Registration Dossier

Administrative data

Description of key information

In vivo studies with the registered substance showed corrosive effects to the skin and severe and irreversible damages to the eye.

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

The registered substance was tested in an acute skin irritation study in white rabbits according to the 49 CFR 173.240 protocol. Six animals received an occlusive patch with the undiluted substance for 4 hours and were subsequently observed for another 48 hours. The study was performed under GLP conditions. Eschar formation was observed in 6/6 animals at the end of the treatment period. The study design was not fully in line with European study protocols because the application was occlusive instead of semi-occlusive, thus giving an exagerated result.

Therefore, another study with a close homologue (C9 side chain instead of C11-12 side chain) was considered in a weight of evidence approach. The skin irritation potential of the homologue was evaluated in a study according to OECD Test Guideline 404 under GLP. The amount of 0.5 ml of the homologue was applied unchanged under occlusive conditions for 4 hours to the shaved skin of three Mol:Russian rabbits, which were observed for 21 days post application. Over the first three days, clear erythema and oedema were observed in all rabbits, which reversed fully within 21 days.

Interpreting these results by applying the evaluation system of the EU regulation 1272/2008, the homologue and consequently the registered substance is considered to be irritating to the skin.

A read across justification document is attached in chapter 13 of this IUCLID.

Eye irritation:

The registered substance was tested in an acute eye irritation study in white rabbits according to the 16 CFR 1500.42 protocol. 0.1 ml of the test substance was instilled to the eyes of 9 animals, 6 of which received a wash-out rinse within 4 seconds after application. 3 animals did not receive the wash-out rinse. The study was performed under GLP conditions. After 7 days post-treatment, the conjunctivitis was not reversible in the rinse group but it can be expected that the conjunctivitis would have been reversible within 21 days as required by the OECD guideline. In the non-rinse group the effects on the iris and cornea were reversible after 7 days of observation whereas the effects on the conjunctiva were not reversible although slight (grade 1). It can be expected that the effect would have been reversible if the observation period had been prolonged. Although the FDA study protocol is not fully in line with European study protocols, the results can be interpreted on the basis of Regulation (EC) 1272/2008. The test substance is considered to be irritating to the eyes (GHS Category 2).

Justification for classification or non-classification

Although the skin and eye irritation studies are not fully in line with European study protocols, the results can be interpreted on the basis of Regulation (EC) 1272/2008. The test substance is considered to be irritating to the skin (GHS category 2) and irritating to the eyes (GHS category 2).