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PBT assessment

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PBT assessment: overall result

PBT status:
further information relevant for the PBT assessment is necessary
Justification:

Based on the avaialble information, the PBT properties of the substance is not able to be assessed, further relevant information is necessary and been collecting at this moment. An update of the PBT assessment containing the final study results will be submitted when all ongoing/planned studies have been finalized (expected in Q1 2022).

Persistence: No conclusion can be reached based on available information

The substance is considered to be not readily biodegradable. In a weight-of-evidence approach, hydrolysis test is waived due to the insolubility of the substance. The study on biodegradability in surface water is ongoing. According to the preliminary study, the substance is likely to be persistent in the surface water compartment. If the findings in the ongoing definitive study confirm this conclusion, then a simulation testing of biodegradation in water: sediment or soil will be unnecessary.

Bioaccumulation: No conclusion can be reached based on available information

The bioaccumulation study is waived at this stage. The performance of an experimental study for bioaccumulation endpoint or not depends on the partition coefficent and the biodegradation properties of the substance. If logKow ≥ 3 or the substance is persistent in surface water, sediment or soil, then an experimental study on bioaccumulation will be carried out. At this moment, both partition coefficient and the biodegradation studies are ongoing. The study on bioaccumulation is waived at this stage until the results of the ongoing studies are available.

Toxicity: No conclusion can be reached based on available information

The test substance does not meet the criteria for classification as carcinogenic in Category 1A or 1B, mutagenic in Category 1A or 1B, reproduction in category 1A,1B or 2, or STOT RE in Category 1 or 2. The toxicity of the substance to aquatic organisms are not fully studied yet. The available long-term NOEC/EC10 for freshwater aquatic organisms (algae and Daphnia) > 0.01 mg/L trigger value. While the long-term toxicity test on fish (fish early-life stage toxicity test) according to OECD TG 210 is ongoing. The toxicity property of the substance will be concluded based on this study.