Registration Dossier
Registration Dossier
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EC number: 218-871-2 | CAS number: 2269-22-9
Carcinogenicity
Administrative data
Description of key information
Although no data on carcinogenicity of aluminium tri-sec-butylate is available, studies from genetic toxicity and repeat dose exposure do not indicate to investigate tumour formation of the substance further. Supportive data as described in the discussion support this finding currently.
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
Classification for carcinogenicity is not possible due to lack of data. However, based on available information from long-term studies and mutagenicity studies of 2 -butanol and aluminium3+ surrogate substances, carcinogenicity is not expected for aluminium tri-sec-butylate.
Additional information
No data on carcinogenicity of aluminium tri-sec-butylate are available. However, as aluminium tri-sec-butylate in contact with moisture or water hydrolyzes immediately to form 2-butanol and aluminium hydroxide indications about carcinogenicity could be thought from 2-butanol and aluminium hydroxide. 2-butanol was not investigated for carcinogenicity as a carcinogenicity study was not need to be conducted as negative results were reported in all genotoxicity studies and the repeated dose study does not indicate that the test substance induces hyperplasia or pre-neoplastic lesions. As representative of aluminium3+ compounds only aluminium oxide was investigated for carcinogenicity using inhalative exposure by Pigott et al. but this study, although absent of showing any tumour incidences following exposure, is considered to be of limited relevance as hydrolysis of aluminium tri-sec-butylate would not result in airborne alumina fibres. However, the study showed, that inhalative exposure to aluminium3+ species did not induce tumour in rats.
For explanation for using surrogate data in a weight of evidence approach see section 13 IUCLID.
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