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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 PBT Assessment for Palatec M is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2012).

 

Persistence

Palatec M is readily biodegradable based on studies conducted according to OECD 301 B, covering all main constituents (82 - 90% based on CO2 evolution in 28 days). Thus, the test substance does not meet the screening criterion for persistence and is not considered to be P or vP.

Bioaccumulation

The log Kow of the main constituents of Palatec M ranges from -3.57 to -1.55. Thus, the substance does not meet the screening criterion for bioaccumulation and is not considered to be bioaccumulative (B) or very bioaccumulative (vB).

Toxicity

There is substantial evidence that Palatec M has no long-term effects on aquatic organisms. Chronic values for fish, daphnia and algae are all > 1000 mg/L (ECOSAR v1.00). Moreover, Palatec M is not classified according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008. Thus, the criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 are not met and the substance is not considered to meet the T criterion.