Reaction mass of (4Z)-4-ethylidene-2-propoxycyclohexanol and (4E)-4-ethylidene-2-propoxycyclohexanol and (5Z)-5-ethylidene-2-propoxycyclohexanol and (5E)-5-ethylidene-2-propoxycyclohexanol

Endpoint summary

Description of key information

The test substance, FRET 13-0156, was considered to be non-corrosive to the skin in an In vitro EPIDERM skin corrosion test, but is classified as a dermal irritant according to an EPISKIN reconstructed human epidermis model.

A BCOP study determined that no prediction of eye irritation due to the test material can be made, BUT ocular effects were seen in rabbits (OECD 405 test), including diffuse corneal opacity, iridial inflammation and moderate conjunctival irritation, which were fully reversible within 14 days. The results showed that the substance is an ocular irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

A study was performed to assess the corrosion potential of the test material to the skin using the EPIDERM model. The method used was OECD Guideline 431: In vitro Skin Corrosion: Reconstructed Human EpiDermis (RHE) Test Method. The percentage viability of the test item was 104.0 after 3 minutes exposure, and 77.0 after 60 minutes exposure.

A study was performed to assess the irritantcy potential of the testmaterial to the skin using the EPISKIN model. The method used was OECD 439. The relative mean viability of the test item treated tissues was 4.2% after the 15 Minute exposure period and 42 Hours post‑exposure incubation period. The quality criteria required for acceptance of results in the test were satisfied.

A study was performed to assess the potential of the test material to induce serious eye damage and to identify if classification for eye irritation or serious eye damage was required. The method used was OECD 437 "Bovine Corneal Opacity and Permeability Assay".

The substance was tested in an eye irritation test in rabbits according to OECD 405. Ocular effects included diffuse corneal opacity, iridial inflammation and moderate conjunctival irritation, which were fully reversible within 14 days. The results showed that the substance is an ocular irritant.

Reliability:

The above studies have all been raanked Reliability 1 according to the Klimisch et al system. The ranking was deemed appropriate as the studies were conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies which do not affect the quality of relevant results.

Justification for classification or non-classification

The test material did not meet the criteria for classification as corrosive to the skin according to the EU labelling regulations during an EPIDERM study, but did meet the criteria for classification as a dermal irritant during an EPISKIN study. The following classification criteria apply:

EU CLP and UN GHS Hazard statement H315 “Causes Skin Irritation” Category 2.

In the BCOP eye irritation study, the In vitro eye irritation score as 18.5, meaning that no prediction of eye irritancy can be made.

Based on the positive results in the rabbit eye irritation test (OECD 405) the substance needs to be classified as an eye irritant. According to EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 this results in classification as 'Irritating to eyes (Category 2), "H319: Causes serious eye irritation".