Registration Dossier
Registration Dossier
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EC number: 403-610-9 | CAS number: 122795-41-9
Endpoint summary
Administrative data
Description of key information
The sensitising potential of the test substance was tested according to OECD TG 406, GPMT test. Based upon the observations made in the Delayed Contact Hypersensitivity Study Neoproxen tested at a 2.0% concentration did not cause delayed contact hypersensitivity in guinea pigs.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The sensitising potential of the test substance was tested according to OECD TG 406, GPMT test. Based upon the results of the dose-range-finding studies the dose chosen for induction, challenge and rechallenge was 2.0%.
No responses were observed in the naive group at 24 or 48 hours after challenge. Two positive responses were observed at 24 hours and three positive responses were observed at 48 hours after challenge in the experimental animals receiving the test article at a 2.0% concentration.
The experimental animals were rechallenged seven days after challenge, with the test article at a 2.0% concentration. Four animals from the negative control group (2 males and 2 females) served as naive control animals for the rechallenge. Responses were observed in the naive control animals at 24 and 48 hours after rechallenge, being indicative for irritation. No positive responses were observed in the experimental animals at 24 or 48 hours after rechallenge.
Based upon the observations made in the Delayed Contact Hypersensitivity Study, test article, Neoproxen induced, challenged and rechallenged at a 2.0% concentration did not cause delayed contact hypersensitivity in guinea pigs.
It can be argued that the concentration (2%) used for induction and challenge is quite low, though some slight irritation was observed during rechallange in the naive control group animals. Neoproxen as such does not contain skin sensitizing structural alerts as can be seen when running the OECD Toolbox and/or Derek Nexus. This further supports the non-skin sensitizing potential.
Justification for classification or non-classification
The substance does not need to be classified for skin sensitisation according to EU CLP (EC No. 1272/2008 and its amendments).
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