Registration Dossier
Registration Dossier
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EC number: 232-430-1 | CAS number: 8027-33-6 A complex combination of organic alcohols obtained by the hydrolysis of lanolin.
Carcinogenicity
Administrative data
Description of key information
Based on expert judgement, there is no evidence that the substance causes carcinogenicity.
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
Additional information
In accordance with Column 2 of Annex X, Section 8.9.1 of Regulation (EC) No 1907/2006, 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 germ cell mutagen category 2 or there is evidence from the repeated dose study(ies) that the substance is able to induce hyperplasia and/or pre-neoplastic lesions.
There is no evidence that the substance induces gene mutations in bacteria or mammalian cells or chromosome aberrations in mammalian cells, as the results of all genotoxicity studies were consistently negative. Furthermore, in the available repeated dose toxicity study and developmental toxicity study, no substance-related increases in the incidence of hyperplasia or pre-neoplastic lesions were observed.
The available and relevant studies do not indicate that the substance fulfills the criteria for classification as germ cell mutagen or that it is able to induce hyperplasia and/or pre-neoplastic lesions. Therefore, the conditions for a carcinogenicity study to be proposed or required set out in Column 2 of Annex X, 8.9.1, are not met. Therefore, a carcinogenicity study is scientifically unjustified, will not be proposed and shall be omitted for reasons of animal welfare in accordance with Annex XI, 1.2, of Regulation (EC) 1907/2006.
Based on expert judgement, a testing proposal for a carcinogenicity study for Lanolin Alcohols would be scientifically unjustified.
Justification for selection of carcinogenicity via oral route endpoint:
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 studies.
Justification for selection of carcinogenicity via inhalation route endpoint:
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 studies.
Justification for selection of carcinogenicity via dermal route endpoint:
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 studies.
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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