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EC number: 223-296-5
CAS number: 3811-73-2
upon studies in animals and in humans (table 7.4.1 below), Sodium
Pyrithione is not classified as sensitizing. In two GLP studies
compliant to OECD 406, [references
7.4.1.001, ESPTF 6015-001 ; 7.4.1.002, ESPTF 6015-002],
it was determined that Sodium Pyrithione is non-sensitizing.
Number of animals sensitised/total number of animals
Guinea pig (female)
OECD 406, 1992: Skin Sensitisation,Directive 96/54/EC, B.6.
Guinea Pig Maximisation Test.
Test material Sodium Pyrion powder (>92.5%)
3 females were administered intra-dermally with Freund`s adjuvant, the test substance (50 % w/w) was applied epicutaneously to the sites of the intradermal injections. 7 days later 4 concentrations of the test substance (50 %, 25 %, 10 % and 1 %) were administered epicutaneously to the flanks of the animals. The duration of the exposure was 24 hours. Skin reactions were severe erythema at 50 %, very slight erythema at 25 % and no reaction at 10 % and 1 %.
After the challenge exposure, 2/20 animals of the test substance group had positive skin reactions 24 h after the end of the exposures. No adverse skin reactions were observed in the control animals. Therefore 2/20 animals of the test substance group (10 %) were regarded as sensitised, which is below the threshold of 30 % for classification as a sensitising substance.
Weiss-Fuchs U (2002)
US EPA 81-6, which complies with OECD 406 (Buehler method). GLP (self certification by the laboratory).
Test material: Sodium Omadine® solution (43.7%).
2/10 , 3/10
Induction A: Scores for erythema were generally severe on the intradermal sites dosed with FCA and FCA/test article mixture and mild to severe on the sites dosed with test article only.
Induction B: Erythema was mild to severe following a 48 hour exposure to a 10% dilution of test article.
Challenge: Following a 24 hour exposure to a 5% dilution of the test article, mild erythema was observed in 2/10 (20%) animals 24.5 hours post does. At 48 hours, 3/10 (30%) animals had mild erythema.
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