Registration Dossier
Registration Dossier
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EC number: 701-203-3 | CAS number: -
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
Persistence Assessment
Sorbitan monooleate, ethoxylated (1-6.5 moles ethoxylated) is readily biodegradable confirmed in one experimental study according to ISO 14593:1999. Thus, the substance does not meet the screening criterion for persistence and it is not considered to be persistent (P) or very persistent (vP).
Bioaccumulation Assessment
Sorbitan monooleate, ethoxylated (1-6.5 moles ethoxylated) is characterized by a log Pow of 4.51 - 5.06 (KOWWIN v1.68) indicating a potential for bioaccumulation. Reliable QSAR estimation using BCFBAF v3.01 indicates a low potential for bioaccumulation. The substance is in the applicability domain of the model indicating that the results are reliable and can be used to assess the bioaccumulation potential of Sorbitan monooleate, ethoxylated (1-6.5 moles ethoxylated). Using the Arnot-Gobas method, including biotransformation (BCFBAF v3.01), BCF values from 12.6 to 14.6 were calculated for the main constituents (Kampara, 2014). An exclusion of biotransformation resulted in a higher BCF values of 18.6 - 42.9 L/kg, indicating that extensive metabolism occurs and significantly reduces the bioaccumulation potential in a short period of time. The QSAR estimated biological half-life is 0.02 - 0.03 d (corresponding to approx. 30 min). For a detailed review on metabolism of the substance, please refer to the toxicokinetics statement in IUCLID section 7.1. Thus, taking all information into account, the substance is not considered to be bioaccumulative (B) or very bioaccumulative (vB).
Toxicity Assessment
Long-term toxicity testing with Daphnia magna resulted in NOELR (21 d) of 10 mg/L for the source substance Sorbitan octanoate (CAS 91844-53-0). Moreover, the target substance is 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 sorbitan monooleate, ethoxylated (1-6.5 moles ethoxylated) is not considered to meet the T criterion.
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