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EC number: - | CAS number: -
No mortality occurred and no signs of systemic toxicity were observed among the study animals. No irritation of the ears was observed in any of the test or control animals. All auricular lymph nodes examined from the test and control animals were considered to be normal in size except for one node of one control animal which was considered to be small. Body weights and body weight gains of the test animals remained in the same range as the controls over the study period.
OBJECTIVE: The dermal sensitizing potential of TFEE-5 (MTDID 21721, batch TFEE5-276/12/09-1) was evaluated in a local lymph node assay (LLNA) in female CBA/J mice.
METHODS: This study was performed according to OECD GLP guidelines (1997). The homogeneity, stability and concentration of the test substance were not analyzed. The study design was based on OECD Guideline 429 (2002), EC No. 440/2008 B42 L142 (2008), and USEPA OPPTS 870.2600 (2003). TFEE-5 was tested as received. Mice (5/treatment) received sham treatment or 100% (undiluted) TFEE-5 on three consecutive days by open application on the ears. Three days after the last exposure all animals were subjected to a 3H-methyl thymidine treatment and the auricular lymph nodes were removed to measure the amount of proliferative DNA by disintegrations per minute (DPM). The stimulation index (SI) was calculated for each group and, if possible, the concentration at which TFEE-5 could elicit an SI greater than or equal to 3 was determined (EC3). Hexylcinnamic aldehyde (HCA) is tested in this study design every 6 months at the test facility as a positive control and the most recent results indicated that model was valid.
RESULTS: Mean DPM/animal value was 269 for the 100% TFEE-5 group. The mean DPM/animal value for the vehicle control group was 328. The SI value was 0.8 for 100% TFEE-5. The EC3 could not be calculated because the 100% concentration produced less than a 3.0 SI.
CONCLUSION: Based on the results of this study, TFEE-5 showed no evidence of a dermal sensitization potential.
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