Registration Dossier
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EC number: 943-428-1 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
Sorbitan C16-18 (even numbered) fatty acid esters, ethoxylated (1-6.5 moles ethoxylated) is assumed to be readily biodegradable based on two studies on read across substances (62.5 to 88%). Thus, the substance does not meet the screening criterion for persistence and it is not considered to be persistent (P) or very persistent (vP).
According to QSAR calculation with the main constituents of the target substance sorbitan C16-18 (even numbered) fatty acid esters, ethoxylated (1-6.5 moles ethoxylated), showed log Kow values of 4.02 – 20.76 (KOWWIN v1.68) indicating partially a potential for bioaccumulation. However, BCFBAF (v3.01) calculations resulted to BCF values between 0.89 and 14.6 L/kg for the main constituents, indicating a low potential for bioaccumulation (Arnot-Gobas method, including biotransformation). An exclusion of biotransformation resulted in higher BCF values of 0.893 - 1082 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 0.01 – 14.93 d. The higher molecular weight components of the substance are not within the applicability of the model and the calculated BCF values should be taken with caution. Nevertheless, they are expected to have a limited potential for bioaccumulation. According to ECHA Guidance R.11 (ECHA, 2014) substances with high molecular weight (> 1100 g/mol) and high log Kow (> 9.3) are expected to have a reduced potential for bioaccumulation and are not likely to meet the B criterion. The substance components which are not in the applicability domain of the model exhibit a molecular weight of 1032 – 1492 g/mol and high log Kow values of 11.33 - 20.76. Thus, they are not expected to have a significant potential for bioaccumulation. Furthermore, the substance can be digested by metabolic hydrolysis and other common metabolic pathways, which enhances the assumption of no bioaccumulation in organisms. 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).
Long-term toxicity testing with Daphnia magna resulted in a NOELR (21 d) of 10 mg/L for the source substance sorbitan monolaurate, ethoxylated (CAS 9005-64-5). Moreover, the target substance is not classified according to Regulation (EC) No. 1272/2008 (6th ATP). Thus, the criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 are not met and sorbitan C16-18 (even numbered) fatty acid esters, ethoxylated (1-6.5 moles ethoxylated) is not considered to meet the T criterion.
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