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:

Ethyl acetate was negative in a Guinea pig Magnusson-Kligman maximization test, conducted according to OECD Guideline 406.

The skin sensitization has been evaluated in humans using patch tests, although the original publications of these studies are not available. A formulation containing 97% ethyl acetate was evaluated in human repeated insult patch testing on two separate groups. Twenty-five subjects were patch-tested with 0.3 ml under occlusive conditions for five consecutive 48 -hr periods. A challenge test 10 days after the final induction patch failed to elicit any skin reactions. A second group of ten subjects received 21 consecutive applications of 0.1ml to the back under closed patches. Each patch was removed after 23 h and the product was rinsed from the skin. Sites were scored 1 hour later. There was no evidence of cumulative skin irritation. The skin sensitization potential of ethyl acetate was also evaluated in the Kligman maximization test. Ethyl acetate was tested at 10% in petrolatum on the skin of 25 volunteers. No sensitization reactions occurred.

Overall, it can be concluded from the evidence available that ethyl acetate has low skin sensitisation potential.


Migrated from Short description of key information:
Guinea pig maximization test:negative

Respiratory sensitisation

Endpoint conclusion
Additional information:

There is no data available on respiratory sensitising properties. Ethyl acetate does not have any functional groups or structures that are associated with respiratory sensitisation.

Justification for classification or non-classification

No classification is proposed based on reliable animal data and supporting data from human volunteer patch testing. Ethyl acetate does not meet the criteria for classification as a skin sensitiser.