Registration Dossier
Registration Dossier
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EC number: 248-363-6 | CAS number: 27247-96-7
Carcinogenicity
Administrative data
Description of key information
No data available on registered substance.
Non carcinogenic. No test is proposed because of:
- clear absence of genotoxic potential of the registered substance in standard assays (this excludes genotoxic carcinogenesis)
- absence of marked organ/tissue toxicity in available repeated-dose or reproductive toxicity studies (this does not sugget non-genotoxic carcinogenesis)
- absence of carcinogenic potential of the closely related substance 2-ethyl hexanol, precursor used in synthesis of registered substance, in rat (24 months) and mouse (18 months), as assessed by FDA and EPA.
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
See discussion. Not classified based on data on the registered substance and on a closely related substance.
Additional information
- Genotoxic potential of the registered substance has been excluded in a standard test battery: Ames test (with limited reliability), chromosomal aberration assay (reliable) and mouse lymphoma assay (reliable); this was further confirmed in a mammalian cell transformation assay which was non-guideline but may be considered as a carcinogenicity screening assay (reliability not assessable).
- No marked organ/tissue toxicity was noted in available repeated-dose or reproductive toxicity studies. In general the observed toxicity was limited to reduced weight gain. This does not sugget non-genotoxic carcinogenesis which may occur due to, e.g., prolonged cell stimulation and/or cytotoxicity.
- The closely related substance 2-ethyl hexanol (NB: the synthesis precursor of the registered substance) was studied for carcinogenic potential in rat (24 months) and mouse (18 months). Both FDA and EPA concluded that it was not carcinogenic. Corresponding reviews are attached.
No data available on registered substance.
No test is proposed because:
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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