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EC number: 252-044-7 | CAS number: 34455-00-0
The dermal sensitization potential of the test article was evaluated in the local lymph node assay (LLNA) with CBA/J strain mice. The study was performed in compliance with OECD GLP ENV/MC/CHEM (98) 17 (revised 1997). The test method was based on OECD Section 4 No. 429 (2010), EC No. 440/2008 B42, and EPA OPPTS 870.2600 (2003). The test article was prepared in N,N-Dimethyl formamide to the appropriate concentrations. A pre-screen test was conducted to select the highest test article concentration of 50%. Female mice (5/treatment) received the control (Dimethyl formamide), 10%, 25%, or 50%, concentrations of the test substance. The corresponding treatment (25 uL/ear) was applied to the dorsal surface of both ears for three consecutive days. Three days after the last exposure, all animals were injected with 0.25 mL sterile phosphate buffered solution containing 3H-methyl thymidine and subsequently euthanized. The auricular lymph nodes were removed to visually estimate the relative size and to observe any abnormalities. The nodes were pooled for each animal to measure the amount of operative DNA by disintegrations per minute (DPM). The stimulation index (SI) was calculated for each group. Consideration was given to the EC3 value. The 6-month reliability check with alpha-hexylcinnamicaldehyde indicated that the LLNA is an appropriate model for evaluating dermal sensitization at the test facility. Observations for mortality (twice daily), body weights (Day 1 and Day 6), clinical signs (once daily), and irritation (once daily) were performed as well. Mean DPM/animal values for the 10%, 25%, and 50%, test article concentrations were 569, 452, and 315 DPM respectively. The control mean DPM/animal value was 457 DPM. The SI values for test concentrations of 10%, 25%, and 50% were 1.2, 1.0, and 0.7 respectively. It was established that the EC3 value (if any) exceeds 50%. No irritation of the ears was observed in any animal. No mortality, clinical signs of toxicity, or significant body weight changes were observed. All auricular lymph nodes of the test and control animals were considered normal in size. Based on the results of the test, the test article showed no evidence of dermal sensitization.
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