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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988-Sep-13 through 1988-Sep-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
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): Sunett
- Physical state: colorless crystalline powder
- Analytical purity: >99%
- Purity test date: 03.09.1987
- Lot/batch No.: CM.-No. 2323957
- Stability under test conditions: stable
- Storage condition of test material: darkness at approx. 22 °C in a fume cupboard
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund, Germany, conventional breed
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 1700 - 2200 mg/kg bw
- Housing: fully air-conditioned rooms, individual cages
- Diet: ad libitum (Altromin 2123 maintenance diet - rabbits, Altromin GmbH, Lippe, Germany)
- Water: ad libitum (tap water)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES:
From: 13-09-1988
To: 16-09-1988
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- physiological saline
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 500 mg moistened with physiological saline
VEHICLE
- Amount(s) applied: 0.1 ml - Duration of treatment / exposure:
- 4 h
- Observation period:
- 3 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: cmcellulose patch an a piece of surgical plaster,
REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm tap water
- Time after start of exposure: after 4 hours
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Acesulfame potassium was not irritating to the skin of rabbits after semi-occlusive application for 4 hours to 3 rabbits.
- Executive summary:
In a primary skin irritation study, 500 mg Acesulfame potassium moisted with 0.1 ml physiological saline was applied to the clipped skin (2.5 cm x 2.5 cm) of 3 New Zealand white rabbits for 4 hours under a semi-occlusive dressing. The animals were observed for up to 3 days and the readings were performed at 30 -60 min, 24, 48 and 72 hours. Irritation was scored according to the scoring scheme of Draize as recommended procedure by OECD guideline 404.
There was no sign of skin irritation at any reading time points.
Conclusion
Acesulfame potassium was examined for its primary skin irritating potential in a valid study conducted according to OECD test guideline No. 404 and under GLP conditions. Acesulfame potassium was shown to be non-irritating to the skin of rabbits.
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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