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EC number: 201-321-0 | CAS number: 81-07-2
- 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- publication
- Title:
- Dietary saccharin kinetics
- Author:
- Wayne A Colburn PhD, Ihor Bekersky PhD and H Peter Blumenthal MD Nutley, N.J
- Year:
- 1 981
- Bibliographic source:
- Clinical Pharmacology and Therapeutics (1981) 30, 558–563; doi:10.1038/clpt.1981.203
Materials and methods
- Objective of study:
- absorption
- distribution
- excretion
- metabolism
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- Data is from Clinical Pharmacology and Therapeutics journal
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Saccharin
- IUPAC Name:
- Saccharin
- Reference substance name:
- 1,2-benzisothiazol-3(2H)-one 1,1-dioxide
- EC Number:
- 201-321-0
- EC Name:
- 1,2-benzisothiazol-3(2H)-one 1,1-dioxide
- Cas Number:
- 81-07-2
- Molecular formula:
- C7H5NO3S
- IUPAC Name:
- 1,2-benzisothiazol-3(2H)-one 1,1-dioxide
- Details on test material:
- - Name of test material (as cited in study report): 1,2-benzisothiazol-3(2H)-one 1,1-dioxide
- Substance type: Organic
- Physical state: solid
Constituent 1
Constituent 2
- Radiolabelling:
- no
Test animals
- Species:
- human
- Strain:
- not specified
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on exposure:
- Six adult female subjects who use saccharin-containing products in their diet were asked to take divided equal doses of saccharin every 6 hr to maintain their average daily intake for 3 days.
At the end of this period, each subject took a single dose that was equal to one divided dose.
Saccharin concentrations in plasma and urine samples were used to assess the kinetic profile. - Duration and frequency of treatment / exposure:
- Average daily intake ranged from 100 to 300 mg/
day. Daily dose was divided by four to establish the 6-hr dose size
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100 to 300 mg/ day (average)
- No. of animals per sex per dose / concentration:
- Six women
- Control animals:
- not specified
Results and discussion
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- Saccharin is absorbed rapidly and completely by the subjects who take it daily with maximum concentrations in plasma in 0.5 to 1.0 hr. Maximum plasma concentrations and areas under the plasma concentration-time curves were proportional to the dose.
- Type:
- distribution
- Results:
- Saccharin is distributed into tissues as a function of lean rather than total body mass. The volume of distribution (Vβ) is large, indicating extensive distribution of saccharin outside of the vascular space though it shows little , no affinity for fat.
- Type:
- metabolism
- Results:
- No details on metabolism provided but there are reports that suggest no metabiolites of saccarin as being detected in humans as well as animals administered saccharin
- Type:
- excretion
- Results:
- Subjects who take saccharin daily eliminate it with mean half life of elimination of 7.5 hr (range 5.5 to 9.0 hr). Renal clearance (clearance via urine) exceeded glomerular (clearance via faeces) filtration rate in all cases
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Saccharin is absorbed rapidly and completely by the subjects who take it daily with maximum concentrations in plasma in 0.5 to 1.0 hr.
Maximum plasma concentrations and areas under the plasma concentration-time curves were proportional to the dose - Details on distribution in tissues:
- Saccharin is distributed into tissues as a function of lean rather than total body mass. The volume of distribution (Vβ) is large, indicating extensive distribution of saccharin outside
of the vascular space even though it shows little or no affinity for fat.
These observations are
consistent with the presence of one or more high-retention compartments within the body
(which has been reported in studies in animals)
- Details on excretion:
- Subjects who take saccharin daily eliminate it with mean half life of elimination of 7.5 hr (range 5.5 to 9.0 hr).
Renal clearance (clearance via urine) exceeded glomerular (clearance via faeces) filtration rate in all cases
Metabolite characterisation studies
- Metabolites identified:
- no
- Details on metabolites:
- No metabolites detected
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): low bioaccumulation potential based on study results
From the above information on absorption, distribution, metabolism and excretion of saccharin; the bio-accumulation potential appears to be low. - Executive summary:
Six adult female subjects who use saccharin-containing products in their diet were asked to take divided equal doses of saccharin every 6 hr to maintain their average daily intake for 3 days.Saccharin concentrations in plasma and urine samples were used to assess the kinetic profile.
Saccharin absorption was rapid with maximum concentrations in plasma in 0.5 to 1.0 hr.
Maximum plasma concentrations and areas under the plasma concentration-time curves were proportional to dose. Renal clearance exceeded glomerular filtration rate in all cases.
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