Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

In a local lymph node assay according to OECD 442B (BASF SE, 2013), three groups of five female mice each were treated once daily with the test item at concentrations of 1, 2, and 5% (w/w) in acetone:olive oil (4:1 v/v) by topical application to the dorsum of each ear for three consecutive days. Concentrations at and above 10% led to excessive irritation as determined by ear weight increase > 25% in the pretests performed. Four days after the first topical application the mice were intraperitoneally injected with BrdU. Approximately 24 hours after intraperitoneally injection, the mice were sacrificed and the draining auricular lymph nodes excised, pooled per animal and immediately weighed. Furthermore, after excision of the lymph nodes, both ears of the mice were punched at the apical area using a biopsy punch and were immediately weighed pooled per animal using an analytical balance. Afterwards, single cell suspensions of lymph node cells were prepared from lymph nodes pooled per animal. An aliquot of each cell suspension was used for determination of lymph node cell count. The proliferative capacity of pooled lymph node cells was determined by the incorporation of BrdU. The animals did not show any relevant signs of systemic toxicity. Very slight erytheme and incrustions were observed in the high dose group. Stimulation Indices (S.I.) of 1.7, and 2.4 were determined with the test item at concentrations of 1, 2 and 5% (w/w) , respectively. Due to the fact that no clear dose response was observed an EC1.6 could not be calculated.

A statistically significant and biologically relevant increase in BrdU labeling and lymph was observed for the low (1%) and high (5%) dose group. This was also observed for these dose groups in lymph node weights and lymph node cell count, thus corroborating the sensitizing potential. The cut-off-value for a positive response regarding the lymph node cell count index of 1.55 reported BALB/c mice was exceeded in the low and high dose group (index of 1.6 (1%) and 1.9 (5%).

Thus the test substance Aminopropyl Vinyl Ether is a skin sensitizer under the test conditions of this study.

Justification for classification or non-classification

Based on these results Aminopropyl Vinyl Ether required to be classified with R43 according to 67/548/EEC and as a skin sensitizer Cat.1 according to CLP/EU-GHS requirements.