Registration Dossier

Administrative data

Description of key information

Based on expert judgment, there is no evidence that Triacetin (CAS 102-76-1) 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

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 Triacetin (CAS 102-76-1) induces gene mutations in bacteria and mammalian cells as well as chromosome aberrations in mammalian cells, as the results of all genotoxicity studies were consistently negative. Furthermore, in the available repeated dose toxicity studies and reproduction/developmental toxicity 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 Triacetin (CAS 102-76-1) fulfils the criteria for classification as germ cell mutagen or that it is 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. Furthermore, the weight of evidence from all available information leads to the conclusion that Triacetin (CAS 102-76-1) is not carcinogenic. 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.

Justification for classification or non-classification

Based on expert judgement, a testing proposal for a carcinogenicity study with the substance would be scientifically unjustified. The conclusion with regard to classification and labelling is "data lacking".