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 sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
According to guideline EEC 84/449 B6, The sensitisation potential of itaconic acid was evaluated in guinea pig according to the maximisation method of Magnusson and Kligman.
Based on the preliminary study, the following dose levels were selected: 0.1 ml of the test substance was administered by intradermal route at a concentration of 1% in NaCl at 0.9% (day 1), 500 mg of the test substance as such was applied topically (day 8) and at challenge (day 20), 500 mg of the test substance as such was applied topically. Twenty test and ten control guinea pigs were used in this study.
No clinical signs and no deaths were observed throughout the study. At challenge, itaconic acid did not produce any cutaneous reaction 24 and 48 hours after removal of the dressing.
Justification for classification or non-classification
Substances shall be classified as Skin sensitisers (Category 1) if there is evidence in humans that the substance can lead to sensitisation by skin contact in a substantial number of persons, or if there are positive results from an appropriate animal test.
Itaconic acid is classified as not sensitising as there are negative results in animal test according to Regulation (EC) No 1272/2008.
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