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EC number: 946-928-8 | CAS number: -
At the tested concentrations of the first pre-test, the animals did not show any signs of systemic toxicity. Redness of the ear skin could not be observed due to the colour of the test item. On day 6, the animal treated with 50 % test item concentration showed eschar formation of the ear skin (per grading table defined as score 4) as well as a swollen face. Both animals showed stiffened ears from day 2 onwards and an increased ear weight above the threshold recommended by OECD.
In the second pre-test, the animals did not show any signs of systemic toxicity at 5 and 10 %. Redness of the ear skin could not be observed due to the colour of the test item. On day 6, upon preparation, both animals showed eschar formation of the ear skin (defined as score 4). Due to the eschar formation a third pre-test was conducted.
At the tested concentrations of 1 and 2 % the animals did not show any signs of local irritation or systemic toxicity. Redness of the ear skin could not be observed due to the colour of the test item.
No animal died during the course of the study. No systemic signs of toxicity were observed. Redness of the ear could not be assessed due to the colour of the test item. 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. The measured lymph node weights and –cell counts of all animals treated were recorded after sacrifice. A statistically significant and biologically relevant increase was observed in lymph node weight and -cell count in the mid and high dose group in comparison to the vehicle control group. Furthermore, the cut-off value of 1.55 for a positive response regarding the lymph node cell count index reported for BALB/c mice was exceeded in the mid and high dose group.
The measured ear weight of all animals treated was recorded on test day 6 (after necropsy). A biologically relevant or statistically significant increase in ear weights was not observed. Furthermore, the cut-off value (1.1) of the ear weight index for a positive response regarding ear skin irritation reported for BALB/c mice was not reached or exceeded in any of the treated groups.
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