Registration Dossier

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

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 3 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 concluded through weight-of-evidence that the registered substance, manganese dioxide, 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.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No. 1272/2008, the substance does not require classification with respect to carcinogenicity.

In accordance with the criteria for classification as defined in Annex VI, Directive 67/548/EEC (DSD), the substance does not require classification with respect to carcinogenicity.