Registration Dossier

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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Bacterial reverse mutation assay (Ames test) with and without metabolic activation (S9 mix): the test substance shows no mutagenic potential

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Genetic toxicity in vitro (Ames test)

The test substance methyl 2 -hydroxyisobutyrate was evalutad in the key study in an in vitro bacterial reverse mutation assay (KS_Ames test_bacteria_1993) using Salmonella typhimurium strains TA100, TA98, TA1535 and TA1537 and Escherichia coli WP2uvrA as tester strains in accordance with the Ames test method described in Article 34 -3 of the Ordinance on Industrial Safety and Health (comparable to OECD Guideline 471) with and without metabolic activation (S9 mix) at concentrations in the main study of 156, 313, 625, 1250, 2500, and 5000 µg/plate.

Results obtained in the present mutagenicity study indicated that the test substance shows no mutagenic potential since the revertant colony counts determined in both the presence (metabolic activation method) and absence (non-metabolic activation method) of S9 mix were within the range of spontaneous revertant colony counts.

Justification for classification or non-classification

Based on the negative result of the in vitro study available for the test substance, methyl 2-hydroxyisobutyrate is considered to be not mutagenic. According to Regulation (EC) No 1272/2008 methyl 2-hydroxyisobutyrate does not meet the criteria for classification and does not require labelling as a mutagen.

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