Registration Dossier
Registration Dossier
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EC number: 215-266-5 | CAS number: 1317-35-7
Carcinogenicity
Administrative data
Description of key information
This endpoint has been waived on the basis that the substance is not classified as a mutagen category 3.
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
In accordance with criteria for classification as defined in Annex I, Regulation 1272/2008, the substance does not require classification for carcinogenicity.
In accordance with the criteria for classification as defined in Annex VI, Directive 67/548/EEC (DSD) the substance does not require classification for carcinogenicity.
Additional information
According to column 2 (specific rules for adaptation from column 1) point 8.9.1, under Annex X of Regulation 1907/2006, a study may be proposed 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 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.
As the substance was found to be non-mutagenic from the conclusions of the genetic toxicity tests, testing for this endpoint is not proposed.
Furthermore, an extensive review of literature (Assessment of Genotoxicity and Carcinogenicity of inorganic-forms of Manganese, MHRP 2009) concluded through weight-of-evidence that the registered substance, trimanganese tetraoxide, is not carcinogenic. This is further supported by the UK HSE report Manganese and its inorganic compounds (EH64 1999), which concludes that there is no evidence linking Manganese and its inorganic compounds to carcinogenicity in humans. The Scientific Committee on Occupational Exposure Limits (SCOEL 2009) states “data on carcinogenicity mutagenicity and genotoxicity are inconclusive and inadequate to establish a definitive position on the carcinogenicity on manganese and its compounds.
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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