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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

PBT status:
PBT assessment does not apply
Justification:

According to Regulation (EC) No. 1907/2006, a substance must fulfil all three criteria for persistence, bioaccumulation and toxicity to be considered as PBT, as listed in part 1 of Annex XIII, and it must fulfil the criteria for persistence and bioaccumulation stated in part 2 of Annex XIII to be considered vPvB. Data for the definitive conclusion on the PBT or vPvB properties according to the criteria set in Regulation (EC) No. 1907/2006, Annex XIII, parts 1 and 2, are not available for all three criteria. Thus, the screening criteria given in the ‘Guidance on information requirements and chemical safety assessment - Chapter R.11: PBT assessment’ (ECHA, 2008) are used as surrogate information to decide whether the substance

may potentially fulfil the PBT or vPvB criteria.

Biodegradation/persistence:

Based on a test result the substance is concluded to be readily biodegradable. Therefore, it is concluded that

Soybean oil, epoxidized, reaction products wirh methanol does not fulfil the sreening criteria for persistent (P) or very persistent (vP) as laid down in Annex XIII of the REACH Regulation.

Bioaccumulation:

QSAR calculations show that the log Kow value of the substance will be over 10.08. All recommended BCF models show values significant lower than 2000 L/kg (between 3.162 and 104.5 L/kg). 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 test results it can be concluded that the L(E)C50 and NOEC values for the substance are not toxic for the environment. It is also concluded 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 that Soybean oil, epoxidized, reaction products with methanol 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 Soybean oil, epoxidized, reaction products with methanol is not a PBT nor a vPvB substance.