Registration Dossier

Toxicological information

Carcinogenicity

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Administrative data

Description of key information

Waiver

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

The criteria in Regulation EC No. 1272/2008 for classification as a carcinogen are not met.

Additional information

Regulation (EC) No.1907/2006, Annex X, 8.9.2, Column 2, states that a carcinogenicity study may be proposed by the registrant or may be required by the Agency in accordance with Articles 40 and 41 if the substances has wide dispersive use or there is evidence of frequent or long-term human exposure; and the substance is classified as a mutagen category 3 or there is evidence from repeated dose studies that the substance is able to induce hyperplasia and/or preneoplastic lesions. The substance is not widely dispersed, nor does it have frequent or long-term human exposure. There is no evidence of mutagenicity, nor is there evidence of hyperplasia and/or preneoplastic lesions from repeated dose studies. Therefore, the conditions for proposing a carcinogenicity test are not met, and the endpoint is adapted.