Butyl Benzyl Phthalate (BBP)

Abstract

The Food Safety Commission of Japan (FSCJ) conducted a risk assessment of butyl benzyl phthalate (BBP) (CAS No.85-68-7) for the revision of the standards and criteria for apparatuses, containers and packages. Major adverse effects of BBP observed are those on body weight, pancreas, liver, kidney, and also on reproduction and development of offspring. FSCJ judged that BBP has no genotoxicity relevant to human health based on the results of genotoxicity studies, and thus judged it to be able to set tolerable daily intake (TDI) on this chemical. Dose-response relationship for human exposure to BBP was unable to obtain from the epidemiological studies, due to the lack of consistency among the results. FSCJ thus concluded it appropriate to specify TDI based on the results of studies in experimental animals rather than the epidemiological data. Similar to the case of bis (2-ethylhexyl) phthalate (DEHP) and dibutyl phthalate (DBP), toxicities toward the offsprings are the most sensitive and critical endpoints for TDI specification. FSCJ concluded it appropriate to establish an overall no-observed-adverse-effect level (NOAEL) of 20 mg/kg bw/day from three available studies on two-generation reproductive toxicity, which were adequately designed. In conclusion, FSCJ specified the TDI of 0.2 mg/kg bw, applying an uncertainty factor of 100 (10 for species difference, 10 for individual difference) to the NOAEL of 20 mg/kg bw/day.