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EC number: 608-209-4 | CAS number: 284461-73-0
Table 1: Summary of the LLNA/IMDS results (means of 6 animals per group)
Dose 2 %
Dose 10 %
Dose 50 %
weight of draining lymph nodes
cell count in draining lymph nodes
Ear swelling in 0.01 mm on day 4 (index)
Ear weight in mg / 8 mm diameter punch on day 4 (index)
The mice did not show any significant dose-dependent increase in the stimulation indices for the weight or cell counts as well as for ear swelling or ear weights. Slight significant decrease compared to vehicle treated animals regarding cell counts was detected in the highest dose group. This decrease is in the normal range of variance for these parameters and is such of no biological relevance. The reason for this decrease is not known but could be due to osmosis in the tissues and/or cytotoxicity induced by a relative high local concentration of the test item.
BAY 43-9006 was investigated in the modified local lymph node assay (LLNA-IMDS) on female mice according to OECD TG 429 (Vohr, 2004). Concentrations of 0 (vehicle control), 2, 10 and 50 % formulated in dimethylformamide were tested. The results show that the test item has neither an irritating nor a sensitizing potential in mice after dermal application.
Based on the study results a classification according to Regulation (EC) No.1272/2008 (CLP) is not required.
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