Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

PBT assessment: overall result

Reference
Type of composition:
legal entity composition of the substance
State / form:
solid: bulk
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

Persistence: From a comparison of the results obtained for the substance with the criteria of REACH Annex XIII, it can be concluded that the substance does not fulfil the criteria for persistent (P) and for Very Persistent (vP) under aerobic conditions as the substance is readily biodegradable.

Bioaccumulation: The substance cannot be regarded as bioaccumulative in aquatic, sediment or terrestrial organisms. Reliable studies indicate that Kow values are < 4.5 and there is absence of toxicity in aquatic organisms. Therefore, based on the criteria of REACH Annex XIII, it can be concluded that the substance is not bioaccumulative (B) or very bioaccumulative (vB).

Toxicity: Reliable measured short-term toxicity data for the substance indicate that the substance meets the screening criteria for toxicity (T) as the lowest EC50 from algae is <0.1 mg/L. However, based on reliable modelled long-term data for toxicity of the substance, the chronic values for fish, invertebrates and algae are all above the 0.01 mg/L threshold and do not meet the definitive toxicity (T) criterion according to the ECHA guidance on PBT assessment. In addition, the experimental study for algae reported a NOEC of 0.016 mg/l. It can be concluded that the substance does not fulfil the toxicity (T) criterion as laid down in Annex XIII of regulation (EC) No 1907/2006. 

The overall conclusion is that the substance is not considered a PBT or a vPvB substance. No further testing is required.