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Toxicological information

Carcinogenicity

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Description of key information

This endpoint was waived on the basis that 2,6-xylenol is non-mutagenic and did not result in hyperplastic or pre-neoplastic lesions in oral repeat dose studies.

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

Additional information

According to Annex X, a carcinogenicity study may be required 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 category 3 mutagen or there is evidence from the repeated dose study(ies) that the substance is able to induce hyperplasia and/or pre-neoplastic lesions. Based on the available data, 2,6-xylenol is not classified as a mutagen and evidence from repeat dose oral studies does not indicate that it would induce hyperplasia and/or pre-neoplastic lesions.

 

Supporting information is submitted in the form of a poor quality study that was awarded a reliability score of 3 in accordance with the criteria for assessing data quality as set forth by Klimisch et al. (1997).

This is a non-guideline, non-GLP study with limited details on methodology and results. A skin painting study was carried out in Sutter mice using benzene as a vehicle, which is in itself carcinogenic.

Thirty mice were exposed to the test material as a 10 % solution in benzene diluent twice weekly for 20 weeks.

8% of survivors developed papillomas at 20 weeks; none developed carcinomas by 28 weeks. According to the EPA classification (U.S. EPA. 1986), this compound would be classified in category D, meaning that there is inadequate evidence to assess the human carcinogenic potential.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No. 1272/2008, the substance does not require classification with respect to carcinogenicity.