Soil Generic Assessment Criteria for Human Health Risk ... - ESdat
Soil Generic Assessment Criteria for Human Health Risk ... - ESdat Soil Generic Assessment Criteria for Human Health Risk ... - ESdat
www.esdat.net Esdat Environmental Database Management Software +61 2 8875 7948 Bromodichloromethane ID oral Organisation Study type Description Response Reference Web link International Agency for Research on Cancer (IARC) WHO Guidelines for drinking water Quality Carcinogenesis bioassay in F344/N rats and B6C3F1 mice. Gavage with corn oil containing bromodichlorometh ane. BDCM in corn oil, when administered to rats by gavage for 102 weeks at doses ranging from 50 to 100 mg/kg of body weight per day, resulted in increased incidences of renal tubular cell adenomas and adenocarcinomas affecting both sexes and a markedly increased incidence of large intestinal tumours (combined adenomas and carcinomas) in both sexes. In mice, BDCM in corn oil, administered by gavage for 102 weeks at dose levels of 0, 25, or 50 mg/kg of body weight per day or 0, 75, or 150 mg/kg of body weight per day in males and females, respectively, caused renal cytomegaly and hepatic fatty metamorphosis, increased incidences of renal tubular adenomas and carcinomas in males, and an increased incidence of combined hepatocellular adenomas and carcinomas in females. The tumours of the large intestine (combined NTP, 1987 adenomatous polyps and carcinomas) in rats were chosen for cancer risk assessment, as they occurred with the highest frequency and affected both sexes in the study, and because of the apparent epidemiological association of this group of compounds (THMs) with colorectal cancer in humans. Furthermore, these tumours appear most likely to be associated with a mutagenic mechanism, as they were not associated with underlying cytotoxicity or other non-epigenetic mechanism. The combined large intestinal tumours had high unit risk value, equal to or higher than the unit risks for the other tumour types in rats (kidney and liver) identified in carcinogenicity studies with this compound. A cancer risk assessment was also conducted in mice, although tumours (combined renal adenomas and adenocarcinomas) were observed only in males. http://www.inchem.org/documents/iarc/vol71/067-bromodicmet.html http://www.who.int/water_sanitation_health/dwq/chemicals/THM200605.pdf Health Canada Toxicological Values Carcinogenesis bioassay in F344/N rats and B6C3F1 mice. Gavage with corn oil containing bromodichlorometh ane. Multistage model used on NTP bioassay data described for WHO above. An allometric scaling factor was applied to the final unit risks, assuming a rat weighs 0.35 kg, a mouse weighs 0.03 kg, and a human weighs 70 kg. in F344/N rats (i.e., intestinal adenomatous polyps and adenocarcinomas; renal tubular cell adenomas and adenocarcinomas) and in male B6C3F1 mice (renal adenomas and adenocarcinomas NTP, 1987 http://www.hc-sc.gc.ca/ewh-semt/pubs/water-eau/trihalomethanes/exposure-expositioneng.php#a2 USEPA Health Advisors Carcinogenesis bioassay in F344/N rats and B6C3F1 mice. Gavage with corn oil containing bromodichlorometh ane. As study referred to for WHO Drinking Water Standards above Renal tumours in rats and male mice NTP, 1987 http://www.epa.gov/waterscience/criteria/drinking/brthm-200605(508).pdf USEPA Health Advisors as above as above as above as above as above Page 4 of 6 EIC_proforma_bromodichloromethane 09/09/2009
www.esdat.net Esdat Environmental Database Management Software +61 2 8875 7948 Bromodichloromethane CAS Number: 75-27-4 Assessor A: J Brown - DTS Raeburn Assessor B: S Cole, URS Final review: Panel/SF Date 21/05/2009 Date 10/08/2009 Date 08/09/2009 USEPA Integrated Risk Information System (IRIS) http://epa.gov/iris/ Mar-93 18/05/2009 B2; probable human carcinogen Based on inadequate human data and Oral slope factor sufficient evidence of carcinogenicity in two animal species (mice and rats) as shown by increased incidence of kidney tumours and tumours of the large intestine in male and female rats, kidney tumours in male mice, and liver tumours in female mice 0.062 (equivalent (mg/kg/day) -1 to 0.16 ug/kg/d for lifetime cancer risk of 10-5) Adequate numbers of animals were used for a lifetime Linearized multistage method used to derive cancer slope factors from 4.9e-3 bioassay with two animal species. to 6.2e-2 per mg/kg/d. Most conservative (6.2e-2) adopted by IRIS as the oral Bromodichloromethane was administered at two dose slope factor. levels. Tumours of multiple tissue types were observed in a dose-related manner. Slope factors derived from tumour incidences of kidney and large intestine are similar and within one order of magnitude in differences. ID inhal Recommended IDinhal Units n/a Justification No information available. Organisation Web Link Last Updated Date Web Checked Non threshold effects Basis Health criteria type Value Units Confidence rating Basis Page 5 of 6 EIC_proforma_bromodichloromethane 09/09/2009
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www.esdat.net Esdat Environmental Database Management Software +61 2 8875 7948<br />
Bromodichloromethane<br />
ID oral<br />
Organisation<br />
Study type Description Response Reference Web link<br />
International Agency <strong>for</strong> Research on<br />
Cancer (IARC)<br />
WHO Guidelines <strong>for</strong> drinking water Quality<br />
Carcinogenesis<br />
bioassay in F344/N<br />
rats and B6C3F1<br />
mice. Gavage with<br />
corn oil containing<br />
bromodichlorometh<br />
ane.<br />
BDCM in corn oil, when administered to rats by<br />
gavage <strong>for</strong> 102 weeks at doses ranging from 50<br />
to 100 mg/kg of body weight per day, resulted<br />
in increased incidences of renal tubular cell<br />
adenomas and adenocarcinomas affecting both<br />
sexes and a markedly increased incidence of<br />
large intestinal tumours (combined adenomas<br />
and carcinomas) in both sexes. In mice, BDCM<br />
in corn oil, administered by gavage <strong>for</strong> 102<br />
weeks at dose levels of 0, 25, or 50 mg/kg of<br />
body weight per day or 0, 75, or 150 mg/kg of<br />
body weight per day in males and females,<br />
respectively, caused renal cytomegaly and<br />
hepatic fatty metamorphosis, increased<br />
incidences of renal tubular adenomas and<br />
carcinomas in males, and an increased<br />
incidence of combined hepatocellular<br />
adenomas and carcinomas in females.<br />
The tumours of the large intestine (combined NTP, 1987<br />
adenomatous polyps and carcinomas) in rats<br />
were chosen <strong>for</strong> cancer risk assessment, as they<br />
occurred with the highest frequency and<br />
affected both sexes in the study, and because of<br />
the apparent epidemiological association of this<br />
group of compounds (THMs) with colorectal<br />
cancer in humans. Furthermore, these tumours<br />
appear most likely to be associated with a<br />
mutagenic mechanism, as they were not<br />
associated with underlying cytotoxicity or other<br />
non-epigenetic mechanism. The combined large<br />
intestinal tumours had high unit risk value, equal<br />
to or higher than the unit risks <strong>for</strong> the other<br />
tumour types in rats (kidney and liver) identified<br />
in carcinogenicity studies with this compound. A<br />
cancer risk assessment was also conducted in<br />
mice, although tumours (combined renal<br />
adenomas and adenocarcinomas) were<br />
observed only in males.<br />
http://www.inchem.org/documents/iarc/vol71/067-bromodicmet.html<br />
http://www.who.int/water_sanitation_health/dwq/chemicals/THM200605.pdf<br />
<strong>Health</strong> Canada Toxicological Values<br />
Carcinogenesis<br />
bioassay in F344/N<br />
rats and B6C3F1<br />
mice. Gavage with<br />
corn oil containing<br />
bromodichlorometh<br />
ane.<br />
Multistage model used on NTP bioassay data<br />
described <strong>for</strong> WHO above. An allometric scaling<br />
factor was applied to the final unit risks,<br />
assuming a rat weighs 0.35 kg, a mouse weighs<br />
0.03 kg, and a human weighs 70 kg.<br />
in F344/N rats (i.e., intestinal adenomatous<br />
polyps and adenocarcinomas; renal tubular cell<br />
adenomas and adenocarcinomas) and in male<br />
B6C3F1 mice (renal adenomas and<br />
adenocarcinomas<br />
NTP, 1987<br />
http://www.hc-sc.gc.ca/ewh-semt/pubs/water-eau/trihalomethanes/exposure-expositioneng.php#a2<br />
USEPA <strong>Health</strong> Advisors<br />
Carcinogenesis<br />
bioassay in F344/N<br />
rats and B6C3F1<br />
mice. Gavage with<br />
corn oil containing<br />
bromodichlorometh<br />
ane.<br />
As study referred to <strong>for</strong> WHO Drinking Water<br />
Standards above<br />
Renal tumours in rats and male mice NTP, 1987 http://www.epa.gov/waterscience/criteria/drinking/brthm-200605(508).pdf<br />
USEPA <strong>Health</strong> Advisors<br />
as above as above as above as above as above<br />
Page 4 of 6 EIC_pro<strong>for</strong>ma_bromodichloromethane 09/09/2009