Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

carcinogenicity: oral
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
Justification for type of information:
Regulation (EC) No. 1907/2006, Annex X, 8.9.1., Column 2, states ‘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 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.’

As required in Annex X, 8.9.1., Column 2, the registrant has evaluated the need to perform a carcinogenicity study. Relevant and reliable information on the target substance and various source substances addressing the genetic toxicity potential and the potential of these substances to induce hyperplasia and/or pre-neoplastic lesions is available.
The target substance is not classified as germ cell mutagen category 2. This is based on the available in vitro genotoxicity studies conducted with the four analogue source substances 2-octyldodecyl isooctadecanoate (CAS 93803-87-3), Fatty acids, C8-10, C12-18-alkyl esters (CAS 95912-86-0), (Z)-octadec-9-enyl oleate (CAS 3687-45-4), and 2-ethylhexyl oleate (CAS 26399-02-0). All available studies showed negative results, indicating a lack of genotoxic potential. The studies cover the genetic toxicity endpoints of in vitro mutagenicity in bacterial cells as well as the in vitro cytogenicity and mutagenicity in mammalian cells (thymidine kinase and hprt locus).

Moreover, in the available subacute and sub-chronic (90-day) repeated dose toxicity studies performed via the oral route of exposure using the analogue source substances tetradecyl octadec-9-enoate (CAS 22393-85-7), decyl oleate (CAS 3687-46-5), and Octanoic acid, 2-propylheptylester (CAS 868839-23-0) no toxicologically relevant effects indicating a potential for inducing hyperplasia and/or pre-neoplastic lesions were observed, up to and including the recommended limit values.

Therefore, the conditions set out in Column 2 of Annex X, Section 8.9.1 are not fully met and performing a carcinogenicity study would be scientifically unjustified.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion