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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988-Sep-13 through 1988-Sep-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

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
Chemical structure
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
- Physical state: colorless crystalline powder
- Analytical purity: >99%
- Purity test date: 03.09.1987
- Lot/batch No.: CM.-No. 2323957
- Stability under test conditions: stable
- Storage condition of test material: darkness at approx. 22 °C in a fume cupboard

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, Germany, conventional breed
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 1700 - 2200 mg/kg bw
- Housing: fully air-conditioned rooms, individual cages
- Diet: ad libitum (Altromin 2123 maintenance diet - rabbits, Altromin GmbH, Lippe, Germany)
- Water: ad libitum (tap water)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20

- Photoperiod (hrs dark / hrs light): 12 h/12 h

IN-LIFE DATES:
From: 13-09-1988
To: 16-09-1988

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
physiological saline
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 500 mg moistened with physiological saline

VEHICLE
- Amount(s) applied: 0.1 ml
Duration of treatment / exposure:
4 h
Observation period:
3 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: cmcellulose patch an a piece of surgical plaster,

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm tap water
- Time after start of exposure: after 4 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Acesulfame potassium was not irritating to the skin of rabbits after semi-occlusive application for 4 hours to 3 rabbits.
Executive summary:

In a primary skin irritation study, 500 mg Acesulfame potassium moisted with 0.1 ml physiological saline was applied to the clipped skin (2.5 cm x 2.5 cm) of 3 New Zealand white rabbits for 4 hours under a semi-occlusive dressing. The animals were observed for up to 3 days and the readings were performed at 30 -60 min, 24, 48 and 72 hours. Irritation was scored according to the scoring scheme of Draize as recommended procedure by OECD guideline 404.

 

There was no sign of skin irritation at any reading time points.

 

Conclusion

Acesulfame potassium was examined for its primary skin irritating potential in a valid study conducted according to OECD test guideline No. 404 and under GLP conditions. Acesulfame potassium was shown to be non-irritating to the skin of rabbits.

 

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