Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The substance did not show genotoxic effects in two Ames tests with Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537, and TA 1538 (10 -5000 microgram/plate), in the Chinese Hamster Ovary K1 cells (20 -1000 mg/l), in two V79 Chinese hamster lung cell tests (0 -1800 mg/l), all with and without metabolic activation.

However, the high boiling fraction from the manufacture of 2-phenyl-2 -imidazoline, consisting of the target compound, its N,N-dibenzoyldiamine derivatives, and other impurities did show genotoxic effects in an Ames test -but only without metabolic activation- with Salmonella typhimurium TA 98, TA 100, TA 102, TA 1535, and TA 1537 (50 -5000 microgram/plate), with a cytotoxic concentration of 1600 microgram/plate (TA100 did not show a cytotoxic effect at all).

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

For this substance no classification according to CLP for genetic toxicity is required