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EC number: 251-156-3 | CAS number: 32687-78-8
No skin sensitisation potential of the test substance was observed in a guinea pig maximization study and in a Maurer Optimization Test.
In a GLP-compliant guinea pig maximization test according to OECD guideline No. 406, 10 male and 10 female animals were first induced and then challenged with the test article to investigate its sensitization potential. Induction was a two-stage operation: First, three pairs of intradermal injections (1 % test substance in sesame oil) were made into the neck of the animals with a 1:1 mixture (v/v) of FCA/ physiological saline, the test substance in sesame oil, and the test substance in a 1:1 mixture (v/v) of FCA/ physiological saline. One week later, 0.4 g of the test article in vaseline at a concentration of 30% was spread onto a filter paper patch (2 x 4 cm) and applied occlusively to the neck of the animals for 48 hours. The application sites were pretreated the day before with 10% sodium lauryl sulfate (open application). Two weeks after the epidermal induction application the animals were tested on the flank with 10% test substance (0.2 g) in vaseline and the vehicle alone for 24 hours. Twenty four hours after removing the dressings the challenge reactions were graded according the Draize scoring scale. An additional evaluation was made 48 hours after removing the dressings. A control group was treated with adjuvant and the vehicle during the induction period. During the challenge period the control animals were treated with the vehicle as well as with the test compound to control the maximum subirritant concentration. No animal of the test group was sensitized by the test substance; all skin reactions at any time point were scored 0. Therefore, under the experimental conditions of this study, the test material is non-sensitizing when topically applied to albino guinea pigs.
The test substance was investigated for its sensitizing potential in a GLP-compliant Maximization test according to OECD guideline 406 (Ciba-Geigy, 1989). Twenty guinea pigs received intradermal induction treatments with 1% in sesame oil and one epicutaneous induction treatment with 30% in vaseline. For intradermal induction, three pairs of injections (adjuvant/saline; test item in vehicle; test item in adjuvant/saline) were given. Epidermal challenge was performed by occlusive application for 24 h two weeks later (10 % in vaseline). Concurrent vehicle control animals were treated similarly, except that during the induction phase the test substance was omitted. No skin reactions were observed either for control or test group animals and therefore no animal was sensitized by the test article under the experimental conditions employed. The sensitivity of the strain is controlled every six months. In conclusion, the test substance is not considered to be a skin sensitizer in albino guinea pigs and does not require classification.
In a supporting study 10 male and 10 female guinea pigs per group were tested on the skin sensitisation potential of the test article following the Maurer Optimization protocol as laid out in the OECD TG 406 adopted in 1981 (Ciba-Geigy, 1983). In this test 10 intradermal inductions (0.1%) followed by an intradermal (0.1%) and epicutaneous (30%) challenges were performed. The vehicle control alone unexpectedly induced a high number of positive reactions (16/20) after intradermal challenge, which was also seen in the test group (16/20). In addition, significant differences between the test group and the vehicle-treated controls were seen after intradermal challenge application, i.e. when the skin barrier was intentionally by-passed. No difference between the test and the control group was seen after epidermal challenge application. The negative results upon epidermal challenge demonstrate that, in artificially sensitized guinea-pigs, exposure of the intact skin to the test compound does not provoke contact dermatitis.
There is no information available on the potential for the test substance to produce respiratory sensitisation in animals or humans.
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. Based on the present data, classification for sensitization is not warranted under Regulation (EC) No.1272/2008.
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