Registration Dossier

Ecotoxicological information

Toxicity to other above-ground organisms

Currently viewing:

Administrative data

Link to relevant study record(s)

Description of key information

Key value for chemical safety assessment

Additional information

The lowest NOEC for mammals refers to a full chronic study for mammals (Morris et al. 1938), which resulted in a NOEC value of 64 mg Pb/kg ww.Sub-chronic and chronic studies for 3 different mammal species were collected from literature, ie for Rattus sp. (different strains), Rattus norvegicus and for mice. For mammal oral toxicity the values varied between 64 and >12800 mg/kg ww. The lowest value of 64 mg Pb/kg ww was used to derive the PNEC, which was observed in several experiments with the Osborn-Mendel rat. According to the guidance, the PNECoral was calculated from the lowest NOECoral using an assesment factor.

An assessment factor of 6 has been selected on the lowest toxicity data. Considering a background concentration of 1.3 mg Pb/kg in the food, the PNECoral can be calculated as:PNECoral= (NOEC +Cb)/AF = (64+1.3)/6 =10.9 mg/kg food (mammal). This value is further used for risk characterisation purposes.