Registration Dossier

Administrative data

Description of key information

Skin irritation/corrosion negative (EU B46); eye irritation negative (OECD 405).

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

In Harlan study No. 41104025, to OECD 439 and to GLP, an in vitro test, using Human Reconstructed Epidermis (RHE) model, the test substance was found to be negative for skin irritation. According to Commission Regulation EC No. 761/2009, amending Commission Regulation EC No. 440/2008 (Test Methods Regulation), this method, referred to as EU method B.46, "may allow determining the skin irritancy of substances as a stand-alone replacement test within a testing strategy, in a weight of evidence approach". Further in vivo testing for this endpoint can be discounted on animal welfare grounds, thus avoiding potential pain and suffering of animals.

In Haarman & Reimer study No. 01732 to OECD 405, and to GLP, in vivo eye irritation study, the substance was found to be not irritating to eyes. An in vitro eye irritation test was not required because of the existence of this in vivo study.

Justification for classification or non-classification

Skin irritation/corrosion

According to Regulation (EC) No. 1272/2008, sections 3.2.2.6 and 3.2.2.7, for skin irritation/corrosion substances can be classified as skin corrosive category 1, skin irritant category 2 or not classified. The substance was found to be non-irritant, and should therefore not be classified for skin irritation or corrosion.

Eye irritation

Regulation (EC) No. 1272/2008, sections 3.3.2.6. and 3.3.2.7 cover "Irreversible effects on the eye/serious damage to eyes (Category 1)" and "Reversible effects on the eye (Category 2) respectively". Haarman & Reimer (2000) found that the substance was not irritating to eyes, interpreting the data in accordance with Directive 93/21/EEC rather than the later Regulation EC No. 1272/2008. Re-interpretation of these data in accordance with the criteria laid out in Regulation (EC) No. 1272/2008 clearly show that the original conclusion is also consistent with that regulation. The substance should therefore not be classified with regards to eye irritation.