Soil Generic Assessment Criteria for Human Health Risk ... - ESdat

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Styrene CAS Number: 100-42-5 Assessor A: Nick Brown, Grontmij Assessor B: Catherine Helm WD Final Review: Panel/SF
Date 26/05/2009 Date 01/06/2009 Date 28/08/2009
Apply TDIoral to exposure routes
Apply IDoral to exposure routes
Apply TDIinh to exposure routes
Apply IDinh to exposure routes
Oral
Inhalation
Dermal
Yes Yes No
No No No
No No Yes
No No No
Combine Oral and Inhalation
TDIs
Yes
Justification
IARC has classified styrene as a Group 2B Carcinogen (possible human carcinogen). Potential carcinogenicity linked to styrene oxide. ATSDR concluded that
humans have a high capacity to metabolise styrene oxide to styrene glycol and therefore low potential for carcinogenic activity from styrene. WHO concluded
that potential genotoxic effects are not critical endpoints for development of HCVs. Health Council of the Netherlands concluded evidence for carcinogenicity
in humans is weak and inconsistent. TDIoral applied to oral and dermal routes. TDIinhal applied to inhalation route.
TDI oral Recommended TDIoral Units
12
ug.kg-1.d-1
Justification
Value based on NOAEL of 12mg/kg bw/day identified by RIVM (Charles River rat study). An uncertainty factor of 1000 has been selected as recomended by SCF, IPCS, WHO, ATSDR
and IRIS. Note that the WHO NOAEL has been incorrectly associated with the male rats and therefore the RIVM NOAEL (based on the same study) preferred.
Organisation Web Link Last Updated Date Web Checked Health criteria type Value Units CLEA Units ug.kg-1.d-1 Confidence
rating
Health Protection Agency (HPA) http://www.hpa.org.uk/ 05/05/2009 Stated that no HCV
values are available
0.02mg/l Drinking water
quality standard
mg/l
Basis Value Units UF UF description Study type
25/03/2009 31/03/2009 Acute oral toxicity
rats, LD50
Acute oral toxicity
mice, LD50
5000 rats
316 mice
Health and Safety Executive (HSE) http://www.hse.gov.uk/ 01/04/2009 Acute NOAEL 100 ppm
mg/kg bw/day
HSE 2
Repeated dose
NOAEL
200 ppm Over 13 weeks in
rats
Scientific Committee on Food (SCF) pre 2002
http://ec.europa.eu/food/fs/sc/scf/index_en.h
tml
05/05/2009 TDI for food 7.7 ug/kg-bw/day 7.7 NOAEL 7.7 mg/kg bw/day 1000 See WHO guidelines for DW See WHO
guidelines for DW
International Programme on Chemical Safety
(IPCS)
http://www.who.int/ipcs/en/ Published 2003 05/05/2009 TDI 7.7 ug/kg-bw/day 7.7 NOAEL 7.7 mg/kg bw/day 1000 x 100 for intra species and inter species
variation and x 10 for carcinogenicity
and genotoxicity of the
intemermediation styrene-7,8-oxide
Charles River
COBS CD 2 year
study of drinking
water in rats
IPCS INCHEM http://inchem.org/ 05/05/2009 TDI 0.04 mg/kg-bw/day 40 NOAEL 7.7 mg/kg bw/day 192.5 (Calculated from
NOAEL level and value
recommended)
Unclear - Basis for NOAEL specified as
7.7mg/kg/day in rats
Charles River
COBS CD 2 year
study of drinking
water in rats
WHO Guidelines for drinking water Quality
http://www.who.int/water_sanitation_health
/dwq/guidelines/en
Published 2006 05/05/2009 TDI 7.7 ug/kg-bw/day 7.7 NOAEL 7.7 mg/kg bw/day 1000 x 100 for intra species and inter species
variation and x 10 for carcinogenicity
and genotoxicity of the
intemermediation styrene-7,8-oxide
Charles River
COBS CD 2 year
study of drinking
water in rats
Dutch National Institute for Public Health and http://www.rivm.nl/en/ Published 2001 05/05/2009 TDI 120 ug/kg-bw/day 120 NOAEL 12 mg/kg bw/day 100 × 10 for interspecies variation, × 10 for
the Environment (RIVM) Maximum
intraspecies variation
Permissible Risk (MPR) levels
2 year study of
drinking water in
rats
Health Canada Toxicological Values http://www.hc-sc.gc.ca/index_e.html 05/05/2009 TDI 120 ug/kg-bw/day 120 NOAEL 12 mg/kg bw/day 100 × 10 for interspecies variation, × 10 for
intraspecies variation
US Agency for Toxic Substances and Disease http://www.atsdr.cdc.gov/ 05/05/2009 Acute MRL 100 ug/kg/day 100 Acute Oral MRL 1000
Registry (ATSDR) Toxicological Profiles and
Minimal Risk levels
USEPA Acute Guideline Levels (AEGLs) http://epa.gov/oppt/aegl/pubs/chemlist.htm 12/12/2006 09/04/2009 AEGLs over 8 hours 20, 130, 340 ppm
Beliles 1985:
Sprague-Dawley
Rat Study
USEPA Health Advisors
USEPA Integrated Risk Information System
(IRIS)
http://www.epa.gov/waterscience/criteria/dri
nking
Summer 2006 09/04/2009 RfD 0.2 mg/kg/day 200
http://epa.gov/iris/ 05/05/2009 RfD 200 ug/kg-bw/day 200 NOAEL 200 mg/kg bw/day 1000 × 10 for interspecies variation, × 10 for
intraspecies variation, x 10 sub-chronic
to chronic
Quast Dog Study
Toxicology Data Network (Toxnet) http://toxnet.nlm.nih.gov/ 05/05/2009 RfD as above as above as above as above as above as above as above as above
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EIC Proforma styrene.xls28/08/2009]