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PBT assessment

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PBT assessment: overall result

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

Persistence

Only screening information is available with regard to persitence properties. In a test following OECD guideline 301B, 8% of the compound was degraded by microorganisms within 28 d. Therefore, the compound can not be considered as readily biodegradable and might potentially fullfill the P criterion.

Bioaccumulation

The experimental Kow and log Kow values of the major component of the test item: at neutral pH the Kow is 2.4x10E2 and the log Kow is 2.38. Therefore, the available screening information indicate that the compound does not fullfill the B criterion.

Toxicity

Short term toxicity studies are available for the standard trophic levels fish (Danio rerio), aquatic invertebrates (Daphnia magna), and algae (Pseudokirchnerella subcapitata). Fish are the most sensitive group when beeing exposed to the substance resulting in a LC50 (96 h) of 0.0602 mg/l. As the LC50 is below 0.1 mg/ml the substance potentially meet the T criteria. However, according to the guidance on information requirements and chemical safety assessment chapter R.11: PBT/vPvB assessment the toxicity criterion cannot be decided upon the basis of acute studies alone.

Impurity 1

For impurity 1 no data is available regarding persistence properties. According to two reliable in silico predictions this impurity has a logKow of and does therefore not fullfill the B criterion. For the impurity no data is available regarding toxicitiy properties. This leads to the conclusion that impurity 1 neither fulfills the criteria for persistent and bioaccumulative (PBT-substances), nor the criteria for very persistent and very bioaccumulative substances (vPvB-substances) according to REACH, Annex XIII and as laid down in the TGD R.11 of the European Chemicals Agency.

Impurity 2

For impurity 2 no data is available regarding persistence properties. According to two reliable in silico predictions this impurity has a logKow of and does therefore not fullfill the B criterion. For the impurity no data is available regarding toxicitiy properties. This leads to the conclusion that impurity 2 neither fulfills the criteria for persistent and bioaccumulative (PBT-substances), nor the criteria for very persistent and very bioaccumulative substances (vPvB-substances) according to REACH, Annex XIII and as laid down in the TGD R.11 of the European Chemicals Agency.

Additive

The additive fulfils the criteria for toxic substances.The additive neither fulfills the criteria for persistent and bioaccumulative (PBT-substances), nor the criteria for very persistent and very bioaccumulative substances (vPvB-substances) according to REACH, Annex XIII and as laid down in the TGD R.11 of the European Chemicals Agency (ECHA).