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EC number: 944-209-3
CAS number: -
Symptoms of systemic toxicity caused by the test substance were not
Body weight development was positive and within normal range.
The intradermal application of the 5 %, 3.5 % and 2 % (w/w) solutions of
the test substance in vehicle showed a strong skin reaction and moderate
skin reaction was observed with the 0.5 % and 0.1 % (w/w) concentration.
Slight skin reaction was observed with the 0.05 % (w/w) concentration.
Dermal application of the 100 %, 75 %, 50 % and 25 % (w/w) concentration
of the test substance in vehicle without Duhring Chambers led to
necrosis of the treated skin sites. The test substance preparation of 5
% (w/w) concentration showed a very slight reaction. Application of the
1 %, 0.5 % and 0.1 % (w/w) concentration in vehicle showed no reaction
on the skin.
Dermal application with Duhring Chambers with the 1 % and 0.5 % (w/w)
concentrations of the test substance in vehicle showed no reactions on
Two animals of the pilot experiment have been sacrificed by an overdose
of a narcotic substance shortly after observation of the strong skin
The intradermal and the epicutaneous induction resulted in slight skin
reactions in a various number of animals indicating that the chosen test
substance concentrations led to slight irritation.
In the control group animals no vehicle related skin reaction was
observed after the application of the vehicle. The results on each
animal are presented in the following table:
Test group animals
Control group animals
First reading after 24h
Second reading after 48h
In a sensitization study with Amides,
C6-C18, N-[3-(dimethylamino)propyl] (a.i. 98.4%) in sesame oil, young
adult Dunkin Hartley guinea pig were tested using the maximization test
method according to OECD Guideline 406, 17 July, 1992 and EU Method B.6,
30 May 2008.
The maximum compatible doses which led to
slight irritation after intradermal and dermal application as well as
the subirritative dose for the challenge were determined in a pilot
experiment. Sesame oil was used as vehicle during induction and
challenge. Based on the results of the pilot study, for the intradermal
and epicutaneous induction procedure test substance concentrations of
0.05 % and 5 % were used, respectively. The test article concentration
for the challenge procedure was 1 %. In the challenge visible changes of
the skin like slight and easily detectable erythema (= grading 1 and 2)
and slight to easily recognizable swelling (= grading 1 and 2) were
observed in five out of ten test group animals 24 h after patch removal;
48 h after the challenge these skin reactions were still observed and
one additional animal showed slight erythema (= grading 1). The five
control animals were free of skin reactions. Thus, the sensitisation
rate was 60 %. In the remaining four test group animals and in all
control group animals no visible skin reactions were noted at any time
(= grading 0).
In this study the test substance has to
be regarded as sensitising under the applied test conditions when
exposed to the skin of experimental animals.
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