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Report of the EPA Peer Review Workshop on Alpha2u-Globulin: Association with Renal Toxicity and Neoplasia in the Male Rat
Risk Assessment Forum
This workshop report highlights issues and conclusions from an EPA workshop on the question of using certain rat kidney tumors for human risk assessment. The workshop was convened to acquire expert opinion on a draft EPA report entitled "Alpha2u-Globulin: Association with Chemically Induced Renal Toxicity and Neoplasia in the Male Rat" (55 Federal Register 46994; November 8, 1990). The Risk Assessment Forum's final report, which is based in part on information described in this workshop report, was published in the fall of 1991.
To provide peer review of the workshop draft, the Risk Assessment Forum sponsored a two-day workshop in Gaithersburg, Maryland, on November 13 to 14, 1990. Sixteen scientists involved in research activity directly related to the male rat kidney tumor issue and seven risk assessment experts were invited to discuss the workshop draft and related concerns. In general, the peer reviewers endorsed EPA's analysis of the male rat kidney tumor issue as presented in the workshop draft. Although questions remain regarding the exact mechanism by which chemically induced alpha2u-globulin (a2u-g) accumulation leads to renal tumors, participants reached provisional decisions regarding use of these tumor data for risk characterization, pending the availability of additional information from research studies. On this basis, the peer reviewers concluded that, under the conditions enumerated in EPA's analysis, a2u-g-associated male rat renal tubule tumors are probably not relevant for human risk assessment.
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Note: a complete electronic version of this document that preserves its original appearance (such as in a pdf file format) is not currently available. However, a scanned version is available in image or text format from EPA's National Environmental Publications Information System. Paper copies may be ordered from the National Technical Information Service.
Citation
US EPA. Report of the EPA Peer Review Workshop on Alpha2u-Globulin: Association with Renal Toxicity and Neoplasia in the Male Rat. U.S. Environmental Protection Agency, Risk Assessment Forum, Washington, DC, EPA/625/3-91/021 (NTIS PB92166826), 1991.