Registration Dossier
Registration Dossier
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EC number: 208-494-1 | CAS number: 530-78-9
Endpoint summary
Administrative data
Description of key information
No internal skin irritation studies were conducted with Flufenamic acid and no such studies were reported in literature (Nov 2011).
However, within a skin sensitisation test also the irritating potential of Flufenamic acid was examined:
Skin Sensitisation, LLNA/IMDS (NMRI mice, GLP, OECD TG 429, EPA OPPTS 870.2600): no sensitising but irritating potential
[Bayer AG, Report No. PH-33765, 2005-02-23]
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Within the skin sensitisiation study (LLNA) no antigen specific activation of the cells of the immune system via dermal route was determined after application of up to and including 50% Flufenamic acid. However, a statistically significant increase compared to vehicle treated animals regarding ear swelling was detected in the mid dose group. In addition, a statistically significant increase of the ear weight was detected for the low and the mid dose group. Therefore, the study showed that Flufenamic acid has no sensitising potential but an irritating potential in mice after dermal application of a 2% concentration.
An eye and respiratory irritation potential can also be assumed although no studies are available.
Effects on skin irritation/corrosion: irritating
Justification for classification or non-classification
Based on the study results Flufenamic acid has to be classified as irritating to eyes, respiratory system and skin (Xi, R36/37/38) according to Directive 67/548/EEC and as Eye Irri. 2 (H319), STOT SE 3 (H335), Skin Irri. 2 (H315) according to Regulation (EC) No. 1272/2008 (CLP), respectively.
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