Registration Dossier

Toxicological information

Carcinogenicity

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Administrative data

Description of key information

Information not available (justified data waiving).

Key value for chemical safety assessment

Additional information

According to column 2 of REACH Annex X, because the substance does not have wide dispersive use and considering that human exposure is limited to the workplaces where RMM can effectively limit the extent of the exposure, no carcinogenicity testing is proposed at present.

Moreover, the following issues support the waiving for carcinogenicity testing:

- the long-term inhalation toxicity test, which foresaw a careful histopathological examination of body tissues of the test animals, did not show the presence of neoplastic lesions neither at the contact site (airways and lungs) nor in other organs;

- after oral exposure the substance is not absorbed and systemic effects (including carcinogenic effects) are not expected.

Justification for classification or non-classification

According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the substance is not classified as carcinogen because of data lacking.