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EC number: 205-031-5
CAS number: 131-57-7
and Results of Individual Data
Test item concentration
number of lymph nodes
DPM per lymph nodeb)
BG = Background
(1 ml 5% trichloroacetic acid) in duplicate CG = Control Group TG = Test
The mean value was taken from the figures BG I and BG II
Since the lymph nodes of the animals of a dose group were pooled,
was determined by
dividing the measured value by the number of lymph nodes pooled.
EC3 Value could not be calculated, since all SI's are below 3.
occurred during the study period.
No symptoms of
local toxicity at the ears of the animals and no systemic findings were
observed during the study period.
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.
study was performed in compliance with Good Laboratory Practice
Regulations and OECD guideline 429: Skin
Sensitisation. Local Lymph Node Assay (adopted 24 April 2002). Test
article dissolved in
DMF was assessed for its possible contact allergenic potential in the
murine local lymph node assay (LLNA) in CBA/CaOlaHsd mice.
The ears of each
4 female mice were topically treated with the test item in
concentrations of 0
(control), 12.5, 25 and 50% for three
consecutive days. Five days after the first topical application the mice
were injected intravenously with 3H-methyl thymidine.
Approximately five hours thereafter, the mice were sacrificed, the
draining lymph nodes excised and pooled. Single cell suspensions of
lymph node cells were prepared and the incorporation of 3H-methyl
thymidine was measured in a p-scintillation counter.
The animals did
not show any local findings or clinical signs of systemic toxicity
during the study and no mortality was observed.
Indices (S.I.) of 1.64, 1.33 and 1.61 were determined with the test item
at concentrations of 12.5, 25 and 50% (w/v) in DMF, respectively, and
thus, were clearly below the limit criterium of a S.I. of 3.
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