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

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Dichloromethane CAS Number: 75-09-2
Assessor A: Nick Brown, Grontmij Assessor B Catherine Helm, WD Final Review:
Panel/SF
Environmental
Date 26/05/2009 Date 01-Jun-09 Date 28/08/2009
TDI inhal Recommended TDIinhal Units
134.3 ug.kg-1.d-1
Justification
Derived from WHO weekly average. WHO based on human study, most conservative value.
Organisation Last Updated Date Web Checked Health criteria type Value Initial Units CLEA units ug.kg-1.d-1 Confidence rating Basis Value Units UF UF description
International Programme on Chemical Safety
(IPCS)
Joint Expert Committee on Food Additives
(JECFA)
WHO Air Quality guidelines for Europe http://www.euro.who.int/air/activities/20050
222_2
http://www.who.int/ipcs/en/ 01/04/2009 As WHO As WHO As WHO As WHO As WHO As WHO As WHO As WHO As WHO As WHO
http://who.int/ipcs/food/jecfa/en/ 02/04/2009 As WHO As WHO As WHO As WHO As WHO As WHO As WHO As WHO As WHO As WHO
02/04/2009 Air Quality Guideline 3 (0.47 - weekly average) mg/m3 857 (134.3) Predicted to cause 1%
increase in COHb
NA
NA
Dutch National Institute for Public Health and http://www.rivm.nl/en/ Published 2001 02/04/2009 TCA 3000 ug/m3 857 WHO value adopted NA NA
the Environment (RIVM) Maximum
Permissible Risk (MPR) levels
US Agency for Toxic Substances and Disease
Registry (ATSDR) Toxicological Profiles and
Minimal Risk levels
http://www.atsdr.cdc.gov/ 05/05/2009 MRL 0.3 (1.05) ppm
(mg/m3)
300 NOAEL 30 x 3 interspecies and x
10 intraspecies
ATSDR 2 http://www.atsdr.cdc.gov/ 05/05/2009
Maximum
concentration
associated with acute
exposure and
irreversible harm
750 ppm
ID oral Recommended IDoral Units
Justification
N/A
ug.kg-1.d-1
Human studies are considered generally inadequate to demonstrate whether or not DCM is carcinogenic, however, carcinogenicity has been demonstrated in mice and
to a lesser extent in female rats. IRIS provides the carcinogenic Classification —B2; probable human carcinogen. IARC classified dichloromethane as possibly
carcinogenic to humans (Group 2B), based on inadequate evidence for the carcinogenicity of dichloromethane in humans and sufficient evidence for the
carcinogenicity of dichloromethane in experimental animals. Health Canada classified dichloromethane as "probably carcinogenic to humans" (Group II) and has
generated PBEK modified TD05 values (5% incidence of tumours). IRIS has also quantified carcinogenic risk by predicting concentrations equivalent to increased cancer
risk of E-5. In relation to the tendency for tumor development in mice through exposure to DCM by inhalation, TERA comment that; "there are clear species
differences in the putatively carcinogenic pathway of metabolism of dichloromethane which are consistent with the hypothesis that humans are likely to be less
sensitive than some species of experimental animals in this regard". RIVM determined that dichloromethane is not considered to be genotoxic to humans, and
therefore, derived risk values based on a threshold approach. Threshold based HCVs are also provided by ATSDR and WHO.
In view of the uncertainty remaining in relation to the actual carcinogenicity of DCM to humans and uncertainty relating to the methods of quantification of nonthreshold
risk, particularly in view of the guidance provided within SR2, the selection of conservative TDIs is considered more appropriate at this stage than the
derivation Index Doses.
Organisation Web Link Last Updated Date Web Checked Non threshold
effects
USEPA Integrated Risk Information System http://epa.gov/iris/ 02/04/2009
(IRIS)
Basis
Health criteria
type
Carcinogenic risk
level of E-5
Value
Units
Confidence rating
50 ug/l 1.42 Extrapolation Method
— Linearized
multistage procedure,
extra risk
Basis
Yes
Toxicology Data Network (Toxnet) http://toxnet.nlm.nih.gov/ 02/04/2009 Yes See IRIS data See IRIS data See IRIS data See IRIS data See IRIS data See IRIS data
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