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EC number: 203-127-1
CAS number: 103-60-6
- No deaths occurred during the study.
- No test material related clinical signs were observed in all the
animals of the control group and those exposed to 0.1, 1 and 10%
dilutions of the test material.
- Approximately 1 hour after the first topical application, a moderate
swell was observed at both sites in all mice exposed to the test
material at 100%. This lasted for four days and then reduced slightly,
effects persisted until termination.
- Bodyweights were within the range commonly recorded for animals of
this strain and age.
Table 1: Results
* undiluted as delivered by the sponsor.
BG = Background (1mL 5% trichloroacetic acide) in duplicated
CG = Control group
TG = Test group
S.I. = Stimulation Index
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.
The skin sensitisation potential of the test material was determined in
accordance with the standard guidelines OECD 429 and OECD 406 using the
mouse Local Lymph Node Assay (LLNA). The test material was applied as
0.1, 1, 10 % w/v preparation in ethanol:water, 7:3 (v/v) and 100%
(undiluted). A vehicle control was run concurrently. The positive
control was shown to have the capacity to cause skin sensitisation
confirming the validity of the protocol used for the study.
Under the conditions of the test, the stimulation index induced by the
test material was less than 3 -fold that of the control at all test
concentrations, and therefore the test material is considered to be
unlikely to be a skin sensitizer.
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