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EC number: 423-970-0 | CAS number: 182926-43-8
Reactive Brown 136 was considered non sensitising to Rabbit skin.
No erythematous or oedematous reaction was observed in the animals treated with bi-distilled water only.
As the test article stained the skin brownish/red, it was not possible to determine whether erythema was present or not. However no oedema was observed.
Skin effects after the challenge - performed on test day 22
CONTROL AND TEST GROUP
No positive reactions were observed in the animals neither when treated with bi- distilled water alone nor when treated with the test article at25 % in bi-distilled water.
A brownish/red discoloration was noted directly after removal of the patch. To remove discoloration all animals were depilated approximately 3 hours prior to challenge reading.
As there were no deaths during the course of the treatment period no necropsies were performed.
Clinical signs, systemic: no symptoms of systemic toxicity were observed in the animals.
One animal (no. 588) of the test group lost weight during its acclimatization period. It recovered during the treatment period. One animal (no. 600) of the epidermal pretest lost weight during Its test article treatment period.
The body weight of the other animals was within the range of physiological variability known for this strain and age.
The Guinea Pig Maximization-Test was carried out to assess the cutaneous allergenic potential of FAT 45'176/A, in accordance with OECD 406 and EU B.6 guideline. The intradermal induction of sensitization was carried out with a 5 % dilution of the test article in bi-distilled water and in an emulsion with Freund's Complete Adjuvant (FCA)/physiological saline. The epicutaneous induction of sensitization was conducted under occlusion with the test article at 50 % in bidistilled water. Two weeks after the epicutaneous induction application the challenge was completed by epicutaneous application of the test article at 25 % in bi-distilled water under occlusive dressing. The animals of the control group were induced with bi-distilled water and FCA/physiological saline and challenged similarly as those of the test group. Cutaneous reactions, i.e. erythema and eschar, as well as oedema formation were evaluated at 24 and 48 h after removal of the dressing.
In this study no erythematous reactions after the challenge were observed in the animals of the test group. No positive skin reactions after treatment with a non-irritant test article concentration of 25 % in bi-distilled water. No skin reactions were observed in the control group. No toxic symptoms or deaths were evident in the guinea pigs of the control or test group.
Therefore, FAT45'176/A applied at a concentration of 25 % in bi-distilled water is considered to be a non-sensitizer when used under the described test conditions.
Based on the findings in the skin sensitisation study, Reactive Orange 136 not considered as Skin Sensitiser according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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