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EC number: 807-040-5
CAS number: 4538-42-5
Summary of the LLNA results (means of 5 animals per group)
BrdU labelling index (mean)(S.D.)
Ear thickness in mm onday 1
Ear thickness in mm onday 6
Ear thickness, Change in % (day 6 - day 1)
Ear thickness increased by 11.11% and 16.67% in the 0.5% and 1% test groups, respectively, although these changes were not statistically significant.
The body weights of the animals were not affected by any treatment.
The test item was investigated in the local lymph node assay (LLNA:BrdU-ELISA) on female mice according to OECD TG 442B. Concentrations of 0 (vehicle control), 0.25 %, 0.5 % and 1 % formulated in dimethyl sulfoxide (DMSO) were tested.
The acute inflammatory skin reaction was observed once each day according to Erythema scores and ear thickness measurements on test day 1, day 3 and day 6 to identify skin irritation properties of the test item. It is important to determine if a positive test result is due to the skin irritation potential of the test item or due to its sensitising properties.
Stimulation indices were calculated for the lymph node cell proliferation by dividing the average values of the BrdU labelling index per group of the test item treated animals by the vehicle treated ones.
Values >= 1.6 (stimulation index to identify sensitisation) are considered positive.
In the main study treatment with PDI at the concentration of 0.25 %, 0.5 % and 1 % led to an increase of the stimulation index above the threshold level of 1.6. Stimulation indices of 3.6, 5.5 and 5.2 were determined for the concentrations of 0.25 %, 0.5 % and 1 %, respectively. Concentrations of 0.5% lead to skin reactions; they were very mild (barely noticeable) erythema (score 1) on both ears.
Concentrations of 1 % lead to well-defined erythema (score 2) on both ears.
Ear thickness increased by 11.11% and 16.67% in both ears of each mouse in the 0.5% and 1% test groups, respectively, although these changes were not statistically significant.
The positive control group caused the expected increases in stimulation index (3.3). Therefore, the study can be regarded as valid.
No signs of systemic intolerance were recorded.
In conclusion, under the present test conditions, PDI at the concentrations of 0.25 %, 0.5 % and 1 % revealed signs of skin sensitisation potential. The stimulation indices for the concentration of 0.25 %, 0.5 % and 1 % were 3.6, 5.5 and 5.2 and hence, the test item PDI is classified to be skin sensitising in this test system.
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