Registration Dossier
Registration Dossier
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EC number: 204-506-4 | CAS number: 121-91-5
Endpoint summary
Administrative data
Description of key information
Isophthalic acid was found to be a minimal skin irritant and a mild eye irritant in studies in the rabbit. Classification of the substance as a skin or eye irritant is not required.
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)
Additional information
Skin irritation
In a modern study, Hatoum & Goon (1990) investigated the dermal irritancy of isophthalic acid in three New Zealand white rabbits following a 4 hour exposure period. No dermal reactions were seen in this study. Baker & Mastri (1975) conducted two skin irritation studies using two different batches of isophthalic acid. Albino rabbits were used in both studies, and 500 mg of the test substance was applied undiluted under an occlusive dressing to intact and abraded skin. It was concluded in both studies that the test substance is a minimal irritant to intact skin.
Eye Irritation
In a modern study, Reckers Andresen et al (1985) instilled 0.1g of the test substance isophthalic acid into one eye of six New Zealand white rabbits. The test animals were observed for 14 days following test substance administration. Signs of mild eye irritation (conjunctival effects) were observed in all animals and were reversible within 96 hours.
Baker and Mastri (1975a,b) conducted two studies with different batches of isophthalic acid using Albino rabbits as the test species. The test substance was applied undiluted at a concentration of 100 mg. In both of these studies, evidence of transient irritation (effects on the cornea, iris and conjunctivae) were seen under the conditions of this study, however all findings were reversible by 48 hours. Individual scores are not reported and scores are summarised according to a non-standard system. Classification of the substance as an eye irritant is considered unlikely to be appropriate according to EU criteria (CLP) based on the transient nature of the findings in this study.
Justification for classification or non-classification
The results of the skin and eye irritation studies do not indicate that isopthalic acid should be classified as a skin or eye irritant according to CLP Regulation EC No. 1272/2008.
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