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EC number: 210-734-5 | CAS number: 622-40-2
Statistical evaluation of the dpm values
With or without inclusion of the outlier in the control group, a statistically significant increase in DPM value was not observed in any test item treated group in comparison to the vehicle control group.
Mortality, Clinical Signs and Body Weigths
No deaths occurred during the study period. Regarding clinical signs on day 2 to 6, the animals belonging to the high dose group showed an erythema of the ear skin (Score 1 on day 2 and 6, Score 2 on day 3 to 5). The animals of the mid dose group also showed an erythema of the ear skin (Score 1 on day 3, Score 2 on day 4, and Score 1 on day 5 and 6). In the animals of the low dose group, an erythema of the ear skin (Score 1) was observed from day 3 to day 6. 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.
Lymph Node Weights and Cell Counts
A statistically significant increase in lymph node cell count was observed in the highest dose group in comparison to the vehicle control group (p≤0.05). For BALB/c mice, a cutoff-value for the lymph node cell count index of 1.55 was reported for a positive response. According to this criterion, the lymph node cell count index determined for the high dose group (1.55) indicates a borderline response.
No statistically significant increase in lymph node weights was observed in any test item treated group in comparison to the vehicle control group.
The measured ear weights of all animals treated were recorded after sacrifice. A statistically significant increase in ear weights was observed in the high dose group in comparison to the vehicle control group (p≤0.05). The cutoff-value of 1.1 of the ear weight index for a positive response regarding ear skin irritation reported for BALB/c mice was exceeded in this dose group (index of 1.2).
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