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EC number: 208-795-8 | CAS number: 541-91-3
Determination of the sensitizing potential (main test):
In the control group, no local irritation reaction was observed 24, 48 and 72 h after patch removal.
In the treated group (previously induced by intradermal and epidermal routes on another site of the skin), the presence of slight local irritation reaction in 1 animal for the three reading times after application of the tested substance at the concentrations 2.5 and 5 % in acetone. The same animal presented a slight erythematous reaction after application of the vehicle only for the 24 and 48 h readings.
Table 7.4.1/1: Main study – Challenge phase results
Group / Animal No.
5 % with acetone
2.5 % with acetone
Group 1: Control group
Reactive animals (%)
Group 2: Treated group
General state - Mortality
The general state of the guinea-pigs was not modified throughout the test period.
The weight growth of all the animals was satisfactory. The mean weight gain calculated for the treated animals during the test period was not significantly different from the control animals.
In a Magnusson & Kligman maximisation study (GPMT) performed according to OECD Guideline 406 and in compliance with GLP, 10 female Hartley guinea pigs were induced with three pairs of intradermal injections (0.1 mL each) of FCA and distilled water in the ratio 1:1 (v/v); a 40 % w/v formulation of the test material in mineral oil; a 40 % w/v formulation of the test material in a 1:1 (v/v) preparation of FCA and distilled water, on Day 1 on both sides of the spinal column, at the scapular level. Whereas, control group of 10 females was intradermally induced with 0.1 mL of FCA and distilled water in the ratio 1:1 (v/v); vehicle (mineral oil); a mixture 1:1 (v/v) of FCA plus distilled water and mineral oil. On Day 8, the experimental area of the control and treated group animals were coated with 0.5 mL of a sodium lauryl sulphate at 10 % in petrolatum to produce a local irritation. On Day 8, the same area was topically induced with 80 % test material in acetone via occluded filter paper patch for 48 ± 1 h in test group, whereas control group was applied with vehicle alone. On Day 21, a challenge filter paper patch loaded with test material (2.5 and 5 % in acetone) was applied to the right flank of all animals, and acetone was applied to the same flank of each animal as the test material. The test concentrations for the main study were determined from a sighting study.
In the control group, no local irritation reaction was observed after 24, 48 and 72 h after patch removal. In the treated group, the presence of slight local irritation reaction in 1 animal for the three reading times after application of the tested substance at the concentrations 2.5 and 5 % in acetone. The same animal presented a slight erythematous reaction after application of the vehicle only for the 24 and 48 h readings. The sensitivity and validity of the experiment was confirmed with known sensitiser, 2-Mercapto benzothiazole.
Under the test conditions, the test material is not classified according to the annex VI of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
This study is considered as acceptable and satisfies the requirement for sensitisation endpoint.
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