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

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1,2-Dichloropropane CAS Number: 78-87-5 Assessor A: J Lymer, Wardell Armstrong Assessor B: D Brooks, Sirius
Final Review: Panel/SF
Date 13/03/2009
Date 14/04/2009
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
Group 3 carcinogen (IARC), not classifiable as to its
carcinogenicity to humans - TDIoral applied to oral
and dermal routes
Group 3 carcinogen (IARC), not classifiable as to its
carcinogenicity to humans - TDIinh applied to
inhalation routes
TDI oral
Recommended
TDIoral
Units
14 ug.kg-1.d-1
Justification
WHO most appropriate value as this is the only fully referenced value
Organisation Web Link Last Updated Date Web Checked Health criteria type Value Initial Units CLEA units ug.kg-
1.d-1
Committee on the Toxicity of Chemicals in
Food, Consumer Products and the
Environment (COT)
http://cot.food.gov.uk/ Sep-02 13/03/2009 No health criteria
value data
Confidence
rating
Basis Value Units UF UF description Study type Description
Genotoxicity in
rodents
1,2-Dichloropropane was a likely candidate in
producing potential genotoxicity as a component
of a pesticide
International Agency for Research on Cancer
(IARC)
http://inchem.org/pages/iarc.html 1999 13/03/2009 No health criteria
value data
There is limited evidence in experimental animals
for the carcinogenicity of 1,2-dichloropropane. No
evaluation of the carcinogenicity of 1,2-
dichloropropane to humans could be made.
IPCS Environmental Health Criteria (EHC)
Monographs
WHO Guidelines for drinking water Quality
http://inchem.org/pages/ehc.html 1993 13/03/2009 No chronic health
criteria value
http://www.who.int/water_sanitation_health
/dwq/guidelines/en
2003 13/03/2009 Oral TDI 14 ug/kg/day 14 N/A LOAEL 71.4 mg/kg/day 5000 100 for inter- and intraspecies
variation, 10 for the use of a LOAEL
instead of a NOAEL, and 5 for
limitations of the database, including
the limited data on in vivo genotoxicity
and use of a subchronic study
Reproductive and
development
(testicular) toxicity
13 week toxicity study in which male rats were
administered with 1,2-DCP by gavage in corn oil
for 5days/week
US Agency for Toxic Substances and Disease
Registry (ATSDR) Toxicological Profiles and
Minimal Risk levels
http://www.atsdr.cdc.gov/
Original December
1989 and published
as MRL December
2008
13/03/2009 Oral chronic MRL 0.09 mg/kg/day 90 N/A 1000
USEPA Integrated Risk Information System
(IRIS)
http://epa.gov/iris/ 01/12/1991 13/03/2009 No health criteria
value data
TDI inhal
Recommended
TDIinhal
1.14 ug.kg-1.d-1
Units
Only available value from reliable source (IRIS) chosen
Organisation Last Updated Health criteria type Value Initial Units CLEA units ug.kg-
1.d-1
US EPA Provisional Peer Reviewed Toxicity
Values (PPRTV)
http://rais.ornl.gov/tox/unauthorized.shtml 30/11/2003 15/07/2009 No health criteria
value data
Confidence
rating
Basis Value Units UF UF description Study type Description
Mice study 80 C3H mice exposed 37 times to 400ppm for 4-7
hrs over 7 months.
USEPA Integrated Risk Information System
(IRIS)
http://epa.gov/iris/ 01/12/1991 13/03/2009 Inhalation RfC 4.00E-03 mg/m3 1.14E+00 Medium LOAEL 1.3 mg/m3 300 The uncertainty factor of 300 reflects a
factor of 10 to protect sensitive
individuals. A factor of 3 is used for
extrapolation from a subchronic study,
since study of the critical effect shows
little progression with exposure time. A
factor of 3 is used for the use of a
minimal LOAEL due to the minimal
nature of the effect. A factor of 3 is
used for interspecies extrapolation due
to the use of dosimetric adjustments.
Mice study
Male and female mice were exposed to 1,2-DCP
for 6 hours per day, 5 days/week for 13 weeks.
ID oral
Recommended
IDoral Units Justification
Organisation Web Link Last Updated Date Web Checked Non threshold
effects
Basis
Health criteria
type
Value Units Confidence rating
Basis
Study type Description
ID inhal
Recommended
IDinhal Units Justification
Organisation Web Link Last Updated Date Web Checked Non threshold
effects
Basis
Health criteria
type
Value Units Confidence rating
Basis
Study type Description
Page 1 of 2 EIC proforma 1,2-dichloropropane.xls 28/08/2009