Scientists at BASF in Germany have determined a TTC value of 8 μg/kg bw/day for prenatal development based on no-observed-adverse-effect levels (NOAELs) for maternal and developmental toxicity data generated from 93 BASF and 18 other selected rat oral reproductive toxicity studies. (A combined NOAEL of 4 mg/kg bw/day was determined from the studies and a safety factor of 500 applied, which is higher than the standard factor of 100 to cover the possible under-representation of certain chemical classes, such as drugs, natural compounds and food additives). The investigators proposed that within the context of REACH, the TTC value may serve as a guidance on whether to perform the recommended animal tests or, if estimated human exposure is sufficiently low, to rely on the TTC concept (van Ravenzwaay B. et al., Regulatory Toxicology and Pharmacology 2011, 59, 81; {187626}.

The above item was taken from the September 2011 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).

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