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EC number: 290-714-0 | CAS number: 90218-39-6
The test substance is not considered to be a skin sensitizer.
VIABILITY / MORTALITY / MACROSCOPIC FINDINGS: 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.
BODY WEIGHTS: Two out of 10 animals of the control group (nos. 325, 330) and one out of 20 animals of the test group (no. 346) incidentally lost weight during the acclimatization period. No weight loss was observed during treatment period.
To assess the allergenic potential of the substance in albino guinea pigs the Maximization-Test of Magnusson and Kligman was used according to OECD test guideline 406. Ten males were used as control group and 20 males were used as test group.
Before the test procedure a pretest was performed in order to identify a maximally tolerated concentration of the test article suitable for the induction phase of the main study. In addition, a suitable non-irritant concentration of the test article, by the topical route of administration, was identified for the challenge application.
The pretest was performed with intradermal (0.1 ml/site, at concentrations of 1, 3 and 5% of the test article in bi-distilled water) and epidermal induction (5, 10, 15 and 25% of test material in bi-distilled water).
The results of the pretest were:
- For intradermal induction application a 5% test article dilution in bi-distilled water was selected.
- For the epidermal induction procedure, the test article at 25% in bi-distilled water was selected and for the challenge procedure, a concentration of 15% in bi-distilled was selected for the challenge application.
In this study 0% of the animals of the test group were observed with positive skin reactions after treatment with a non-irritant test substance concentration of 15% in bi-distilled water. No skin reactions were observed in the control group. According to the rating of allergenicity by Magnusson and Kligman the test article is considered a non-sensitizer.
There are two studies available for this endpoint. Both of them were performed according to Guideline OECD 406 and were GLP compliant.
In the study of Hagemann (1993) the test material used for testing was "roh trocken" meaning "crude". The sample tested had a content of 91% of active substance and inside the report it is defined that purity is 27%. In a more recent study done by Arcelin (1995) the test material is described as "gereignit" meaning "purified". The composition of the tested sample is not known. When purified, it is assumed that the purity of the sample will be higher than the one used in Hagemann (1993) test.
Under the test conditions of Arcelin (1995), EC 215-397-8 at concentrations of 15% in bi-distilled water is considered to be a non-sensitizer. Similar results are obtained with testing conditions of Hagemann (1993) at concentration 20% in vaseline.
There is also one study done with humans in 1972, Shelansky (1972). This is a human repeated insult patch test and the tested material gave a negative result on sensitisation when tested at 4% in 200 individuals covering a wide range of ages. The human patch test does not give any information concerning classification.
The substance to register has a higher purity than the test item used in the Hagemann’s study (27%) and therefore closer to the test substance used in Arcelin’s study. It can be concluded that the test substance is not skin sensitizer.
Based on the above stated assessments of the skin sensitisation potential, the substance is classified as non-sensitising according to CLP (Regulation (EC) No 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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