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:

No evidence of skin sensitisation was seen with hexyl acetate, either in the Freund's Complete Adjuvant Test (FCAT: an adjuvant method) or in the Open Epicutaneous Test (OET: a non-adjuvant method). Although the studies are of non-standard design, the constently negative results are considered to be sufficient to conclude an absence of sensitising potential for hexyl acetate. The results of the two guinea pig assays are also consistent with the results of human testing. Following induction and challenge of 25 male volunteers with hexyl acetate, using a version of the repeat insult patch test, no reactions were apparent in any of the 25 volunteers challenged with hexyl acetate. No evidence of delayed contact hypersensitivity was seen in this human patch test. It is considered unlikely hexyl acetate would elicit contact sensitisation in humans in normal use.

Migrated from Short description of key information:
Complementary testing of n-hexyl acetate in two guinea pig models, one with and one without adjuvant, confirmed the absence of sensitising potential determined in a human repeat insult test.

Justification for selection of skin sensitisation endpoint:
Only one study is available for this endpoint.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The absence of positive sensitisation reactions in animal models and in human patch tests confirmed hexyl acetate does not require classification for delayed contact hypersensitivity according to the CLP Regulation.