Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The potential for 1 -isopropyl-2,2 -dimethyltrimethylene diisobutyrate to cause dermal sensitization is well understood. In a contemporary, GLP-compliant human repeat insult patch test, it was concluded that the test article was not sensitizing. In a non-guideline study in which guinea pigs were repeatedly exposed to 1% of the test material over a two week period, there was no increased incidence of erythema or edema when compared to the negative control group. The response in the positive control group, treated with topical application of the known skin sensitizer phenylhydrazine, was as expected. Taken together, these studies support the conclusion that 1 -isopropyl-2,2 -dimethyltrimethylene diisobutyrate is not sensitizing.

Justification for classification or non-classification

No evidence of a sensitization response was observed in either a human repeat insult patch test, or when guinea pigs were repeatedly exposed to 1 -isopropyl-2,2 -dimethyltrimethylene diisobutyrate over a two week period. Taken together, these studies support the conclusion that 1 -isopropyl-2,2 -dimethyltrimethylene diisobutyrate is not sensitizing.