Registration Dossier

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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:

In an LLNA study performed according to OECD 429, three experimental groups of five female CBA/J mice were treated with test substance concentrations of 5, 10 or 25% w/w on three consecutive days, by open application on the ears. Five vehicle control animals were similarly treated, but with vehicle alone (propylene glycol). Three days after the last exposure, all animals were injected with 3H-methyl thymidine and after five hours the draining (auricular) lymph nodes were excised and pooled for each animal. After precipitating the DNA of 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. The positive control showed appropriate results.

The SI values calculated for the substance concentrations 5, 10 and 25% were 2.2, 1.7 and 1.8 respectively.

Since there was no indication that the test substance elicits an SI ≥ 3 when tested up to 25%, FAT 41043/A TE was considered not to be a skin sensitizer. It was established that the EC3 value (the estimated test substance concentration that will give a SI =3) (if any) exceeds 25%.

Migrated from Short description of key information:
One Local Lymph Node Assay performed according to OECD/EC guideline and GLP principles.

Justification for selection of skin sensitisation endpoint:
only reliable study available performed according to guideline

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on these results, FAT 41043/A TE would not be regarded as a skin sensitizer. The test substance does not have to be classified and has no obligatory labelling requirement for sensitization by skin contact according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2007) and the Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.