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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:

Introduction. 

A study 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 method was designed to be compatible with the following:

OECD Guideline for the Testing of Chemicals No. 429 "Skin Sensitisation: Local Lymph Node Assay" (adopted 22 July 2010)

Method B42 Skin Sensitisation (Local Lymph Node Assay) of Commission Regulation (EC) No. 440/2008

Methods. 

Following a preliminary screening test in which no clinical signs of toxicity were noted at a maximum attainable concentration of 10% 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 the test item as a solution in butanone at concentrations of 10%, 5% or 2.5% v/v. A further group of five animals was treated with butanone 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 15% v/v in butanone.

Results. 

The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group are as follows:

Treatment Group

Concentration

Stimulation Index

Result

Test Item

2.5% w/w in
butanone

0.79

Negative

5% w/w in
butanone

1.17

 Negative

10% w/w in
butanone

2.40

 Negative

Positive
Control Item

15% v/v in
butanone

11.70

Positive

.

Conclusion. 

The test item was considered to be a non-sensitiser under the conditions of the test.

The positive control item, α-Hexylcinnamaldehyde, tech., 85%, gave a Stimulation Index of greater than 3 when tested at a concentration of 15% v/v in butanone.


Migrated from Short description of key information:
A GLP study, classified as K1, using the OECD 429 mouse lymph node assay (LLNA) was performed on the test substance after formulation in Butanone at 2.5, 5.0 and 10% w/w. The conclusion of the study was that the substance is negative (non-sensitizing).

Justification for selection of skin sensitisation endpoint:
A GLP study, classified as K1, using the OECD 429 mouse lymph node assay (LLNA) provided a negative (non-sensitizing) conclusion.

Justification for classification or non-classification

The GLP, K1 study was negative for sensitisation, therefore no classification is warranted.