Health & Environmental Research Online (HERO)

Technical Report 
Guidelines for reproductive toxicity risk assessment 
U.S. Environmental Protection Agency :: U.S. EPA 
U.S. Environmental Protection Agency, Risk Assessment Forum 
Washington, DC 
is also published as 007581 Guidelines for reproductive toxicity risk assessment
The U.S. Environmental Protection Agency (EPA) is today publishing in final form a
document entitled Guidelines for Reproductive Toxicity Risk Assessment (hereafter “Guidelines”).
These Guidelines were developed as part of an interoffice guidelines development program by a Technical Panel of the Risk Assessment Forum. They were proposed initially in 1988 as separate guidelines for the female and male reproductive systems. Subsequently, based upon the public comments and Science Advisory Board (SAB) recommendations, changes made included combining those two guidelines, integrating the hazard identification and dose-response sections, assuming as a default that an agent for which sufficient data were available on only one sex may also affect reproductive function in the other sex, expansion of the section on interpretation of female endpoints, and consideration of the benchmark dose approach for quantitative risk assessment. These Guidelines were made available again for public comment and SAB review in 1994. This notice describes the scientific basis for concern about exposure to agents that cause reproductive toxicity, outlines the general process for assessing potential risk to humans from exposure to environmental agents, and addresses Science Advisory Board and public comments on the 1994 Proposed Guidelines for Reproductive Toxicity Risk Assessment. Subsequent reviews have included the Agency’s Risk Assessment Forum and interagency comment by members of subcommittees of the Committee on the Environment and Natural Resources of the Office of Science and Technology Policy. The EPA appreciates the efforts of all participants in the process and has tried to address their recommendations in these Guidelines 
• Ammonia
     Literature Search – March 2012 (private)
     Literature Search Results
     Not Chemical Specific
          Guidance, notices
• Benzo(a)pyrene (BaP)
• Biphenyl
     Cited References
• tert-Butanol
     Cited in Document
     • Cited 2016 Public Comment Draft
          Tox Review
     Cited in Public Comment Draft – May 2016
          Toxicological Review
• Chloroprene
     Cited 2009 Draft
     Cited 2010 Final
• DCM (Dichloromethane) (Final, 2011)
• 1,4-Dioxane - with inhalation update
     Final (2013)
     External Review Draft (2011)
• Hexabromocyclododecane (HBCD)
     Guidance/contextual references added during assessment development
• Libby Amphibole Asbestos (Draft, 2011)
• Methanol (Non-Cancer)
     Cited in Final (2013)
     Cited in External Review Draft (2013)
     Cited in External Review Draft (2011)
• Phthalates – Targeted Search for Epidemiological Studies
• RDX (121-82-4)
     Cited 2015 (private)
     Guidance documents and contextual references
• Tetrachloroethylene (Perc) (Final, 2012)
• Trichloroacetic acid (TCA) (Final, 2011)
• Trichloroethylene (TCE) (Final, 2011)
     All References
• Trimethylbenzenes (TMB)
     Considered Studies
     Cited Studies
     Cited in Tox Review – Revised TMBs Draft
     Cited in Revised TMBs Draft - All
• Vanadium Pentoxide (Draft, 2011)
          2nd Draft
          Final Cited
     Cited in First ERD Nov2015
     Cited Second ERD Dec2016
     Cited in Final ISA Dec2017
          Chapter 5 – Health