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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 for the substance is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2017).

 

Persistency assessment
One experimental study is available investigating the biodegradability of the substance. The study was performed according to OECD 301B. After 28 d the substance was degraded to 49% indicating that the substance is not readily biodegradable according to the OECD criteria
(49% based on O2 consumption, OECD 301 B, activated sludge of a local municipal STP).Thus, the substance is considered to meet the P/vP criteria based on the available data.

Bioaccumulation
The substance has a log Pow of 1
.1 (calculation method based on measured water solubility of phosphorus based anaylsis and measured octanol solubility of neat active test item). In accordance with the ECHA Guidance R.11 substances with a log Pow of > 4.5 are considered to be B/vB. Thus, the substance is considered to be not B/vB based on the screening criteria.

Toxicity
Aquatic studies are available for three trophic levels. The chronic endpoint of the algae studie was with 85.86 mg a.i./L above the 0.01 mg/L. Also all endpoints for the acute aquatic toxicity were above 1 mg/L.

The substance is furthermore not classified as carcinogenic, mutagenic or toxic for reproduction nor is there any evidence of chronic toxicity according to the consolidated version of Regulation (EC) No. 1272/2008 (CLP) considering all further amendments. The criteria for “T” are therefore not met. Thus, in accordance with ECHA Guidance R.11 no further assessment is necessary.