2-phenylpropionaldehyde-dimethyl acetal

Endpoint summary

Description of key information

Skin corrosion: Not corrosive based on no irritation in an OECD TG 439 test.

Skin irritation: Not irritating based on an OECD TG 439 test.

Eye corrosion/irritation: Not requiring classification based on an OECD TG 437 test.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin corrosion

The test item is not considered to be skin corrosive because no irritation was observed was observed in the skin irritation test.

Skin irritation

The skin irritation potential of the test substance was tested in vitro using the EPISKIN™ model after a treatment period of 15 minutes followed by a post-exposure incubation period of 42 hours. The study procedures were according to OECD TG 439 and GLP principles. The principle of the assay was based on the measurement of cytotoxicity in reconstructed human epidermal cultures following topical exposure to the test substance by means of the colorimetric MTT reduction assay. Triplicate tissues were treated with 10 µL undiluted test item for an exposure period of 15 minutes. Concurrent positive (5% SDS solution in aqueous solution) and negative (Dulbecco’s Phosphate Buffered Saline) controls were included. The optical density was measured at 570 nm. Tests for direct MTT reduction and colour interference were negative. The relative mean viability of the test item treated tissues was 67.2%. Under the conditions of this study the test item was considered to be not irritating to the skin, because the relative mean tissue viability was above 50% after 15 min exposure.

Eye irritation/corrosion

To identify whether the test item can induce serious eye damage or is not requiring classification for eye irritation or serious eye damage, an OECD TG 437 test, following GLP, was performed. The undiluted test item was applied to bovine eyes for 10 minutes followed by an incubation period of 120 minutes. Negative (sodium chloride 0.9% w/v) and positive (ethanol) control items were tested concurrently. All tests were performed in triplicate. The two endpoints, decreased light transmission through the cornea (opacity) and increased passage of sodium fluorescein dye through the cornea (permeability) were combined in an empirically derived formula to generate an In Vitro Irritancy Score (IVIS). The corneas treated with the test item and with the negative control were clear post treatment and post incubation, while the corneas treated with the positive control were cloudy post treatment and post incubation. The positive and negative acceptance criteria were fulfilled. The IVIS observed for the test material was 1.1 and subsequently the test substance does not require classification.

Justification for classification or non-classification

Based on the negative results of the available in vitro skin and eye studies, classification of the substance for skin and eye irritation is not warranted according to EU CLP (EC 1272/2008 and its amendments).