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Revision Date: February 2021 1 SORBITAN MONOOLEATE SORBITAN MONOOLEATE POLYOXYETHYLENE DERIVATIVE This dossier on sorbitan monooleate polyoxyethylene derivative presents the most critical studies pertinent to the risk assessment of sorbitan monooleate polyoxyethylene derivative in its use in drilling muds. This dossier does not represent an exhaustive or critical review of all available data. The information presented in this dossier was obtained from the ECHA database that provides information on chemicals that have been registered under the EU REACH (ECHA), and the European Food and Safety Authority (EFSA, 2015). Where possible, study quality was evaluated using the Klimisch scoring system (Klimisch et al., 1997). Screening Assessment Conclusion – Sorbitan monooleate polyoxyethylene is classified as a tier 1 chemical and requires a hazard assessment only. 1 BACKGROUND Sorbitan monooleate polyoxyethylene derivative is a hydrophilic, non-ionic surfactant used as an emulsifier. It is considered a UVCB substance (substance of unknown or variable composition, complex reaction products or biological materials). Based on the substance group types evaluated, the substance is likely to biodegrade, has a low potential to bioaccumulate and, based on its non- ionic surfactant properties will adsorb to soils. Based on read across from a similar substance (sorbitan monolaurate, ethoxylated (1-6.5 moles ethoxylated) [CAS No. 9005-64-5]), acute and chronic toxicities are relatively low. 2 CHEMICAL NAME AND IDENTIFICATION Chemical Name (IUPAC): Sorbitan monooleate polyoxyethylene derivative CAS RN: 9005-65-6 Molecular formula: Not available (UVCB substances) Molecular weight: Not available (UVCB substances) Synonyms: See below. The composition of sorbitan monooleate polyoxyethylene derivative (CAS No. 9005-65-6) is unknown. The CAS No. 9005-65-6 is a generic CAS No. that can include at least the following UVCB substance groups: 1. An ethoxylated sorbitan ester of oleic acid with an average of 3 moles of ethylene oxide (e.g., PEG- 3-sorbitan oleate). PubChem CID: 78382488 2. A mixture of oleate esters of sorbitol and sorbitol anhydrides, consisting predominantly of the monoester, condensed with approximately 5 moles of ethylene oxide (e.g., Polysorbate 81). 3. An ethoxylated sorbitan ester of oleic acid with an average of 6 moles of ethylene oxide (e.g., PEG- 6 sorbitan oleate). Revision date: February 2021 1 4. An ethoxylated sorbitan ester of oleic acid with an average of 20 moles of ethylene oxide (e.g., PEG-20 sorbitan oleate). 5. A mixture of oleate esters of sorbitol and sorbitol anhydrides, consisting predominantly of the monoester, condensed with approximately 20 moles of ethylene oxide (e.g., Polysorbate 80). This dossier will include information from the following substances: Sorbitan monooleate, ethoxylated (1-6.5 moles ethoxylated) [CAS No. 9005-65-6] Polysorbate 80 (CAS No. 9005-65-6) Sorbitan monolaurate, ethoxylated (1-6.5 moles ethoxylated) [CAS No. 9005-64-5] 3 PHYSICO-CHEMICAL PROPERTIES Key physical and chemical properties for the substance are shown in Table 1. Table 1 Overview of the Physico-chemical Properties of Sorbitan Monooleate, Ethoxylated (1 – 6.5 Moles Ethoxylated) [CAS No. 9005-65-6]* Property Value Klimisch Reference score Physical state at 20oC and 101.3 kPa Liquid 2 ECHA Melting point -32.7oC @ 101.3 kPa 2 ECHA -33.90C @ 101.3 kPa 2 Boiling point No data - ECHA Density 1030 kg/m3 @ 25oC 2 ECHA Vapour pressure 0 Pa @ 20oC (QSAR) 2 ECHA Partition coefficient (log Kow) 4.51 to 5.06 (QSAR)** 2 ECHA Water solubility 0.035 to 0.100 g/L @ 20oC*** 1 ECHA Dissociation constant (pKa) 13.89 @ @ 20oC 2 ECHA Viscosity 672.3 840.4 mPa s @ 20oC 2 ECHA *Data located in REACH database for dehydrated sorbitol, C18 (unsaturated) fatty acid esters, ethoxylated (EC No. 701-203-3). **QSAR (KOWWIN v1.68): sorbitan monooleate, ethoxylated 5EO and sorbitan monooleate, ethoxylated 3EO, respectively. ***Sorbitan monooleate, ethoxylated 3EO: ~100 mg/L; sorbitan monooleate, ethoxylated 5EO: ~35 mg/L. Revision date: February 2021 2 4 DOMESTIC AND INTERNATIONAL REGULATORY INFORMATION A review of international and national environmental regulatory information was undertaken (Table 2). This chemical is listed on the Australian Inventory of Chemical Substances – AICS (Inventory). No conditions for its use were identified. No specific environmental regulatory controls or concerns were identified within Australia and internationally for sorbitan monooleate polyoxyethylene derivative. Table 2 Existing International Controls Convention, Protocol or other international control Listed Yes or No? Montreal Protocol No Synthetic Greenhouse Gases (SGG) No Rotterdam Convention No Stockholm Convention No REACH (Substances of Very High Concern) No United States Endocrine Disrupter Screening Program No European Commission Endocrine Disruptors Strategy No 5 ENVIRONMENTAL FATE SUMMARY A. Summary The substance is likely to biodegrade, has a low potential to bioaccumulate and, based on it non- ionic surfactant properties will adsorb to soils. The data supporting these conclusions are discussed below. B. Biodegradation In an ISO Standard 14593 ready biodegradation test, degradation of Tween 81 (CAS No. 9005-65-6) was 61% after 28 days, indicating ready biodegradability (ECHA) [Kl. score = 2]. If a chemical is found to be readily biodegradable, it is categorised as Not Persistent since its half-life is substantially less than 60 days (DoEE, 2017). C. Environmental Distribution No experimental data are available for sorbitan monooleate polyoxyethylene derivative. Using KOCWIN v2.00, the estimated Koc values for the main components in sorbitan monooleate, ethoxylated (1-6.5 moles ethoxylated) [CAS No. 9005-65-6] based on the molecular connectivity index (MCI) ranged from 794 to 1,259 L/kg (ECHA). Based on these estimated Koc values, the substance is likely to adsorb to soil or sediments. Further, the molecular structure indicates a potential of surface-active properties, which are not taken into account by the QSAR model calculations. As a result, the adsorption of non-ionic surfactants to soil is generally high (ECHA). Based on these considerations, there is a low potential for mobility. Revision date: February 2021 3 D. Bioaccumulation There are no experimental bioaccumulation studies on sorbitan monooleate polyoxyethylene derivative. The bioaccumulation potential was estimated for sorbitan monooleate, ethoxylated (1- 6.5 moles ethoxylated) [CAS No. 9005-65-6] using BCFBAF v3.01 (Arnot-Gobas method, including biotransformation). The calculated BCF values were 12.6 to 14.6 L/kg. When biotransformation was excluded, the BCF values were 18.6 to 42.8 L/kg (ECHA). Thus, sorbitan monooleate polyoxyethylene derivative has a low potential for bioaccumulation. 6 ENVIRONMENTAL EFFECTS SUMMARY A. Summary Based on read across from a similar substance, acute and chronic toxicities are relatively low. Data to support this conclusion are discussed below. B. Aquatic Toxicity Acute Studies There are no adequate aquatic toxicity studies on sorbitan monooleate polyoxyethylene derivative. Aquatic toxicity data has been read-across from sorbitan monolaurate, ethoxylated (1-6.5 moles ethoxylated) [CAS No. 9005-64-5]; see Table 3. Table 3 Acute Aquatic Toxicity Studies on Sorbitan Monolaurate, Ethoxylated (1-6.5 Moles Ethoxylated) [CAS No. 9005-64-5] Test Species Endpoint Results (mg/L) Klimisch score Reference Brachydanio rerio 96-hr LL50 >100 [WAF] 2 ECHA Pseudokirchneriella 72-hr EL50 58.84 [WAF] 2 ECHA subcapitata Chronic Studies The 21-day NOELR (no-observed-effect-loading-rate) for sorbitan monolaurate, ethoxylated (1-6.5 moles ethoxylated) [CAS No. 9005-64-5] in a Daphnia reproduction test was 10 mg/L WAF (ECHA) [Kl. score = 2]. The 72-hr EL10 for sorbitan monolaurate, ethoxylated (1-6.5 moles ethoxylated) [CAS No. 9005-64-5] to Pseudokirchneriella subcapitata is 19.05 mg/L WAF (ECHA) [Kl. score = 2]. C. Terrestrial Toxicity No studies are available. Revision date: February 2021 4 7 CATEGORISATION AND OTHER CHARACTERISTICS OF CONCERN A. PBT Categorisation The methodology for the Persistent, Bioaccumulative and Toxic (PBT) substances assessment is based on the Australian and EU REACH Criteria methodology (DEWHA, 2009; ECHA, 2008). Sorbitan monooleate polyoxyethylene derivative is readily biodegradable; thus, it does not meet the screening criteria for persistence. Based on the estimated BCF values of 12.6 to 14.6 L/kg, sorbitan monooleate polyoxyethylene derivative does not meet the criteria for bioaccumulation. The chronic toxicity data on sorbitan monooleate polyoxyethylene derivative are >0.1 mg/L WAF. The acute EL50 values for sorbitan monooleate polyoxyethylene derivative are >1 mg/L WAF. Thus, sorbitan monooleate polyoxyethylene derivative does not meet the criteria for toxicity. The overall conclusion is that sorbitan monooleate polyoxyethylene derivative is not a PBT substance. B. Other Characteristics of Concern No other characteristics of concern were identified for sorbitan monooleate polyoxyethylene derivative. Revision date: February 2021 5 8 SCREENING ASSESSMENT Chemical Databases of Persistence Assessment Bioaccumulative Toxicity Assessment Step Concern Assessment Step Step Assessment Step Overall PBT Listed as a Risk Assessment Chemical Name CAS No. Identified as Assessment 1 COC on P criteria Other P T criteria Acute Chronic Actions Required3 Polymer of B criteria fulfilled? relevant fulfilled? Concerns fulfilled? Toxicity 2 Toxicity2 Low Concern databases? Sorbitan monooleate polyoxyethylene derivative
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