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:

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 10, 25 and 50% or dimethylformamide on three consecutive days by open application on the ears. Three days after the last exposure, all animals were injected with 3H-methyl thymidine and after 5 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 10, 25 and 50% were 11.7, 13.4 and 20.1, respectively. The EC3 value was established to be lower than 10%. FAT 40854/A TE is considered to be a skin sensitiser.


Migrated from Short description of key information:
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 the data available, FAT 40854/A TE has to be classified as a skin sensitiser according to the:

-Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011),

-Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.