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Toxicological information

Carcinogenicity

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Description of key information

Key value for chemical safety assessment

Additional information

In REACH Annex X column II it is stated: “A carcinogenicity study may be proposed by the registrant or may be required by the Agency in accordance with Articles 40 or 41 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.”

The substance is not classified as mutagenic and there is no evidence from RA repeated dose studies that it is able to induce hyperplasia and/or pre-neoplastic lesions. Therefore performing a carcinogenicity study is not justified.

Justification for classification or non-classification

The substance is not classified as mutagenic and there is no evidence from RA repeated dose studies that it is able to induce hyperplasia and/or pre-neoplastic lesion and thus do not need to be classified.