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

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1986-Oct-21 through 1986-Nov-04

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Scientifically reliable study with sScientifically reliable study with sufficient information for evaluation and assessmentufficient information for evaluation and assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: DIN 53436 Part 1 - 3

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

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):Sunett (Acesulfame K)
- Physical state: lolorless white crystals
- Lot/batch No.: CM 1261956

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HOECHST AG, Kastengrund, SPF-breed
- Age at study initiation:8 - 10 weeks
- Weight at study initiation: males: 189 - 214 g (mean 202 g), females: 188 - 202 g (mean 196 g)
- Fasting period before study: no data
- Housing: Makrolon cages
- Diet: ad libitum (rat diet Altromin 1324
- Water: ad libitum (tap water)
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1 °C
- Humidity (%): 50 ± 20%.
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES:
From: 21-Oct-1986
To: 04-Nov-1986

Administration / exposure

Route of administration:

inhalation

Type of inhalation exposure:

nose only

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: 20 l PVC-cylinder situated in an exhaustor
- Exposure chamber volume: 9.5 m³
- Method of holding animals in test chamber: During the study single rats were kept in cylindrical plastic cages.
- System of generating particulates/aerosols:
Sunett was inserted into a silica tube of 1000 mm length and 40 mm diameteron a sample tray of 400 mm length and 1.7 mm width. A ring oven of 100 mm length around the silica tube can be moved along the tube with a constant rate of 10 mm/min and adjusted to a defined temperature. The ring oven was moved over the sample tray once per test, corresponding to aduration of 30 min per test. The ocurring the products of pyrolyses were transported into the inhalation cylinder by a stream of air of 100 l/h (primary air) blown into the inhalationcylinder. Simultaneously a second stream of air of 200 l/h (secondary air) was added before the inhalation cylinder, but after the silica tube. An exhausting equipment placed on the bottom of the inhalation chamber removespotentially formed products of pyrolysis through two absorption bottles filledwas water, one absorption flask filled with calcium chloride and a Buehler filterwith 300 l/h.
The test was carried out at 250°C according to DIN (German Industrial Standard) 53436. The temperature was tested prior to each test with a standard block. Thesamples were weighed before and after the test and difference was determined

- Method of particle size determination:
Not determined.

TEST ATMOSPHERE
- Brief description of analytical method used: no data

VEHICLE
Air


TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: not determined
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): not determined

CLASS METHOD
Not applicable

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

4 h

Concentrations:

Not measured as animals were exposed to potentially pyrolyses products after heating up to 250 °C.

No. of animals per sex per dose:

10 males and 10 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs and behavior: twice per days; body weight determination: days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed:
During exposition CO, CO2, 02, humidity and temperature in the exposure chamberwere monitored continuously by an air monitoring system.
Immediately after inhalations blood samples were taken from all animals for thedetermination of C0-Hb.

Statistics:

Not applicable

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

other: Mortality

Exp. duration:

4 h

Remarks on result:

other: The effect of exposure of potential pyrolsis products were investigated

Mortality:

No mortality in males and females.

Clinical signs:

other: Signs of intoxication were irregular and intermittent respiration, nasal dischargeand crouched position. One day after exposition all animals were free from clinical symptoms.

Body weight:

No effect.

Gross pathology:

Dissection of the animals killed at the end of the observation period did notshow macroscopically visible changes.

Other findings:

The investigation of CO hemoglobin did not show increased CO-Hb values immediately after exposure.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Inhalation exposure to Acesulfam potassium or possible pyrolises products investigated at a temperature of 250° C did not cause mortality or any sign of systemic toxicity.

Executive summary:

Acesulfame potassium was investigated at a temperature of 250°C in a study of the inhalation toxicity of thermal degradation products. All test animals survived. Symptoms of intoxication were disturbance of respiration, of autonome reactionsand of body position. The investigation of CO hemoglobin did not show increased CO-Hb values immediately after exposure. Pathological examination of the animals killed immediately after the study did not show any abnormal signs.