Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The component diisotridecyl adipate was tested up to the limit concentration of 10 µL/plate, which exhibited slight toxicity. The positive controls induced the appropriate responses in the corresponding strains. Diisotridecyl adipate did not increase the number of revertants in the test strains used. There was no evidence of induced mutant colonies over background.

The analogue diisotridecyl dodecanedioate was negative in an Ames-test (Zeneca, 1995).

The read-across substance bis (2-ethylhexyl) adipate was negative in the mouse lymphoma test and in the in vitro chromosome aberration test.

Zeneca Central Toxicology Laboratory Genetic Toxicology Screening, 1995, Report No. CTL/L/6341


Short description of key information:
For the test item Reaction product of adipic acid and sebacic acid and isotridecan-1 -ol is no study available. However, it is likely that the studies conducted on the read-across substanced bis (2 -ethylhexyl) adipate and diisotridecyl dodecanedioate are valid for Reaction product of adipic acid and sebacic acid and isotridecan-1 -ol (please see justification for read-across). All genotox tests were negative.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

All genotox tests on the component Diisotridecyl adipate and the analogue bis(2 -ethyl hexyl) adipate and diisotridecyl dodecanedioate were negative. Thus Reaction product of adipic acid and sebacic acid and isotridecan-1 -ol has not to be classified.