Registration Dossier
Registration Dossier
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EC number: 205-526-6 | CAS number: 142-18-7
PBT assessment
Administrative data
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. 2,3-dihydroxypropyl laurate (CAS No. 142-18-7) is readily biodegradable. Therefore, it is not expected to be persistent in the environment and it 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. From literature it is well known, that these hydrolysis products will be metabolised and excreted in fish effectively (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. Based on the available information, the substance does not meet the B or vB criteria.
Toxicity (T) Assessment:
2,3-dihydroxypropyl laurate (CAS No. 142-18-7) 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. On the other hand, aquatic toxicity testing is still ongoing (OECD 203, 211 and 201) and therefore, a conclusive assessment of the T criterion for this substance cannot be established. The dossier will be updated as soon as possible with the results of the aquatic toxicity tests and the T criterion according to Regulation (EC) No. 1907/2006, Annex XIII will be evaluated.
Nevertheless, 2,3-dihydroxypropyl laurate (CAS No. 142-18-7) is considered not to be PBT or vPvB.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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