Registration Dossier

Administrative data

Description of key information

Based on expert judgment, there is no evidence that 1,2 benzenedicarboxylic acid, di-C16-C18-alkyl esters (CAS 90193-76-3) causes carcinogenic effects.

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

There are no carcinogenicity studies for 1,2 benzenedicarboxylic acid, di-C16-C18-alkyl esters (CAS 90193-76-3) available.

According to the Reach regulation (1907/2006/EC), 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 mutagen category 3 or there is evidence from repeated dose studies that the substance is able to induce hyperplasia and/or pre-neoplastic lesions.

There is no evidence that 1,2 benzenedicarboxylic acid, di-C16-C18-alkyl esters (CAS 90193-76-3) cause carcinogenicity by a direct genotoxic mechanism, as the results of all genotoxicity studies were negative. Furthermore, in all available repeated dose toxicity studies and developmental studies, no evidence for hyperplasia or preneoplastic lesions was seen.

Thus, the proposal for a carcinogenicity study would be scientifically unjustified.


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 for 1,2 benzenedicarboxylic acid, di-C16-C18-alkyl esters (CAS 90193-76-3) would be scientifically unjustified. The conclusion with regard to classification and labelling is "data lacking".