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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 258-946-7 | CAS number: 54060-92-3
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The test item is considered to be not readily biodegradable based on the design of textile dyes and the BOD/COD ratio of a test with the methyl sulfate salt, which showed a biological degradation of 26.3 %. In addition, the biodegradation is < 10 % under the conditions of a modified Zahn-Wellens-Test. Thus, the test substance is considered to be potentially P and vP.
The water solubility of the test item at 20 °C was determined to be 8.8 g/L, the partition coefficient n-octanol/water is as follows: log Kow = -1.1. Therefore, it is concluded that the substance is not B or vB.
The test substance does not meet the criteria of Annex XIII for aquatic toxicity based on the EC50 of 0.21 mg/L and the EC10/NOEC of 0.02 mg/L for algal growth inhibition as the most sensitive aquatic species - without taking into account inhibition of growth due to the UV absorption by the dyestuff. The test substance was negative in in-vitro and in-vivo genotoxicity tests performed. The substance is not classified for specific organ toxicity or toxicity to reproduction based on the results of GLP studies according to OECD 407 and OECD 421. In addition, the test item in various salt forms is used since decades for coloration of various materials without causing any suspicion of carcinogenic properties. Thus, it is concluded that the test item is not T.
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.
