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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

Reference
Name:
Imazalil sulfate
Type of composition:
legal entity composition of the substance
State / form:
solid: bulk
Related composition:
Imazalil sulfate
Reference substance:
Imazalil sulfate
PBT status:
the substance is not PBT / vPvB
Justification:

An evaluation of the inherent properties of imazalil sulphate is performed against the ANNEX XIII criteria. If insufficient data were available, the screening criteria as laid down in ECHA Guidance on information requirements and chemical safety assessment Chapter R.11: PBT Assessment (2014) were applied.

The persistency assessment is based on the screening criteria in Annex XIII of the REACH Regulation. The biodegradation potential of the test substance has been assessed in a guideline study on ready biodegradability following the OECD 301C. The results reveal that the test substance does not degrade and hence the substance is considered not to be readily biodegradable.It can therefore be concluded that based on the criteria mentioned above the substance is persistent in the environment. However DT50 values for biodegradation in the soil indicated that the substance is not vP. Therefore the substance is concluded to be P/not vP.

The bioaccumulation assessment is based on the screening criteria in Annex XIII of the REACH Regulation.The available evidence on the bioaccumulation potential for the substance indicates that the screening criteria for bioaccumulation potential (B and vB) are not met. Based on a BCF of 64.4l/kg the screening criteria for bioaccumulation are not fulfilled and the substance is concluded not to have a bioaccumulative potential (not B / not vB).

The substance is classified as Carc 2 and STOT RE exp 2 and therefore fulfilled the criteria T.

As a conclusion, taking into account that the substance is potentially P and not vP and T, but not B/vB, the substance should not be considered as a PBT/vPvB substance.