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:

- skin sensitisation:

The skin sensitisation potential of FAT 40841/A TE was tested in a Local Lymph Node Assay according to OECD TG 429 (administration to the dorsum of both ear lobes of mice).

The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. Due to the colour of the test item, redness of the ear skin could not be observed. In this study Stimulation Indices (S.I.) of 10.27, 11.27, and 4.44 were determined with the test item at concentrations of 5, 10, and 25% in dimethylformamide, respectively. The test item FAT 40841/A TE was found to be a skin sensitizer.


Migrated from Short description of key information:
- skin sensitisation: FAT 40841/A TE was found to be a skin sensitiser in the mouse (OECD Guideline 429); study Meurer (2008) / Skin sensitisation

Respiratory sensitisation

Endpoint conclusion
Additional information:

- respiratory sensitisation:

no data available


Migrated from Short description of key information:
- respiratory sensitisation: No data available

Justification for classification or non-classification

- skin:

Based on the assessment of the sensitizing effects on skin, stated above, FAT 40841/A TE is classified as skin sensitiser (R43 May cause sensitisation by skin contact) according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and Category 1B (Warning; H317: May cause an allergic skin reaction) according to CLP (REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL) as implementation of UN-GHS in the EU.

- respiration:

As no data on respiratory sensitisation is available for FAT 40841/A TE a classification is not possible according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and according to CLP (REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL) as implementation of UN-GHS in the EU.