Toxicological Evaluation and Limit Values for ... - Miljøstyrelsen

8 TDI, health based limit values8.1 TDINPLOAEL 15 mg/kg b.w./dayTDI = = SF I x SF II x SF III 10 x 10 x 30= 0.005 mg/kg b.w./dayThe safety factor SF I is set to 10 assuming that humans are more sensitivethan animals. The SF II is set to 10 to protect the most sensitiveindividuals in the population. The SF III is set to 30 since a LOAEL isused and because data for genotoxicity and carcinogenicity are lacking.NPELOAEL 40 mg/kg b.w./dayTDI = = SF I x SF II x SF III 10 x 10 x 30= 0.013 mg/kg b.w./dayThe safety factor SF I is set to 10 assuming that humans are more sensitivethan animals. The SF II is set to 10 to protect the most sensitiveindividuals in the population. The SF III is set to 30 since a LOAEL isused and because data for genotoxicity and carcinogenicity are lacking.AllocationThe sources of NP and NPE exposure for the general population are viaconsumer products and via the environment through food, drinkingwater, and air. The size of these exposures is unknown, although it isexpected that exposure via air is negligible.For the purpose of setting a limit value, only 10 % of the TDI is allocatedto ingestion of soil and 10 % to drinking water.8.2 Limit value in soilNPBased on the TDI of 0.005 mg/kg b.w. per day for NP, and 0.04 mg/kgb.w. per day for NPE, and assuming a daily ingestion of 0.2 g soil for achild weighing 10 kg (w child ), a limit value is calculated:LV soilTDI x X% x w child 0.005 mg/kg day x 0.1 x 10 kg= = ingestion soil0.0002 kg/day37