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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
- For the epidermal induction
procedure, the test article at 25% in bi-distilled water was selected
and for the challenge
concentration of 15% in bi-distilled was selected for the challenge
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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