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

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Dichloromethane
TDI inhal
Organisation
Study type Description Response Reference Web link
International Programme on Chemical Safety
(IPCS)
Joint Expert Committee on Food Additives
(JECFA)
WHO Air Quality guidelines for Europe
As WHO As WHO As WHO As WHO As WHO
As WHO As WHO As WHO As WHO As WHO
Linear extrapolation from Divecenzo and
Kaplan (1981) - Human study of vapour
intake
Humans exposed to doses between 175-Critical effect linked to the accumulation of
700mg/m3 for 7.5 hours - exhaled
vapours were analysed to allow
estimation of biotransformation
carboxyhaemoglobin (COHb) to unsafe
levels (3%). The recommended value of
3mg/m3 is predicted to cause a 0.1%
increase in COHb
WHO Regional Office for Europe, Copenhagen, Denmark. 2000, Air Quality
Guidelines 2nd Edition Primary study reference: Divecenzo GD and Kaplan CJ
(1981): Effect of exercise or smoking on the uptake, metabolism and excretion
of methylene chloride vapour by humans. Toxicol Appl Parmacol 59, 141-148
http://www.euro.who.int/document/aiq/5_7dichloromethane.pdf
Dutch National Institute for Public Health and
the Environment (RIVM) Maximum
Permissible Risk (MPR) levels
RIVM have adopted WHO approach. See
above
RIVM have adopted WHO approach.
See above
RIVM have adopted WHO approach. See
above
RIVM Report 711701 025. Re-evaluation of human toxicological maximum
permissible risk levels A.J. Bars, R.M.C Theelan, P.J.C.M. Janssen, J.M. Hesse,
M.E. van Apeldoorn, M.C.M. Meijerink, L.Verdam, M.J.Zeilmaker March 2001
http://www.rivm.nl/bibliotheek/rapporten/711701025.pdf
US Agency for Toxic Substances and Disease
Registry (ATSDR) Toxicological Profiles and
Minimal Risk levels
Chronic inh. To determine NOAEL
To determine a NOAEL for toxicity and
carcinogenicity exposure
concentrations of 0, 50, 200 and
500ppm selected. Sprague Dawley Rats
exposed for 6hrs/day and 5 days/week
for 2 years. NOAEL of 50 ppm identified
and used to determine MRL
Liver: Hepatocellular cytoplasmic
vacuolisation consistent with fatty changes
and multinucleated hepatocytes
Nitsche KD, Burek JD, Bell TJ, et al 1988a. Methylene Chloride: A 2-year
inhalation toxicity and oncogenicity study in rats. Fundam Appl Toxic 11:60-67.
http://www.atsdr.cdc.gov/toxprofiles/tp14-a.pdf
ATSDR 2
Acute symptoms associated with
oxygen deprivation as a result of
carboxyhaemoglobin accumulation
No Info
http://www.atsdr.cdc.gov/MHMI/mmg14.pdf
ID oral
Organisation
Study type Description Response Reference Web link
USEPA Integrated Risk Information System
(IRIS)
Toxicology Data Network (Toxnet)
mouse/B6C3F1 B6C3F1 mice received 0, 60, 125, 185,
or 250 (mg/kg)/day of dichloromethane
in drinking water. Treatment groups
consisted of 50 female mice and 200,
100, 100, and 125 male mice (low to
high dose). One hundred females and
125 males served as controls.
See IRIS data See IRIS data See IRIS data
Male mice had an increased incidence of
combined neoplastic nodules and
hepatocellular carcinoma (24/125, 51/200,
30/100, 31/99, 35/125). The increase was
not dose-related, but the pair wise
comparisons for the two mid- dose groups
were reported to be statistically significant
(U.S. EPA, 1985a). The hepatocellular
carcinoma incidence alone for male mice
(which was about 55 to 65% of the total)
was not significantly elevated.
NCA (National Coffee Association). 1983. Twenty-four month oncogenicity
study of methylene chloride in mice. Final Report. Prepared by Hazleton
Laboratories, America, Inc., Vienna, VA.
http://toxnet.nlm.nih.gov/cgi-bin/sis/search/f./temp/~ic5Vi3:1
http://toxnet.nlm.nih.gov/cgi-bin/sis/search/f./temp/~ic5Vi3:1
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