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EC number: 277-753-9
CAS number: 74186-17-7
The test item was not sensitising in a LLNA in mice.
Calculation and results of individual data
Test item concentration %
number of lymph nodes
DPM per lymph nodeb)
1 = Control
a) = The mean value was taken from the
figures BG I and BG II
b) = Since the lymph nodes of the
animals of a dose group were pooled, DPM/node was determined by dividing
the measured value by the number of lymph nodes pooled
Calculation of the EC3 value
VIABILITY / MORTALITY
No deaths occurred during the study period.
symptoms of local skin irritation at the ears of the animals and no
signs of systemic toxicity were observed during the study period.From
day 2 to 5, redness of the earskin could partly not be detected due to
the colour of the test item.
The body weight of the animals, recorded prior to the
first application and prior to treatment with 3HTdR, was within the
range commonly recorded for animals of this strain and age.
order to study a possible skin sensitising potential of Aluminium-Braun
1134 p, three groups each of four female mice were treated once daily
with the test item at concentrations of 5, 10, and 20% in 1% aqueous
Pluronic®by topical application to the dorsum of each
ear for three consecutive days. The highest concentration tested was the
highest concentration that could technically be achieved whilst avoiding
systemic toxicity and excessive local skin irritation as confirmed by a
pre-experiment. A control group of four mice was treated with the
vehicle (1% aqueous Pluronic®) only. Five days after the
first topical application the mice were injected intravenously into a
tail vein with radio-labelled thymidine (3H-methyl
thymidine). Approximately five hours after intravenous injection, the
mice were sacrificed, the draining auricular lymph nodes excised and
pooled per group. Single cell suspensions of lymph node cells were
prepared from pooled lymph nodes, which were subsequently washed and
incubated with trichloroacetic acid overnight. The proliferative
capacity of pooled lymph node cells was determined by the incorporation
of3H-methyl thymidine measured in ab-scintillation
treated animals survived the scheduled study period and no signs of
systemic toxicity or local skin irritation were observed. From day 2 to
5, redness of the earskin could partly not be detected due to the colour
of the test item. A statistically significant increase in ear weight was
observed in the low and high dose groups. This is not biological
relevant, since the increase is below the recommended threshold of 25%
as recommended by OECD 429 and all S.I. determined were below 3.
item is regarded as a sensitiser in the LLNA if the exposure to one or
more test concentration resulted in a 3-fold or greater increase in
incorporation of3HTdR compared with concurrent controls, as
indicated by the Stimulation Index (S.I.). The estimated concentration
of test item required to produce a S.I. of 3 is referred to as the EC3
No classification; No adverse effects were detected in a LLNA-study.
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