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
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
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. 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 an irritating potential in mice after dermal application of a 2% concentration but a sensitising potential has not been detected.
Additionally, results of patch tests in humans were found in literature (Nov 2011):
In one publication in 371 patients presenting for diagnosis of presumed contact allergy patch tests were performed with a standard series and additionally with a series of NSAIDs, including Flufenamic acid. Patch test reaction to Flufenamic acid was found in one patient diagnosed with balanoposthitis, however, a clinical relevance could not be established.
For the second puplication 102 patients with (photo)dermatitis induced by systemic or topical NSAIDs were studied. All patients were patch tested with a standard series of allergens, a series of NSAIDs (including Flufenamic acid) and their own medicaments. One case of allergic contact dermatitis due to Flufenamic acid was reported.
In summary, two single positive responses to Flufenamic acid were detected in patch tests performed in human patients with allergy.
Migrated from Short description of key information:
Skin Sensitisation, LLNA/IMDS (NMRI mice, GLP, OECD TG 429, EPA OPPTS 870.2600): irritating but no sensitising potential
[Bayer AG, Report No. PH-33765, 2005-02-23]
Morover, results of patch tests in humans were found in literature (Nov 2011):
Patch test (371 patients with allergic contact dermatitis, atopic dermatitis, stomatitis, leg ulcers, adverse drug reactions or other diseases): delayed hypersensitivity to Flufenamic acid in 1 patient (0.3%)
(Contact Dermatitis, v. 40, p. 63, 1990)
Patch test (102 patients with (photo)dermatitis induced by systemic or topical NSAID): 1 case of allergic contact dermatitis with Flufenamic acid
(Contact Dermatitis, v. 29, p. 39, 1993)
Justification for classification or non-classification
Based on the study results a classification according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (CLP) with respect to skin sensitization is not required.
With respect to skin irritation the substance has to be classified as irritating to skin (Xi, R38) or as Skin Irri. 2 (H315), respectively.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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