Risk Assessment and Class-Based Evaluation of Three Phosphate Esters

ABSTRACT

A category approach was used in the evaluation of a group of chemicals (triethyl phosphate, tripropyl phosphate, and tributyl phosphate) in drinking water, in support of determination of safe-harbor level for use by a standard-setting organization. Both non-cancer and cancer endpoints were considered, and risk assessment methodology developed by the U.S. Environmental Protection Agency (USEPA) was used to determine a class-based evaluation level (CBEL) and a total allowable concentration (TAC) in drinking water considered adequately protective of human health. The critical study was a chronic oncogenicity study on tributyl phosphate, with a no-observed-adverse-effect-level (NOAEL) of 9 mg/kg-day. The critical effect, combined incidence of bladder papilloma/transitional cell carcinoma, was likely non-genetic in nature, as supported by the lack of genetic toxicity observed in tributyl phosphate. The effect thus demonstrated a threshold, and this study used an oral reference dose approach and a total uncertainty factor of 100. This conservative analysis demonstrated the TAC should be twenty times greater than the default value of 0.01 mg/L.

Key Words:

• risk assessment
• triethyl phosphate
• tributyl phosphate
• class-based evaluation level

Notes

*Significantly different from control (p < .01).