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Diss Factsheets
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EC number: 928-226-3 | CAS number: 1179884-99-1
- 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 in vitro / ex vivo
- Type of information:
- not specified
- Adequacy of study:
- supporting study
- Study period:
- 12 May 2015 to 12 January 2016
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted according to well established method, but not a GLP guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
- Objective of study:
- absorption
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The aim of these studies was to develop a sensitive analytical method for the quantification of the registered substance 'Polurea Thickener' capable of supporting In vitro absorption studies across everted gut sac measured as estimation of absorption from the small intestine via the oral route
- GLP compliance:
- no
Test material
- Reference substance name:
- Polyurea Thickener
- IUPAC Name:
- Polyurea Thickener
- Test material form:
- other: Beige solid peices
- Details on test material:
- - Name of test material (as cited in study report): Polyurea Thickener
-Date of receipt: 27th April 2015
- Physical state: Beige solid peices
- Batch number: VPSG011
- Expiration date of the lot/batch: Originally 14 December 2015. Expiry date extended by Sponsor to 28 February 2016
- Storage condition of test material: Room temperature in the dark
Constituent 1
- Radiolabelling:
- no
Administration / exposure
- Details on study design:
- The aim of these studies was to develop a sensitive analytical method for the quantification of the registered substance 'Polyurea thickener' capable of supporting absorption studies. Initially, CXR's intention was to develop an assay for the registered substance in rat plasma. CXR identified an ion at m/z 817 which appeared to be associated with the registered substance. The initial observed limit of detection in rat plasma extracts, monitoring the m/z 817 ion, was 2 μg/mL (2.5 μM) and this was regarded to be unacceptable for toxicokinetic studies as it represents 30 μg compound in blood of an average rat, or 1 % of a 10 mg/kg dose, at one time.
CXR then attempted to develop an assay for the registered substance in Fed State Simulated Intestinal Fluid (FeSSIF) to assess its stability at gastric pH and absorption potential in-vitro using everted gut sacs. The rationale for assessing the in-vitro method was that the external concentration would only be limited by solubility and the assay sensitivity requirement would be less than that for an in-vivo approach.
Subsequently, it was suggested that the m/z 817 entity was an impurity from the manufacture of the registered substance and it was concluded that the registered substance does not dissolve in xylene or any of the other 7 additional solvents tested (acetonitrile, DMSO, hexane, isooctane, diethyl ether, acetone, chloroform). As CXR were unable to identify a solvent suitable for the preparation of calibration and quality control standards for the registered substance in rat plasma and FeSSIF media it was not possible to develop a quantitative analytical method.
The analytical techniques assessed during this work were GC/MS, direct infusion electrospray ionisation (ESI MS, atmospheric pressure chemical ionisation (APCI) MS and matrix-assisted laser desorption/ionization (MALDI)-Tof. The most abundant entity in xylene extracts of the registered susbtance was tentatively identified as an unusual by-product of isocyanate, hence it was concluded that all method development be terminated due to the fact that no quantitative assay could be established for the polyurea thickener itself.
Further information on the study design and conclusiuons can be found in the attached study report.
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- The registered substance appears to be insoluble in all solvents tested. A component of the mixture was detected in xylene solutions but the Sponsor has suggested that this is an impurity from the manufacture of the registered substance.
As no quantitative analytical method could be developed, attempts to assess the absorption of the registered substance in-vivo or in-vitro had to be abandoned for this reason. It was decided not to terminate any rats for the collection of fresh intestine for ethical reasons as no analytical technique was available. The procedure for the everted rat intestinal sac incubations did not proceed due to this fact.
Although it was not possible to proceed with absorption testing due to the difficulties in finding a suitable solvent/quantitative analytical method it is believed that the insolubility of the regsistered substance can be used as evidence to support the lack of bioavailability that this compound would have.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no data
- Executive summary:
The aim of this non-GLP compliant, non-guideline studies was to develop a sensitive analytical method for the quantification of the registered substance capable of supporting absorption studies. Initially, CXR's intention was to develop an assay for the registered substance in rat plasma. However as this proved impossible CXR attempted to develop an assay for the registered substance in Fed State Simulated Intestinal Fluid (FeSSIF) to assess its stability at gastric pH and absorption potential in-vitro using everted gut sacs. The rationale for assessing thein-vitro method was that the external concentration would only be limited by solubility and the assay sensitivity requirement would be less than that for an in-vivo approach.
The studies demonstrated that the registered substance appears to be insoluble in all solvents tested. A component of the mixture was detected in xylene solutions but this was considered by the registrant to be an impurity from the manufacture of the registered substance.
As no quantitative analytical method could be developed, attempts to assess the absorption of BP’s Polyurea Thickener in-vivo or in-vitro had to be abandoned for this reason. It was decided not to terminate any rats for the collection of fresh intestine for ethical reasons as no analytical technique was available. The procedure for the everted rat intestinal sac incubations did not proceed due to this fact.
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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