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:

Biodegradation/persistence:

Based on read-across data the substance2,2-bis[[(2-ethyl-1-oxohexyl) oxy]methyl]propane-1,3-diyl bis(2-ethylhexanoate) (EC# 230-743-8) is concluded to be not readily biodegradable. Therefore, it is concluded that the substance fulfils the screeningcriteria for persistent (P) or very persistent (vP) as laid down in Annex XIII of the REACH Regulation.

 

Bioaccumulation:

Based on read-across a log Kow of > 6.7 has been determined. QSAR calculations show that the log Kow value is 12.3. All recommended BCF models show values lower than 2000 L/kg. Therefore, it can be concluded that the substance does not fulfill the screening criteria for bioaccumulating (B) or very bioaccumulating (vB) as laid down in Annex XIII of the REACH Regulation.

 

Toxicity:

Based on read-across it can be concluded that the L(E)C50 values for the substance are higher than the maximum water solubility of 0.1 mg/L. It is also concluded based on read-across that the substance does not need to be classified for CMR or repeated dose toxicity. From this it can be concluded that the toxicity criteria as laid down in Annex XIII of the REACH regulation have not been fulfilled.

 

Conclusion:

It can be concluded that2,2-bis[[(2-ethyl-1-oxohexyl) oxy]methyl]propane-1,3-diyl bis(2-ethylhexanoate) (EC# 230-743-8)does not fulfill the P(ersistence), B(ioaccumulation) and T(toxicity) criteria as laid down in Annex XIII of the REACH regulation. It can be concluded that the substance is not a PBT nor a vPvB substance.