Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
5855876 | Regulatory Toxicology and Pharmacology | 2016 | 9 Pages |
â¢A safety range for non-cancer endpoints is proposed, similar to the cancer risk range.â¢The safety range enables effective remedial actions and risk management decisions.â¢The safety range is chemical-specific, derived from toxicological information.â¢A case study is presented for trichloroethylene-contaminated sites.â¢The safety range for trichloroethylene was judged to be 3 μg/m3 to 30 μg/m3.
A method for determining a safety range for non-cancer risks is proposed, similar in concept to the range used for cancer in the management of waste sites. This safety range brings transparency to the chemical specific Reference Dose or Concentration by replacing their “order of magnitude” definitions with a scientifically-based range. EPA's multiple RfCs for trichloroethylene (TCE) were evaluated as a case study. For TCE, a multi-endpoint safety range was judged to be 3 μg/m3 to 30 μg/m,3 based on a review of kidney effects found in NTP (1988), thymus effects found in Keil et al. (2009) and cardiac effects found in the Johnson et al. (2003) study. This multi-endpoint safety range is derived from studies for which the appropriate averaging time corresponds to different exposure durations, and, therefore, can be applied to both long- and short-term exposures with appropriate consideration of exposure averaging times. For shorter-term exposures, averaging time should be based on the time of cardiac development in humans during fetal growth, an average of approximately 20-25 days.