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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. As Glycerides, palm-oil mono-, hydrogenated, acetates (CAS No. 93572-32-8) is readily biodegradable (86.7% biodegradation in 28 days), it is not expected to be persistent in the environment, and therefore the substance does not meet the Persistent (P) or very Persistent (vP) criteria.

 

Bioaccumulation (B) Assessment:

Due to the rapid environmental biodegradation and metabolization via enzymatic hydrolysis of the Glycerides category members, a relevant uptake and bioaccumulation in aquatic organisms is not expected. Enzymatic breakdown will initially lead to the free fatty acid and glycerol (and for this substance additionally acetic acid). From literature it is well known, that these hydrolysis products will be metabolised and excreted in fish effectively (Lehninger, Nelson and Cox (1994); Tocher, 2003). This is supported by calculated BCF values ranging from 0.89-57.1 L/kg within the category (BCFBAF v3.01, Arnot-Gobas, including biotransformation, upper trophic). Experimental data on glycerol tristearate (CAS No. 555-43-1, category member) showed a BCF value in fish < 10 (Freitag, 1985). Please refer to IUCLID Section 5.3.1 for a detailed overview on bioaccumulation of the Glycerides category members.

 

Toxicity (T) Assessment:

The chronic no-observed effect concentration (NOEC value) reported in the test conducted with algae is 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, palm-oil mono-, hydrogenated, acetates does not meet the T criterion according to Regulation (EC) No. 1907/2006, Annex XIII.

 

In conclusion, Glycerides, palm-oil mono-, hydrogenated, acetates is considered not to be PBT or vPvB.