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EC number: 253-455-4 | CAS number: 37310-83-1
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- other: expert statement
- Adequacy of study:
- key study
- Study period:
- 2013-05-06
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- other: expert statement
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Expert statement according to ECHA Guidance 2008, chapter R.7c
Test material
- Reference substance name:
- 9-Octadecen-1-ol, (Z)-, phosphate
- EC Number:
- 253-455-4
- EC Name:
- 9-Octadecen-1-ol, (Z)-, phosphate
- Cas Number:
- 37310-83-1
- Molecular formula:
- C18H37O4P
- IUPAC Name:
- [(9Z)-octadec-9-en-1-yloxy]phosphonic acid
Constituent 1
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- ORAL ABSORPTION
The reaction product of oleyl alcohol is poorly water soluble independent of the pH and will not readily dissolve into the gastrointestinal fluids. Suitably in addition the log Pow of the main compound oleyl phosphate is above 4. Therefore, even if the molecular weight of the main compound is below 500 g/mol and the phosphate group is ionisable the oral absorption is not favoured.
With regard to toxicological data, a study in rats revealed an LD50 value above 2000 mg/kg bw (limit dose). In a 14 day dose range finder study and the related subacute 28 day study no signs of systemic toxicity were observed up to the highest test concentration of 1000 mg/kg bw/day.
Taken together, due to its physico-chemical properties, primarily the low water solubility, and the absence of systemic toxicity in acute and subacute studies the oral absorption is expected to be negligible.
DERMAL ABSORPTION
The physico-chemical properties of the reaction product of oleyl alcohol with polyphosphoric acid do not favour dermal absorption. The low water solubility of the test item below 1 mg/L makes dermal uptake unlikely since the substance must be sufficiently soluble in water to partition from the stratum corneum into the epidermis. The surface tension as a parameter for dermal absorption was not determined because of the low water solubility. Molecular weights less than 100 g/mol favour the dermal uptake; the molecular weight of the main compound oleyl phosphate is 348.47 g/mol. In addition, the log Pow of the main compound is above 4. Therefore, transfer between the stratum corneum and the epidermis is limited.
Consequently, an acute systemic dermal toxicity test with the reaction product of oleyl alcohol with polyphosphoric acid in rats did not reveal that toxicological relevant amounts were absorbed into the systemic circulation. Here, no systemic effects were observed and the LD50 was determined to be greater than 2000 mg/kg bw (limit dose).
Taken together, based on its physico-chemical properties and absence of toxicity in an acute dermal toxicity study very limited absorption into the systemic circulation is expected after dermal application.
RESPIRATORY ABSORPTION
Considering the very low vapour pressure, the resulting low volatility of the high viscous liquid it is unlike that the substance will be inhaled either in vapour form or as dust particles under use conditions. - Details on distribution in tissues:
- Since the absorption is expected to be very low the assessment of the distribution of the poorly water soluble reaction product of oleyl alcohol with polyphosphoric acid is not considered to be relevant. According to this no signs of systemic toxicity and no target organs were observed in acute and subacute toxicity studies in rats.
- Details on excretion:
- The absorption is expected to be very low, thus, the reaction product of oleyl alcohol with polyphosphoric acid will be likely be excreted on the faecal route after oral exposure.
Metabolite characterisation studies
- Details on metabolites:
- Due to the very low absorption the assessment of the metabolism and the accumulation potential of the poorly water soluble reaction product of oleyl alcohol with polyphosphoric acid is not considered to be relevant. According to this no signs of systemic toxicity and no target organs were observed in acute and subacute toxicity studies in rats. If low amounts will be systemically available metabolism pathways which mediates the chain degradation of the fatty acid by esterases and β-oxidation are likely.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
In accordance with the Guidance on Information Requirements and Chemical Saftey Assessment, chapter R.7c (ECHA, 2008) the profile on basic toxicokinetics of the reaction product of oleyl alcohol with polyphosphoric acid was derived from its physico-chemical data and toxicological data.
Due to its physico-chemical properties, primarily the low water solubility, and the absence of systemic toxicity in acute and subacute studies the oral absorption is expected to be negligible.
Based on its physico-chemical properties and absence of toxicity in an acute dermal toxicity study very limited absorption into the systemic circulation is expected after dermal application.
Considering the very low vapour pressure, the resulting low volatility of the high viscous liquid it is unlike that the substance will be inhaled either in vapour form or as dust particles under use conditions.
Since the absorption is expected to be very low the assessment of distribution, metabolism, accumulating potential and excretion of the poorly water soluble reaction product of oleyl alcohol with polyphosphoric acid is not considered to be relevant. According to this no signs of systemic toxicity and no target organs were observed in acute and subacute toxicity studies in rats.
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