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www.ephect.eu EMISSIONS, EXPOSURE PATTERNS and HEALTH EFFECTS of CONSUMER PRODUCTS in the EU M. Trantallidi 1 , P. Carrer 1 , C. Dimitroulopoulou 2 , G. Efthimiou 2 , J. Bartzis 2 , P. Wolkoff 3 1 Occupational and Environmental Health, Dept. of Biomedical and Clinical Sciences, University of Milan, Italy 2 Mechanical Engineering Dept., University of West Macedonia, Greece 3 Indoor Environment Group, National Research Centre for the Working Environment, Denmark Focus HRA was conducted accounting only irritative and respiratory end-points, since EPHECT focuses on air pollutants considered to be risk factors of respiratory diseases. Housewives and retired people (> 65 years old) were considered as target population, as these groups spend the majority of their time indoors. For acute exposure, a 30-min time period was chosen, reflecting exposure during use of the product. For long-term exposure, a 24-h time period was selected, reflecting exposure during daily activity of the target population (considered as representative of all days of a year). A ‘worst-case scenario’ strategy was followed for HRA. Selection of target compounds On the basis of a literature review, evaluation of toxicological information from inhalation exposure studies and assessment of chamber testing results, the following pollutants were selected for HRA: Methodology (1) Hazard identification and dose response relationship: Human and animal toxicological data regarding effects of short- and long- term inhalation exposure to the target compounds were evaluated in order to: identify the critical effect identify the corresponding No-Observed-Adverse-Effect-Level (NOAEL) or Lowest- Observed-Adverse-Effect-Level (LOAEL) calculate a health-based limit of exposure for risk characterization according to the (NOAEL or LOAEL) / (Assessment Factor) approach. Target pollutant End-point Study NOAEL or LOAEL Assessment Factors Limit of Exposure acrolein short-term expo increase in eye blinking rate Weber-Tschopp et al. (1977) (human study) NOAEL: 0.39 mg/m 3 (0.17 ppm) intra-species: 5 78 μg/m 3 (34 ppb) subjective eye irritation Weber-Tschopp et al. (1977) (human study) LOAEL: 0.21 mg/m 3 (0.09 ppm) LOAEL-to-NOAEL: 2* intra-species: 5 21 μg/m 3 (9 ppb)* acrolein long-term expo nasal respiratory epithelium lesions Dorman et al. (2008) (animal study) NOAEL adj : 82.8 μg/m 3 (36 ppb) inter-species: 3 intra-species: 2 duration: 1 10 μg/m 3 (4 ppb) formaldehyde short-term expo subjective and objective eye irritation Lang et al. (2008)** (human study) NOAEL: 0.63 mg/m 3 (0.5 ppm) intra-species: 5 100 μg/m 3 WHO IAQ-GV (30-min) formaldehyde long-term expo short-term WHO guideline value of 100 μg/m 3 considered protective against long-term effects naphthalene short-term expo inadequate data to establish DNEL naphthalene long-term expo severe nasal effects NTP (2000) (animal study) LOAEL adj : 10 mg/m 3 LOAEL-to-NOAEL: 10 inter-species: 10 intra-species: 10 10 μg/m 3 WHO IAQ-GV*** (annual) d-limonene short-term expo subjective eye, nose, throat irritation Falk-Filipsson et al. (1993) (human study) NOAEL: 450 mg/m 3 (81 ppm) intra-species: 5 90 mg/m 3 (16 ppm) d-limonene long-term expo inadequate data of long-term exposure. Extrapolation from short-term expo data. intra-species: 5 duration: 10 9 mg/m 3 (1.6 ppm) α-pinene short-term expo subjective eye, nose, throat irritation Falk et al. (1990) (human study) LOAEL: 450 mg/m 3 (81 ppm) LOAEL-to-NOAEL: 2 intra-species: 5 45 mg/m 3 (8 ppm) α-pinene long-term expo inadequate data of long-term exposure. Extrapolation from short-term expo data. LOAEL-to-NOAEL: 2 intra-species: 5 duration: 10 4.5 mg/m 3 (0.8 ppm) * LOAEL-to-NOAEL: 1 may be used as a less conservative approach resulting in a limit of exposure of 42 μg/m 3 (18 ppb) ** supported by Mueller et al. (2013) *** conservative approach use of default assessment factors (2) Exposure assessment: Construction of scenarios for the use of 15 consumer products by two population groups (Housewives, Retired) in 4 geographical areas of Europe (North, West, South, East), based on further analysis of IPSOS data. “Most representative worst-case scenario” strategy: scenarios reflecting the worst-cases for the use of each product, under realistic conditions, used for HRA. Microenvironmental modelling to simulate indoor air pollutant concentrations in dwellings, resulting from the use of the 15 consumer products, with inputs: Quantified emission rates derived from chamber testing, according to the above constructed scenarios. Ventilation rates from literature (N: 0.3, S: 0.5, E: 0.75, W: 0.35 ach Dimitroulopoulou, 2012) plus ventilation ‘zero’ (0.1 ach) to be proactive in case of ‘airtight’ future building regulations. Room volumes derived from data across EU countries (Dol and Haffner, 2010). ‘CONC_CPM’ model used: Outcome: indoor air concentrations (μg/m 3 ) in home microenvironments acute exposure (max 30-min rolling average) long-term exposure (24 h mean) (3) Risk Characterization: Comparison of microenvironmental modelling outcome with health-based limits of exposure derived for the purposes of EPHECT for each target compound . HEALTH RISK ASSESSMENT ASSOCIATED WITH EMISSIONS FROM HOUSEHOLD USE OF SELECTED CONSUMER PRODUCTS The case of single product use’ 90 m2 dwelling 90 m2 dwelling 90 m2 dwelling 64 m2 dwelling N S W E LIVING ROOM 90 m3 90 m3 90 m3 64 m3 BEDROOM 45 m3 45 m3 45 m3 32 m3 KITCHEN 30 m3 30 m3 30 m3 21 m3 WC 24 m3 24 m3 24 m3 17 m3 Results i. per target compound: ii. per consumer product class: i j j i t t s j j i t t V C C E t V C t C 1 0 0 )] ( exp[ ] ) ( [ 1 ) ( Where 0 C the room initial concentration j E the pollution emission rate within time step j t the room ventilation rate d the pollutant decay rate k denotes the surrounding microenvironment k (i.e. outdoors and surrounding spaces) For each of the five target pollutants emitted from the selected consumer products tested, the estimated worst-case indoor air concentration in each microenvironment, resulting from the most representative conditions of single product use, was lower than the corresponding limit of exposure, both in the case of acute (30 min) and long- term (24 h) exposure. Restriction: acrolein d-limonene naphthalene formaldehyde α-pinene 30 min product 1: d-limonene 1715 μg/m3 (1.9 % - 2.2 % in case of 0.1 ach) 24 h product 1: d-limonene 142 μg/m 3 (1.6 % - 8.6 % in case of 0.1 ach) 30 min product 1: formaldehyde 82 μg/m3 (82 % - 96 % in case of 0.1 ach) 30 min product 2: formaldehyde 20 μg/m3 (20 % - 21 % in case of 0.1 ach) 24 h product 1: formaldehyde 8 μg/m3 (8 % - 37 % in case of 0.1 ach) 24 h product 2: formaldehyde 3 μg/m3 (3 % - 8 % in case of 0.1 ach) 24 h product 2: naphthalene 1.5 μg/m3 (15 % - 40 % in case of 0.1 ach) 30 min product 1: acrolein 1 μg/m3 (4 % - 9 % in case of 0.1 ach ) 30 min product 1: formaldehyde 10 μg/m3 (10 % - 20 % in case of 0.1 ach) 30 min product 2: formaldehyde 9 μg/m3 (9 % - 18 % in case of 0.1 ach) 24 h product 1: acrolein 0.2 μg/m3 (1.8 % - 8 % in case of 0.1 ach) 24 h product 1: formaldehyde 2 μg/m3 (2 % - 9 % in case of 0.1 ach) 24 h product 2: formaldehyde 2 μg/m3 (2 % - 8 % in case of 0.1 ach) 30 minproduct 1: formaldehyde 16.5 μg/m3 (16.5 % - 47.6 % in case of 0.1 ach) 24 h product 1: formaldehyde 9.4 μg/m3 (9.4 % - 30 % in case of 0.1 ach) A2 kitchen cleaning agent A3 floor cleaning agent A6 furniture polish A8 candle A11 electric air freshener Max results per compound (30 min): Max results per compound (24 h): acrolein (A8 candle 1): about 4 % of its limit of exposure formaldehyde (A3 floor cleaning agent 1): about 82 % of its limit of exposure d-limonene (A2 kitchen cleaning agent 1): about 2 % of its limit of exposure α-pinene (A3 floor cleaning agent 2): about 0.04 % of its limit of exposure acrolein (A8 candle 1): about 2 % of its limit of exposure formaldehyde (A3 floor cleaning agent 1): about 8 % of its limit of exposure naphthalene (A6 furniture polish 2): about 15 % of its limit of exposure d-limonene (A2 kitchen cleaning agent 1): about 2 % of its limit of exposure α-pinene (A10 passive air freshener 2): about 0.2 % of limit of exposure Results > 1 % of health-based limit of exposure: Conclusion European collaborative action - Small scale project -June 2010 October 2013 EPHECT is co-funded by European Union (Executive Agency for Health and Consumers- EAHC), framework of the Health Programmes 2006-2013

HEALTH RISK ASSESSMENT ASSOCIATED WITH EMISSIONS … · 30 min–product 1: formaldehyde 16.5 µg/m3 (16.5 % - 47.6 % in case of 0.1 ach) 24 h – product 1: formaldehyde 9.4 µg/m3

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Page 1: HEALTH RISK ASSESSMENT ASSOCIATED WITH EMISSIONS … · 30 min–product 1: formaldehyde 16.5 µg/m3 (16.5 % - 47.6 % in case of 0.1 ach) 24 h – product 1: formaldehyde 9.4 µg/m3

www.ephect.eu

EMISSIONS, EXPOSURE PATTERNS and HEALTH EFFECTS of

CONSUMER PRODUCTS in the EU

M. Trantallidi1, P. Carrer1, C. Dimitroulopoulou2, G. Efthimiou2, J. Bartzis2, P. Wolkoff3 1Occupational and Environmental Health, Dept. of Biomedical and Clinical Sciences, University of Milan, Italy

2Mechanical Engineering Dept., University of West Macedonia, Greece 3Indoor Environment Group, National Research Centre for the Working Environment, Denmark

Focus • HRA was conducted accounting only irritative and respiratory end-points, since EPHECT

focuses on air pollutants considered to be risk factors of respiratory diseases.

• Housewives and retired people (> 65 years old) were considered as target population, as these groups spend the majority of their time indoors.

• For acute exposure, a 30-min time period was chosen, reflecting exposure during use of the product.

• For long-term exposure, a 24-h time period was selected, reflecting exposure during daily activity of the target population (considered as representative of all days of a year).

• A ‘worst-case scenario’ strategy was followed for HRA.

Selection of target compounds On the basis of a literature review, evaluation of toxicological information from inhalation exposure studies and assessment of chamber testing results, the following pollutants were selected for HRA:

Methodology (1) Hazard identification and dose – response relationship:

Human and animal toxicological data regarding effects of short- and long- term inhalation exposure to the target compounds were evaluated in order to:

• identify the critical effect

• identify the corresponding No-Observed-Adverse-Effect-Level (NOAEL) or Lowest-Observed-Adverse-Effect-Level (LOAEL)

• calculate a health-based limit of exposure for risk characterization according to the (NOAEL or LOAEL) / (Assessment Factor) approach.

Target

pollutant End-point Study

NOAEL

or LOAEL Assessment Factors Limit of Exposure

acrolein

short-term expo

increase in eye

blinking rate

Weber-Tschopp et al. (1977)

(human study)

NOAEL: 0.39 mg/m3 (0.17 ppm) intra-species: 5 78 µg/m3 (34 ppb)

subjective eye

irritation

Weber-Tschopp et al. (1977)

(human study)

LOAEL: 0.21 mg/m3 (0.09 ppm) LOAEL-to-NOAEL: 2*

intra-species: 5

21 µg/m3 (9 ppb)*

acrolein

long-term expo

nasal respiratory

epithelium lesions

Dorman et al. (2008)

(animal study)

NOAELadj: 82.8 µg/m3 (36 ppb) inter-species: 3

intra-species: 2

duration: 1

10 µg/m3 (4 ppb)

formaldehyde

short-term expo

subjective and

objective eye

irritation

Lang et al. (2008)**

(human study)

NOAEL: 0.63 mg/m3 (0.5 ppm) intra-species: 5

100 µg/m3

WHO IAQ-GV (30-min)

formaldehyde

long-term expo short-term WHO guideline value of 100 µg/m3 considered protective against long-term effects

naphthalene

short-term expo inadequate data to establish DNEL

naphthalene

long-term expo

severe nasal

effects

NTP (2000)

(animal study)

LOAELadj: 10 mg/m3 LOAEL-to-NOAEL: 10

inter-species: 10

intra-species: 10

10 µg/m3

WHO IAQ-GV***

(annual)

d-limonene

short-term expo

subjective eye,

nose, throat

irritation

Falk-Filipsson et al. (1993)

(human study)

NOAEL: 450 mg/m3 (81 ppm) intra-species: 5 90 mg/m3 (16 ppm)

d-limonene

long-term expo inadequate data of long-term exposure. Extrapolation from short-term expo data.

intra-species: 5

duration: 10

9 mg/m3 (1.6 ppm)

α-pinene

short-term expo

subjective eye,

nose, throat

irritation

Falk et al. (1990)

(human study)

LOAEL: 450 mg/m3 (81 ppm) LOAEL-to-NOAEL: 2

intra-species: 5

45 mg/m3 (8 ppm)

α-pinene

long-term expo inadequate data of long-term exposure. Extrapolation from short-term expo data.

LOAEL-to-NOAEL: 2

intra-species: 5

duration: 10

4.5 mg/m3 (0.8 ppm)

* LOAEL-to-NOAEL: 1 may be used as a less conservative approach resulting in a limit of exposure of 42 µg/m3 (18 ppb)

** supported by Mueller et al. (2013)

*** conservative approach – use of default assessment factors

(2) Exposure assessment:

Construction of scenarios for the use of 15 consumer products by two population groups (Housewives, Retired) in 4 geographical areas of Europe (North, West, South, East), based on further analysis of IPSOS data.

“Most representative worst-case scenario” strategy: scenarios reflecting the worst-cases for the use of each product, under realistic conditions, used for HRA.

Microenvironmental modelling to simulate indoor air pollutant concentrations in dwellings, resulting from the use of the 15 consumer products, with inputs:

• Quantified emission rates derived from chamber testing, according to the above constructed scenarios.

• Ventilation rates from literature (N: 0.3, S: 0.5, E: 0.75, W: 0.35 ach – Dimitroulopoulou, 2012) plus ventilation ‘zero’ (0.1 ach) to be proactive in case of ‘airtight’ future building regulations.

• Room volumes derived from data across EU countries (Dol and Haffner, 2010).

‘CONC_CPM’ model used:

Outcome: indoor air concentrations (µg/m3) in home microenvironments acute exposure (max 30-min rolling average) long-term exposure (24 h mean)

(3) Risk Characterization:

Comparison of microenvironmental modelling outcome with health-based limits of exposure derived for the purposes of EPHECT for each target compound .

HEALTH RISK ASSESSMENT ASSOCIATED WITH EMISSIONS FROM HOUSEHOLD USE OF SELECTED CONSUMER PRODUCTS

‘The case of single product use’

90 m2 dwelling 90 m2 dwelling 90 m2 dwelling 64 m2 dwelling

N S W E

LIVING ROOM 90 m3 90 m3 90 m3 64 m3

BEDROOM 45 m3 45 m3 45 m3 32 m3

KITCHEN 30 m3 30 m3 30 m3 21 m3

WC 24 m3 24 m3 24 m3 17 m3

Results i. per target compound:

ii. per consumer product class:

i

j

jittsjji ttVCCEtV

CtC1

00 )](exp[])([1

)(

Where

0C the room initial concentration

jE the pollution emission rate within time step jt

the room ventilation rate

d the pollutant decay rate

k denotes the surrounding microenvironment k (i.e. outdoors and surrounding spaces)

For each of the five target pollutants emitted from the selected consumer products tested, the estimated worst-case indoor air concentration in each microenvironment, resulting from the most representative conditions of single product use, was lower than the corresponding limit of exposure, both in the case of acute (30 min) and long- term (24 h) exposure.

Restriction:

acrolein

d-limonene naphthalene

formaldehyde

α-pinene

30 min – product 1: d-limonene 1715 µg/m3 (1.9 % - 2.2 % in case of 0.1 ach) 24 h – product 1: d-limonene 142 µg/m3 (1.6 % - 8.6 % in case of 0.1 ach)

30 min – product 1: formaldehyde 82 µg/m3 (82 % - 96 % in case of 0.1 ach) 30 min – product 2: formaldehyde 20 µg/m3 (20 % - 21 % in case of 0.1 ach) 24 h – product 1: formaldehyde 8 µg/m3 (8 % - 37 % in case of 0.1 ach) 24 h – product 2: formaldehyde 3 µg/m3 (3 % - 8 % in case of 0.1 ach)

24 h – product 2: naphthalene 1.5 µg/m3 (15 % - 40 % in case of 0.1 ach)

30 min – product 1: acrolein 1 µg/m3 (4 % - 9 % in case of 0.1 ach ) 30 min – product 1: formaldehyde 10 µg/m3 (10 % - 20 % in case of 0.1 ach) 30 min – product 2: formaldehyde 9 µg/m3 (9 % - 18 % in case of 0.1 ach) 24 h – product 1: acrolein 0.2 µg/m3 (1.8 % - 8 % in case of 0.1 ach) 24 h – product 1: formaldehyde 2 µg/m3 (2 % - 9 % in case of 0.1 ach) 24 h – product 2: formaldehyde 2 µg/m3 (2 % - 8 % in case of 0.1 ach)

30 min–product 1: formaldehyde 16.5 µg/m3 (16.5 % - 47.6 % in case of 0.1 ach) 24 h – product 1: formaldehyde 9.4 µg/m3 (9.4 % - 30 % in case of 0.1 ach)

A2 kitchen cleaning agent

A3 floor cleaning agent

A6 furniture polish

A8 candle

A11 electric air freshener

Max results per compound (30 min):

Max results per compound (24 h):

acrolein (A8 candle 1): about 4 % of its limit of exposure formaldehyde (A3 floor cleaning agent 1): about 82 % of its limit of exposure d-limonene (A2 kitchen cleaning agent 1): about 2 % of its limit of exposure α-pinene (A3 floor cleaning agent 2): about 0.04 % of its limit of exposure

acrolein (A8 candle 1): about 2 % of its limit of exposure formaldehyde (A3 floor cleaning agent 1): about 8 % of its limit of exposure naphthalene (A6 furniture polish 2): about 15 % of its limit of exposure d-limonene (A2 kitchen cleaning agent 1): about 2 % of its limit of exposure α-pinene (A10 passive air freshener 2): about 0.2 % of limit of exposure

Results > 1 % of health-based limit of exposure:

Conclusion

European collaborative action - Small scale project -June 2010 – October 2013 EPHECT is co-funded by European Union (Executive Agency for Health and Consumers- EAHC), framework of the Health Programmes 2006-2013