Registration Dossier
Registration Dossier
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EC number: 202-599-6 | CAS number: 97-65-4
Endpoint summary
Administrative data
Description of key information
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)
Additional information
Based on the guideline EEC 84/449 B4, six male albinorabbits were each administered a single dermal dose ofofitaconic acidmoistened with 0.25 ml distilled water. The test substance was applied on the intact skin for 4 hours. At the end of the treatment the semi‑occlusive dressing and gauze pad were removed and the cutaneous primary irritation was evaluated on day 1 (1 hour after the removal of the pad) and on days 2, 3 and 4.
There were no signs of toxicity during the observation period. No dermal response to treatment was observed in any animal throughout the observation period.
Based on the guideline EEC 84/449 B5, Six male albino New Zealand rabbits were each administered a single ocular dose of 0.1 g of itaconic acid. The responses were very severe: chemosis (score 4), enanthema (score 3), iris lesion (score 2), and corneal opacity (score 4). Because of the increasing severity in the lesions the study was terminated on human grounds.
Itaconic acid is considered as severe irritant to the eyes.
Effects on eye irritation: highly irritating
Effect level: empty Endpoint conclusion: Adverse effect observed
Justification for classification or non-classification
The major criterion for the skin irritation category is that at least 2 of 3 tested animals have a mean score of > or = 2.3 - < or = 4.0.
Itaconic acid is classified as not irritant for skin as the maximum score after 72 hours is 0 according to the Regulation (EC) No 1272/2008.
A substance is classified as Irreversible effects on the eye (Category 1) when it produces at least in one animal effects on the cornea, iris or conjunctiva that are not expected to reverse or have not fully reversed within an observation period of normally 21 days; and/or at least in 2 of 3 tested animals a positive response of corneal opacity > or = 3 and/or iritis > 1.5 calculated as the mean scores the following grading at 24, 48 and 72 hours after installation of the test material.
Itaconic acid is classified as Eye damage 1 as it induces maximum scores after 1 hour (cormeal opacity = 3), 24 hours (chaemosis conjunctival = 4) and 72 hours (iris lesion = 2).
According to the Regulation (EC) No 1272/2008, Itaconic acid is classified as Eye damage category 1.
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