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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987-Jan-13 through 1987-Feb-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Minitry of Health and Welfare (MHW)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- no
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): Acesulfame K
- Physical state: white crytsal
- Analytical purity: 99.4%
- Lot/batch No.: CM0879585
- Stability under test conditions: stable
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Shizuoka Agricultural Cooperative Association for Laboratory Animals (Hamamatsu City, Shizuoka Pre., Japan )
- Age at study initiation: 4 weeks
- Weight at study initiation: males: 96 - 110 g, females: 84 - 96 g
- Fasting period before study: 16 h
- Housing: 5 per cage
- Diet: ad libitu4m (commercial laboratory chew (CE-2, CLEA Japan, Inc.)
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21° C - 25°C
- Humidity (%): 45% - 65%
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES:
From: 1987-Feb-10
To: 1987-Feb-24
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Justification for choice of vehicle: solubility
MAXIMUM DOSE VOLUME APPLIED:
4 mL/kg bw - Doses:
- 4167, 5000, 6000, 7200, 8640, 10368 mg/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs and deaths: daily; body weight: days -1, 3, 7, 10, 14
- Necropsy of survivors performed: yes - Statistics:
- Student's t-test or Welch's t-test.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 5 438 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 4 839 - <= 5 994
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 5 565 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 5 083 - <= 6 071
- Mortality:
- Dead animals were observed from 20 min. to 24 hr. after administration in both sexes.
0 mg/kg bw: males: 0/10; females: 0/10
4167 mg/kg bw: males: 0/10; females: 0/10
5000 mg/kg bw: males: 4/10; females: 4/10
6000 mg/kg bw: males: 8/10; females: 6/10
7200 mg/kg bw: males: 9/10; females: 9/10
8640 mg/kg bw: males: 9710; females: 10/10
10368 mg/kg bw: males: 10/10; females: 10/10 - Clinical signs:
- other: Dose dependent effects consisted of a decrease in spontaneous movement, crawling, convulsions, diarrhea. All surviving animals recovered within 2 days after administration.
- Gross pathology:
- Macroscopic findings in dead rats of both sexes included hemorrhage in the gastric mucosa and hyperemia in the small intestine and caecum in many cases and sporadic congestion in the lung and sporadic petechial hemorrhage in the thymus. The autopsy of survivors exhibited no macroscopic abnormalities in any organs.
- Other findings:
- Not applicable
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The oral LD50 values and 95% confidence limits were 5438 (4839-5994) mg/kg bw for males and 5565 (5083-6071) mg/kg bw for females.
- Executive summary:
The oral acute toxicity of Acesulfame potassium was examined in rats (10 males and10 females/group).The oral LD50 values and 95% confidence limits were 5438 (4839 -5994) mg/kg bw for males and 5565 (5083 -6071) mg/kg bw for females. Major symptoms observed were a decrease in spontaneous movement, crawling, convulsions and diarrhea. The suppression of body weight gains was trendently observed at 4167 and 5000 mg/kg bw males, and at 5000 mg/kg bw females. There was no difference in body weight between the treated groups and control group at the end of observation period. The autopsy of dead animals revealed hemorrhage in the gastric mucosa, hyperemia in the small intestine and cecum, congestion in the lung, and petechial hemorrhage in the thymus. The autopsy of surviving animals exhibited no macroscopic abnormalities in any organs in either sex.
Acesulfame K was non-toxic after acute oral administration.
The study result triggers the following classification/labelling:
EU Directive 1999/45/EC (as amended): none
Regulation (EC) No 1272/2008 (CLP): none
GHS (rev. 4) 2011: unclassified
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