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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:

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.

 

Persistence (P) Assessment:

A valid screening criterion to evaluate persistence (P) is the potential of a substance for ready biodegradability. Glycerides, C8-18 and C18-unsatd. mono- and di-, acetates is not readily biodegradable (24% after 28 days) Thus, persistency in the environment (P and vP) cannot be excluded.

 

Bioaccumulation (B) Assessment:

An evaluation of the bioaccumulation potential ofGlycerides, C8-18 and C18-unsatd. mono- and di-, acetatesis presented in Section 5.3 of the technical dossier indicating that bioaccumulation is expected to be low. Due to metabolism (see IUCLID section 5.3.1) and the estimated BCF/BAF values, this substance is likely to show low bioaccumulation potential. Based on the above information, the test substance does not meet the Bioaccumulative (B) or very Bioaccumulative (vB) criteria.

 

Toxicity (T) Assessment:

The long-term no-observed effect concentrations (NOEC values) reported in the tests conducted with aquatic invertebrates and algae are higher than 0.01 mg/L, and the substance is not classified as carcinogenic, mutagenic or toxic for reproduction nor is there any evidence of chronic toxicity according to the 2nd ATP of Regulation (EC) No. 1272/2008 (CLP) and Directive 67/548/EEC. Therefore, Glycerides, C8-18 and C18-unsatd. mono- and di-, acetates does not meet the T criterion according to Regulation (EC) No. 1907/2006, Annex XIII.

 

In conclusion,Glycerides, C8-18 and C18-unsatd. mono- and di-, acetates (CAS No. 91052-13-0) is considered not to be PBT or vPvB.