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EC number: 259-715-3 | CAS number: 55589-62-3
- 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
Specific investigations: other studies
Administrative data
- Endpoint:
- specific investigations: other studies
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1989-Oct-23 through 1989-Nov-20
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Scientifically reliable study with sufficient information for evaluation and assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
- Principles of method if other than guideline:
- The study was performed to investigate the properties of Acesulfame potassium as an artificial sweetener when administered incorporated into the diet to rats with streptozotocin induced diabetic status for 28 days.
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- in vivo
Test material
- Reference substance name:
- 6-methyl-1,2,3-oxathiazine-4(3-H)-one-2,2-dioxide potassium salt
- IUPAC Name:
- 6-methyl-1,2,3-oxathiazine-4(3-H)-one-2,2-dioxide potassium salt
- Reference substance name:
- 6-methyl-1,2,3-oxathiazin-4(3H)-one 2,2-dioxide, potassium salt
- EC Number:
- 259-715-3
- EC Name:
- 6-methyl-1,2,3-oxathiazin-4(3H)-one 2,2-dioxide, potassium salt
- Cas Number:
- 55589-62-3
- Molecular formula:
- C4H5NO4S.K
- IUPAC Name:
- potassium 6-methyl-2,2,4-trioxo-3,4-dihydro-1,2λ⁶,3-oxathiazin-3-ide
- Reference substance name:
- Acesulfame potassium
- IUPAC Name:
- Acesulfame potassium
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): Acesulfam K
- Physical state: white powder
- Lot/batch No.: 89 284/188 1958
- Stability under test conditions: stable
- Storage condition of test material: stored at room temperature in the dark
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: 4 - 5 weeks
- Weight at study initiation: 80 - 120 g
- Fasting period before study: no
- Housing: individual in macrolone cages
- Diet: ad libitum
- Water: ad libitum (tap water):
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES:
From: 1989-Oct-23
To: 1989-Nov-20
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): once for the study period
- Mixing appropriate amounts with (Type of food): standard laboratory chow (Ssniff R 10; Ssniff Spezialdiäten GmbH, Soest, Germany)
- Storage temperature of food: room temperature - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Samples of each test diet preparation (top, middle, and bottom) for groups 2 to 5 were together with a reference sample of the control article and were analyzed for test article concentrations.
- Duration of treatment / exposure:
- 28 day
- Frequency of treatment:
- daily
- Post exposure period:
- none
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Basis:
nominal in diet
0, 1000, 3000, 10000, 30000 ppm
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, plain diet
- Details on study design:
- Wistar rats of both sexes were rendered diabetic by a single i.v. dose of streptozotocin (60 mg/kg bw) 12 days prior to the commencement of the study. Groups of 20 male and 20 female rats were selected from the diabetic animals, only those with blood glucose levels greater than 300 mg% being
used
Examinations
- Examinations:
- Morbidity/mortality: All animals were examined twice daily at the beginning and end of the workingday for morbidity and mortality.
Clinical signs: All animals were examined at least once daily for signs of ill health or overt signs of toxicity and each finding was recorded.
Body weight: Body weight of male and female animals was recorded once weekly during the treatment period.
Food consumption: Food consumption of males and females was recorded three times weekly during the treatment period.
Clinical chemistry: glucose, triglycerides - Positive control:
- None
Results and discussion
- Details on results:
- Mortality:
No animal died during the course of the study
Clinical findings:
Major clinical findings observed in all animals of either sex followingsingle streptozotocin treatment were excessive water consumption and polyuria which is considered to be due to the induced diabetic status. There were no clinical changes directly attributable to dietary administration of Acesulfam K.
Body weight:
Body weights/body weight gain were not affected by treatment
Food consumption:
Group mean food consumption was statistically significantly slightly reduced in group 5 males on days 5 to 8 and group 4 and 5 femaleson days 1 to 3.
Clinical chemistry:
Blood chemistry parameters examined once predose revealed extremely increased glucose and markedly increased triglyceride levels in all animals of all groups and of either sex due to the single intravenous streptozotocin administration to all animals. Examination of cholesterol, triglycerides, and lipoproteins did not reveal any pathologically relevant change of the serum lipoprotein constellation.
Applicant's summary and conclusion
- Conclusions:
- Acesulfame potassium was well tolerated when administered for 28 days at dietary concentrations of 1000, 3000, 10000,and 30000 ppm to male and female Sprague-Dawley rats with streptozotocin induced diabetic status.
- Executive summary:
Administration of Acesulfame potassium mixed to the basic powdered diet at1000, 3000, 10000 and 30000 ppm did not elicit any toxic effects on male and female animals throughout the four week study period.
Minimal statistically significant reductions in food consumption seen on single occasions are considered to be of minor nature and may be rather associated with the induced diabetic status and its concomitant variability of individual data than directly related to Acesulfame potassium as an artificial sweetener.
Clinical findings such as excessive water consumption and polyuria observed in all animals of either sex throughout the study were considered to be related to the streptozotocin induced diabetic status.
Extremely increased blood sugar and markedly increased triglyceride levels seen in all animals of either sex at the predose examination were in accordance with the expected and required precondition of a diabetic status at the start of treatment with Acesulfame potassium.
Conclusion:
Acesulfame potassium was well tolerated when administered for 28 days mixed to the basic powdered diet at concentrations of 1000, 3000, 10000 and 30000 ppm.
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