Registration Dossier
Registration Dossier
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EC number: 270-287-7 | CAS number: 68424-27-1 This substance is identified by SDA Substance Name: C16 and C18 unsaturated trialkyl carboxylic acid trimethylolpropane triester and SDA Reporting Number: 09-015-00.
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
Data for the definitive conclusion on the PBT or vPvB properties of Fatty acids, C16-18 (even numbered) and C16-18-unsatd. (even numbered), triesters with trimethylolpropane (CAS 68002-79-9) 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:
The screening criterion for Persistence (P) is the potential of a substance to be readily biodegradable. As Fatty acids, C16-18 (even numbered) and C16-18-unsatd. (even numbered), triesters with trimethylolpropane (CAS 68002-79-9) is readily biodegradable, the substance is not fulfilling the criteria for persistence and is thus not “P” and not “vP”.
Bioaccumulation (B) Assessment:
An evaluation of the bioaccumulation potential of Fatty acids, C16-18 (even numbered) and C16-18-unsatd. (even numbered), triesters with trimethylolpropane (CAS 68002-79-9) is presented in IUCLID chapter 5.3 and chapter 4.3 in the Chemical Safety Report (CSR) indicating that bioaccumulation is expected to be low due to a calculated BCF of 0.89 L/kg wet weight (Arnot-Gobas). Thus, the substance does not meet the Bioaccumulative (B) or very Bioaccumulative (vB) criteria and can therefore considered not to be bioaccumulative.
Toxicity (T) Assessment:
Long-term toxicity testing with Daphnia magna resulted in a NOELR (21 d) of ≥ 0.11 g/L (nom.). Furthermore, Fatty acids, C16-18 (even numbered) and C16-18-unsatd. (even numbered), triesters with trimethylolpropane (CAS 68002-79-9) shows no acute toxicity on all three trophic levels (fish, aquatic invertebrates, algae) in the range of water solubility. The test substance is not classified according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (2nd ATP). Therefore, Fatty acids, C16-18 (even numbered) and C16-18-unsatd. (even numbered), triesters with trimethylolpropane (CAS 68002-79-9) does not meet the T criterion set out in Annex XIII of Regulation (EC) No. 1907/2006.
Conclusion
In conclusion the substance is not considered to meet the criteria to be classified as PBT or vPvB based on the available data.
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