1,4:5,8-Dimethanonaphthalene, 2-ethylidene-1,2,3,4,4a,5,8,8a-octahydro-

Endpoint summary

Description of key information

Skin Corrosion, In-vitro (EPI Derm) = Non-corrosive.
Skin Irritation, In-vitro (EPISKIN) = Irritating.
Eye Irritation, In-vitro (BCOP) = Non-irritating.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

An In-vitro skin corrosion test (Epiderm, Huntingdon Life Sciences, 2010) was conducted to predict the potential of ETD to cause skin corrosion. The study was conducted according to OECD Test Guideline 431 and in compliance with GLP.

ETD elicited a mean tissue viability of 103.1% for three minute contact and 94.4% for one hour contact and was predicted as non-corrosive.

An In-vitro skin irritation test (EPISKIN, Huntingdon Life Sciences, 2010) was conducted to predict the potential of ETD to cause skin irritation. The study was conducted according to OECD Test Guideline 439 and the relevant L’Oreal Standard Operating Procedure (SOP), which is accepted by ECVAM, and in compliance with GLP.

The mean tissue viability of three replicate samples was 22.7 ± 2.0; as this was below 50% the test substance should be considered Irritating to skin, and classified as R38 according to the dangerous substances directive, or Skin Irritant Category 2 according to GHS.

An In-vitro eye irritation test (Bovine Corneal Opacity and Permeability assay, BCOP: Huntingdon Life Sciences, 2010) was conducted to predict the capacity for the test substance ETD to cause eye irritation. The study was conducted according to OECD test guideline 437, and in compliance with GLP.

The mean (of three replicates) In Vitro Irritancy Score (IVIS) was -0.3 ± 1.1; in accordance with the OECD guideline, a substance with an IVIS of less than 55.1 is considered to be non-corrosive and not to be a severe eye irritant. Concurrent negative (saline) and positive (10% (w/v) Sodium hydroxide solution) controls confirmed the validity of the test.

On the basis of the negative result in the above BCOP assay, an in-vivo eye irritation study (Huntingdon Life Sciences, 2012) was conducted to confirm the absence of eye irritant activity for ETD. This study was conducted according to EU test method B5, OECD method 405, and US EPA and Japanese guidelines; the study was conducted in compliance with GLP.

Three female rabbits were administered ETD test material in one eye, then observed for irritant response' observations were recorded at 1, 24, 48, and 72 hours after administration. It was concluded that ETD does not require classification for eye irritant effects, according to the criteria specified in the CLP Regulation (Commision Regulation 1272/2008).

Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

The result of the Epiderm test noted above predicted that ETD would not be corrosive, and so on the basis of this in-vitro test, classification for skin corrosion is not applicable.

As noted above, the results from the EPISKIN correspond to a classification as Skin Irritation Category 2 under GHS (and therefore the CLP Regulation), Hazard code "H315: Causes skin irritation", or as R38 under the Dangerous Substances Directive.

As stated above, on the basis of an in-vitro eye irritation test, and the subsequent in-vivo test, ETD does not require classification as an eye irritant.