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Diss Factsheets

Administrative data

Description of key information

This substance is an EU Category 2 skin irritant and an EU Category 1 eye irritant with a specific concentration limit of 10% for eye irritation. 

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)

Additional information

Skin Irritation/Corrosion:

In a key study the test substance was applied undiluted or at concentrations of 50%, 25%, 12.5%, and 6.25% to groups of New Zealand white rabbits under semi-occlusive dressing for four hours (Kiplinger, G.R., 1993). Following the exposure period, the test sites were washed with light, white mineral oil and disposable paper towels. The test sites were evaluated in accordance with Draize. Mean 24-72 hour erythema and edema scores were 2.6 and 1.3, respectively, undiluted, 2.9 and 1.2, respectively at 50%, 2.7 and 0.7, respectively, at 12.5%, and 2.1 and 0.5, respectively, at 6.25%. All effects were not fully reversible at 72 hours.

 

In a supporting study the test substance was applied to New Zealand white rabbits under semi-occlusive dressing for four hours (Shults, S.K. et al., 1993). Following the exposure period, the test sites were wiped with gauze moistened with mineral oil and then gently patted with clean, dry paper towels. The test sites were evaluated in accordance with Draize. Mean 24-72 hour erythema and edema scores were 1.7 and 1.1, respectively. Erythema was not fully reversible in 14 days; edema was fully reversible in 4 days.

 

 

In another supporting study a 5% suspension of this substance was applied to New Zealand white rabbits under semi-occlusive dressing for four hours (Bonnette, K.L., 1996). Following the exposure period, the test sites were wiped with gauze moistened with mineral oil followed by dry gauze. The test sites were evaluated in accordance with EC guidelines (1993) which resulted in average scores at 24, 48, and 72 hours of 3.17, 2.17, and 1.83, respectively, for erythema and 1.67, 1.00, and 0.67, respectively, for edema. The mean values used for classification and labeling in accordance with GHS criteria were 1.11 for edema and 2.39 for erythema. Adverse effects were reversible in 14 days.

 

 

 

Serious eye damage/irritation:

In a keystudy the testmaterial was instilled in the eye of six albino rabbits (Hershman, RJ and Moore, GE, 1983).The group mean ocular irritation scores according to the Draize scale were 18.2, 20.7, 26.5, 28.8, 27.5, 7.0, and 5.6 out of 110 at 1, 2, 3, 4, 7, 14, and 21 days, respectively. Conjunctival and corneal effects were not fully reversible by day 21.

 

In a supporting study, a 15% suspension of this substance in mineral oil was administered to New Zealand white rabbits (Bonnette, K.L., 1996). Exposure to the test substance produces iritis in 3/6 test eyes at the 1 hour scoring interval. The iridal irritation resolved completely in the affected eyes by the 24 hours scoring interval. Conjunctivitis (redness, swelling and/or discharge) was noted in 6/6 test eyes at the 1 hour scoring interval. The conjunctival irritation resolved completely in all animals by 96 hours. The mean 24-72 hour scores for corneal opacity, iritis, conjunctivae redness and conjunctival edema were 0.00, 0.00, 1.00, and 0.61, respectively.


Effects on skin irritation/corrosion: moderately irritating

Effects on eye irritation: highly irritating

Justification for classification or non-classification

This substance meets the requirement under EU CLP (Regulation (EC) No. 1272/2008) for classification as a Category 2 skin irritant and a Category 1 eye irritant with a specific concentration limit of 15% for eye irritation.