Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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 registered substance is not readily biodegradable. However, in the prolonged Close Bottle test, the substance was biodegraded by 62% at day 60. This indicated that the registered substance undergoes a biodegradation and should be considered as non-persistent following the EU PBT/vPvB criteria.

 

The average bioconcentration factor (BCF) of the registered substance determined, by read-across, at 373 L/kg indicates that the substance did not bioaccumulate in the rainbow trout. As BCF is lower than 2000, the registered substance should be considered as non-bioaccumulable following the EU PBT/vPvB criteria.

 

Finally, for the T criterion, long-term toxicity data are available for the three trophic levels (fish, aquatic invertebrate and algae). The lowest E(L)C10/NOEC value was determined at 0.066 mg/L (21d-EC10 value for daphnid), so greater than 0.01 mg/L. In addition, the substance is not classified as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) according to Regulation EC No 1272/2008 and no other evidence of chronic toxicity was observed, as identified by the classification specific target organ toxicity after repeated exposure (STOT RE Category 1 or 2) according to Regulation EC No 1272/2008. Therefore, the registered substance should be considered as non-toxic following the EU PBT/vPvB criteria.

In conclusion, the registered substance cannot be considered PBT or vPvB.