6-methyl-1,2,3-oxathiazin-4(3H)-one 2,2-dioxide, potassium salt

Acute Toxicity: other routes

Administrative data

Endpoint:

acute toxicity: other routes

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1977-Feb-09 tghrough 1977-Mar-03

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:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

The LD50 was determined by means of a probit analysis (method according to LINDER and WEBER).

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

Constituent 1

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

Constituent 2

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

Constituent 3

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):
- Molecular formula (if other than submission substance):
- Molecular weight (if other than submission substance):
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type:
- Physical state:
- Analytical purity:
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.:
- Expiration date of the lot/batch:
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions:
- Storage condition of test material:
- Other:
- Name of test material (as cited in study report): Acesulfam-K
- Physical state: hwite, crystalline
- Lot/batch No.: CIVO 4
- Stability under test conditions: stable

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: inhouse breed
- Weight at study initiation: 80 - 103 g (mean 92 g)
- Fasting period before study: 16 h
- Diet: ad libitum (standard chow, Altromin, Altromin GmbH, Lage, Germany)
- Water: ad libitum (tap water)

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

water

Remarks:

10%

Details on exposure:

The test substance was administered by single injection as a 10 % solution in different doses to female SPF-Wistar rats.

Doses:

500, 800, 1250, 2000, 2500, 3200 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: body weight determination once a week
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

2 243 mg/kg bw

Based on:

test mat.

95% CL:

>= 1 926 - <= 2 611

Mortality:

Animals which received a lethal dose died within 24 to100 minutes after treatment; the symptoms were:
sluggish behaviour, pouting, proneness, jactitatory convulsions, tonic convulsion.
500 mg/kg bw: 0/10
800 mg/kg bw: 0/10
1250 mg/kg bw: 1/10
2000 mg/kg bw: 6/10
2500 mg/kg bw: 4/10
3200 mg/kg bw: 9/10

Clinical signs:

In animals that died revealed sluggish behaviour, pouting, proneness, jactitatory convulsions, tonic convulsion.

Body weight:

No effect reported.

Gross pathology:

The animals that died showed diffuse reddening in various area sof the wall of the small intestine. Macroscopic examination
of the animals killed at the end of the test showed no abnormal findings.

Applicant's summary and conclusion

Conclusions:

The acute intraperitoneal LD 50 was 2243 mg/kg bw (1926 - 2611 mg/kg bw).

Executive summary:

The acute intraperitoneal toxicity of Acesulfame potassium was examined in 10 female Wistar rats. The LD50 value and 95% confidence limits were 2243 (1926 - 2611) mg/kg bw. Animals which received a lethal dose died within 24 to100 minutes after treatment; the symptoms were: sluggish behaviour, pouting, proneness, jactitatory convulsions, tonic convulsion. Body weight was not affected. The animals that died showed diffuse reddening in various area sof the wall of the small intestine. Macroscopic examination of the animals killed at the end of the test showed no abnormal findings.

Acesulfame K was non-toxic after acute intraperitoneal 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