Registration Dossier

Diss Factsheets

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

PBT assessment: overall result

Referenceopen allclose all

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

The substance does not fulfil the PBT and vPvB criteria. The available information shows that the properties of the substance do not meet the specific criteria provided in REACH Annex XIII Section 1, the information does not allow a direct comparison with all the criteria and there is no indication of P or B properties based on screening information or other information. The substance does not meet the criteria for Bioaccumulation (B nor vB), as it has a log Kow < 4.5; it does not meet the criteria for Toxicity (T), and it is not expected to persist (P nor vP) in the environment as such, as it is readily biodegradable.


 


PBT/vPvB criteria and justification:


 


Persistence assessment


Screening criteria:


The substance is readily biodegradable (study performed according to OECD Guideline 301F).


Bioaccumulation assessment


Screening criteria:


Based on the composition of the substance, where all the components have a Log Kow <4.5, the substance is determined to have a Log Kow < 4.5.


Toxicity assessment


Screening criteria:


Based on acute aquatic toxicity calculations (EPI-Suite, ECOSAR v1.11) in fish, Daphnids and green algae, no L(E)C50 < 0.01 mg/L was observed.


Criteria based on Annex XIII of REACH:


No data is available for long-term aquatic toxicity. Based on estimations using EPI-Suite, ECOSAR v1.11, no ChV (geometric mean between LOEC and NOEC) < 0.01 mg/L was observed for any component of the substance.


The substance is not classified as CMR nor STOT RE according to the Regulation EC no. 1272/2008.


 


Conclusion: The substance is determined to be not PBT/vPvB.