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EC number: -
CAS number: -
See attached document for Tables.
There were no death. No signs of systemic
toxicity or irritation indicated by an equal to or greater than 25%
increase in mean ear thickness were noted in the test or control animals
during the test.
Very slight erythema on the ears was noted
on Day 1 in three animals treated with the undiluted test item and
persisted in two animals on Day 2. No signs of local irritation were
noted in the remaining test animals or vehicle control animals during
Bodyweight: On animal treated with the
test item at a concentration of 50% v/v in butanone showed a greater
than expected bodyweight loss. Bodyweight changes of the remaining test
animals beween Day 1 and Day 6 were comparable to those observed in the
corresponding control group animals over the same period.
Guideline 429 and EC Method B.42 (Skin Sensitisation: Local Lymph Node
of CBA/Ca (CBA/CaOlaHsd) mice (5 females/dose) were topically applied
with 50 µL (25 µL per ear) of the undiluted test item or the test item
as a solution in butanone at concentrations of 50 % or 25 % v/v. A
further group of five animals was treated with vehicle alone. On Day 6,
the animals received a single intravenous injection of tritiated methyl
thymidine (3HTdR). Five hours later, the animals were sacrificed and the
auricular lymph nodes were excised. The proliferation of lymphocytes in
the lymph node draining the application site was measured by
incorporation of 3HTdR. The results were expressed as disintegrations
per minute (dpm) per group and the obtained values were used to
calculate Stimulation Indices (SI). Animals were observed for mortality,
clinical signs and body weight during the study. The test concentrations
for the main study were determined from a preliminary study using one
female mouse at the concentration of 100 %.
mortality and no clinical signs were observed during the observation
period. On animal treated
with the test item at a concentration of 50% v/v in butanone showed a
greater than expected bodyweight loss. Bodyweight changes of the
remaining test animals beween Day 1 and Day 6 were comparable to those
observed in the corresponding control group animals over the same
DPM per group for vehicle, 25, 50 and 100
% were 1610.55, 12035.69, 21194.12, and 21015.39, respectively.
Stimulation index for 25, 50 and 100 % were 7.47, 13.6 and 13.05,
respectively. Positive control (α-hexylcinnamaldehyde, 15%) exhibited
evidence of sensitisation indicating the validity of the study. In this
study, the substance is a skin sensitiser in mice.
these test conditions, the substance is classified as sensitizing to the
skin according to the CLP Regulation (EC)No.
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