Registration Dossier

Administrative data

Description of key information

skin irritation test according to the OECD TG 404 (1992) under semi-occlusive conditions, in rabbit; the test conduct followed GLP (Huntingdon Life Sciences Ltd 964055). 
eye irritation test in rabbit according to the OECD TG 405 (1987); the test conduct followed GLP (Huntingdon Life Sciences Ltd 964056).

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The test substance was tested for skin irritation according to the OECD TG 404 (1992) under semi-occlusive conditions in rabbit (Huntingdon Life Sciences Ltd 964055). The observation period was restricted to 72 hours since no dermal effects were seen at all in the 3 treated animals. Since neither erythema nor edema was observed in any animals throughout the observation period, it was concluded that the test substance was non irritant.

The test substance was tested for eye irritation in rabbit according to the OECD TG 405 (1987); after instillation, the test substance was not removed from the eye (Huntingdon Life Sciences Ltd 964056). No corneal damage was observed. Iridial inflammation graded 1 was seen in one animal at reading time point 24 hours only. Redness of the conjunctivae with slight swelling was seen in all animals within one hour of treatment. These reactions gradually ameliorated and the eyes were normal after 3 (i.e. 72 hours) or 4 days following instillation. Evaluation of the mean scores according to actual criteria (Directive 67/548/EEC and GHS) leads to the conclusion that the test substance is non irritating to the eye.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for skin or eye irritation under Directive 67/548/EEC, as amended for the 31st time in Directive2009/2/EG.

 

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin or eye irritation under Regulation (EC) No. 1272/2008, as amended for the third time in Directive EC 618/2012.