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:

This substance was tested in according to mouse local lymph node assay (OECD 429) 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 (Sanders, 2012).
Following a preliminary screening test in which no clinical signs of toxicity were noted at a concentration of 100%, 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 the undiluted test item or the test item as a solution in acetone/olive oil 4:1 at concentrations of 50% or 25% v/v. A further group of five animals was treated with acetone/olive oil 4:1 alone. In order to determine the concentration of test item expected to cause a 3 fold increase in 3HTdR incorporation (EC3 value), and at the request of the Study Sponsor, additional groups of five animals were treated with the test item at concentrations of 25%, 10% and 2.5% v/v in acetone/olive oil 4:1. An additional 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, α-Hexylcinnamaldehyde tech., 85%, at a concentration of 25% v/v in acetone/olive oil 4:1.
The stimulation scores were positive at concentrations of ≥ 25% in acetone/olive oil 4:1 ratio; the EC3 was calculated to be 14.2%. 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.
The test item was considered to be a sensitiser under the conditions of the test.


Migrated from Short description of key information:
The test material is a skin sensitizer.

Respiratory sensitisation

Endpoint conclusion
Additional information:

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

Justification for classification or non-classification

In accordance to Directive 67/548/EEC and EU CLP (Regulation (EC) No. 1272/2008), this substance was classified as a skin sensitizer. As the EC3 is greater than 2 %, the substance is classified as a Skin Sensitisation Category 1B.