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EC number: 216-600-2
CAS number: 1623-05-8
A local lymph node assay (LLNA) was conducted on PPVE. The
result of the study was:
Non-sensitizing in a local lymph node assay conducted according to OECD
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 sensitization potential.
Based on the results of the study, the criteria for classifying PPVE as
a dermal sensitizer are not met.
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