Registration Dossier

Administrative data

Description of key information

Skin irritation (OECD 404), rabbit: not irritating

Eye irritation (EPA OPPTS 870.2400), rabbit: not irritating

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

Reliable in vivo studies regarding eye and skin irritation/corrosion are available.

Skin:

In a primary dermal irritation study (performed according to OECD 404, in compliance with GLP, M-003613), 3 female New Zealand Albino rabbits were dermally exposed to 0.5 g test substance moistened with water for 4 h under semiocclusive conditions. Animals then were observed for 3 days. Irritation was scored by the method of Draize as described in the OECD 404. The mean scores for the 24, 48 and 72 h reading for erythema and edema for each animal was 0, respectively. No skin reactions were observed at the 1-hour reading point. In this study, the test substance was not a dermal irritant.

 Eye:

An eye irritation test was performed with three female New Zealand Albino rabbits according to OPPTS 870.2400 in compliance with GLP (M-267442-01-1). Eyes were not washed after application of 0.1 mL (corresponding to 0.04 g) test substance and the animals were observed for 3 days. Irritation was scored by the method of Draize. One hour after test substance instillation, all three treated eyes exhibited iritis (score 1 for all animals) and conjunctivitis (score 3 for 2 animals, score 2 for one animal).By 24 h, cornea opacity (score 1) developed in one animal but was fully reversible at 72 h. No cornea opacity developed in the other two animals. Mean scores (24, 48, 72 h) for cornea opacity are 0, 0 and 0.67, respectively. Also iritis (score 1) was noted at 24 h in 2/3 animals being fully reversible within 48 h and resulting in mean iritis scores (24, 48, 72 h) of 0.33, 0.00 and 0.33, respectively. Moderate conjunctival irritation (grade 1-2) were observed in 3/3 animals but were fully reversible within 72 h in all animals. Mean scores (24, 48, 72 h) regarding conjunctival irritation were 1.00 for all animals. Chemosis (grade 1) was also noted in 2/3 animals but was fully reversible within 48 h. Mean scores (24, 48, 72 h) for chemosis were 0, 0.33 and 0.67, respectively.All animals were free of ocular irritation by 72 h.

Based on the study results, the test substance is considered to be mildly irritating to eyes. However, the slight signs of irritation observed in this study were not sufficient to warrant classification for eye irritation.

A second eye irritation test was performed with three female New Zealand Albino rabbits and performed according to OECD 405 in compliance with GLP (M-003615-01-1). Eyes were washed 1 h after application of 0.1 g test substance and the animals were observed for 7 days. Irritation was scored by the method of Draize. The mean scores for the 24-, 48- and 72-h reading for iritis and cornea opacity were 0 for each animal. Moderate conjunctival irritation (mean scores for the 24-, 48- and 72 h-reading: 1.67, 0.33 and 1.0, respectively) were observed in 3/3 animals but were fully reversible within 72 h in 2/3 animals and 7 days in 1/3 animals. Chemosis (mean scores for the 24-, 48- and 72 h-reading: 0.33 for each animal) was also noted in 3/3 animals but was fully reversible within 48 h.

Based on the study results, the test substance is considered to be mildly irritating to eyes. However, the slight signs of irritation observed in this study were not sufficient to warrant classification for eye irritation.

Justification for classification or non-classification

The available data on skin and eye irritation do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.