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Guidelines for Reproductive Toxicity Risk Assessment

Risk Assessment Forum

The Guidelines for Reproductive Toxicity Risk Assessment discuss the scientific basis for concern about exposure to agents that cause reproductive toxicity and describe the principles and procedures to be followed in conducting risk assessments for reproductive toxicity. They include the female (non-pregnant and pregnant) and male reproductive systems. Together with the Agency's Guidelines for Developmental Toxicity Risk Assessment, developing young are covered. The Guidelines will promote consistency in the Agency's assessment of toxic effects on the male and female reproductive systems, including outcomes of pregnancy and lactation, and inform others of approaches that the Agency will use in assessing those risks. They identify and discuss the use of default assumptions, present summaries of the standardized testing protocols used to generate information on reproductive toxicity, discuss the various types of information that may be encountered in evaluations of reproductive toxicity, and specify the approaches that are appropriate for quantitative risk assessment and exposure assessment. Although specific program policies and procedures are still evolving, these Guidelines discuss attributes of the Agency's risk characterization policy as it applies to reproductive toxicity.

Contact: Risk Assessment Forum Staff, 202-564-6483, or risk.forum@epa.gov

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Additional Information

Published in the Federal Register on October 31, 1996, FR 61 (212):56274-56322.


U.S. EPA. Guidelines for Reproductive Toxicity Risk Assessment. U.S. Environmental Protection Agency, Risk Assessment Forum, Washington, DC, 630/R-96/009, 1996.

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