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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1975
- 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:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- application GD 6 - 15
- GLP compliance:
- no
- Remarks:
- Study performed prior to implementation of GLP
- 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): Hoe 0-95 K
- Substance type: sweetener
- Physical state: crystalline powder
- Analytical purity: 99.8%
- Lot/batch No.: VP 528 G 511
- Stability under test conditions: stable
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Central Institute for the Breeding of Laboratory Animals TNO, Zeist, The Netherlands
- Age at study initiation: adult
- Weight at study initiation: mean: 165 - 167 g
- Fasting period before study: no
- Housing: individually in wire-bottom cages
- Diet: ad libitum (standard laboratory stock diet)
- Water: ad libitum (tap water)
- Acclimation period: at least 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled
- Humidity (%): controlled
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES:
From: no data
To: no data
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: diet
- Details on exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): no data
- Mixing appropriate amounts with (Type of food): institutute' stock diet
- Storage temperature of food: room temperature - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- Not applicable
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1:4
- Length of cohabitation: overnight, until positive vaginal smears
- Verification of same strain and source of both sexes: yes
- Proof of pregnancy: sperm in vaginal smear referred to as day 0
- Any other deviations from standard protocol: no - Duration of treatment / exposure:
- Gestation days 6 - 15
- Frequency of treatment:
- Daily
- Duration of test:
- From maing until necropsy on gestation day 20.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 other: %
- Dose / conc.:
- 0.3 other: %
- Dose / conc.:
- 1 other: %
- Dose / conc.:
- 3 other: %
- No. of animals per sex per dose:
- 20
- Control animals:
- yes, plain diet
- other: Positive control: Vitamin A palmitate (75000 IU/day)
- Details on study design:
- - Dose selection rationale: At request of sponsor based on low subchronic toxicity
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: days 0, 6, 16, 21
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No
- Time schedule for examinations:
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 21
- Organs examined: complete necropsy
- organ weights: ovaries - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes
- Other:
- pre-/post implantation loss - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: third per litter
- Skeletal examinations: Yes: two third per litter
- Head examinations: No data - Statistics:
- Student's t-test: mean maternal body weights, mean food consumption, mean litter data
Chi-square test: skeletal and visceral anomalies - Indices:
- Pre-/post-implantation loss,
- Historical control data:
- Yes
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- effects observed, non-treatment-related
- Description (incidence and severity):
- A decreased in the number of live foetuse/litter in the low (0.3%) dose group only which was attributed to an increased number of embryonal resoptions in two dams. However, this low number of live foetuses/litter is within the normal range of control findings. it did not occurr in the high dose group.
- Total litter losses by resorption:
- effects observed, non-treatment-related
- Description (incidence and severity):
- An increased number of embryonal resoptions in two dams in the low dose group within the normal range in controls. However, this low number of live foetuses/litter was within the normal range of control findings. It did not occurr in the high dose group.
- Early or late resorptions:
- not specified
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- not specified
- Changes in number of pregnant:
- not specified
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
Not applicable
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 30 000 ppm (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: lack of maternal toxicity
Maternal abnormalities
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- The foetal weight increased with increasing feeding level and slightly higher but not significantly highter than the controls.
- Reduction in number of live offspring:
- not specified
- Changes in sex ratio:
- not specified
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- no effects observed
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
Not applicable
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 3 other: %
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no effects
Fetal abnormalities
- Key result
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Any other information on results incl. tables
Summary of data:
Parameter/Concentration % (diet) |
0 |
0.3 |
1.0 |
3.0 |
Vit. A 75000 IU/rat/day |
Number of females mated |
20 |
20 |
20 |
20 |
11 |
Number of females pregnant |
18 |
16 |
17 |
13 |
8 |
Number of females with live fetuses |
18 |
16 |
17 |
13 |
5 |
Number of live fetuses |
185 |
141 |
170 |
131 |
31 |
Mean number of live fetuses/ litter |
10 |
8.8** |
10 |
10 |
5... |
Pre-implantation loss % |
6.1 |
11.2 |
8.0 |
8.9 |
6.5 |
Post-implantation loss % |
2.0 |
10.6* |
7.8 |
3.3 |
64.0*** |
Mean ovary weight/dam (g) |
0.07 |
0.07 |
0.07 |
0.07 |
0.06* |
Mean empty uterus weight/dam (g) |
4.03 |
3.63* |
3.78 |
3.66 |
1.97*** |
Mean number of corpora lutea/dam |
11.2 |
11.2 |
11.4 |
11.5 |
10.4 |
Mean number of implantation sites/dam |
10.5 |
9.9 |
10.6 |
10.5 |
9.6 |
Mean number of embryonic resorption/dam |
0.17 |
0.81* |
0.35 |
0.38 |
2.4** |
Mean number of fetal resorption/dam |
0.06 |
0.19 |
0.24 |
0 |
3.3** |
Mean number of dead fetuses/dam |
0 |
0.06 |
0 |
0 |
0.1 |
Mean fetal weight/dam (g) |
5.07 |
5.26 |
5.32** |
5.42** |
4.52* |
Number of litters with externally visible malformed fetuses |
3 |
0 |
0 |
1 |
5 |
Number of fetuses with externally visible malformations |
3 |
0 |
0 |
1 |
19 |
Number of fetuses with visceral anomalies |
9 |
- |
- |
8 |
21 |
Number of fetuses with skeletal anomalies |
22 |
- |
- |
16 |
10 |
- = not examined, * p<0.05, ** 0.01 >p>0.001; *** p<0.001 |
Applicant's summary and conclusion
- Conclusions:
- Acesulfame potassium was administered to pregnant Wistar rats orally via the diet at 0, 0.3%, 1.0% and 3.0 % from implantation at gestation day (GD) 6 through GD 15 (counting from day 0 of pregnancy).
All dose levels were tolerated without maternal or developmental toxicity and especially without morphological alterations in the fetuses.
The no observed adverse effects level (NOAEL) for maternal toxicity as well as for developmental toxicity including teratogenicity was 3.0% in the diet (30000 ppm corresponding to about 1500 mg/kg bw/day) and was thus clearly above the current limit dose of 1000 mg/kg bw/day. - Executive summary:
The prenatal developmental toxicity of Acesulfame potassium was investigated in pregnant female Wistar rats. Each 20 pregnant females received dietary dose levels of 0, 0.3%, 1.0% and 3.0% from implantation at gestation day (GD) 6 through GD 15 (counting from day 0 of pregnancy). A positive control group received 75000 IU Vitamin A palmitate/day dissolved in soybean oil.
This study is assessed as appropriate and valid since it was performed similar to internationally accepted testing guideline and reporting, assessment and data presentation in the study report was considered as appropriate.
Signs of maternal toxicity did not occur and food consumption and body weight/body weight gain was not adversely affected. Increased food consumption was noted but this can not be considered as adverse effects.
The oral administration of the test substance to the dams at all 3 dose levels had no influence on the gestational parameters.
Signs of prenatal developmental toxicity including morphological alterations were not observed at any concentration. The mean fetal weights were slightly increased but this can not be considered as adverse effect.
The positive control group showed a wide range of known abnormalities and demonstrated the sensitivity of the test system.
Conclusion:
Acesulfame potassium administered to pregnant Wistar rats orally via the diet at 0, 0.3%, 1.0% and 3.0 % from implantation at gestation day (GD) 6 through GD 15 (counting from day 0 of pregnancy) did not lead to any maternal or developmental toxicity and especially to no morphological alterations in the fetuses.
The no observed adverse effects level (NOAEL) for maternal toxicity as well as for developmental toxicity including teratogenicity was 3.0% in the diet (30000 ppm corresponding to about 1500 mg/kg bw/day) and was thus clearly above the current limit dose of 1000 mg/kg bw/day.
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