Dibutyl Phthalate (DBP)

Summary

Abstract

The Food Safety Commission of Japan (FSCJ) conducted a risk assessment of dibutyl phthalate (DBP) (CAS No.84–74-2) for the revision of the standards and criteria for apparatuses, containers and packages. DBP showed major adverse effects on liver and kidney, and also showed the reproductive and developmental toxicities (mice, rats and rabbits). The reproductive toxicities were observed in both sexes of experimental animals (mice and rats). No consistent results were obtained on human epidemiological studies, although some data suggested the possible association of DBP exposures with toxicological parameters including reproductive/developmental systems No definitive studies on carcinogenicity and chronic toxicity were available with DBP in experimental animals. No clear information is thus available on the carcinogenic effects of DBP in humans to date. FSCJ judged that DBP has no genotoxicity relevant to human health. Therefore, it is appropriate to specify a tolerable daily intake (TDI) based on the results of reproductive-developmental toxicity studies in experimental animals. Among the test values for the no-observed-adverse-effect level (NOAEL) or the lowest-observed-adverse-effect level (LOAEL), the lowest value was the LOAEL of 2.5 mg/kg bw/day in a dietary toxicity study in rats. FSCJ judged it appropriate to apply an uncertainty factor of 500 (10 for species difference, 10 for individual difference, and additional 5 for the use of the LOAEL) to the LOAEL (0.25 mg/kg bw/day) and specified the TDI of 0.005 mg/kg bw/day.