Ethyl 2-(dimethylamino)-1-phenylcyclohex-3-ene-1-carboxylate

Endpoint summary

Description of key information

Trans-Tilidin-HCL-Hemidhydrat, a structural analogue of ethyl 2-(dimethylamino)-1-phenylcyclohex-3-ene-1-carboxylate is considered to be irritating to the eye under the test conditions of a GLP-compliant eye irritation study (OECD guideline 405).

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no study available

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

No studies on the potential to cause eye damage of ethyl 2-(dimethylamino)-1-phenylcyclohex-3-ene-1-carboxylate were available. However, Article 13 of REACH states that, in case no appropriate animal studies are available for assessment, information should be generated whenever possible by means other than vertebrate animal tests, i.e. applying alternative methods such as in vitro tests, QSARs, grouping and read-across. One OECD 405 guideline study, that evaluates the potential to cause eye damage, is available for the structural analogue Trans-Tilidin-HCL-Hemidhydrat.

The potential to cause damage to the conjunctiva, iris of cornea was assessed, in a GLP complaint OECD 405 guideline study in 3 white Vienna rabbits subjected to a single ocular application of 0.1 mL (approx. 49 mg) Trans-Tilidin-HCL-Hemidhydrat on day 0 (BASF 2002). About 24 hours after application the eye was rinsed with tap water. Slight to severe conjunctival redness, slight to marked conjunctival chemosis and slight to severe discharge were observed during the course of the study. In addition moderate or severe iritis and slight corneal opacity was noted within the first week of the observation period. Moreover the animals exhibited injected scleral vessels in a circumscribed area as well as circular, small retraction in the eyelid, suppuration, contracted pupil, discharge of blood and white discolored parts of the nictitating membrane during the study period. Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 1.0 and 1.0 for corneal opacity, 0.0, 1.3 and 0.7 for iris lesions, 2.0, 3.0 and 2.0 for redness of the conjunctiva and 1.3, 2.3 and 1.3 for chemosis, for animals 1, 2, and 3 respectively. Findings were reversible within 14 days after application. It was concluded that the substance was irritating to the eye.

Justification for selection of eye irritation endpoint:
There is one study available that evaluated the potential to cause eye damage for a structural analogue of ethyl 2-(dimethylamino)-1-phenylcyclohex-3-ene-1-carboxylate. This study is performed according to OECD 405 and GLP. This study is sufficiently adequate for this endpoint.

Effects on eye irritation: irritating

Justification for classification or non-classification

In all 3 animals exposed to Trans-Tilidin-HCL-Hemidhydrat eye irritation was observed. Because Trans-Tilidin-HCL-Hemidhydrat is a structural analogue of ethyl 2-(dimethylamino)-1-phenylcyclohex-3-ene-1-carboxylate, ethyl 2-(dimethylamino)-1-phenylcyclohex-3-ene-1-carboxylate is also suspected to be eye irritating. Based on this ethyl 2-(dimethylamino)-1-phenylcyclohex-3-ene-1-carboxylate is classified as Xi:R36: Irritating to eyes in accordance with Directive 67/548/EEC (DSD) and Eye Irrit 2:H319 Causes serious eye irritation in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.