A proposed methodology for selecting a trichloroethylene inhalation unit risk value for use in risk assessment.
U.S. EPA's 2001 draft assessment of trichloroethylene (TCE) toxicity reviews the existing human and animal data on TCE carcinogenicity and proposes a 20-fold range of cancer potency values for use in risk assessment. Each value in the range is derived from a different source of data, either animal bioassays or epidemiology studies, and thus the range does not represent a distribution which can be characterized by statistical parameters such as a mean or 95% confidence interval. The U.S. EPA suggests users choose a single slope factor from among those it describes as appropriate for the population of interest and mode of exposure, but little guidance is given for making this choice. We propose an approach for determining the most scientifically defensible carcinogenic inhalation unit risk estimate from the range of slope factors developed by U.S. EPA, one that relies on accepted principles for evaluating scientific studies. Based on these considerations, we identify the most appropriate interim unit risk for low-level inhalation exposure as 9 x 10(-7) per microg/m(3). This approach may have fairly broad utility if U.S. EPA elects to use a similar approach in future assessments of other chemicals.
Lewandowski
T A
TA
Gradient Corporation, 600 Stewart Street, Suite 803, Seattle, WA 98101, USA. tlewandowski@gradientcorp.com
Rhomberg
L R
LR
D000280:Administration, Inhalation; D000818:Animals; D004353:Drug Evaluation, Preclinical; D006801:Humans; D051379:Mice; D051381:Rats; D015203:Reproducibility of Results; D018570:Risk Assessment / Q000379:methods*; D012997:Solvents / Q000008:administration & dosage / Q000633:toxicity; D014241:Trichloroethylene / Q000008:administration & dosage / Q000633:toxicity; D014481:United States; D014484:United States Environmental Protection Agency / Q000592:standards*
D012997:Solvents; D014241:Trichloroethylene