Registration Dossier
Registration Dossier
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EC number: 204-010-8 | CAS number: 112-85-6
Carcinogenicity
Administrative data
Description of key information
Based on expert judgement, there is no evidence that members of the Fatty acids category cause 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
Based on expert judgement, a testing proposal for a carcinogenicity study within the Fatty acids category would be scientifically unjustified. The conclusion with regard to classification and labelling is "data lacking".
Additional information
For the members of the Fatty acids category no data are available for carcinogenicity.
According to the Regulation (EC) No 1907/2006, Column 2 of Annex X, Section 8.9.1, 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 repeated dose study(ies) that the substance is able to induce hyperplasia and/or pre-neoplastic lesions.
There is no evidence that fatty acids cause carcinogenicity by a direct genotoxic mechanism, as the results of all available genetic toxicity studies were negative. Furthermore, in repeated dose toxicity studies and developmental toxicity studies, no evidence for hyperplasia or pre-neoplastic lesions was seen.
Thus, the proposal for a carcinogenicity study would be scientifically unjustified.
Justification for selection of carcinogenicity via oral route endpoint:
No study required in accordance with Regulation (EC) No 1907/2006, Column 2 of Annex X, Section 8.9.1.
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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