Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

All four of the studies indicated that in at least one of the tester strains (Salmonella typhimurium TA92, TA98, TA100, TA102, TA1535, TA1537, and TA1538) 2 -NP was shown to be positive with or without metabolic activation.

In the rat and mouse micronuclei tests, the results were a negative increase in the number micronucleated polychromatic erythrocytes in the bone marrow but an increase in micronuclei in the treated rat liver.


Short description of key information:
One key study and three supporting studies were identified evaluating the mutagenic activity of 2-nitropropane in the reverse bacteria mutation assay (Ames test).

For the in vivo genetic toxicity tests one key study and one supporting study was identified. One study was conducted in rats to determine the increase in micronuclei in bone marrow and liver. The other study conduct was a mouse bone marroe micronucleus test.

Endpoint Conclusion: Adverse effect observed (positive)

Justification for classification or non-classification

Based on the positve results in the Ames tests and the positive result in the number of liver micronuclei in the in vivo rat micronucleus test, 2 -nitropropane warrants a Category 2 as a mutagenic substance under GHS.