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EC number: 419-480-1 | CAS number: -
The incidences of skin reddenings after challenge are summarized in the following table-.
Test substance Group (20 animals)
1stControl group (10 animals)
Test substance patch
Reactive Blue FC 75311 was evaluated for potential skin sensitizing properties in a maximisation test as described by MAGNUSSON and KLIGMANN. The test was performed on female guinea pigs.
The test compound was formulated in physiological saline solution (sterile) as a suspension.
After challenge one animal (5%) and two animals (10%) of the test substance group reacted with skin reddening to the 50% and 25% test compound formulation, respectively. In the control group two animals (20%) and one animal (10%), respectively, showed skin reactions.
Thus, under the conditions of the maximization test, the test compound has no skin sensitizing potential.
Sensitisation was assessed using the Magnusson and Kligmann sensitisation assay. During the induction phase of the study, irritation reactions were noted in both control and test groups. After the challenge exposure one animal (5%) and two animals (10%) of the test substance group reacted with skin reddening to the 50% and 25% test compound formulation, respectively. In the control group two animals (20%) and one animal (10%), respectively, exhibited skin reactions.
On the basis of the results, the substance cannot be considered to be a skin sensitiser.
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 (spay 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.
The above study has been ranked reliability 1 according to the Klimish et al system. This ranking was deemed appropriate because the studies were conducted to GLP an 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 effects is therefore required.
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.
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