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EC number: 241-300-3 | CAS number: 17265-14-4
- 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 in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Tracer Study of Metabolism and Tissue Distribution of Sebacic Acid in Rats
- Author:
- Tataranni, P.A.
- Year:
- 1 992
- Bibliographic source:
- Annals of Nutrition and Metabolism
Materials and methods
- Objective of study:
- distribution
- excretion
- metabolism
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 417 (Toxicokinetics)
- Version / remarks:
- 22.06.2010
- Deviations:
- yes
- Remarks:
- According to i.v. application, no data on bioavailability; no data on enzyme induction/inhibition
- Principles of method if other than guideline:
- - Principle of test: Three groups of rats were treated with 14C-labeled test substance i.v.
- Short description of test conditions:
Group A: plasma elimination was examined for two doses (80 and 160 mg)
Group B: expired labeled CO2, urine tracer and faeces tracer were determined
Group C: autopsy and organ distribution of labeled test substance
- Parameters analysed / observed: plasma elimination, elimination routes and substance related pathological findings and organ distribution - GLP compliance:
- not specified
Test material
- Reference substance name:
- Disodium sebacate
- EC Number:
- 241-300-3
- EC Name:
- Disodium sebacate
- Cas Number:
- 17265-14-4
- Molecular formula:
- C10H18O4.2Na
- IUPAC Name:
- disodium sebacate
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No. of test material:
14C-labeled sebacic acid tracer (specific activity 102 mCi/mmol) was purchased from Amersham (Buckinghamshire, UK).
Sebacic and azelaic acids were obtained from Sigma (St. Louis, Mo., USA).
RADIOLABELLING INFORMATION
- Specific activity: 14C-labeled sebacic acid tracer (specific activity 102 mCi/mmol) - Radiolabelling:
- yes
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 220 - 250 g
- Diet: ad libitum, standard pellet diet containing 20% protein, 4% fat and 50% carbohydrate
- Water: ad libitum
Administration / exposure
- Route of administration:
- intravenous
- Vehicle:
- unchanged (no vehicle)
- Duration and frequency of treatment / exposure:
- Single dose i.v. application of the test substance
Doses / concentrationsopen allclose all
- Dose / conc.:
- 80 other: mg i.v.
- Remarks:
- enriched with 25 µCi tracer; Group A
- Dose / conc.:
- 160 other: mg i.v.
- Remarks:
- enriched with 25 µCi tracer, Group A, B and C
- No. of animals per sex per dose / concentration:
- 14 male animals per dose in group A
4 male rats in group B
10 male rats in group C - Details on dosing and sampling:
- TOXICOKINETIC / PHARMACOKINETIC STUDY
- Tissues and body fluids sampled: blood, urine, feces, expired air, liver, kidney, heart, lung, muscle, fat.
- Time and frequency of sampling:
Blood samples (Group A): 5, 10, 20, 40, 80, 160 and 320 min after injection
CO2 sampling (Group B): 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 300, 360, 420, 480, 540 and 1440 min post dose
Urine sample (Group B): 0-4 h and 4 -24 h post dose
Faeces sample (Group B): 24 h post dose
Tissue sampling (Group C): sacrifice of the animals at 30, 60, 120, 240 and 360 min postdose. At each time and from each sacrificed animal the following tissue samples were collectcd for radioactivity measurement: liver, kidney, heart, lung, muscle, fat.
Results and discussion
Main ADME resultsopen allclose all
- Type:
- excretion
- Results:
- After 24 h, 58.01 ±3.57 % of the injected radiocarbon dose was recovered in urine, 25 ±0.01 % in expired air.
- Type:
- metabolism
- Results:
- The amount of recovered sebacate retrieved from the 24 h urine collection was 34.6 ±1.97 %
Toxicokinetic / pharmacokinetic studies
- Details on distribution in tissues:
- Tracer half-life:
heart: 16 min
muscle: 32 min
kidney: 42 min
lung: 48 min
liver: 72 min
fat: 135 min
- Details on excretion:
- 24 h feces samples did not show any beta-emission activity.
Toxicokinetic parametersopen allclose all
- Toxicokinetic parameters:
- half-life 1st: global plasma half-life: 38.71 min
- Toxicokinetic parameters:
- other: Volume of distribution (Vd): 62.65 mL/100 g body weight
Any other information on results incl. tables
The authors could demonstrate that sebacic acid can be oxidized by tissues and that it is only partially eliminated in the urine. It seems reasonable to suppose that linear kinetics describe the elimination of Sb from plasma in the tested dose range. In their study the authors found a large apparent volume of distribution (62.65 ml/ l 00 g body weight), suggesting wide diffusion or, more likely, tissue binding of Sb. The global plasma elimination rate (half-life 38.71 min) reflects the contribution of both sebacate uptake and metabolism by tissues and of sebacate elimination by the kidney. The appearance of a 14CO2 peak value in expired air few minutes after intravenous injection of labeled Sb indicates that this compound is readily used as an energy substrate. The authors retrieved 25% of administered tracer in expired CO2 but the total recovered tracer was only about 85% ofthat administered, and it seems likely that thc oxidation is somewhat underestimated at 25 %. Moreover, part of the metabolites produced with the breakdown of sebacate for energy purposes can be excreted with urine, Iike 14CO2-containing bicarbonates or succinate. While 60% of the total administered radioactivity was recovered from urine, only 35% of administered scbacate was recovered unchanged from urine. From all the above considerations, it seems likely that about 30-50 % of administered sebacate may be used by tissues for energy purposes. No appreciable accumulation of radioactivity is present in the body: after 24 h practically all of the administered tracer has disappeared from the sampled organs, fat included, although fat has the longest elimination time. A rough comparison between tissue elimination times seems to indicate that a delay in tracer elimination occurs also at the liver level. This suggests that fat and liver are possible preferential sites of Sb metabolism. On the other hand, heart, kidney, lung and skeletal muscle seem to have a faster sebacate elimination,
consistent with the hypothcsis of a simple dilution of the molecule in these areas, or of its use there eminently for energy production.
Applicant's summary and conclusion
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