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EC number: 216-600-2
CAS number: 1623-05-8
The dermal sensitization potential of the test article (Clear
colorless liquid, purity 98.5%, Batch 114B1005) was evaluated in the
local lymph node assay (LLNA) with female 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 No. 429 (2010). The test
article was prepared in methyl ethyl ketone. A pre-screen test was
conducted to select test article concentrations of 10%, 30% and 100%.
Female mice (4/treatment) received the negative control (methyl ethyl
ketone), 10%, 30%, or 100% 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
(Day 6), all animals were injected with 0.25 mL sterile phosphate
buffered saline containing 3 H-methyl thymidine and subsequently
euthanized. The nodes were pooled for each animal, and lymphocyte
proliferation was determined by measuring disintegrations per minute
(DPM). The stimulation index (SI) was calculated for each group.
Observations for mortality (once daily), body weights (Day 1 and Day 6),
clinical signs (once daily), ear thickness (Days 1-3, and Day 6), and
irritation (Days 1-3 and 6) were performed as well. A six-month
reliability check with Alpha-hexyl cinnamaldehyde is performed to ensure
that the model is appropriate for testing contact hypersensitivity. Mean
DPM/node values for the 10%, 30%, and 100% test article concentrations
were 351, 395, and 396 DPM respectively. The negative control mean
DPM/node value was 258 DPM. The SI values for test concentrations of
10%, 30%, and 100% were 1.4, 1.5, and 1.5 respectively. No EC3 value was
calculated because all SI values were < 3. The positive control SI was
>3 so the test method was considered valid. No irritation of the ears
was observed in any animal. No mortality, clinical signs of toxicity, or
significant body weight changes were observed. Based on the results of
the study, the test article did not show evidence of dermal
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