Registration Dossier

Administrative data

Description of key information

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 429 (2010).

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Additional information:

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.

Justification for classification or non-classification

Based on the results of the study, the criteria for classifying PPVE as a dermal sensitizer are not met.