Registration Dossier

Toxicological information

Carcinogenicity

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Description of key information

Key value for chemical safety assessment

Additional information

REACH Annex X, Section 8.9.1, Column 2 states:

"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 of 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."

The available genetic toxicity studies show an absence of any genetic toxicity, as such the registration substance is not classified as a germ cell mutagen. The repeated toxicity studies (OECD 407 and 408) did not show any significant toxicological findings, notably there was no evidence of hyperplasia and/or pre-neoplastic lesions. Therefore, in accordance to the aforementioned REACH text, the carcinogenicity study is waived.

Justification for classification or non-classification

No carcinogenicity study exists for the registration substance. However, the available genetic toxicity studies give no indication of genetic toxicity, nor do the repeated dose studies show any indication of hyperplasia and/or pre-neoplastic lesions. As such, the registration substance is not classified as carcinogenic.