EXPOSURE TO COSMETICS CALCULATION OF THE 暴露于化妆品的计算.ppt

Calculation of The Daily Exposure Dose of Substance Applied to The Skin A (g/application) = amount of finished cosmetic product applied per application C (%) = concentration of ingredients under study in the finished product F (day-1) = frequency of application of the substance I (mg/day) = A (g/application) x 103 (mg/g) x C (%) x 10-2 x F (day-1) CALCULATION OF THE SYSTEMIC EXPOSURE DOSE (SED) CALCULATION OF THE SYSTEMIC EXPOSURE DOSE BASED ON THE PERCENTAGE OF SUBSTANCE PENETRATING THE SKIN I (mg/day) = daily dermal exposure to the substance DAp (%) = dermal absorption of the substance expressed in percentage 60 kg bw = default human body weight SED = I (mg/day) x DAp (%) x 10-2 (mg/kg bw/day) 60 kg bw CALCULATION OF THE SYSTEMIC EXPOSURE DOSE BASED ON THE ABSOLUTE AMOUNT OF SUBSTANCE PENETRATING THE SKIN DAa (μg/cm2) = dermal absorption of the substance reported as amount (μg)/cm2 SSA (cm2) = surface of skin area expected to be in contact with the cosmetic product 60 kg bw = default human body weight F (day-1) = frequency of application of the substance SED = DAa (μg/cm2) x 10-3 (mg/μg) x SSA (cm2) x F (day-1) (mg/kg bw/day) 60 kg bw CALCULATION OF THE MARGIN OF SAFETY (MOS) MoS never below 100 Margin of Safety = NOAEL (mg/kg bw/day) SED (mg/kg bw/day) x Animals Humans Kinetics 4.0 Dynamics 2.5 Kinetics 3.2 Dynamics 3.2 Interspecies differences Intraspecies differences 10 10 x x UV filter example : Isopentyl 4 methoxycinnamate (S27) Based on daily application of 1 mg formulation/cm2 over the entire body surface (1.8 m2) containing at maximum 10% of the active ingredient Maximum amount of ingredients applied I = 1800 mg/day Maximum absorption through the skin DAp = o/w : 0.4% or w/o : 2% Systemic exposure dose : SED = I (mg/day) x DAp (%)/100 o/w : 0.12 mg/kg bw/d