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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Skin sensitizer

Key value for chemical safety assessment

Skin sensitisation

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

The authors of this study report conducted the assessment of Contact Hypersensitivity to the test substance in the Mouse (Local Lymph Node Assay). The study was carried out according to the OECD guideline n° 429 with no observed deviations or restrictions.

The test substance concentrations were selected for the main study were based on the results of a preliminary study.

In the main study, three experimental groups of five female/J mice were treated with test substance concentrations of 1, 5 or 10% w/w on three consecutive days, by open application on the ears. Five vehicle control animals were similarly treated, but with vehicle alone (Acetone/Olive oil (4:1 v/v)).

Three days after the last exposure, all animals were injected with3H-methyl thymidine and after five hours the draining (auricular) lymph nodes were excised and pooled for each animal.

After precipitating theof the lymph node cells, radioactivity measurements were performed. The activity was expressed as the number of Disintegrations Per Minute (DPM) and a stimulation index (SI) was subsequently calculated for each group.

No oedema was observed in any of the animals examined.

All nodes of the test substance treated animals were increased in size. The largest auricular lymph nodes were found in the higher dose groups

No macroscopic abnormalities of the surrounding area were noted in any of the animals.No macroscopic abnormalities of the surrounding area were noted.

Body weights and body weight gain of experimental animals remained in the same range as controls over the study period. The slight body weight loss, noted in some animals, was considered not toxicologically significant.

Mean DPM/animal values for the experimental groups treated with test substance concentrations 1, 5 and 10% were 8538, 18776 and 23082 DPM respectively. The mean DPM/animal value for the vehicle control group was 1182 DPM.

The SI values calculated for the substance concentrations 1, 5 and 10% were 7.2, 15.9 and 19.5 respectively. These results show that the test substance elicits an SI ≥ 3. The EC3 value (the estimated test substance concentration that will give a SI =3) was established to be between 0 and 1 %.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The test substance was evaluated for its skin sensitisation properties according to the procedure described in the OECD guideline 429, i.e. the LLNA assay.

According to the CLP Regulation (EC 1272/2008), 3.4 Sensitiser, a substance is considered as skin sensitiser Category 1 in the LLNA assay if thecalculated stimulation index (SI) is three or more. I t can be thenallocated in one the the two sub-categories 1A and 1B as follows:

-sub-category 1A: Local lymph node assay, EC3 value ≤ 2 %

- sub-category 1B: Local lymph node assay, EC3 value > 2 %

The SI value calculated in the available study was > 3 and the EC3 value was established to be between 0 and 1 % therefore, the test substance is classified as skin sensitizer sub-category 1A.