Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

In a reverse gene mutation assay according to Gee et al. (1998), Salmonella typhimurium strains TA7001, TA7002, TA7003, TA7004, TA7005, TA7006 and TA98 were exposed to 2‑methylvaleraldehyde at concentrations of 6, 30, 150, 750, 3750, 7500 µg/mL (vehicle: DMSO) in the presence and absence of mammalian metabolic activation (S9-mix) in a liquid fluctuation test (AMAX test procedure; BASF AG, 2007). No precipitation of the test substance was found with and without S9-mix. No bacteriotoxic effect was observed under all test conditions. An increase in the number of positive wells (his+ revertants) was not observed either without S9-mix or after the addition of a metabolizing system compared to historical control data. The positive controls induced the appropriate responses in the corresponding strains. Thus, 2‑methylvaleraldehyde was not mutagenic in the Ames II Assay (Salmonella typhimurium reverse mutation assay) under the given experimental conditions.

In a supporting study of Florin et al. (1980) Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537 were exposed to 2‑methylvaleraldehyde (2-Methylpentanal) in the presence and absence of a mammalian metabolic activation system (S9-mix) according to the Ames test (1975). Only one concentration (300 µg/plate) was tested which induced precipitations. The test substance was not found mutagenic.

Short description of key information:
2 methylvaleraldehyde was not mutagenic in vitro in the Ames II test (BASF, 2007) and in the Ames test (Florin, 1980) with and without metabolic activation.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Considering the negative results observed in all genotoxicity tests, 2‑methylvaleraldehyde is not subject to classification for mutagenicity according to Directive 67/548/EEC and Regulation 1272/2008/EC.