Registration Dossier

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:

Reactive Red F08-0146, tested in a suitable vehicle, was shown to have no sensitisation potential (sensitiser) in guinea pig using the Magnusson & Kligman Method.

In a Local Lymph Node Assay in the Mouse, stimulation index values for Reactive Red F08 -0146 were 16.4, 23.9 and 6.8 at treatment concentrations of 25, 10 and 5 (w/v) %, respectively. Therefore, under the conditions of the assay, Reactive Red F08-0146 was shown to have a sensitisation potential (sensitiser), however, this study is not considered valid due to the reaction of the dye with the organic solvent. In a separate evaluation, a precipitate was observed when the test substance was mixed with the vehicle (N,N-dimethylformamide) used in this study.


Migrated from Short description of key information:
Summary of skin sensitisation data

Respiratory sensitisation

Endpoint conclusion
Additional information:

The registered chemical is a reactive dye. For this class of dyes it was generally agreed between the members of theEcological and Toxicological Association of Dyes and Organic Pigments Manufacturers (ETAD) that a possible risk for respiratory sensitisation for workers exists at high exposure. However the following should be noted:

 

1) For the substance no history of respiratory problems, such as occupational asthma, is associated with the manufacture and use of the specific substance.

 

2) Due to the granular form of the substance (spray dried in closed system from aqueous solution directly after synthesis) no risk for inhalative exposure arises.

 

The potential to cause respiratory sensitisation is therefore not considered to be applicable for this substance.

No evidence of respiratory sensitisation was noted in any of the studies conducted, and it is proposed that the substance is not a respiratory sensitiser.


Migrated from Short description of key information:
Not assessed. No evidence of respiratory sensitisation was noted in any of the studies conducted, and it is proposed that the substance is not a respiratory sensitiser.

Justification for classification or non-classification

The skin sensitisation study in the guinea pig using the Magnusson & Kligman Method has been ranked reliability 1 according to the Klimisch et al system. This ranking was deemed appropriate because the study was conducted to GLP and in compliance with agreed protocols. Sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds.

The above results triggered no classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008). No classification for sensitisation is therefore required.