Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986-Jul-15 through 1986-Sep-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
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: colourless-white crystals
- Analytical purity: 99%
- Impurities (identity and concentrations): Fluorid: <3 ppm; Arsen: <3 ppm, Selen: <3 ppm, heavy metals: < 10 ppm
- Purity test date: 1986-05-06
- Lot/batch No.: 126 1955
- Stability under test conditions: stable
- Storage condition of test material: dark at 22 °C
Constituent 1
Constituent 2
Constituent 3
Method
- Target gene:
- In the Ames test with Salmonella typhimurium strains the effect of the test compound upon the number of back mutations to histidine prototrophy using histidine auxotrophic mutants is investigated. Using Escherichia ca1i WP2uvrA, a tryptophan dependent auxotroph strain, mutagenicity is based an reversion to tryptophan independence.
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 1538
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced liver homogenate from male Sprague-Dawöley rats
- Test concentrations with justification for top dose:
- 1st experiment: all strains: 0, 4, 20, 100, 500, 2500, 10000 µg/plate (with/without metabolic activation)
2nd experiment: all strains: 0, 4, 20, 100, 500, 2500, 5000 µg/plate (with/without metabolic activation)
3rd experiment: TA 100: 0, 4, 20, 100, 500, 2500, 5000 µg/plate (with/without metabolic activation) - Vehicle / solvent:
- Vehicle:
- Vehicle: bi-distilled waterMSO
- Justification for choice of solvent/vehicle: non toxicity and solubility
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- other: 2-aminoanthracene, N-methyl-N-nitro-N-nitrosoguanidine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: A reduced rate of spontaneously occuring colonies as well as visible thinning of the bacterial lawn were used as indicator for toxi¬city
METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 – 72 h at 37 °C
- Expression time (cells in growth medium): 48 – 72 h
- Selection time (if incubation with a selection agent): 48 – 72 h
- Fixation time (start of exposure up to fixation or harvest of cells): 48 – 72 h
SELECTION AGENT: Histidine
NUMBER OF REPLICATIONS: 3
NUMBER OF EXPERIMENTS: 2 (strains: TA 1535, TA 1537, TA 1538, TA 98, WP2uvrA), 3 (strain TA 100)
DETERMINATION OF CYTOTOXICITY
- Method: reduced rate of spontaneous occurring colonies - Evaluation criteria:
- According to OECD 471
- Statistics:
- None
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no
- Effects of osmolality: no
- Water solubility: no
- Precipitation: no
RANGE-FINDING/SCREENING STUDIES: Yes
COMPARISON WITH HISTORICAL CONTROL DATA: No - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Results: Experiment 1: Number of mean revertant colonies per plate in bacteria strains
|
S. typhimurium |
E. coli |
||||
Dose µg/plate |
TA100 |
TA1535 |
1537 |
1538 |
98 |
WP2uvrA |
|
Without metabolic activation |
|||||
0 |
132 |
14 |
7 |
12 |
27 |
34 |
4 |
143 |
14 |
7 |
15 |
28 |
34 |
20 |
143 |
16 |
6 |
13 |
26 |
36 |
100 |
148 |
14 |
7 |
12 |
27 |
32 |
500 |
148 |
11 |
8 |
8 |
25 |
32 |
2500 |
151 |
13 |
5 |
13 |
23 |
31 |
10000 |
155 |
19 |
6 |
10 |
26 |
35 |
|
With metabolic activation |
|||||
0 |
128 |
13 |
6 |
18 |
35 |
30 |
4 |
146 |
11 |
6 |
21 |
34 |
38 |
20 |
129 |
14 |
8 |
16 |
35 |
39 |
100 |
148 |
9 |
4 |
23 |
28 |
37 |
500 |
137 |
11 |
4 |
21 |
29 |
33 |
2500 |
123 |
14 |
6 |
21 |
36 |
40 |
10000 |
145 |
12 |
8 |
20 |
34 |
26 |
Results: Experiment 2: Number of mean revertant colonies per plate in bacteria strains
|
S. typhimurium |
E. coli |
||||
Dose µg/plate |
TA100 |
TA1535 |
1537 |
1538 |
98 |
WP2uvrA |
|
Without metabolic activation |
|||||
0 |
208 |
13 |
9 |
15 |
24 |
41 |
4 |
205 |
16 |
9 |
12 |
24 |
48 |
20 |
221 |
16 |
7 |
13 |
22 |
37 |
100 |
227 |
15 |
7 |
15 |
25 |
45 |
500 |
239 |
14 |
6 |
18 |
23 |
37 |
2500 |
258 |
20 |
7 |
14 |
26 |
38 |
5000 |
263 |
19 |
7 |
14 |
24 |
39 |
|
With metabolic activation |
|||||
0 |
200 |
16 |
8 |
17 |
29 |
42 |
4 |
230 |
18 |
6 |
22 |
26 |
40 |
20 |
206 |
17 |
8 |
21 |
23 |
37 |
100 |
217 |
16 |
6 |
17 |
27 |
33 |
500 |
241 |
16 |
9 |
20 |
33 |
39 |
2500 |
225 |
16 |
6 |
15 |
37 |
41 |
5000 |
237 |
13 |
10 |
19 |
34 |
38 |
Results: Experiment 3: Number of mean revertant colonies per plate in S. typhimurium strain TA100 only
|
S. typhimurium |
Dose µg/plate |
TA100 |
|
Without metabolic activation |
0 |
179 |
4 |
173 |
20 |
172 |
100 |
174 |
500 |
168 |
2500 |
172 |
5000 |
146 |
|
With metabolic activation |
0 |
177 |
4 |
173 |
20 |
178 |
100 |
179 |
500 |
172 |
2500 |
174 |
5000 |
170 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with/wihtout metabolic activation
Acesulfame potassium was not mutagenic in the in vitro reverse gene mutation assay in bacteria with the strains TA 100, TA 1535, TA 1537, TA 1538, TA 98 of Salmonella typhimurium and Escherichia coli WP2uvrA in the presence and absence of metabolic activation. - Executive summary:
Acesulfame potassium was investigated for its potential mutagenic activity in thein vitroreverse gene mutation assay in bacteria with the strains TA 100, TA 1535, TA 1537, TA 1538, TA 98 ofSalmonella typhimuriumandEscherichia coliWP2uvrA. The test was performed in the absence and presence of a metabolizing system derived from rat liver homogenate (male Sprague-Dawley rat liver S9-mix induced by Aroclor 1245). The test substance (batch: 126 1955 dated 06 May 1986, crystalline, purity: 99%) was dissolved in bi-distilled water and up to 3 independent experiments with 3 replicate each were performed. A range-finding study to investigate bacteriotoxicity was performed. The solvent served also as negative control and appropriate positive controls were used.
This study is assessed as appropriate and valid since it was performed according to internationally accepted OECD and EU testing guidelines and according to GLP. Reporting, assessment and data presentation in the study report was considered as appropriate.
Control plates without mutagen showed that the number of spontaneous revertant colonies was similar to that described in the literature. All the positive control compounds led to the expected increase in the number of revertant colonies.
Acesulfame potassium was not toxic to the bacterial strains up to the highest concentration of each 5000 or 10000 µg/plate in the presence or absence of metabolic activation.
In the presence and absence of a metabolic activation, Acesulfame potassium did not led to any relevant increase in the number of revertant colonies in the bacterial tester strains.
Conclusion:
Acesulfame potassium was not mutagenic in thein vitroreverse gene mutation assay in bacteria with the strains TA 100, TA 1535, TA 1537, TA 1538, TA 98 ofSalmonella typhimuriumandEscherichia coliWP2uvrA in the presence and absence of metabolic activation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.