An abbreviated repeat dose and reproductive/developmental toxicity test for high production volume chemicals.
A novel protocol is described for obtaining preliminary data on repeated dose systemic effects and reproductive/developmental toxicity. The test protocol was developed by a group of experts at the request of the U.S. Environmental Protection Agency (EPA) for use as part of a Screening Information Data Set on high production volume chemicals. Interest in this protocol is shared by several regulatory agencies, including the Organization for Economic Cooperation, the European Community, and the EPA. To validate the study protocol, ethylene glycol monomethyl ether (EGME) was used. After a dosing period of approximately 6 weeks, EGME showed both systemic and reproductive/developmental effects similar to those previously reported using standard protocols. Thus, this test protocol may be used as a screening tool for high production volume chemicals.
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Exxon Biomedical Sciences, Inc., East Millstone, New Jersey 08875.
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Beyer
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D000014:Abnormalities, Drug-Induced / Q000209:etiology*; D000818:Animals; D001522:Behavior, Animal / Q000187:drug effects; D001835:Body Weight / Q000187:drug effects; D002617:Chemical Industry; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004353:Drug Evaluation, Preclinical / Q000379:methods; D004822:Epididymis / Q000187:drug effects; D005026:Ethylene Glycols / Q000633:toxicity*; D005069:Evaluation Studies as Topic; D005260:Female; D005313:Fetal Death / Q000139:chemically induced; D008098:Litter Size / Q000187:drug effects; D008297:Male; D009929:Organ Size / Q000187:drug effects; D011247:Pregnancy; D051381:Rats; D017207:Rats, Sprague-Dawley; D012098:Reproduction / Q000187:drug effects*; D012997:Solvents; D013094:Spermatozoa / Q000187:drug effects; D013737:Testis / Q000187:drug effects
D005026:Ethylene Glycols; D012997:Solvents; C005219:methyl cellosolve