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EC number: 291-768-8 | CAS number: 90480-35-6
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
For the endpoint of genetic toxicity there are three key in vitro studies available, an Ames test, a micronucleus assay and a mammalian cell gene mutation assay (HPRT). All were performed under the respective OECD guidelines and in compliance to GLP.
Ames test
The test item was found to be not mutagenic under the conditions of the Ames test.
In vitro micronucleus assay
The test item is considered to be non-mutagenic in this in vitro micronucleus test, when tested up to cytotoxic and/or phase separating concentrations.
In vitro mammalian cell gene mutation assay (HPRT)
Under the experimental conditions reported the test item did not induce gene mutations at the HPRT locus in V79 cells and the test item is considered to be non-mutagenic in this HPRT assay.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Ames test
An Ames test according to OECD guideline 471 was conducted on the test item, using Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537 and at the tryptophan locus of Escherichia coli strain WP2uvrA in the presence and absence of S9 mix at concentrations up to 5000 µg/plate. No increase in the mean number of revertant colonies was observed at any of the tested dose levels in any tester strain in the presence or absence of S9 in the initial or confirmatory assay. All positive and vehicle control values were within the acceptable ranges, and all validity criteria were met. Therefore, the test item was found to be negative under the conditions of the Ames test.
In vitro micronucleus assay
The test item dissolved in DMSO, was assessed for its potential to induce micronuclei in human lymphocytes in vitro in two independent experiments and in conformity to the OECD guideline and GLP regulations.
In this study, in the absence and presence of S9 mix, no relevant increases in the number of micronucleated cells were observed after treatment with the test item. In Experiment II, in the absence of S9 mix, however, the value of 1.18 % micronucleated cells at the highest evaluated concentration (133 μg/mL), exceeded the range of the laboratory historical solvent control data (0.05 – 1.05 % micronucleated cells). Since the value is not statistically significantly increased, the finding can be regarded as biologically irrelevant.
It can be stated that under the experimental conditions reported, the test item citrylal did not induce micronuclei as determined by the in vitro micronucleus test in human lymphocytes and is considered to be non-mutagenic when tested up to cytotoxic and/or phase separating concentrations.
In vitro mammalian cell gene mutation assay (HPRT)
The study was performed to investigate the potential of the test item to induce gene mutations at the HPRT locus in V79 cells of the Chinese hamster. The study was in conformance to the OECD TG 476 and in copliance to GLP.
The treatment period was 4 hours with and without metabolic activation.
No substantial and reproducible dose dependent increase of the mutation frequency was observed in the main experiment.
Justification for classification or non-classification
Ames test
Under the experimental conditions reported, the test item was found to be negative in the Ames test.
In vitro micronucleus assay
Under the experimental conditions reported, the test item did not induce micronuclei as determined by the in vitro micronucleus test in human lymphocytes. Therefore, the test item is considered to be non-mutagenic in this in vitro micronucleus test, when tested up to cytotoxic and/or phase separating concentrations.
In vitro mammalian cell gene mutation assay (HPRT)
Under the experimental conditions reported the test item did not induce gene mutations at the HPRT locus in V79 cells and the test item is considered to be non-mutagenic in this HPRT assay.
In conclusion, the test substance should not be considered as genotoxic/mutagenic according to the EU Regulation No. 1272/2008, section 3.5.
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