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Description of key information

There are 10 skin irritation and 6 eye irritation studies for the hydrotrope category substances.  The studies consistently demonstrate that the hydrotrope substances are not irritating or only slightly irritating to the skin and slightly to moderately irritating to the eye.

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:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

There are a total of 10 skin irritation and 6 eye irritation studies on the hydrotrope category substances.

 

The key study for skin irritation is a 1993 study on sodium cumene sulphonate. This is an OECD 404 guideline study conducted according to GLP guidelines. Three shaved and intact skin rabbits were exposed to 200 mg of the test substance in solution for 4 hours under occluded conditions followed by observation and scoring through 72 hours. There was slight erythema in all three animals at 4 hours but it was completely resolved at 72 hours. Per OECD GHS the test substance was scored as mildly to slightly irritating. The other 9 skin irritation studies show results which ranged from non-irritating to slightly irritating.

 

The key eye irritation study is a 2007 study on sodium cumene sulphonate. This is an OECD 405 study conducted according to GLP guidelines. Three male rabbits were dosed with 0.1 g of undiluted test substance in the conjunctival sac of one eye. The eyes were not washed and evaluations were done daily for 7 days. The MMTS (maximum mean total score) at 24 hours was 27. There was full reversal on day 7. Per OECD GHS guidelines the conclusion is that the test substance is moderately irritating. The other 5 eye irritation studies show results which ranged from slightly to moderately irritating.


Effects on eye irritation: moderately irritating

Justification for classification or non-classification

Based on the available skin irritation studies no classification for skin effects is warranted.

The effects observed in the six eye irritation studies vary from slightly to moderately irritating. In only one of the available studies were the effects shown not to be reversible (in one single animal after 21 days). In all other studies the effects were observed to be reversible in all animals. Therefore based on the weight of evidence of data across the category members, a classification as "Eye irritant, category 2" is justified.

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