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EC number: 407-240-9
CAS number: 159604-94-1
BLUE 10 25 964
PRIMARY IRRITATION EXPERIMENTS
No signs of systemic toxicity were observed during the primary irritation experiments, however body weight loss was noted in one of the five animals. The choice of milli-R0 water as vehicle in this test was based on the following:
In accordance with Magnusson and Kligman (1969) and based on the findings in the primary irritation experiments, the following concentrations were selected for the induction and challenge phase:
Intradermal induction: 2.5% (w/w) in physiological saline Epidermal induction: 25% (w/w) in milli-R0 water. Challenge:
a = 25% (w/w) in milli-R0 water.
b = 10% (w/w) in milli-R0 water.
c = 5% (w/w) in milli-RO water.
d = milli-R0 water.
All experimental animals showed slight to well defined skin irritation after the 48 hours occluded epidermal induction exposure.
Severe skin reactions, characterised by small crusts, erythema and oedema were noted in nine control animals in response to the 25% concentration, in one control animal in response to the 10% concentration and in one animal in response to the 5% concentration.
Similar skin reactions were noted in sixteen experimental animals in response to the 25% concentration and in two experimental animals in response to the 10% concentration.
Based on these results it was concluded to carry out a second challenge.
No skin reactions were evident after this challenge exposure.
Seven animals showed a positive reaction in response to the 5% concentration.
The reactions were characterised by redness and scaliness.
TOXICITY SYMPTOMS / MORTALITY
No symptoms of systemic toxicity were observed in the animals during the study.
No mortality occurred during the study.
The average body weight gain of experimental and control animals was simi lar
However, one control (no. 334) and one experimental animal (no. 320) gained only 44 grams and 23 grams, respectively, during the study period.
The purpose of the study was to obtain information on the potential of the test item to induce delayed contact hypersensitivity (skin sensitisation) in the guinea pig after intradermal and epidermal exposures.
This study was carried out in accordance with the OECD Guideline No. 406, "Skin Sensitisation", the EEC Directive 84/449/EEC, Part 8.6, "Skin Sensitisation" and in accordance with the method described by Magnusson and Kligman, "Allergic Contact Dermatitis in the Guinea Pig - Identification of Contact Allergens".
After identification of the slightly irritating and the non-irritating test article concentrations in the primary i rritation experiments, a main study was performed with the selected test article concentrations. The experimental animals were intradermally applied with a 2.5% concentration and epidermal ly with a 25% concentration, while the control animals were similar treated, but with the vehicle only. Immediately after the epidermal exposure, the skin irritation was scored. Thereafter, all animals were chal lenged with the following test article concentrations (25%, 10% and 5%) and the vehicle. This rst challenge reaction was inconclusive and a second challenge was carried out with the following test article concentrations (5%, 2% and 1%) and the vehicle. Both the challenge reactions were assessed 24 and 48 hours after bandage removal.
The epidermal exposure of the test item in the induction phase resulted in slight to well defined erythema. The epidermal exposure of he test item in the second challenge phase resulted in seven positive sensitisation reactions in response to the 5% test article concentration.
Under the conditions used in this study, the test item resulted in a sensitisation rate of 35 per cent.
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