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EC number: 700-242-3 | CAS number: 62037-80-3
No statistically significant differences in mean body weights and body weight compared to the vehicle control group were observed at any test concentration. A statistically significant increase in mean body weight gains compared to the vehicle control group was observed at the 25% test concentration. No clinical signs of toxicity were observed in the study. One mouse in the 100% test concentration group was found dead on test day 3.
0% Vehicle Control
25% Positive Controla
a Data were not included in the statistical analysis of the test substance groups.
b one mouse was found dead on test day 3.
# - Statistically significant increase in dpm data from vehicle control at p < 0.01 by Jonckheere-Terpstra trend test.
The objective of this study was to evaluate the potential of the test substance to produce a dermal sensitization response in mice using the local lymph node assay (LLNA). Five groups of 5 female CBA/JHsd mice were dosed for 3 consecutive days with 0% (vehicle control), 5%, 25%, 50%, or 100% of test substance on both ears. Dimethylformamide (DMF) was used as the diluting vehicle. One group of 5 female mice was dosed for 3 consecutive days with 25% hexylcinnamaldehyde (HCA) in DMF as a positive control. On test day 5 of the assay, mice received ³H-thymidine by tail vein injection and were sacrificed approximately 5 hours later. The cell proliferation in the draining auricular lymph nodes of the ears from the test substance groups was then evaluated and compared to the vehicle control group.
No statistically significant differences in mean body weights and body weight compared to the vehicle control group were observed at any test concentration. A statistically significant increase in mean body weight gains compared to the vehicle control group was observed at the 25% test concentration. No clinical signs of toxicity were observed in the study. One mouse in the 100% test concentration group was found dead on test day 3. Although, statistically significant increases in cell proliferation measurements compared to the vehicle control group were observed at the 50% and 100% test concentrations, stimulation indices (SIs) of less than 3.0 were observed at all test concentrations of the test substance. Therefore, the EC3 value (the estimated concentration required to induce a threshold positive response, i.e., SI = 3) for the test substance under the conditions of this study was not calculable. A 25% concentration of the positive control, HCA, produced a dermal sensitization response in mice. Therefore, the LLNA test system was valid for this study with the test substance.
Under the conditions of this study, the test substance did not produce a dermal sensitization response in mice. Based on these data, the test substance is not a dermal sensitizer in mice.
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