Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:
On the basis of the currently available information, the substance is expected to be not-PBT.

 

PERSISTENCE

The substance is not readily biodegradable in standard tests for biodegradability. Furthermore, abiotic degradation by hydrolysis is considered as negligible, since the substance resulted to be hydrolytically stable.

Based on the available information, the substance can be considered as potentially P or vP.

 

BIOACCUMULATION

Many substances with a molecular mass greater than 700 are not readily taken up by fish, because of possible steric hindrance at passage of gill membranes or cell membranes of respiratory organs. Direct Black 168 has a molecular weight higher than 800 g/mol and is characterized by a negative log Kow.

Thus, B-criterion is not met.

 

TOXICITY

Aquatic long-term toxicity data is not available, therefore the aquatic toxicity assessment and classification are based mainly on the short-term toxicity data. Short-term toxicity studies show that the substance should be considered as harmful to aquatic life with long lasting effects for aquatic life, according to the criteria of CLP Regulation (EC) No 1272/2008.

The substance is not classified as carcinogenic, germ cell mutagenic, or toxic for reproduction and it does not meet the criteria of CLP Regulation (EC) No 1272/2008 to be classified for specific target organ toxicity after repeated exposure evidence of chronic toxicity.

A definitive conclusion about the T-criterion cannot be reached.