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EC number: 939-526-9 | CAS number: 90506-73-3
- 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
- Type of information:
- other: Assessment based upon available information.
- Adequacy of study:
- key study
- Study period:
- June 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, the test material is expected to be limited, and the substance has low systemic toxicity.
Reference
The test material, is a multi-constituent substance with five constituents in the molecular weight range of 322 to 602 daltons. Only one of the five constituentsis present at less than 10%.
The substance is a waxy solid at room temperature with a melting point range of 51 to 69 deg.C at 101.3 kPa and a vapor pressure of 0.004 Pa at 25 deg. C. The substance is not expected to be respirable.
The substance is highly insoluble in water,with a measured water solubility of 0.162 mg/L. The partition coefficients (Log Pow) are less than 0.3 to 2.31.
These data indicate that the substance is not bioavailable via the oral route based on Lipinski’s Rule (Oasis structure-activity relationship (SAR) analysis). Additionally, the substance did not result in any systemic effects up to the limit doses tested in oral toxicology studies in rats, including up to 2000 mg/kg in the acute oral toxicity study, and up to1000 mg/kg/day in the14-day repeated dose oral range-finding toxicity study. In the 90-day repeated dose oral toxicity studyandtheprenatal developmental toxicitystudyin rats,systemic toxicity was not established due to the inherent physical properties of the substance. The arachis oil dose formulation of the substance, particularly the 1000 mg/kg/day dose formulation, became a white wax-like substance at room temperature and had to be warmed to approximately 46 deg.C to keep it ina liquid state prior to administration to rats. There is evidence of resolidification in the stomach, which probably impacted normalgastrointestinal (GI)function and led to a decline in physical condition for some rats; thus several mortalities at 1000 mg/kg/daywere considered to result from the intrinsic physical properties of the unabsorbed substance formulation rather than any systemic effect. SAR analysis also shows that the substance may be hydrolyzed releasing fatty alcohol and phosphoric acid. Some alkyl phosphates are used in cosmetics, and a toxicokinetic study of phosphoric acid, 2-ethylhexyl ester in rats has been reported.[1] In the study, a single oral dose of 200 mg/kg phosphoric acid, 2-ethylhexyl ester in corn oil to F344 rats (5/sex) was completely hydrolyzed to phosphate and 2-ethyl-hexanol. The ester was efficiently absorbed, metabolized, and excreted quantitatively by the body, and there was no indication of accumulation.
The physical/chemical properties of the substance also indicate that the substance is not expected to be absorbed via the dermal route. The hydrolytic metabolites of the substance, fatty alcohol, may be absorbed through skin, however.
The ready biodegradability test of the substance showed that it was considered not readily biodegradable. The analysis of the test preparations showed measured test concentrations of less than the limit of quantification (LOQ, 0.062 mg/L) in the acute toxicity test in Daphnia magna. Based on the available information, there is no indication of a bioaccumulation potential.
In conclusion, based upon the available data, bioavailability of the substance, the test material is expected to be limited, and the substance has low systemic toxicity.
[1]CIR, Safety Assemment of Alkyl Phosphates as Used in Cosmetics. Final report, September 29, 2014, Cosmetic Ingredient Review, Washington, DC.
Description of key information
In conclusion, based upon the available data, bioavailability of the substance, the test material is expected to be limited, and the substance has low systemic toxicity.
Key value for chemical safety assessment
Additional information
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.