Registration Dossier
Registration Dossier
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EC number: 947-738-8 | 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

Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- not specified
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Justification for type of information:
- The assessment is based on the REACH Annex VIII provisions and ECHA's Guidance on information requirements and chemical safety assessment R.7c: Endpoint specific guidance (ECHA, June 2017).
Data source
Reference
- Reference Type:
- other: expert statement
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Expert statement according to REACH Annex VIII (section 8.8.1) provision: assessment of the toxicokinetic behaviour of the substance to the extent that can be derived from the relevant available information
- GLP compliance:
- no
- Remarks:
- this is an expert statement, however based on data generated under GLP
Test material
- Reference substance name:
- Phosphoric acid, mixed esters with alcohols, C7-9-iso-, C8-rich and alcohols, C11-14-iso-, C13-rich, ethoxylated, potassium salt
- EC Number:
- 947-738-8
- Molecular formula:
- Molecular formulas of exemplary components: C33H68KO10P C49H100KO16P C24H49K2O10P C24H50KO10P C16H34KO4P C8H17K2O4P C8H18KO4P
- IUPAC Name:
- Phosphoric acid, mixed esters with alcohols, C7-9-iso-, C8-rich and alcohols, C11-14-iso-, C13-rich, ethoxylated, potassium salt
- Test material form:
- liquid
Constituent 1
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- The substance is a mixture of mono and di-potassium salts of various phosphate esters of alcohols C7-9-iso, C8-rich and C11-14-iso, C13-rich, ethoxylated. Molecular weights of particular components are within a range from approx. 248 to approx. 1020 Da. Molecules with a molecular weight below 500 Da (approx. 50% of the substance) are generally well absorbed, while molecular weights above 500 Da do not favor absorption (relatively large particle).
As the most favorable values of partition coefficient for absorption are between -1 and 4, and many of the components of this UVCB substance have log Kow (estimated) within this range (some are more hydrophilic with log Kow of approx. -2), oral and dermal adsorption can be anticipated and the substance may dissolve in GI fluids, as well as in blood. Additionally, surfactant properties of the substance causing skin corrosion may increase likelihood of dermal penetration.
Vapour pressure of the substance and all its components is very low, therefore inhalation route would not be of first concern for absorption of the actual substance. - Details on distribution in tissues:
- Adverse effects were found in liver and kidneys of animals orally dosed 750 mg/kg b.w. (HD), which is insufficient however for classification. It may be anticipated the substance is being distributed systematically. The highest estimated value of BCF among all constituents amounts to 2.75 log L/kg(wet). This means there is a low risk of accumulation in fat.
- Details on excretion:
- Due to the substance constituents various molecular weights (small and large molecules) and partition coefficient values (more or less hydrophilic) it can be anticipated both urinary route (small molecules, hydrophilic) and excretion via bile (large molecules, hydrophobic) will play a role. Portion of the substance not being absorbed will be excreted with feces.
Metabolite characterisation studies
- Metabolites identified:
- no
- Details on metabolites:
- No significant changes in genotoxicity studies were found after addition of S9 fraction.
Applicant's summary and conclusion
- Conclusions:
- Properties of the substance indicate a possibility of absorption through oral and dermal route in particular. Inhalation route is of lower concern. The substance will be probably excreted with urine, bile and feces. Adverse effects were observed in liver and kidneys of HD animals in the OECD 422 study (750 mg/kg b.w.). This does not allow for substance classification though.
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