Registration Dossier

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:

One key study according 301B (enhanced test, 60 days with natural river water) indicate that the test item is not readily biodegradable but primarily degradable. The 3 supporting studies according OECD 301 A and OECD 302 B shows that the substance is not readily and not inherently biodegradable. In all 3 supporting studies the level of biodegradation is in a range 20 - 50 %.

The ‘P’ criterion according to Annex XIII is fulfilled for environmental compartments.

 

The partition coefficient (1-octanol /water) of the test substance has been determined as LogPow = 2.23. The calculated BCF is < 2000 L/kg.

 

The ‘B’ criterion for the substance is NOT fulfilled.

 

The substance is classified as hazardous to the aquatic environment (long-term) – Aquatic Chronic 2. This classification results from 3 acute aquatic toxicity tests. The lowest value is the 48-hour EC50 of 8.58 mg/L for freshwater daphnia. The substance is not classified as CMR and not as T, R48. The criteria for T are not fulfilled.

 

The 'T' criterion for the substance is NOT fulfilled as the toxicity value of 8.58 mg/L is above the toxicity criteria of 0.1 mg/L for the aquatic compartment and the substance is not classified as CMR or with T, R48.

 

 

For the REACH substance the ‘P’ criteria is fulfilled but the ‘B’ and ‘T’ criteria not. Nevertheless the substance is neither a 'PBT' nor a 'vPvB' substance.