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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

The PBT Assessment 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 (P) Assessment:

A valid screening criterion to evaluate persistence (P) is the potential of a substance for ready biodegradability. The test substance is readily biodegradable. Therefore, it is not expected to be persistent in the environment and it does not meet the Persistent (P) or very Persistent (vP) criteria.

Bioaccumulation (B) Assessment:

Based on valid QSAR calculations the substance can be considered as not bioaccumulative according to REACh criteria. QSAR calculations were performed using the EPISuite BCFBAF v3.01 calculation tool. Using the Arnot-Gobas method including biotransformation a BCF value (for the upper trophic level) was calculated to be 172.5 L/kg and a BAF value was calculated to be 316.5 L/kg. The BCF value markedly increased assuming a biotransformation rate of zero. However, based on ADME data in presented in detail in chapter 7.1 it is obvious that biotransformation occurs and is of utmost important for the fate of the substance in organisms after uptake. Therefore, QSAR calculation considering biotransformation are considered to be relevant and were used for the bioaccumulation assessment of the substance.

Based on these data the test substance is considered to be not bioaccumulative and neither meet the Bioaccumulative (B) nor the very Bioaccumulative (vB) criterion.

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