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PBT assessment

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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.

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