Registration Dossier

Toxicological information

Carcinogenicity

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Administrative data

Description of key information

Testing not required based on Column 2 of REACH Annex X.

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 carcinogenic potential of the study substance is expected to be low and classification is not warranted.

Additional information

In accordance with Column 2 of REACH Annex X, 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 widespread dispersive use or there is evidence of frequent or long-term human exposure; and the substance has been classified as mutagen category 3 or there is evidence from the repeated dose studies that the substance is able to induce hyperplasia and/or pre-neoplastic lesions. In multiple genetic toxicity studies of the study substance, no evidence of mutagenic potential has been identified. In addition, repeated exposure to the study substance by either the oral or dermal route showed no significant treatment-related hyperplasia and/or pre-neoplastic lesions. In addition a dermal carcinogenicity study of a surrogate alkylated naphthalene material, reported no treatment-related tumors following a two year daily dietary exposure of doses up to 1500ppm. Therefore carcinogenicity testing is not warranted.