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Toxicological information

Carcinogenicity

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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

Additional information

In accordance with Column 2 of REACH Annex X, information requirement 8.9.1, 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 germ cell 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, and there are no known reports of carcinogenicity in humans in the public domain, testing for this endpoint is not proposed.

To substantiate the above, an extensive review of literature (Assessment of Genotoxicity and Carcinogenicity of inorganic-forms of Manganese, MHRP 2009) concluded through weight-of-evidence that inorganic manganese, 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 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.

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.