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EC number: 500-155-9 | CAS number: 62362-49-6 1 - 2.5 moles ethoxylated
- 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
Endpoint summary
Administrative data
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics, other
- Type of information:
- other: Assessment based upon available information.
- Adequacy of study:
- key study
- Study period:
- May 2019
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Information selected for the toxicokinetic assessment is primarily study data. Studies were conducted inaccordance with recognised testing guidelines.
- Conclusions:
- In conclusion, based upon the available data, bioavailability of the substance,Octadecan-1-ol, ethoxylated, phosphates,is expected to be limited and the substance has low systemic toxicity.
Reference
The substance, Octadecan-1-ol, ethoxylated, phosphates, is a complex combination of mono- and di-phosphate esters of ethoxylated octadecanol, phosphate esters of non-ethoxylated octadecanol, non-esterified ethoxylated octadecanol, and unreacted octadecanol. No more than 10% of other fatty alcohols are present. The physical state of the substanceis white solid pastilles with melting point approximately 33 to 58 deg.C and is not expected to be respirable.
The substance is practically insoluble with a measured water solubility of ≤14.5 mg/L. This substance is an Unknown or Variable composition, Complex reaction products or Biological materials (UVCB) with multiple constituents comprised of fairly soluble components, insoluble components, and extremely insoluble components. The partition coefficients (Log Pow) are in the range 2.7 to >6.5, at pH 5.0 using HPLC as described by guideline OECD 117. Using area normalization, 96% of the substance showed a Log Pow of >6.5 at pH 5.0.
These data indicate that the substance is practically insoluble in water and is highly lipophilic, and thus the substance is not bioavailable via the oral route based on Lipinski Rule Oasis of the structure-activity relationship (SAR) analysis. Additionally, the substance did not result in any systemic effects up to the limit doses tested in the oral toxicology studies in rats, including up to 2000 mg/kg in the acute oral toxicity study and up to1000 mg/kg/day in the10-day repeated dose oral range-finding toxicity study and the combined repeated dose oral toxicity study with the reproductive/developmental toxicity screening test. SAR analysis also shows that the substance may be hydrolyzed releasing fatty alcohol ethoxylates and phosphoric acid under basic or neutral condition. The hydrolytic metabolites of the substance, fatty alcohol ethoxylates, might be absorbed through gastrointestinal (GI) tract, however. Alcohol ethoxylates are non-ionic surfactants that are widely used in cosmetics and household laundry and cleaning detergents. A toxicokinetic study of 14C-labeled C12AE3, C12AE6 and C12AE10 in rats was reported.* In the study, the three alcohol ethoxylates were absorbed from the GI tract and the14C activity was recovered primarily in the urine, but also in the feces and expired air. No parent compounds were detected in the urine. The main materialism of alcohol ethoxylates was a function of chain Length and appeared to be the degradation of the ether linkage and oxidation of the alkyl chain to form ethoxylates of varying length and ultimately CO2 and water.
The extremely low water solubility and very high lipophilicity of the substance also indicate that the substance is not expected to be absorbed via the dermal route, either. The hydrolytic metabolites of the substance, fatty alcohol ethoxylates, may be absorbed through skin, however. In dermal metabolism studies with hairless mice treated with 0.25% laureths in ethanol, the percutaneous absorption decreased with increasing number of ethylene oxide units. Absorbed laureths were rapidly metabolized to CO2and excreted with expired air. With increasing number of ethylene oxide units, the percentage in expired air was decreased, and the amount excreted in feces and urine increased.+
The ready biodegradability test of the substance showed that it was not considered readily biodegradable. The measured test concentrations of the substance in aquatic medium were very low (≤0.67 mg/L) in the acute toxicity test in algae. The substance is therefore expected to have low potential for bioaccumulation in aquatic organisms although the substance is persistent and its Log Pow exceeds 5.
In conclusion, based upon the available data, bioavailability of the substance,Octadecan-1-ol, ethoxylated, phosphates,is expected to be limited and the substance has low systemic toxicity.
* HERA, alcohol ethoxylates, 2009, available at https://www.heraproject.com/files/34-F-09%20HERA%20AE%20Report%20Version%202%20-%203%20Sept%2009.pdf
+ CIR, Safety Assemment of Alkyl PEG Ether as Used in Cosmetics. IJT 31(Suppl. 2):169-244, 2012
Description of key information
The toxicokinetic assessment is based upon the available data on the test item contained within this dossier. Data is taken from reliable sources, all rated as a 2 or higher for reliability and relevance according to the Klimisch scale as identified in Klimisch et al, 1997 scale. The toxicokinetic assessment is therefore considered reliable, based upon the information available.
Key value for chemical safety assessment
Additional information
Based upon the available data, bioavailability of the substance,Octadecan-1-ol, ethoxylated, phosphates,is expected to be limited and the substance has low systemic toxicity.
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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