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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

In a key study this substance was applied to white rabbits under semi-occlusive dressing for four hours (Kern, TG, 1999). The test material was administered at concentrations of 100, 50, 25, and 12.5% in mineral oil. The primary irritation index of 4.84, 4.58, 3.93, and 3.08 were calculatedfor the 100, 50, 25, and 12.5% w/v concentrations, respectively. The mean 24 to 72 hour erythema scores were determined to be 3.0, 2.94, 2.84, and 2.33 for 100, 50, 25, and 12.5% w/v concentrations, respectively, and the mean 24 to 72 hour edema scores were determine to be 1.83, 1.67, 1.11, and 0.83 for 100, 50, 25, and 12.5% w/v concentrations, respectively.

In a key study, this substance was instilled into the conjunctival sac of white rabbits(Hershman, RJ and Moore, GE, 1983). The mean eye irritation scores were 22.3, 18.7, 18.3, 9.3, and 2.3 at days 1, 2, 3, 4, and 7, respectively. The mean (24, 48, and 72 hour) cornea opacity, iritis, conjunctival erythema and conjunctival edema scores were 0.49, 0.33, 1.36, and 1.94, respectively. The test substance was an irritant.

In a supporting study this substance was instilled into the conjunctival sac of white rabbits at concentrations of 10% in mineral oil (Hershman, RJ and Moore, GE, 1983). The mean eye irritation scores were 0.3 at day 1 and 0.0 on days 2 through 7. The mean (24, 48, and 72 hour) cornea opacity, iritis, conjunctival erythema and conjunctival edema scores were 0.0, 0.0, 0.0, and 0.06, respectively. The 10% solution of the test substance in mineral oil was not an irritant

 


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 10% for eye irritation.

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