Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
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EC number: - | CAS number: -
Endpoint summary
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:
A skin sensitisation study was performed in the guinea pig according to the Magnusson-Kligman method, using a maximisation method with Freund's complete adjuvant, to evaluate the sensitisation potential of Reactive Blue F08-0170. Challenge with Reactive Blue F08-0170 evoked no positive responses in the test animals sensitised previously with the test item or in the control group. The net response value represented an incidence rate of 0 % and the net score value of 0.00. In conclusion, Reactive Blue F08-0170 was shown to have no skin sensitisation potential and is classified as a non-sensitiser, according to current EU-regulations.
Migrated from Short description of key information:
Summary of skin sensitisation
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 the Ecological 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 above study 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).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
