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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

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Name:
Indaziflam
Type of composition:
legal entity composition of the substance
State / form:
solid: bulk
Related composition:
Indaziflam
Reference substance:
Indaziflam
Reference substance:
Indaziflam
Name:
Indaziflam
Type of composition:
boundary composition of the substance
State / form:
solid: bulk
Reference substance:
Indaziflam
Reference substance:
Indaziflam
PBT status:
the substance is not PBT / vPvB
Justification:

Summary PBT assessment

The PBT assessment of the substance is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (2017).

 

Persistence assessment

The substance is not readily biodegradable following the screening criteria according to OECD and mineralization in surface water is negligible (DT50 > 1000 days at 20°C). If released into natural water the substance is quickly eliminated from the water body, by translocation into the sediment (DT50 water 2.7 – 4.8 days at 20 °C). The DT50 values for the substance in the entire water-sediment systems were determined to range between 126.7 days and > 365 days at 20 °C under aerobic conditions. Also in soil the parent substance degrades under aerobic conditions. The determined half life time in soil ranged from 22 to 177 days at 20-25 °C. No transformation products were formed under anaerobic conditions.

Therefore, the substance does meet the P and vP criterion.

Bioaccumulation assessment

Results of a BCF study reveal that the substance does not show significant accumulation in aquatic organisms. Due to rapid depuration, the potential for biomagnification through the food chain is low as indicated by a flow-through bioaccumulation and metabolism study with Bluegill Sunfish (Lepomis macrochirus) with a BCF (whole fish) of 16, and the steady-state BCF for the substance normalized to 6% lipid content is 11. The available information indicates that the substance has a very low potential for bioconcentration and will not accumulate to significant levels in aquatic organisms.

Therefore, the substance does not meet the B criterion.

 

Toxicity assessment

From the ecotoxicity perspective the toxicity criterion is met for the substance with a lowest NOEC of 0.00032 mg/L (plants, mesocosm) being below the ecologically relevant NOEC triggers of less than 0.01 mg/L.

Thus, the substance meets the T criterion.

 

In conclusion, the substance is not PBT/vPvB.