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EC number: 617-065-1 | CAS number: 80370-59-8
Cranial and caudal injection sites: Local irritations were observed in all animals beginning on the day after the injections. The irritations started with local erythema, which became more severe and led to ulcerations. Lesions did not heal until the end of the study. This local alterations are known effects of Freund's adjuvant. Middle injection sites: 24 hours after induction exposure, no irritative reactions were observed in the negative control group, whereas very slight to well defined erythema were noted in 14 /20 animals of the test substance group. After the epicutaneous induction exposure all animals had severe erythema and oedema in the interscapular region (score "3"), which were attributed to the effects of the adjuvant. After the challenge exposure there were reactions of major interest for the grading of an allergenic potency of the test substance.
Negative control group:
Vehicle site: no positive skin reaction in any animal at any reading time.
Test substance site: no positive skin reaction in any animal at any reading time.
No animal had a "positive skin reaction".
Test substance group:
Test substance site: well defined to severe erythema and/or oedema in 16/20 animals
24 and/or 48 hours after the end of the exposure.
16/20 animals had a "positive skin reaction".
The "maximisation test" of B. Magnusson and A. M. K.ligman was performed to reveal a possible sensitising potential of "1-CFT". 20 female guinea pigs were used as a test
substance group and another 5 females were used as a negative control group. There were two induction exposures (intradermally and epicutaneously) and one epicutaneous challenge exposure. Test substance concentrations were:
2.5 % in physiological saline for the intradermal induction
25 % in white petrolatum for the epicutaneous induction and
25 % in white petrolatum for the challenge exposure.
Investigations performed were in conformance with the OECD-guideline 406. Application of Freund's complete adjuvant was included in the intradermal exposure of both groups to
enhance a possible sensitisation.
All animals survived till the end of the study. Intradermal injections of Freund's adjuvant caused severe local reactions in all animals, a known effect of the adjuvant. Sensitisation
excluded, no other adverse effects were noted.
In the negative control group, the control sites of all animals were also normal. At the test substance treated sites, positive skin reactions were noted in 16/20 animals. These animals, i.e. 80% of the test substance group animals, were regarded as sensitised.
1 -CFT is a skin sensitizer according to the criteria in 67/548/EEC and 1272/2008.
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