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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

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

The substance was found to be readily biodegradable but not meeting the 10-day window criterion. The substance achieved 76.84% biodegradation (based on CO2 evolution) and 72.03% biodegradation (based on DOC) after 28 days. The substance was tested for inherent biodegradability in freshwater at a concentration of 0.1825 ml/l. After 56 days the degradation value was found to be 78.6%. This indicated that the substance did not meet the criteria for classification as inherently biodegradable but instead showed good potential for ultimate biodegradation (>70% degradation). In addition, a formulated product containing 44.7% of the registered substance was found to be inherently biodegradable with 29.6% biodegradation (based on O2 consumption) after 28 days, with 2.5 mg/l of the test substance, and 22.1% biodegradation after 28 days with, 3.5 mg/l of the test substance. This indicates that the formulated product demonstrates inherent biodegradability in seawater. In addition, the Log Kow of the triethanolamine component of the substance was found to be -1.75-1.32. The Log Kow of the substance is <4.5 and therefore the substance does not demonstrate the potential for bioaccumulation. The substance was not found to be toxic to fish or aquatic invertebrates. The 48 hour EC50 for aquatic algae was estimated to be 10.28 mg/l for the registered substance based on the results of testing on a formulated product containing the registered substance. However, the substance is only provided as a formulated product and the weight-of-evidence shows that there is limited toxicity to aquatic organisms. The substance is not classfied as a CMR in accordance with EU CLP criteria, and does not demonstrate evidence of chronic toxicity or specific target organ toxicity.