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 Hexachloroethane CAS Number: 67-72-1 Assessor A: A Fellows - Ecologia Assessor B: J Brown - DTS RaeFinal review: Panel/SF Date 15.04.09 Date 16.04.09 Date 28/08/2009 Apply TDIoral to exposure routes Apply IDoral to exposoure routes Apply TDIinh to exposure routes Apply IDinh to exposure routes Oral Dermal Inhalation Yes Yes Yes No No No No No No No No No Justification Group C carcinogen (IRIS), Insufficient evidence to be a human carcinogen - TDIoral applied to oral and dermal routes Group C carcinogen (IRIS), Insufficient evidence to be a human carcinogen. Insufficient data to allow formulation of inhalation TDI. TDIoral applied to inhalation exposure routes. TDI oral Recommended TDIoral Initial Units CLEA Units Justification 1 mg/kg/day ug.kg-1.d-1 most conservative value (USEPA and IRIS) Organisation Web Link Last Updated Date Web Checked Health criteria type Value Units Units Confidence Basis Value Units UF UF description Study type US Agency for Toxic Substances and Disease http://www.atsdr.cdc.gov/ Sep-97 06/04/2009 MRL intermediate 0.01 mg/kg/day 10 no data NOAEL 1 mg/kg/day 100 10 for extropaltion from animals to rats Registry (ATDSR) Toxicological Profiles and Minimal Risk levels humans, 10 for inter human variability US Agency for Toxic Substances and Disease Registry (ATDSR) Toxicological Profiles and Minimal Risk levels http://www.atsdr.cdc.gov/ Sep-97 06/04/2009 MRL acute 1 mg/kg/day 1000 no data NOAEL 100 mg/kg/day 100 10 for extrapolation form animals to humans, 10 for human variability rabbits USEPA Health Advisors USEPA Integrated Risk Information System (IRIS) http://www.epa.gov/waterscience/criteria/ drinking Aug-06 06/04/2009 RFD 0.001 mg/kg/day 1 no data no data no data no data no data no data no data http://epa.gov/iris/ 01/01/1991 06/04/2009 RFD 0.001 mg/kg/day 1 Medium NOEL 1 mg/kg/day 1000 10 to account for interspecies rats extrapolation, 10 for the range of sensitivity within the human population to xenobiotics and 10 for the use of a subchronic study. Toxicology Data Network (Toxnet) http://toxnet.nlm.nih.gov/ 1999 14.04.09 TDI 0.0047 mg/kg/day 4.7 LOAEL 0.0047 mg/kg/day 10000 10 for animals to humans, 10 for human variability, 10 for non-chronic study and 10 for LOAEL Sub-chronic oral TDI inhal Recommended TDIinhal Initial Units CLEA Units Justification n/a n/a ug.kg-1.d-1 Current studies undertaken considered insufficient for derivation of TDI Inhalation. Using Oral Extrapolation. Organisation Last Updated Health criteria type Value Units Confidence rating Basis Value Units UF UF description Study type International Agency for Research on Cancer http://inchem.org/pages/iarc.html 1999 14.04.09 TDI 10 mg/m3 no data LOAEL 10 mg/m3 no data no data Acute - Short (IARC) term repeated dose International Programme on Chemical Safety (IPCS) http://www.who.int/ipcs/en/ 2004 14/04/2009 MAK - Maximum Workplace Concentration 9.8 mg/m3 2.8 no data no data 9.8 mg/m3 no data no data Animal Study (rat) Dutch National Institute for Public Health http://www.rivm.nl/en/ N/A 14/04/2009 N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A Health Canada Toicological Values http://www.hc-sc.gc.ca/index_e.html Jun-05 06.04.09 no data no data no data no data no data LOEC 465 mg/m3 no data no data female rats US Agency for Toxic Substances and Disease Registry (ATDSR) Toxicological Profiles and Minimal Risk levels US Agency for Toxic Substances and Disease Registry (ATDSR) Toxicological Profiles and Minimal Risk levels http://www.atsdr.cdc.gov/ Sep-97 14.04.09 MRL intermediate 6 ppm no data NOAEL 48 ppm 30 10 for human variability, 3 for animal - Intermediate - human extrapolation Animal Study http://www.atsdr.cdc.gov/ Sep-97 14.04.09 MRL acute 6 ppm no data NOAEL 48 ppm 30 10 for human variability, 3 for animal - Acute - Animal human extrapolation. Converted for Study humans by 48 ppm (0.22 m3/day/0.204kg) / 20 m3/day/70kg) = 181 ppm
www.esdat.net Esdat Environmental Database Management Software +61 2 8875 7948 Hexachloroethane TDI oral Organisation US Agency for Toxic Substances and Disease Registry (ATDSR) Toxicological Profiles and Minimal Risk levels Description Target organ/Critical Effect Reference Web link Groups of 10 male and 10 female rats fed HCE liver and kidney weight increased ATSDR, Toxicological Profile For Hexachloroethane, 1997 http://www.atsdr.cdc.gov/toxprofiles/tp97.pdf in diet for 16 weeks US Agency for Toxic Substances and Disease Registry (ATDSR) Toxicological Profiles and Minimal Risk levels Groups of 5 male New Zealand rabbits treated by gavage for 12 days. liver degeneration and necrosis ATSDR, Toxicological Profile For Hexachloroethane, 1997 http://www.atsdr.cdc.gov/toxprofiles/tp97.pdf USEPA Health Advisors USEPA Integrated Risk Information System (IRIS) no data no data EPA, 2006 Edition of the Drinking Water Standards and Health Advisories, http://www.epa.gov/waterscience/criteria/drinking/dwstandards.pdf 2006 Groups of 10 male and 10 female rats fed HCE in diet for 16 weeks liver and kidney weight increased IRIS online database, last updated in 2003 http://www.epa.gov/NCEA/iris/subst/0167.htm#carc Toxicology Data Network (Toxnet) Subchronic rat studies. In subchronic studies kidney degeneration at 15 and 62 mg/kg bw/day and increased kidney weights at 62 mg/kg were seen. Signs of kidney toxicity were seen at 47 mg/kg bw/day. Kidneys Nord Vol:15 (1999) pp 269-83 http://toxnet.nlm.nih.gov/cgi-bin/sis/search/f./temp/~VYlc6H:5 TDI inhal Organisation Description Response Reference Web link International Agency for Research on Cancer (IARC) International Programme on Chemical Safety (IPCS) In humans, exposure by inhalation to hexachloroethane (10-20 mg/m3) produced mild irritation of the skin and mucous membrane. Occupational Exposure Limit (DFG 2004). Skin The substance may have effects on the liver and kidneys. Exposure at far above the OEL may have effects on the central nervous system, inducing tremors and ataxia. IARC Monographs on the evaluation of the carcinogenic risk of chemicals to humans Vol:73 (1999) pp 295-306 International Chemical Safety Cards http://www.inchem.org/documents/iarc/vol73/73-10.html http://www.inchem.org/documents/icsc/icsc/eics0051.htm Dutch National Institute for Public Health Health Canada Toicological Values US Agency for Toxic Substances and Disease Registry (ATDSR) Toxicological Profiles and Minimal Risk levels US Agency for Toxic Substances and Disease Registry (ATDSR) Toxicological Profiles and Minimal Risk levels N/A N/A N/A N/A LOEC for development toxicity. LOEC for short term repeated dose toxicity = 2517mg/m3 (different study) Groups of 25 male and female rates subjected to 0, 15, 48 and 260 ppm for 6 hrs/day, 5 days/week for 6 weeks. Groups of 22 pregnant rats exposed to vapours for 6 hrs day on gestation days 6-16. Health Canada, State of the Science Report for a Screening Health Assessment – Hexachloroethane, 2005 Reduced body weight, eye irritation, ATSDR, Toxicological Profile For Hexachloroethane, 1997 tremors and reduced infection resistance. Reduced body weight, eye irritation, ATSDR, Toxicological Profile For Hexachloroethane, 1997 tremors and reduced infection resistance. http://www.hc-sc.gc.ca/ewh-semt/alt_formats/hecssesc/pdf/pubs/contaminants/hexachloroethane/hexachloroethane-eng.pdf http://www.atsdr.cdc.gov/toxprofiles/tp97.pdf http://www.atsdr.cdc.gov/toxprofiles/tp97.pdf
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www.esdat.net Esdat Environmental Database Management Software +61 2 8875 7948<br />
Hexachloroethane<br />
TDI oral<br />
Organisation<br />
US Agency <strong>for</strong> Toxic Substances and Disease<br />
Registry (ATDSR) Toxicological Profiles and<br />
Minimal <strong>Risk</strong> levels<br />
Description Target organ/Critical Effect Reference Web link<br />
Groups of 10 male and 10 female rats fed HCE liver and kidney weight increased ATSDR, Toxicological Profile For Hexachloroethane, 1997 http://www.atsdr.cdc.gov/toxprofiles/tp97.pdf<br />
in diet <strong>for</strong> 16 weeks<br />
US Agency <strong>for</strong> Toxic Substances and Disease<br />
Registry (ATDSR) Toxicological Profiles and<br />
Minimal <strong>Risk</strong> levels<br />
Groups of 5 male New Zealand rabbits treated<br />
by gavage <strong>for</strong> 12 days.<br />
liver degeneration and necrosis ATSDR, Toxicological Profile For Hexachloroethane, 1997 http://www.atsdr.cdc.gov/toxprofiles/tp97.pdf<br />
USEPA <strong>Health</strong> Advisors<br />
USEPA Integrated <strong>Risk</strong> In<strong>for</strong>mation System<br />
(IRIS)<br />
no data no data EPA, 2006 Edition of the Drinking Water Standards and <strong>Health</strong> Advisories, http://www.epa.gov/waterscience/criteria/drinking/dwstandards.pdf<br />
2006<br />
Groups of 10 male and 10 female rats fed HCE<br />
in diet <strong>for</strong> 16 weeks<br />
liver and kidney weight increased IRIS online database, last updated in 2003 http://www.epa.gov/NCEA/iris/subst/0167.htm#carc<br />
Toxicology Data Network (Toxnet)<br />
Subchronic rat studies. In subchronic studies<br />
kidney degeneration at 15 and 62 mg/kg<br />
bw/day and increased kidney weights at 62<br />
mg/kg were seen. Signs of kidney toxicity were<br />
seen at 47 mg/kg bw/day.<br />
Kidneys Nord Vol:15 (1999) pp 269-83 http://toxnet.nlm.nih.gov/cgi-bin/sis/search/f./temp/~VYlc6H:5<br />
TDI inhal<br />
Organisation<br />
Description Response Reference Web link<br />
International Agency <strong>for</strong> Research on Cancer<br />
(IARC)<br />
International Programme on Chemical<br />
Safety (IPCS)<br />
In humans, exposure by inhalation to<br />
hexachloroethane (10-20 mg/m3) produced<br />
mild irritation of the skin and mucous<br />
membrane.<br />
Occupational Exposure Limit (DFG 2004).<br />
Skin<br />
The substance may have effects on the<br />
liver and kidneys. Exposure at far above<br />
the OEL may have effects on the central<br />
nervous system, inducing tremors and<br />
ataxia.<br />
IARC Monographs on the evaluation of the carcinogenic risk of chemicals to<br />
humans Vol:73 (1999) pp 295-306<br />
International Chemical Safety Cards<br />
http://www.inchem.org/documents/iarc/vol73/73-10.html<br />
http://www.inchem.org/documents/icsc/icsc/eics0051.htm<br />
Dutch National Institute <strong>for</strong> Public <strong>Health</strong><br />
<strong>Health</strong> Canada Toicological Values<br />
US Agency <strong>for</strong> Toxic Substances and Disease<br />
Registry (ATDSR) Toxicological Profiles and<br />
Minimal <strong>Risk</strong> levels<br />
US Agency <strong>for</strong> Toxic Substances and Disease<br />
Registry (ATDSR) Toxicological Profiles and<br />
Minimal <strong>Risk</strong> levels<br />
N/A N/A N/A N/A<br />
LOEC <strong>for</strong> development toxicity. LOEC <strong>for</strong> short<br />
term repeated dose toxicity = 2517mg/m3<br />
(different study)<br />
Groups of 25 male and female rates subjected<br />
to 0, 15, 48 and 260 ppm <strong>for</strong> 6 hrs/day, 5<br />
days/week <strong>for</strong> 6 weeks.<br />
Groups of 22 pregnant rats exposed to vapours<br />
<strong>for</strong> 6 hrs day on gestation days 6-16.<br />
<strong>Health</strong> Canada, State of the Science Report <strong>for</strong> a Screening <strong>Health</strong><br />
<strong>Assessment</strong> – Hexachloroethane, 2005<br />
Reduced body weight, eye irritation, ATSDR, Toxicological Profile For Hexachloroethane, 1997<br />
tremors and reduced infection resistance.<br />
Reduced body weight, eye irritation, ATSDR, Toxicological Profile For Hexachloroethane, 1997<br />
tremors and reduced infection resistance.<br />
http://www.hc-sc.gc.ca/ewh-semt/alt_<strong>for</strong>mats/hecssesc/pdf/pubs/contaminants/hexachloroethane/hexachloroethane-eng.pdf<br />
http://www.atsdr.cdc.gov/toxprofiles/tp97.pdf<br />
http://www.atsdr.cdc.gov/toxprofiles/tp97.pdf