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EC number: 949-316-9
CAS number: 1965233-46-8
After the intradermal induction well-defined erythema and slight edema
were observed at the injection sites of all control group animals and
all test group animals at which only Freund's adjuvant/0 .9% aqueous
NaCl-solution (1 : 1) was applied . Injections of 5% test substance
preparations in Tylose CB 30 .000, 1% in aqua bidest . or in Freund's
adjuvant/0 .9% aqueous NaCl-solution (1 : 1) caused well-defined
erythema and slight edema in all test group animals . The injection
sites of all control group animals at which Tylose CB 30 .000, 1% in
aqua bidest . was applied, did not show any skin reactions .
After the percutaneous induction with a 25% test substance preparation
incrustation, partially open (caused by the intradermal induction),
could be observed in addition to well-defined erythema and slight edema
in all test group animals . The animals of control groups 1 and 2, which
were applied with Tylose CB 30 .000, 1% in aqua bidest ., exhibited the
same skin reactions as the animals of the test group .
After the lst challenge 1 out of 10 test group animals showed very
slight erythema 24 hours after removal of the patches . 2 test group
animals exhibited well-defined erythema . 1 out of these animals
additionally showed scaling and very slight edema . Very slight erythema
were observed in 3 out of 10 test group animals 48 hours after removal
of the patches . 2 out of these animals additionally showed scaling .
The animals of control group 1 did not show any skin reactions . Tylose
CB 30 .000, 1% in aqua bidest ., which was applied as a vehicle control
to all animals, did not cause any skin reactions .
After the 2nd challenge with a 10% test substance preparation no skin
reactions were observed in all animals of the test group and control
groups 1 and 2 24 and 48 hours after removal of the patches .
Tylose CB 30 .000, 1% in aqua bidest, which was applied as a vehicle
control to all animals, did not cause any skin reactions .
Table 1: Skin findings after the challenge
(10% in vehicle)
No application of test substance
* number of positive
reactions/number of animals tested (reading at 24h and/or at 48 hours
after removal of the patch)
The expected body weight gain was generally observed in the course of
the study .
1 animal of control group 1 and 1 animal of control group 2 died 10 days
after the beginning of the study . Macroscopic examination revealed that
the animals suffered from pneumonia . The cause of death was not related
to the test substance treatment .
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