Registration Dossier
Registration Dossier
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EC number: 209-097-6 | CAS number: 555-43-1
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. Glycerol tristearate (CAS No. 555-43-1) is readily biodegradable (64% biodegradation in 28 days). 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:
Experimental data on glycerol tristearate (CAS No. 555-43-1) showed a BCF value in fish < 10 (Freitag, 1985). Furthermore, 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). 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:
Glycerol tristearate (CAS No. 555-43-1) is not classified according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008. The long-term toxicity test conducted with Daphnia magna (OECD 211) on a structurally related category members used as read-across (propane-1,2,3-triyl trisheptanoate) needs to be repeated, since a NOEC could not be determined. No effects were observed in the study with algae (NOEC > 1.8 mg/L). Thus, based on the current data, the criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 are not met and glycerol tristearate does not fulfil the T criterion. The toxicity assessment will be re-evaluated when the additional study on aquatic invertebrates is available.
Glycerol tristearate (CAS No. 555-43-1) 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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