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EC number: 700-308-1 | CAS number: 1335203-19-4
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable well-documented study report that followed sound scientific principles.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Reference Type:
- publication
- Title:
- Opinion of the SCF on hydrogenated poly-1-decene.
- Author:
- Scientific Committe on Food (SCF)
- Year:
- 2 001
- Bibliographic source:
- Document SCF/ADD/MsAd/199 Final (July 12, 2001). http://ec.europa.eu/food/fs/sc/scf/out95_en.pdf
Materials and methods
- Objective of study:
- absorption
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 417 (Toxicokinetics)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Dec-1-ene, homopolymer, hydrogenated Dec-1-ene, oligomers, hydrogenated
- EC Number:
- 500-183-1
- EC Name:
- Dec-1-ene, homopolymer, hydrogenated Dec-1-ene, oligomers, hydrogenated
- Cas Number:
- 68037-01-4
- IUPAC Name:
- 68037-01-4
- Details on test material:
- Name of test material as cited in the report: Nexbase 2006 FG
Substance type: 1-decene homopolymer, hydrogenated
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- compound administered undiluted
- Duration and frequency of treatment / exposure:
- single dose or 15 daily doses
Doses / concentrations
- Remarks:
- Doses / Concentrations:
30, 2010, or 1500 mg/animal
- No. of animals per sex per dose / concentration:
- 3 rats per sex per dose per time point
- Control animals:
- no
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- very little of the dose was absorbed in any of the studies
- Details on distribution in tissues:
- What little was absorbed was found in the liver, fat, lymph nodes, kidney spleen
- Details on excretion:
- The majority of the test compound was excreted into the faeces without being absorbed (>92%). Urinary excretion was low (<1%). Very little of the dose was recovered in the bile (0.01%).
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
Very little of orally administered Nexbase 2006 FG was absorbed after either a single or multiple dose. The majority of the administered dose was recovered in the feces (70.03%) adn GI tract (24.7%) at sacrifice (48h post dosing). Very little of the dose (mean 0.01%) was recovered in the bile - Executive summary:
This study report describes the experimental procedures and results of 4 studies designed to assess the toxicokinetic profile of3H-Nexbase 2006 FG in male rats. In each study, three rats were used per dose for each time point and endpoint measured.
The test compound was prepared by catalytic reduction, using a mixture of tritium and hydrogen, of a mixture of poly-1-decenes identical to that used in the manufacture of regular hydrogenated poly-1-decene. The radiochemical purity of 3H labelled hydrogenated poly-1 - decene used in the studies was >97%. Rats were given single oral doses (30, 120 or 1500
mg/rat) or an intravenous dose (30 mg/rat) of radiolabelled test compound to investigate absorption, toxicokinetics, tissue distribution and excretion. Other rats were given repeated daily oral doses of unlabelled compound (210 mg/rat) over 14 days followed by a single oral dose of labelled compound on day 15 to investigate the influence of repeated dosing. A fourth
group of rats with cannulated bile ducts were given a single oral dose of radiolabelled compound (210 mg/rat) to investigate biliary, urinary and faecal excretion.
Very low 3H concentrations were found in plasma after oral or intravenous dosing. The data were fitted to a kinetic model which gave a long half-life consistent with 3H2O in the body water of rats. As expected from tritium exchange, 3H2O accounted for most of plasma radioactivity, especially at 24 hours or more after dosing. At plasma Cmax values for oral dosing, tritium exchange represented about 0.1-0.5% of the dose. Non-volatile radioactivity (3H-hydrogenated poly-1-decene or its metabolites) accounted for only 14-31% of plasma radioactivity. At tissue Tmax values, most of the radioactivity within the carcass was associated with the gastrointestinal tract. The proportion of the dose in, or estimated to be in, fat, kidneys, lymph nodes and spleen was <0.1% of the dose. Only the liver (at 8 and 24 hrs after the 30 mg dose) contained >0.1% dose, with the proportion decreasing with increasing dose level, as expected for a poorly-absorbed compound. The amounts of radioactivity excreted in the urine (mean 0.16% of dose) and bile (mean 0.01% of dose) were very small. Faeces were the major route of elimination after oral dosing and represented an average of 102.0%, 94.9% and 91.7% of the dose at 30, 210 and 1,500 mg/rat respectively. Absorption of the dose can be estimated by summation of radioactivity present in urine, cage wash and
residual carcass (excluding the gastrointestinal tract): the averages were 0.31%, 0.07% and 0.95% for doses of 30, 210 and 1,500 mg/rat respectively. These estimates are <1% in total and represent a value lower than the level of impurities (<3%).
This study received a Klimisch score of 2 and is classified as reliable because it generally followed OECD guideline 417 and was GLP compliant.
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