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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

Persistence

The substance is neither readily nor inherently biodegradable biodegradable. Abiotic degradation by hydrolysis is considered as negligible, since the substance is expected to be hydrolytically stable.

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

Bioaccumulation

The substance shows a very high affinity to the water phase (logKow < -3.4) which excludes a bioaccumulation potential in organisms. In attition, generally 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. The organic content of the substance is represented by molecules with molecular weights higher than 800 g/mol.

Therefore, B-criterion is not met.

Toxicity

While both long term and short term data on fish (Oncorhynchus mykiss) are available, data on aquatic invertebrates (Daphnia magna) and on algae (Scenedesmus supspicatus) are only for short term toxicity.

Based on this data, the substance should be considered as toxic 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 CLP criteria to be classified for specific target organ toxicity after repeated exposure evidence of chronic toxicity.

As the long-term no-observed effect concentration NOEC for marine or freshwater organism (i.e. fish) is higher than 0.01 mg/L, the substance is not considered to fulfil the toxicity criterion (T).

Based on the currently available information, the substance is expected to be not-PBT.

Likely routes of exposure:

Due to its high affinity to the hydrophilic phase and because bioaccumulation is not significant, exposure from the consumption of contaminated water seems to be the most relevant route.