Proposition 65 Maximum Allowable Dose Level (MADL) for DEHP by Oral Exposure

The maximum allowable dose levels (MADL) for di(2-ethylhexyl)phthalate (DEHP) by the oral route of exposure are 410 micrograms/day (μg/day) for adults, 58 μg/day for infant boys (29 days to 24 months of age) and 20 μg/day for neonatal infant boys (birth to 28 days of age). These values are based on the male reproductive effects of DEHP observed in the study by David et al. (2000a). As specified in regulation, when the applicable reproductive effect is upon the male, the MADL is calculated based on a human body weight of 70 kg (Title 22, California Code of Regulations, section 12803(b)). In the case of DEHP, however, developing animals are sensitive to the testicular effects of DEHP (e.g., Sjoberg et al., 1985; 1986; Li et al., 2000; CERHR, 2000; U.S. FDA, 2001; Borch et al., 2004). Bodyweights of infants and neonatal infants are markedly lower than that of an adult. Accordingly, age-specific MADLs have been calculated for infant and neonatal infant boys based on bodyweights of 10 and 3.5 kg, respectively (Sections 12801(a) and 12803(a)(6)). Children and adolescents also differ in bodyweight from adults. Age-specific MADLs for males in those age groups can be calculated by application of the default bodyweights specified in Section 12703(a)(8).