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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

Reference
Name:
2 hydroxyethylene glycol palmitate
Type of composition:
boundary composition of the substance
State / form:
solid: bulk
Reference substance:
Composition 1
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

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 substances of the Glycol Ester category may potentially fulfil the PBT or vPvB criteria.

Persistence Assessment

The members of the Glycol Esters category are all readily biodegradable confirmed in several studies according to accepted guidelines. Thus, the category members do not meet the screening criterion for persistency and they are not considered to be persistent (P) or very persistent (vP).

Bioaccumulation Assessment

The members of the Glycol Esters category are characterized by log Kow values of 5.12 - 16.12 (KOWWIN v1.68) indicating a potential for bioaccumulation. But due to the low water solubility, rapid environmental biodegradation and metabolisation via enzymatic hydrolysis of the Glycol Esters category members, a relevant uptake and bioaccumulation in aquatic organisms is not expected. Enzymatic breakdown will initially lead to the free fatty acid and the free glycol alcohol (e. g. ethylene glycol). From literature it is well known, that these hydrolysis products will be metabolised and excreted in fish effectively (Heymann, 1980; Lech & Bend, 1980; Lech & Melancon, 1980; Murphy & Lutenske, 1990). This is supported by low calculated BCF values of 0.893 - 89.4 L/kg ww (BCFBAF v3.01, Arnot-Gobas, including biotransformation, upper trophic). Please refer to IUCLID Section 5.3 for a detailed overview on bioaccumulation of the Glycol Esters category members. Thus, taking all information into account, the category members are not considered to be bioaccumulative (B) or very bioaccumulative (vB).

Toxicity Assessment

Long-term toxicity testing with Daphnia magna resulted in a NOELR of ≥ 0.02 mg/L for the category member Butylene glycol dicaprylate/dicaprate (CAS 853947-59-8) (OECD 211). Moreover, the Glycol Esters category members are not classified according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008. Thus, the criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 are not met and the category members are not considered to meet the T criterion.