /to vessels/large containers at non-

dedicated facilities.





Amounts used

100-1000 L/min.


Daily, up to 480 minutes.



weight for workers.


Indoors, large industrial workrooms (300 m3)


Outdoor use is safe once a vapour recovery system is available


Submerged loading

Medium level of containment (99% reduction), consisting of:









Not relevant



factor 98%).



Use of respiratory protective equipment (90% reduction).

Contributing exposure scenario 7b controlling worker exposure for PROC 8a

Workers related free short title Manufacturing of formalin (5% formaldehyde); transfer into large containers (non-

dedicated filling).


FORMOL







Liquid, formalin (5% formaldehyde in water)

Amounts used

100-1000 L/min.





weight for workers.



Room temperature (15-25°C)



Submerged loading










Not relevant


Stringent use of protective gloves with specific activity training (reduction factor 95%).



Contributing exposure scenario 8c controlling worker exposure for PROC 8a

Workers related free short title Manufacturing of formalin (1.5% formaldehyde); transfer into large containers (non-

dedicated filling).







Liquid, formalin (1.5 % formaldehyde in water)

Amounts used

100-1000 L/min.





weight for workers.


Indoors, large industrial workrooms (300 m3) only




FORMOL


Submerged loading










Not relevant





Contributing exposure scenario 9a controlling worker exposure for PROC 8b

Workers related free short title Manufacturing of formalin (30-60% formaldehyde); transfer into large containers

(dedicated filling).

Use descriptor covered SU3, PROC 8b

Processes, tasks, activities covered PROC 8b: Transfer of substance or preparation from /to vessels/large containers at






Amounts used

>1000 L/min.





weight for workers.






Submerged loading









Transfer system is provided with a vapour recovery system (reduction 80%)


Not relevant



factor 98%).




FORMOL


Contributing exposure scenario 8b controlling worker exposure for PROC 8b

Workers related free short title Manufacturing of formalin (5% formaldehyde); transfer into large containers



Processes, tasks, activities

covered

PROC 8b: Transfer of substance or preparation from /to vessels/large containers at





Liquid, formalin (5 % formaldehyde in water)

Amounts used

>1000 L/min.





weight for workers.






Submerged loading









Transfer system is provided with a vapour recovery system (reduction 80%)


Not relevant





Contributing exposure scenario 8c controlling worker exposure for PROC 8b

Workers related free short title Manufacturing of formalin (1.5% formaldehyde); transfer into large containers




covered

PROC 8b: Transfer of substance or preparation from /to vessels/large containers at





Liquid, formalin (1.5 % formaldehyde in water)

Amounts used

>1000 L/min.




FORMOL



weight for workers.






Submerged loading










Not relevant





Contributing exposure scenario 9a controlling worker exposure for PROC 9

Workers related free short title Manufacturing of formalin (30-60% formaldehyde); transfer into small containers




covered

PROC 9: Transfer of substance or preparation into small containers (dedicated filling line,

including weighing).





Amounts used

10 - 100 L/min.


Daily, 480 minutes.



weight for workers.



Hot process (50-150 °C).


Submerged loading

Low level of containment (90% reduction), consisting of:


• The air within the enclosure is not actively ventilated or extracted. The enclosure is not opened during the activity. The

process is contained with a loose lid or cover, which is not air tight. This includes tapping molten metal through covered

launders and placing a loose lid on a ladle. This class also includes bags or liners fitted around transfer points from source to

receiving vessel. These include Muller seals, Stott head and single bag, and associated clamps and closures.


General ventilation at least 3 air changes per hour.

Local exhaust ventilation (fixed capturing hoods, 90% reduction) at potential emission points.


Not relevant.

FORMOL




factor 98%).




Contributing exposure scenario 9b controlling worker exposure for PROC 9

Workers related free short title Manufacturing of formalin (5% formaldehyde); transfer into small containers




covered






Liquid, formalin (5% formaldehyde in water)

Amounts used

10 - 100 L/min.


Daily, 480 minutes.



weight for workers.





Submerged loading









Local exhaust ventilation (fixed capturing hoods, 90% reduction) at potential emission points.


Not relevant.





Contributing exposure scenario 9c controlling worker exposure for PROC 9

Workers related free short title Manufacturing of formalin (1.5% formaldehyde); transfer into small containers




covered






Liquid, formalin (1.5% formaldehyde in water)

Amounts used

10 - 100 L/min.

FORMOL



Daily, 480 minutes.



weight for workers.





Submerged loading










Not relevant.






Workers related free short title Manufacture of formalin; use of formalin in the production of preparations or articles



covered

PROC 14: Production of preparations or articles by tabletting, compression, extrusion,

pelletisation

Assessment Method ECETOC TRA v2 (with modifications) is used for both inhalation and dermal exposure

because it is not possible to assess evaporation from solids by use of ART



Amounts used

Not relevant





weight for workers.


Industrial setting, indoor


Not relevant.


Local exhaust ventilation (90% efficacy).


Not relevant



factor 98%). Use of respiratory protective equipment (90% reduction). Wear suitable eye protection if exposure to the eyes may be

possible, e.g. due to splashing, working overhead or when the face of the worker needs to be close to the source.


FORMOL


Workers related free short title Use of formalin as a laboratory reagent up to 62%.



covered PROC 15: Use as laboratory reagent





Amounts used

<0.1 L/min





weight for workers.


Indoor, small workrooms (100 m3)

Covers both industrial and professional laboratory settings


Not relevant.



Local exhaust ventilation (enclosing hood, fume cupboard, 99% reduction).


Not relevant



factor 98%).



Section 3.- Exposure estimation

See: http://www.ercros.es/eng/internas.asp?arxiu=sl_1

Section 4.- Guidance to DU to evaluate whether he works inside the boundaries set by the ES

The DU works inside the boundaries set by the ES if either the proposed risk management measures as described above are met or

the downstream user can demonstrate on his own that his operational conditions and implemented risk management measures are

adequate. This has to be done by showing that they limit the inhalation and dermal exposure to a level below the respective DNEL

(given that the processes and activities in question are covered by the PROCs listed above) as given below. If measured data are

not available, the DU may make use of an appropriate scaling tool such as

Dermal exposure: ECETOC TRA v2 (with modifications)


Important note: By demonstrating a safe use when comparing exposure estimates with the long-term DNEL, the acute DNEL is

therefore also covered (according to R.14 guidance, acute exposure levels can be derived by multiplying long-term exposure

estimates by a factor of 2).

Section 1.- Title Formulations of preparations (30-60%)

Free short title Formulations of preparations (30-60%)


descriptor

SU 3, 10

PROC 1,2,3,4,5,6,8a,8b,9,14,15

ERC 2, 3

FORMOL


Identified use covered:

Formulation (IU3)



Use in closed process, no likelihood of exposure (PROC 1)


Use in closed batch process (synthesis / formulation) (PROC 3)

Use in batch or other process (synthesis) where opportunity for exposure arises (PROC 4)

Mixing or blending in batch processes (multistage and/or significant contact) (PROC 5)

Calendering operations (PROC 6)

Transfer of substance or preparation (charging/discharging) from/to vessels/ large

containers at non dedicated facilities (PROC 8a)

Transfer of chemicals (charging/ discharging) from/to vessels/ large containers at

dedicated facilities (PROC 8b)

Transfer of substance or preparations into small containers (dedicated filling line including

weighing) (PROC 9)

Production of preparations or articles by tabletting, compression, extrusion, pelletisation

(PROC 14)

Use as laboratory reagent (PROC 15)

Environment characteristic

covered No environmental assessment is performed

Assessment Method See Exposure Scenario 1 for the description of the Exposure Scenarios and the

accompanying exposure assessments

Section 1.- Title Industrial use of preparations containing formaldehyde up to 60%

Free short title Industrial use of preparations containing formaldehyde up to 60%


descriptor

SU: 3, 8

PROC: 1, 2

ERC: 5

Identified uses covered:

16; production of fertilizer granules (IU14)

Name of contributing

environmental scenario 1 and

corresponding ERC

No environmental assessment has been performed


Name(s) of contributing worker

scenarios and corresponding

PROCs

Use in closed process, no likelihood of exposure (PROC 1),


Assessment Method See Exposure Scenario 1 for the description of the Exposure Scenarios and the

accompanying exposure assessments

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descriptor

SU: 2a, 3, 5, 8, 9, 10, 11, 12, 13, 14, 17, 19

PROC: 1, 2, 3, 4, 5, 6, 7, 8a, 8b, 9, 10, 13, 14, 16, 21, 22, 23, 24, 25

ERC: 2, 3, 5, 6d

Consortium use number covered:

Industrial use of formaldehyde products (IU4)

2; production of foams (IU15)

10; production of bonded particulates (IU8)

11; use of adhesives and coatings (IU9)

13; production of rubber (IU10)

14; production of firelighters (IU16)

15; production of leather (IU13)

Name of contributing environmental

scenario 1 and corresponding ERC No environmental assessment has been performed



scenarios and corresponding PROCs


Use in closed, continuous process with occasional controlled exposure (PROC 2),

Use in closed batch process (synthesis or formulation) (PROC 3), Use in batch and other

process (synthesis) where opportunity for exposure arises (PROC 4),

Mixing or blending in batch processes (multistage and/or significant contact) (PROC 5),

Calendering operations (PROC 6),

Industrial spraying (PROC 7),

Transfer of chemicals from/to vessels/ large containers at non dedicated facilities (PROC

8a),

Transfer of chemicals from/to vessels/ large containers at dedicated facilities (PROC 8b),

Transfer of chemicals into small containers (dedicated filling line) (PROC 9),

Roller application or brushing (PROC 10),

Treatment of articles by dipping and pouring (PROC 13), Production of preparations or

articles by tabletting, compression, extrusion, pelletisation (PROC 14),

Using materials as fuel sources, limited exposure to unburned product to be expected

(PROC 16),

Low energy manipulation of substances bound in materials and/or articles (PROC 21),

Potentially closed processing operations with minerals/metals at elevated temperature

(PROC 22),

Open processing and transfer operations with minerals/metals at elevated temperature

(PROC 23),

High (mechanical) energy work-up of substances bound in materials and/or articles

(PROC 24),

Other hot work operations with metals (PROC 25),

Assessment Method All exposure assessments were done by use of ECETOC TRA, version 2 with

modifications (see beginning of chapter 9)

2.1 Control of workers exposure


Name of contributing exposure

scenario Use in closed process

Further specification Use in closed process, no likelihood of exposure


Liquid, diluted substance, up to 5%

Amounts used

Not relevant

FORMOL






weight for workers.

Other given operational conditions affecting workers/consumers exposure

Indoor, industrial setting

Conditions and measures at level of article production to prevent release during service life

Not relevant


Not relevant


Not relevant


Not relevant

Conditions and measures related to information and behavioural advice to consumers

Not relevant


Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%).

Additional good practice advice (for environment) beyond the REACH CSA

Not relevant



scenario Use in closed, continuous process

Further specification Use in closed, continuous process with occasional controlled exposure



Amounts used

Not relevant





weight for workers.




Not relevant


Local exhaust ventilation with an efficacy of 90%.


Not relevant


Not relevant


Not relevant


FORMOL




Not relevant



scenario Use in closed batch process

Further specification Use in closed batch process (synthesis or formulation)



Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant




Not relevant


Not relevant




Not relevant



scenario Use in batch and other process

Further specification Use in batch and other process (synthesis) where opportunity for exposure arises



Amounts used

Not relevant





weight for workers.


FORMOL




Not relevant




Not relevant


Not relevant




Not relevant



scenario Mixing or blending in batch processes

Further specification Mixing or blending in batch processes (multistage and/or significant contact)



Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant




Not relevant


Not relevant




Not relevant



scenario Calendering operations

Further specification Calendering operations

FORMOL




Amounts used

Not relevant





weight for workers.




Not relevant




Not relevant


Not relevant


Not relevant




Not relevant



scenario Industrial spraying

Further specification Industrial spraying



Amounts used

Not relevant


Up to 1 hour, daily exposure



weight for workers.




Not relevant


Not relevant



FORMOL



Ensure operation is limited to at most 60 minutes


Not relevant




Not relevant

Contributing exposure scenario 17 controlling worker exposure for PROC 8a


scenario Transfer of chemicals, non-dedicated

Further specification Transfer of chemicals from/to vessels/ large containers at non-dedicated facilities



Amounts used

Not relevant





weight for workers.





Not relevant




Not relevant


Not relevant




Not relevant

Contributing exposure scenario 18 controlling worker exposure for PROC 8b


scenario Transfer of chemicals, dedicated

Further specification Transfer of chemicals from/to vessels/ large containers at dedicated facilities



Amounts used

Not relevant



FORMOL




weight for workers.





Not relevant


Not relevant




Not relevant


Not relevant




Not relevant



scenario Transfer of chemicals into small containers

Further specification Transfer of chemicals into small containers (dedicated filling line)



Amounts used

Not relevant





weight for workers.




Not relevant




Not relevant


Not relevant




Not relevant

FORMOL




scenario Roller application or brushing

Further specification Roller application or brushing



Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant




Not relevant


Not relevant




Not relevant



scenario Treatment of articles

Further specification Treatment of articles by dipping and pouring



Amounts used

Not relevant





weight for workers.




Not relevant

FORMOL





Not relevant


Not relevant




Not relevant



scenario Production of preparations or articles

Further specification Production of preparations or articles by tabletting, compression, extrusion, pelletisation



Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant




Not relevant


Not relevant




Not relevant



scenario Using materials as fuel sources

Further specification Using materials as fuel sources, limited exposure to unburned product to be expected



Amounts used

FORMOL


Not relevant





weight for workers.




Not relevant


Not relevant


Not relevant


Not relevant




Not relevant



scenario Low energy manipulation of substances

Further specification Low energy manipulation of substances bound in materials and/or articles


Solid, bound substance in materials and/or articles, up to 5%

Amounts used

Not relevant





weight for workers.




Not relevant




Not relevant


Not relevant




FORMOL


Not relevant



scenario Potentially closed processing operations with minerals/metals

Further specification Potentially closed processing operations with minerals/metals at elevated temperature



Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant




Not relevant


Not relevant




Not relevant



scenario Open processing and transfer operations with minerals/metals

Further specification Open processing and transfer operations with minerals/metals at elevated temperature



Amounts used

Not relevant





weight for workers.




FORMOL


Not relevant




Not relevant


Not relevant




Not relevant



scenario High (mechanical) energy work-up of substances

Further specification High (mechanical) energy work-up of substances bound in materials and/or articles



Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant




Not relevant


Not relevant




Not relevant



scenario Other hot work operations with metals

Further specification Other hot work operations with metals



FORMOL


Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant


Not relevant


Not relevant




Not relevant







(given that the processes and activities in question are covered by the PROCs listed above) as given below. If measured data are not

available, the DU may make use of an appropriate scaling tool such as






Section 1.- Title Industrial use of preparations containing formaldehyde up to 2.5%


descriptor

SU: 3, 5, 6a, 6b, 10, 11, 12, 13, 18, 19

PROC: 1, 2, 3, 4, 5, 6, 7, 8a, 8b, 9, 10, 13, 14, 16, 21, 22, 23, 24, 25

ERC: 2, 3, 5, 6d



3; production of woodbased materials (IU5)

4; production of impregnated paper (IU6)

5; production of paper (IU12)

6; impregnation of textile (IU11)

7; production of bonded fibers or fiber mats (IU7)

FORMOL















8a),







(PROC 16),



(PROC 22),


(PROC 23),


(PROC 24),

Other hot work operations with metals (PROC 25)


modifications

2.1.-Control of workers exposure






Liquid, diluted substance, up to 2.5%

Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant

FORMOL



Not relevant


Not relevant


Not relevant




Not relevant







Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant


Not relevant


Not relevant


Not relevant




Not relevant







FORMOL


Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant




Not relevant


Not relevant




Not relevant







Amounts used

Not relevant





weight for workers.




Not relevant




Not relevant


Not relevant


FORMOL




Not relevant







Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant




Not relevant


Not relevant




Not relevant







Amounts used

Not relevant





weight for workers.


FORMOL




Not relevant




Not relevant


Not relevant


Not relevant




Not relevant







Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant




Ensure operation is limited to at most 240 minutes


Not relevant




Not relevant


FORMOL







Amounts used

Not relevant





weight for workers.





Not relevant




Not relevant


Not relevant




Not relevant







Amounts used

Not relevant





weight for workers.





Not relevant


FORMOL


Not relevant




Not relevant


Not relevant




Not relevant







Amounts used

Not relevant





weight for workers.




Not relevant




Not relevant


Not relevant




Not relevant







Amounts used

Not relevant

FORMOL






weight for workers.




Not relevant


Not relevant




Not relevant


Not relevant




Not relevant







Amounts used

Not relevant





weight for workers.




Not relevant




Not relevant


Not relevant




FORMOL


Not relevant







Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant




Not relevant


Not relevant




Not relevant







Amounts used

Not relevant





weight for workers.




FORMOL


Not relevant



Not relevant


Not relevant




Not relevant






Solid, bound substance in materials and/or articles, up to 2.5%

Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant


Not relevant


Not relevant




Not relevant







Amounts used

Not relevant

FORMOL






weight for workers.




Not relevant


Not relevant


Not relevant


Not relevant


Not relevant




Not relevant







Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant


Not relevant


Not relevant




FORMOL


Not relevant







Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant


Not relevant


Not relevant


Not relevant




Not relevant







Amounts used

Not relevant





weight for workers.




FORMOL


Not relevant


Not relevant


Not relevant


Not relevant




Not relevant














Section 1.- Title Industrial use of preparations containing formaldehyde up to 1.5%


descriptor

SU: 2a, 3, 5, 8, 9, 10, 11, 12, 13, 14, 17, 19

PROC: 1, 2, 3, 4, 5, 6, 7, 8a, 8b, 9, 10, 13, 14, 16, 21, 22, 23, 24, 25

ERC: 2, 3, 5, 6d



2; production of foams (IU15)

10; production of bonded particulates (IU8)

11; use of adhesives and coatings (IU9)

13; production of rubber (IU10)

14; production of firelighters (IU16)

15; production of leather (IU13)














8a),



FORMOL






(PROC 16),



(PROC 22),


(PROC 23),


(PROC 24),

Other hot work operations with metals (PROC 25),










Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant


Not relevant


Not relevant


Not relevant




Not relevant





FORMOL




Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant


Not relevant


Not relevant


Not relevant




Not relevant







Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant


Not relevant

FORMOL



Not relevant


Not relevant




Not relevant







Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant


Not relevant


Not relevant




Not relevant







Amounts used

Not relevant




FORMOL



weight for workers.




Not relevant


Not relevant




Not relevant


Not relevant




Not relevant







Amounts used

Not relevant





weight for workers.




Not relevant




Not relevant


Not relevant


Not relevant




Not relevant

FORMOL








Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant




Not relevant


Not relevant




Not relevant







Amounts used

Not relevant





weight for workers.





FORMOL


Not relevant




Not relevant


Not relevant




Not relevant







Amounts used

Not relevant





weight for workers.





Not relevant


Not relevant




Not relevant


Not relevant




Not relevant






FORMOL



Amounts used

Not relevant





weight for workers.




Not relevant




Not relevant


Not relevant




Not relevant







Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant




Not relevant


Not relevant

FORMOL





Not relevant







Amounts used

Not relevant





weight for workers.




Not relevant




Not relevant


Not relevant




Not relevant







Amounts used

Not relevant





weight for workers.



FORMOL



Not relevant


Not relevant




Not relevant


Not relevant




Not relevant







Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant


Not relevant


Not relevant




Not relevant






FORMOL



Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant


Not relevant


Not relevant




Not relevant







Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant


Not relevant


Not relevant


Not relevant

FORMOL





Not relevant







Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant


Not relevant


Not relevant




Not relevant







Amounts used

Not relevant





weight for workers.



FORMOL



Not relevant


Not relevant


Not relevant


Not relevant


Not relevant




Not relevant







Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant


Not relevant


Not relevant




Not relevant




FORMOL














descriptor

SU: 3, 5, 6a, 6b, 10, 11, 12, 13, 18, 19

PROC: 1, 2, 5, 6, 7, 8a, 8b, 9, 10, 13, 14, 24

ERC: 2, 3 5, 6d



3; production of woodbased materials (IU5)

4; production of impregnated paper (IU6)

5; production of paper (IU12)

6; impregnation of textile (IU11)

7; production of bonded fibers or fiber mats (IU7)



corresponding ERC





PROCs







8a),






High (mechanical) energy work-up of substances bound in materials and/or articles (PROC

24)










Amounts used

Not relevant


FORMOL





weight for workers.




Not relevant


Not relevant


Not relevant


Not relevant


Not relevant




Not relevant







Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant


Not relevant


Not relevant


Not relevant



FORMOL



Not relevant







Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant




Not relevant


Not relevant




Not relevant







Amounts used

Not relevant





weight for workers.



FORMOL



Not relevant




Not relevant


Not relevant


Not relevant




Not relevant







Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant




Not relevant


Not relevant




Not relevant




FORMOL





Amounts used

Not relevant





weight for workers.





Not relevant




Not relevant


Not relevant




Not relevant







Amounts used

Not relevant





weight for workers.





Not relevant


Not relevant


FORMOL




Not relevant


Not relevant




Not relevant







Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant




Not relevant


Not relevant




Not relevant







FORMOL


Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant




Not relevant


Not relevant




Not relevant







Amounts used

Not relevant





weight for workers.




Not relevant




Not relevant


Not relevant


FORMOL




Not relevant







Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant




Not relevant


Not relevant




Not relevant







Amounts used

Not relevant





weight for workers.


FORMOL




Not relevant


Not relevant


Not relevant


Not relevant


Not relevant




Not relevant


http://www.ercros.es/eng/internas.asp?arxiu=sl_1












Section 1.- Title Professional use of preparations containing formaldehyde up to 1.5%


descriptor

SU: 22

PROC: 5, 8a, 8b, 10, 11, 13, 15, 16, 19, 21, 22, 23, 24, 25

ERC: 2, 3, 5, 8a, 8b, 8c, 8d, 8f

PC: 8, 9a, 13, 31, 35, 39


Professional use of formaldehyde products (IU17)

2p; production of foams (IU21)

11p; application of adhesives and coatings (IU19)

14p; use of firelighters (IU20)

21p; cleaning agents (IU22)

Remark: PROC 22 can not be assessed within the professional domain and is therefore not

included in this ES. It is assumed that the other PROC describe the situation at the

workplace accurately.



corresponding ERC




FORMOL




PROCs



8a),



Non industrial spraying (PROC 11),

Treatment of articles by dipping and pouring (PROC 13),

Use of laboratory reagents in small scale laboratories (PROC 15), Using materials as fuel

sources, limited exposure to unburned product to be expected (PROC 16),

Hand-mixing with intimate contact and only PPE available (PROC 19),



PROCs



(PROC 23),

High (mechanical) energy work-up of substances bound in materials and/or articles (PROC

24),

Other hot work operations with metals (PROC 25)









Amounts used

Not relevant





weight for workers.


Indoor, professional setting


Not relevant


Not relevant


Not relevant


Not relevant


Not relevant


Use chemically resistant gloves in combination with ‘specific’ activity training (efficacy 95%). Wear a respirator with Type A

filter or better (efficacy 90%).


Not relevant

FORMOL








Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant


Not relevant


Not relevant





Not relevant







Amounts used

Not relevant





weight for workers.




FORMOL


Not relevant


Not relevant




Not relevant


Not relevant




Not relevant







Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant


Not relevant


Not relevant


Not relevant





Not relevant

FORMOL




scenario Non industrial spraying

Further specification Non industrial spraying



Amounts used

Not relevant





weight for workers.




Not relevant




Not relevant


Not relevant





Not relevant







Amounts used

Not relevant





weight for workers.



FORMOL



Not relevant


Not relevant


Not relevant


Not relevant





Not relevant



scenario Use of laboratory reagents

Further specification Use of laboratory reagents in small scale laboratories



Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant


Not relevant


Not relevant




Not relevant





FORMOL




Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant


Not relevant


Not relevant




Not relevant



scenario Hand-mixing with intimate contact

Further specification Hand-mixing with intimate contact and only PPE available



Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant


Not relevant

FORMOL



Not relevant


Not relevant





Not relevant






Solid, substance bound in materials and/or articles, up to 1.5%

Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant


Not relevant


Not relevant




Not relevant







Amounts used

Not relevant

FORMOL






weight for workers.




Not relevant


Not relevant


Not relevant


Not relevant




Not relevant







Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant


Not relevant


Not relevant


Not relevant

FORMOL





Not relevant







Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant


Not relevant


Not relevant




Not relevant














FORMOL


Section 1.- Title Professional use of preparations containing formaldehyde up to 1%


descriptor

SU: 22

PROC: 5, 8a, 8b, 10, 15

ERC: 2,3,8c, 8f

PC: 1


Professional use of formaldehyde products (IU17)

3p; professional use of resins in wood applications (e.g. glues) (IU18)



corresponding ERC






PROCs



8a),



Use of laboratory reagents in small scale laboratories (PROC 15)









Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant




Not relevant


Not relevant

FORMOL





Not relevant







Amounts used

Not relevant





weight for workers.




Not relevant




Not relevant


Not relevant




Not relevant







Amounts used

Not relevant





weight for workers.

FORMOL





Not relevant


Not relevant




Not relevant


Not relevant




Not relevant







Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant




Not relevant


Not relevant




FORMOL


Not relevant



scenario Use of laboratory reagents

Further specification Use of laboratory reagents in small scale laboratories



Amounts used

Not relevant





weight for workers.




Not relevant


Not relevant


Not relevant


Not relevant




Not relevant














Documents

Formol liquide fds 01122010 - Cadilhac · FORMOL Date15/05/2011; Revision 01 SDS: 2-111 page 3 of 95 P271: Use only outdoors or in a well-ventilated area