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Diss Factsheets
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EC number: 204-886-1 | CAS number: 128-44-9
- 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:
- 4 (not assignable)
Data source
Reference
- Reference Type:
- publication
- Title:
- The pharmncokinetics of saccharin in man
- Author:
- Sweatman, T. W.. Renwick. A. G. & Burgess. C. D.
- Year:
- 1 981
- Bibliographic source:
- Xemlhiotico 11, 531.
Materials and methods
- Objective of study:
- toxicokinetics
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- Three adult males were given IO mg sodium saccharin dihydrate/kg body weight intravenously and, 3 wk later. the same dose during a course of probenecid taken in 500.mg doses I2 and 2 hr before and 2 hr after the intravenous dose. Blood and urine samples were collected at intervals t”or up to 4Shr lollowing the saccharin doses. The same subjects were also given an oral dose (Ig) or saccharin. both after an overnight last and, 2 wk later. following a standardized
brcaklast. Blood and urine samples were taken at intervals [or up to 96 hr and faeces were collected [or 96 hr lollowing the saccharin doses. - GLP compliance:
- not specified
Test material
- Reference substance name:
- 1,2-benzisothiazol-3(2H)-one 1,1-dioxide, sodium salt
- EC Number:
- 204-886-1
- EC Name:
- 1,2-benzisothiazol-3(2H)-one 1,1-dioxide, sodium salt
- Cas Number:
- 128-44-9
- Molecular formula:
- C7H5NO3S.Na
- IUPAC Name:
- sodium 1,1,3-trioxo-2,3-dihydro-1H-1λ⁶,2-benzothiazol-2-ide
- Details on test material:
- - Name of test material (as cited in study report): 1,2-benzisothiazol-3(2H)-one 1,1-dioxide, sodium salt
- Substance type: organic
- Physical state: solid
Constituent 1
- Radiolabelling:
- not specified
Test animals
- Species:
- human
- Strain:
- not specified
- Sex:
- male
Administration / exposure
- Route of administration:
- other: Oral and intravenous
- Vehicle:
- other: Probenecid
- Duration and frequency of treatment / exposure:
- Duration - 2 weeks
- No. of animals per sex per dose / concentration:
- 3 Adult Males
Results and discussion
- Preliminary studies:
- The plasma-saccharin levels decreased rapidly after intravenous dosina. with a half-life of about 70 min. and recovery of the dose in the urine was complete within 48 hr.
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Studies on the fate in humans of orally administered saccharin have shown almost complete absorption followed by the rapid excretion or the unchanged compound in the urine . The authors interpreted the curve following oral administration as an increase to peak determined by absorption from the stomach and upper intestine, an initially rapid decline in plasma levels resulting from either declining absorption rates or from elimination and a variable late. slow decline determined by absorption from the lower gut. The authors compare the results of this study with those of the previous investigation in rats and concluded that the absorption of orally administered saccharin in similar in both the species and the sweetner is rapidly eliminated from the blood larger by kindeys via renal tubular secretion.
- Details on excretion:
- Sodium Saccharin sweetener is rapidly eliminated by the blood largely by the kidneys via renal tubular secretion.
Approximately 90% of the oral dose was recovered in the urine and up to 8%, was present in lhe faeces within 96hr irrespective of whether or not breakfast had been taken belore dosing and it was calculated that about 85% of the dose was absorbed.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
- Executive summary:
It is concluded therefore that there is little possibility of saturation of the renal clearance route of excretion at ‘normal’ esposure levels since the doses given in the present study were at least 20 times those estimated as the average daily intake.
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