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:

One fully reliable study is available (Vogel (2010) Skin sensitisation) conducted according to OECD TG 429 and GLP (1, 2.5, and 5% (w/v) in dimethylformamide).

The SI values calculated for the substance concentrations 1.0, 2.5 and 5.0% (w/v) were 6.15, 13.29, and 15.76 respectively. The EC3 value could not be calculated, since all S.I. are above 3. Based on these results according to the recommendations made in the test guidelines, FAT 40849/A TE would be regarded as skin sensitizer. As there is a clear dose response and the S.I: is >3 at a concentration of 1.0 % (w/v) the substance is deemed a strong sensitiser (category 1A) according to CLP


Migrated from Short description of key information:
- skin sensitisation: sensitising, category 1A, OECD TG 429; study " Vogel (2010) 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 sensitisation:

Based on the above stated assessment of the skin sensitisation potential of FAT 40849/A TE (S.I: is >3 at a concentration of 1.0 % (w/v)) the substance needs to be classified as R43 (May cause sensitisation by skin contact) according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and as Category 1A (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.

 

- respiratory sensitisation:

As no data on respiratory sensitisation is available for FAT 40849/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.