Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

PBT assessment: overall result

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

Persistence assessment

Evidence of P but not vP properties

After 28 d, the degradation of the reference item reached 88.0%, confirming the activity of the inoculum and degrdation afer 28d was observed. Therefore, the substance is considered P but not vP.

Bioaccumulation assessment

Evidence of non-B / non-vB properties

Remarks on criterion “Log Kow<=4.5”: The partition coefficient study (Log Kow) was performed in accordance with OECD 117 resp. EU A.8 and followed OECD Principles of Good Laboratory Practice (GLP). The estimated value was 1.85 which is lower than the screening criteria. On the basis of this screening assessment the substance is considered to be not bioaccumulative (B) or very bioaccumulative (vB).

Toxicity assessment

- Remarks on Annex XIII criteria (T):

The information gathered indicates that the target substance is toxic to the aquatic environment. However, None of the studies evaluated meet the acute toxicity (T) screening criteria of <0.01 mg/L. Therefore, the target substance is not considered to be T on the basis of the screening criterion. Furthermore, there is no other evidence of repeated dose toxicity. Thus, it does not meet the criteria for classification for carcinogenic, mutagenic, toxic to reproduction or toxic after repeated exposure according to Regulation EC No 1272/2008