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Administrative data

Key value for chemical safety assessment

Additional information

Ames test

The test item was tested for mutagenicity in the Ames test and in the E. coli- reverse mutation assay both in the plate incorporation test and in the preincubation test with and without the addition of a metabolizing system obtained from rat liver (S-9 mix) using the Salmonella strains TA 1535, TA 100, TA 1537, TA 98 and Escherichia coli WP2 uvrA at a dose range of 20-5000 µg/plate (GLP guideline study, BASF AG, 1998). Positive control substances caused increases in the number of revertants as expected, indicating proper test conditions. The test substance showed no mutagenic effects at any dose level including the recommended limit dose of 5000 µg/plate.

Chromosome Aberration Test in V79 Cells

In a mammalian cell cytogenetics assay (Harlan CCR, 2012), V79 cell cultures were exposed to Delta-Valerolactone at concentrations of 0, 128.8, 257.5, 515.5 or 1030.0 µg/mL with metabolic and 0, 257.5, 515.0, 772.5, 901.5 or 1030.0 µg/mL without metabolic activation (Phenobarbital/beta-Naphtoflavone induced rat liver S9). Delta-Valerolactone was tested up to a concentration equal to approximately 10 mM, the recommended highest concentration for freely-soluble test items. Positive controls induced the appropriate response. There was no evidence of chromosome aberrations induced over background. This study is classified as acceptable.

HPRT Test in V79 Cells

In a mammalian cell gene mutation assay (Harlan CCR, 2012), V79 cells cultured in vitro were exposed to Delta-Valerolactone at concentrations of  0, 64.4, 128.8, 257.5, 515.0 or 1030.0 µg/mL in the presence and absence of mammalian metabolic activation (Phenobarbital/beta-Naphtoflavone induced rat liver S9). Delta-Valerolactone was tested up to a concentration equal to approximately 10 mM, the recommended highest concentration for freely-soluble test items. The positive controls did induce the appropriate response. There was no evidence of induced mutant colonies over background. This study is classified as acceptable. 

 


Short description of key information:
The test substance was not mutagenic in a bacterial reverse mutation assay in Salmonella and E.coli (OECD 471, Ames).
The test substance was non-clastogenic in the Chromosome Aberration Test (OECD 473, In vitro Mammalian Chromsome Aberration Test).
The test substance was non-mutagenic in the HPRT assay (OECD 476, In vitro Mammalian Cell Gene Mutation Test).

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Classification for mutagenicity is not warranted according to the criteria of EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No 1272/2008.