Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Non mutagenic with and without metabolic activation (in vitro bacterial reverse mutation assay)
Non-clastogenic with and without metabolic activation (in vitro mammalian chromosome aberration test)
Non mutagenic with and without metabolic activation (in vitro mammalian cell gene mutation assay)
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The genetic toxicity of the substance is evaluated by considering data on the similar substances. Justification for Read Across is given in Section 13 of IUCLID.
The similar substance was tested in the Salmonella typhimurium reverse mutation assay with four histidine-requiring strains of Salmonella typhimurium (TA1535, TA1537, TA98 and TA100) and in the Escherichia coli reverse mutation assay with a tryptophan-requiring strain of Escherichia coli (WP2uvrA). The test was performed in two independent experiments in the presence and absence of S9-mix (rat liver S9-mix induced by a combination of phenobarbital and ß-naphthoflavone) and did not induce a significant dose-related increase in the number of revertant (His+) colonies in any of the four tester strains (TA1535, TA1537, TA98 and TA100) or in the number of revertant (Trp+) colonies in tester strain WP2uvrA both in the absence and presence of S9-metabolic activation.
Furthermore another substance was tested for chromosomal aberration on human lymphocytes and no effects on the number of polyploid cells and cells with endoreduplicated chromosomes were observed both in the absence and presence of S9-mix. It does not disturb mitotic processes and cell cycle progression and does not induce numerical chromosome aberrations under the experimental conditions described in this report.
Read across from other similar substancesn
indicate the substances are non-mutagenic (per the Ames Test) and
non-clastogenic to human lymphocytes in vitro (per the Chromosome
Abberation Test).
Gene mutation has been also tested on the analogous substance with
negative results and based on the outcome of the study, it can be
concluded that the substance has no effects on genetic toxicity.
Justification for classification or non-classification
The substance is not classified for genetic toxicity following CLP criteria set out in the 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.
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