Registration Dossier
Registration Dossier
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EC number: 308-208-6 | CAS number: 97925-95-6
Carcinogenicity
Administrative data
Description of key information
No carcinogenicity study is required, since the substance is not mutagenic and no hyperplasia or pre-neoplastic lesions were observed in any of the available repeated dose studies.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on expert judgement, a testing proposal for a carcinogenicity study for Atmer 163 is not scientifically justified. The conclusion with regard to classification and labelling according to Regulation (EC) 1272/2008 for carcinogenicity is "data lacking".
Additional information
There are no carcinogenicity studies available for Atmer 163.
According to the REACH regulation (1907/2006/EC), a carcinogenicity study may be proposed by the registrant or may be required by the Agency in accordance with Articles 40 or 41 if the substance has a widespread dispersive use or there is evidence of frequent or long-term human exposure, and the substance is classified as mutagen category 3 or there is evidence from repeated dose studies that the substance is able to induce hyperplasia and/or pre-neoplastic lesions.
There is no evidence that Atmer 163 causes carcinogenicity by a direct genotoxic mechanism, as the results of all genotoxicity studies were negative. Furthermore, in all available repeated dose toxicity studies, no evidence for hyperplasia or preneoplastic lesions was seen.
Thus, a proposal for a carcinogenicity study is scientifically neither required nor justified.
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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