Phenethyl phenylacetate

Endpoint summary

Description of key information

The skin sensitizing potential of the test substance was determined in an open epicutaneous test with guinea pigs. No skin sensitizing effects were observed. This result is in-line with the result of an human maximization test. No skin sensitizing effects were observed in 25 healthy adult volunteers examined. In conclusion it can be stated that the test substance is not skin sensitizing.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

The endpoint Sensitisation is covered with an Weight of Evidence Approach, as two studies are availabe:

Klecak (1985)

Open epicutaneous test with guinea pigs

The skin sensitizing potential of the test item was tested in the open epicutaneous test with guinea pigs. The test was conducted on groups of 6 -8 male and female animals weighting 300 -450 grams. Daily applications (induction) were made for 3 weeks to a clipped 8 cm2 area on the flank of each guinea pig at concentrations of 100 %, 30 %, 10 %, 3 %, 1 % and 0.3 %. The test sites were not covered and the reactions were read 24 hours after each application. A total of 21 applications of 0.1 mL test material in an unspecified vehicle were made for 21 days. The 10 controls were either left untreated or treated with 0.1 mL of the vehicle for 21 days. At the challenge phase, both the test and control animals were treated at some lower primary non-irritating concentrations or the minimal irritating concentration. No skin sensitizing effects were observed.

Kligman (1971)

In an human sensitization study a Maximization Test was conducted on 25 healthy male humans to determine the contact sensitizing potential of the test item, applied in diluted form of 2 %. The test substance was applied under occlusion to the volar forearms for five alternate-day 48 hour periods. The challenge sites were read on removal of the patch and 24 hours thereafter. As no skin reactions were observed, the Maximization test results did not indicate a sensitizing effect of the test substance to the skin. The details of the study are shown in 7.10.4.

Conclusion: The skin sensitizing potential of the test substance was determined in an open epicutaneous test with guinea pigs. No skin sensitizing effects were observed. This result is in-line with the result of an human maximization test. No skin sensitizing effects were observed in 25 healthy adult volunteers examined. In conclusion it can be stated that the test substance is not skin sensitizing.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is not considered to be classified for skin sensitisation under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.