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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: FX511 can be considered to be readily bioegradable based on a reliable measured biodegradation study. Consequently, in line with the detailed ECHA guidance, FX511 does not fulfil the criteria for Persistence (P).

Bioaccumulation: Based on reliable measured study results, it is concluded FX511 is neither bioaccumulative nor very bioaccumulative. Evidence is provided based on measured log Kow is less than 4.5. It is concluded that there is a low potential for exposure and bioaccumulation in aquatic and terrestrial organisms. FX511 does not fulfil the criteria “bioaccumulative (B)” or “very bioaccumulative (vB)”. According to ECHA Guidance on information requirements and chemical safety assessment (May 2008), Chapter R.11, Figure 11-2: Integrated testing strategy for B-assessment, no further testing is required for the bioaccumulation criterion.

 

Toxicity: Based on available reliable data for toxicity of FX511, long-term chronic toxicity (NOEC) to aquatic organisms is >1 mg/L and does not meet the definitive toxicity criterion according to the ECHA guidance on PBT assessment. However FX511 is classified as toxic for reproduction (category 2) according to Regulation (EC) No 1272/2008. Therefore, it can be concluded that the substance fulfills the toxicity (T) criterion as laid down in Annex XIII of Regulation (EC) No 1907/2006.

 

The overall conclusion is that FX511does not meet the PBT or vPvB criteria. No further testing is required.

Likely routes of exposure:

Exposure to the terrestrial compartment is not expected due to the substance's ready biodegradability in the aquatic environment and is expected to degrade rapidly in wastewater treatment. In addition, the substance has a low Log Kow and potential to bioaccumulate and is therefore unlikely to be spread to land in sludge from STW processes or accumulate through aquatic or terrestrial food chains.