Registration Dossier

Administrative data

Description of key information

Results of a local lymph node assay showed the test item to be non-sensitising (OECD 429 and EU Method B.42).

Key value for chemical safety assessment

Skin sensitisation

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

An investigation was performed to assess the skin sensitisation potential of the test item in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear. The study was conducted in compliance with OECD Guideline for the Testing of Chemicals No. 429 "Skin Sensitisation: Local Lymph Node Assay" (adopted 22 July 2010) and Method B.42 Skin Sensitisation (Local Lymph Node Assay) of Commission Regulation (EC) No. 440/2008.

 

Following a preliminary screening test in which no clinical signs of toxicity were noted at a concentration of 50 % w/w, this concentration was selected as the highest dose investigated in the main test of the Local Lymph Node Assay. Three groups, each of five animals, were treated with 50 μL (25 μL per ear) of test item as a solution in acetone/olive oil 4:1 at concentrations of 50 %, 5 % or 0.5 % w/w. A further group of five animals was treated with acetone/olive oil 4: 1 alone. A concurrent positive control test, using a group of five animals, was also performed with the known sensitiser, a-Hexylcinnamaldehyde tech., 85%, at a concentration of 25% v/v in acetone/olive oil 4: 1.

 

Stimulation Index values, expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group, were determined as 1.73 (0.5 % w/w in acetone/olive oil 4:1; negative); 2.30 (5 % w/w in acetone/olive oil 4:1; negative); 2.09 (50 % w/w in acetone/olive oil 4:1; negative). The Stimulation Index for the positive control item was 7.34 (25 % v/v in acetone/olive oil 4:1; positive).

 

The substance was considered to be a non-sensitiser under the conditions of the test. The positive control α-Hexylcinnamaldehyde, tech., 85% gave a Stimulation Index of greater than 3 when tested at a concentration of 25 % v/v in acetone/olive oil 4: 1, thus, demonstrating the sensitivity and reliability of the test system.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

LLNA results determined the test item to be non-sensitising (Stimulation Index 3) and, in accordance with ECHA Guidance on the Application of the CLP Criteria (Version 4.1; June 2015), classification as a skin sensitiser is not required under the terms of Regulation (EC) No 1272/2008.