Registration Dossier
Registration Dossier
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EC number: 219-943-6 | CAS number: 2580-56-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Non mutagenic in Ames test.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
According to the CLP Regulation (EC 1272/2008) a mutation means a permanent change in the amount or structure of the genetic material in a cell. The term ‘mutation’ applies both to heritable genetic changes that may be manifested at the phenotypic level and to the underlying DNA modifications when known.
The more general terms ‘genotoxic’ and ‘genotoxicity’ apply to agents or processes which alter the structure, information content, or segregation of DNA, including those which cause DNA damage by interfering with normal replication processes, or which in a non- physiological manner (temporarily) alter its replication.
For the purpose of classification for germ cell mutagenicity, substances are allocated to one of two categories:
Category 1: substances known to induce heritable mutations or to be regarded as if they induce heritable mutations in the germ cells of humans.
Category 1A: based on positive evidence from human epidemiological studies.
Category 1B: based on:
- positive result(s) from in vivo heritable germ cell mutagenicity tests in mammals; or
- positive result(s) from in vivo somatic cell mutagenicity tests in mammals, in combination with some evidence that the substance has potential to cause mutations to germ cells.
- positive results from tests showing mutagenic effects in the germ cells of humans, without demonstration of transmission to progeny; for example, an increase in the frequency of aneuploidy in sperm cells of exposed people.
Category 2: substances which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans, based on positive evidence obtained from experiments in mammals and/or in some cases from in vitro experiments, obtained from:
- somatic cell mutagenicity tests in vivo, in mammals; or
- other in vivo somatic cell genotoxicity tests which are supported by positive results from in vitro mutagenicity assays
Based on negative results in two available studies, relying on a weight of evidence approach, a mutagenic potential to bacteria was excluded for the target substance.
Accordingly, it is not classified under the CLP Regulation (EC 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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