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EC number: 208-807-1
CAS number: 542-28-9
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
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.
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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