Registration Dossier
Registration Dossier
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EC number: 242-670-9 | CAS number: 18917-91-4
Carcinogenicity
Administrative data
Description of key information
No carcinogenicity study is required.
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
Available data give no concern on carcinogenic properties of the test substance. Thus, classification of Aluminium trilactate as carcinogenic is not required according to Directive 67/548/EEC as well as GHS Regulation EC No 1272/2008 and therefore labelling is not necessary.
Additional information
No carcinogenicity study is required. There is no concern for mutagenicity or genotoxicity at physiologically relevant levels. In the available sub-chronic studies and publications there are no indications of non-specific organ damage or chronic inflammation. Available data give no concern on carcinogenic properties of the test substance.
Moreover, EFSA (2008) concluded that “Overall the database on carcinogenicity of aluminium compounds is limited. In the most recent study no indication of any carcinogenic potential was obtained in mice given aluminium potassium sulphate at high levels in the diet. Overall the Panel concluded that aluminium is unlikely to be a human carcinogen at exposures relevant to dietary intake.”
EFSA (2008) Safety of aluminium from dietary intake, The EFSA Journal 754, 1-34, available via internet: http://www.efsa.europa.eu/de/efsajournal/pub/754.htm
Justification for selection of carcinogenicity via oral route endpoint:
No carcinogenicity study is required. There is no concern for mutagenicity or genotoxicity at physiologically relevant levels. In the available sub-chronic studies and publications there are no indications of non-specific organ damage or chronic inflammation. Available data give no concern on carcinogenic properties of the test substance.
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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