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Administrative data

Description of key information

Based on expert judgment,  there is no evidence that Fatty acids, C18-unsatd., dimers, 2-ethylhexyl esters causes carcinogenicity.

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

Based on expert judgement, a testing proposal for a carcinogenicity study within Fatty acids, C18-unsatd., dimers, 2-ethylhexyl esters would be scientifically unjustified.

Additional information

In accordance with Column 2 of Annex X, 8.9.1, of Regulation (EC) No 1907/2006, 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 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.

There is no evidence that Fatty acids, C18-unsatd., dimers, 2-ethylhexyl esters induces gene mutations in bacteria or chromosome aberrations in mammalian cells, as the results of all genotoxicity studies were consistently negative. Furthermore, in the available repeated dose toxicity studies and developmental studies, no substance-related increases in the incidence of hyperplasia or pre-neoplastic lesions were observed.

The available and relevant studies do not indicate that the Fatty acids, C18-unsatd., dimers, 2-ethylhexyl esters fulfills the criteria for classification as germ cell mutagen or that they are able to induce hyperplasia and/or pre-neoplastic lesions. Therefore, the conditions for a carcinogenicity study to be proposed or required set out in Column 2 of Annex X, 8.9.1, are not met. Therefore, a carcinogenicity study is scientifically unjustified, will not be proposed and shall be omitted for reasons of animal welfare in accordance with Annex XI, 1.2, of Regulation (EC) 1907/2006.


Justification for selection of carcinogenicity via oral route endpoint:
No carcinogenicity study is required, since the substance is not mutagenic and no hyperplasia or pre-neoplastic lesions were observed in any of the available studies.

Justification for selection of carcinogenicity via inhalation route endpoint:
No carcinogenicity study is required, since the substance is not mutagenic and no hyperplasia or pre-neoplastic lesions were observed in any of the available studies.

Justification for selection of carcinogenicity via dermal route endpoint:
No carcinogenicity study is required, since the substance is not mutagenic and no hyperplasia or pre-neoplastic lesions were observed in any of the available studies.

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