Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

There is a reliable study available to assess the skin sensitising potential of the test substance.

In a LLNA skin sensitisation test according to OECD guideline 429 (Calvert Lab. 2006), groups of 5 CBNJ female mice were treated on the dorsal surface of both ears once per day for 3 days with 0.1 %, 1 %, 5% or 10% (w/v) of the test substance, with the vehicle (DMSO), with the vehicle for the positive control (acetone/olive oil, 4:1), or with the positive control (HCA at 35%). On Day 6, the mice were injected iv with 20 µCi of 3H-thymidine in sterile saline. Five hours later, the mice were euthanized and the draining auricular lymph nodes were removed. The lymph node cells were precipitated with 5% trichloroacetic acid (TCA) and the pellets counted in a beta-scintillation counter to determine incorporation of the 3-thymidine.

A test material is considered to have skin sensitizing activity if, at one or more concentrations, it induces a 3-fold or greater increase in proliferative activity relative to the concurrent vehicle treated control.

There was no mortality and all animals appeared normal throughout the study. The application sites on the mice from the positive control group appeared wet on Days 2-4. The positive vehicle control animals also exhibiting wet ears on Day 4. There were no other findings. At termination, the lymph nodes of the mice treated with the positive control were enlarged relative to the lymph nodes from the positive control vehicle treated mice but otherwise appeared normal. The lymph nodes from the mice in the vehicle treated groups and all the test article treated groups were normal in size and appearance. Mean body weights at Day 1 and Day 6 and mean changes in body weights were evaluated. There were no statistically significant differences observed between any of the treatment groups. Therefore, the test articles did not appear to cause any overt toxicity. The positive control, 35% (vfv) HCA, resulted in a stimulation index (SI) of 5.1 indicating a positive response. This response was also statistically significant when compared to the A00 vehicle control group (p = 0.0001). Exposure to the test substance at 0.1 %, 1.0%, 5% or 10% (w/v) resulted in stimulation indices of 1.25, 1.17, 1.96 and 1.64, respectively. No statistically significant differences were found between the groups treated with the test substance at 0.1%, 1.0 % or 10% (w/v) and the DMSO vehicle control. A statistically significant difference was found between the 5.0% (w/v) group and the DMSO vehicle control (p = 0.0343). However, given the low stimulation index and the absence of any dose response, this difference is not considered meaningful.

Treatment with the test substance up to did not resulted in stimulation indices of 3 or greater, indicating a negative response.

Under our experimental conditions, the test substance 1-((2-Butyloctyloxymethyl)-2-(3,4-dihydro-isoquinolinium-2-yl)ethyl)sulfate did not induce delayed contact hypersensitivity in the murine Local Lymph Node Assay.


Migrated from Short description of key information:
The test substance 1-((2-Butyloctyloxymethyl)-2-(3,4-dihydro-isoquinolinium-2-yl)ethyl)sulfate did not induce delayed contact hypersensitivity in the murine Local Lymph Node Assay and is thus not regarded as skin sensitiser (Calvert Lab. 2006).

Respiratory sensitisation

Endpoint conclusion
Additional information:

No data available.


Migrated from Short description of key information:
No data available.

Justification for classification or non-classification

Skin sensitisation

Based on the available LLNA study, there is no indication for a relevant skin sensitising potential of the test substance. Thus, no classification is warranted according to 67/548/EEC and Regulation (EC) No 1272/2008 (GHS, CLP), respectively.

Respiratory sensitisation

No data available.