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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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Remarks:
- Local Lymph Node Assay in the Mouse with Acesulfame Potassium
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-Jul-12 through 2012-Sep-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
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 potassium
- Physical state: White, crystalline powder
- Analytical purity:100%
- Lot/batch No.: 0000522972
- Expiration date of the lot/batch: 08 October 2012
- Stability under test conditions: stable
- Storage condition of test material: Controlled Room temperature (15-25 °C, below 70 RH%), protected from humidity
Constituent 1
Constituent 2
Constituent 3
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: ELEVAGE JANVIER; Route des Chènes Secs B.P. 4105; 53940 LE GENEST-ST-ISLE, France
- Age at study initiation: 10 weeks
- Weight at study initiation: 20.7 - 22.8 g
- Housing: group caging
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 - 70
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light) 12 h/12h
IN-LIFE DATES:
From: 19-Sep-2012
To: 25-Sep-2012
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 5%, 10%, 25% (w/v)
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: soluble at 25% (w/v)
- Irritation: none at 25% (w/v)
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method:
- Criteria used to consider a positive response: the DPN value of the negative (vehicle) control group falls within the range of historical laboratory control data, the positive control substance produces a significant lympho-proliferative response increases (SI>3), each treated and control group includes at least 4 animals, the test item did not cause serious systemic or local toxicity.
TREATMENT PREPARATION AND ADMINISTRATION:
Groups of four female CBA/J Rj mice were treated with: 25, 10 and 5% (w/v), respectively Acesulfame Potassium in DMSO. The negative control group received DMSO and the positive control group received 25 % -Hexylcinnamaldehyde (HCA) in DMSO.
The solutions of the test item were applied on the dorsal surface of ears of experimental animals (25 µl/ear) for three consecutive days (Days 1, 2 and 3). There was no treatment on Days 4, 5 and 6. On Day 6, the cell proliferation in the local lymph nodes was measured by incorporation of tritiated methyl thymidine (3HTdR) and the values obtained were used to calculate stimulation indices (SI). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Not applicable
Results and discussion
- Positive control results:
- α-Hexylcinnamaldehyde (25% (w/v) dissolved in DMSO) was used as a positive control to demonstrate the appropriate performance of the assay [1]. A significant lymphoproliferative response (stimulation index value of 15.7) was noted for the positive control chemical and this result confirmed the validity of the assay.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: Stimulation index values of the test item were 1.3, 1.4, and 1.5 at treatment concentrations of 25, 10 and 5% (w/v), respectively.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: DPM/group were were 1061, 1195 and 1275 at treatment concentrations of 25, 10 and 5% (w/v), respectively.
- Parameter:
- SI
- Value:
- 1.3
- Parameter:
- SI
- Value:
- 1.4
- Parameter:
- SI
- Value:
- 1.5
Any other information on results incl. tables
Body Weights
Animal |
Test Group |
Initial Body |
Terminal Body |
Change# |
Number |
Name |
Weight (g) |
Weight (g)* |
(%) |
424 |
|
22.8 |
22.7 |
-0.4 |
456 |
Negative control |
21.8 |
23.8 |
9.2 |
478 |
DMSO |
21.7 |
21.7 |
0.0 |
481 |
|
21.0 |
22.5 |
7.1 |
|
Mean |
21.8 |
22.7 |
3.9 |
427 |
|
22.3 |
23.4 |
4.9 |
451 |
Acesulfame Potassium |
21.8 |
21.7 |
-0.5 |
460 |
25% (w/v) in DMSO |
21.2 |
23.0 |
8.5 |
462 |
|
21.4 |
21.0 |
-1.9 |
|
Mean |
21.7 |
22.3 |
2.8 |
449 |
|
22.7 |
22.7 |
0.0 |
474 |
Acesulfame Potassium |
20.7 |
20.5 |
-1.0 |
468 |
10% (w/v) in DMSO |
21.4 |
23.1 |
7.9 |
452 |
|
21.3 |
20.5 |
-3.8 |
|
Mean |
21.5 |
21.7 |
0.8 |
466 |
|
22.0 |
22.7 |
3.2 |
454 |
Acesulfame Potassium |
22.4 |
22.9 |
2.2 |
470 |
5% (w/v) in DMSO |
21.0 |
21.9 |
4.3 |
480 |
|
20.9 |
21.8 |
4.3 |
|
Mean |
21.6 |
22.3 |
3.5 |
477 |
|
22.4 |
21.5 |
-4.0 |
484 |
Positive control |
21.5 |
21.7 |
0.9 |
455 |
25 % HCA in DMSO |
21.4 |
23.9 |
11.7 |
469 |
|
20.8 |
22.4 |
7.7 |
|
Mean |
21.5 |
22.4 |
4.1 |
*: Terminal body weights were measured on Day 6. #: (Terminal Body Weight – Initial Body Weight) / Initial Body Weight x 100
|
Desintegration per minute (DPM), desintegration per node (DPN) and Stimulation Index Values for all Groups:
Test Group |
Measured |
Group |
No. of |
DPN |
Stimulation |
Name |
DPM/group |
DPM |
Nodes |
|
Index Values |
Background |
|
|
|
|
|
(5 (w/v) % TCA ) |
37 |
|
- |
|
|
Negative control |
|
|
|
|
|
DMSO |
850 |
813 |
8 |
101.6 |
1.0 |
Acesulfame Potassium |
|
|
|
|
|
25% (w/v) in DMSO |
1061 |
1024 |
8 |
128.0 |
1.3 |
Acesulfame Potassium |
|
|
|
|
|
10% (w/v) in DMSO |
1195 |
1158 |
8 |
144.8 |
1.4 |
Acesulfame Potassium |
|
|
|
|
|
5% (w/v) in DMSO |
1275 |
1238 |
8 |
154.8 |
1.5 |
Positive control |
|
|
|
|
|
25 % HCA in DMSO |
12789 |
12752 |
8 |
1594.0 |
15.7 |
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Acesulfame potassium tested in dimethyl sulphoxide as vehicle, was shown to have no sensitization potential in the Local Lymph Node Assay in female CBA/J Rj mice .
According to the UN Globally Harmonised System of Classification and Labelling of Chemicals, Acesulfame Potassium does not require classification as a skin sensitiser. - Executive summary:
The potential of Acesulfame potassium to induce skin sensitization was investigated in groups of four female CBA/J Rj mice treated with: 25, 10 and 5% (w/v) in DMSO. The negative control group received DMSO and the positive control group received 25 %a-Hexylcinnamaldehyde (HCA) in DMSO.
The solutions of the test item were applied on the dorsal surface of ears of experimental animals (25 µl/ear) for three consecutive days (Days 1, 2 and 3). There was no treatment on Days 4, 5 and 6. On Day 6, the cell proliferation in the local lymph nodes was measured by incorporation of tritiated methyl thymidine (3HTdR) and the values obtained were used to calculate stimulation indices (SI).
No mortality or sign of systemic toxicity or local irritation were observed during the study. No treatment body weight loss was observed during the study.
Stimulation index values of the test item were 1.3, 1.4, and 1.5 at treatment concentrations of 25, 10 and 5% (w/v), respectively.
The positive control demonstrated the appropriate performance of the assay as a significant lymphoproliferative response (stimulation index value of 15.7) was noted.
Conclusion
Acesulfame Potassium tested for its sensitizing potential according to OECD 429 under GLP conditions was shown to have no sensitization potential in the murine Local Lymph Node Assay.
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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