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EC number: 290-714-0
CAS number: 90218-39-6
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.
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