Human risk assessment and GC/MS analysis of phthalates in excipients for pharmaceuticals

Abstract

Toluene was detected in shoes (ND ∼27ppm), shoe polish (ND ∼806ppm), leather cleaner (6071ppm), oil-based ballpen (ND201). Xylene was detected in shoe polish (ND ∼87,298ppm), leather cleaner (12,266ppm), pencil (ND-16). Exposure assessment showed that ethylbenzene, and xylene in permanent pens ranged from ND ∼3.11mg/kg/day (men) and ND ∼3.75mg/kg/day (women) for ethylbenzene, and ND ∼2.57mg/kg/day (men) and ND ∼3.1mg/kg/day (women) for xylene, and benzene in whiteouts ranged from ND ∼0.00059mg/kg/day (women), respectively. Hazard index [HI = exposure/reference dose (RfD)] values for ethylbenzene [31.1 =3.11 (mg/kg/day)/0.1 (mg/kg/day), RfD)] and xylene [12.85=2.57 (mg/kg/day)/0.2 (mg/kg/day), RfD)] exceeded 1 and cancer risk for benzene [3.2E−05=0.00059(mg/kg/day)×0.055 (mg/kg-day)−1, cancer potency factor], respectively, assuming that 100% of detected levels in some products such as permanent pens and whiteouts were exposed in a worst-case scenario. These data suggest that exposure to VOCs via consumer products exceeded the safe limits and should be reduced.