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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (GLP)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
adopted 1984
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 1981-05-12
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: Potassium sorbate
- Physical state: colourless powder



Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Frankfurt, Germany
- Age: approximately 3 to 5 months
- Weight at study initiation: 2.7-3.4 kg

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg potassium sorbate mixed with 0.15 ml 0.9 % NaCl solution were given onto a gauze patch.
- Concentration in vehicle: 3333 mg/mL potassium sorbate
Duration of treatment / exposure:
4 hours
Observation period:
Examination time points: 30-60 min, 24h, 48h and 72h after removal of test substance
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: Potassium sorbate mixed with 0.9 % NaCl solution were given onto a gauze patch, and this was applied to the shaved intact dorsal skin (area of exposure: 2.5 x 2.5 cm at the dorsal area of the trunk; total volume applied: 0.15 ml 0.9 % NaCl solution with 500 mg potassium sorbate per animal)

REMOVAL OF TEST SUBSTANCE
- Washing: with tepid tap water
- Time after start of exposure: after 4h

SCORING SYSTEM: Draize scoring system; erythema and oedema

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal # 1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24 , 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
One animal showed very slight erythema and oedema, and another animal showed well defined erythema and oedema one hour after removal of the test substance. At 24 hours after removal of the test substance all individual scores for erythema and oedema were "zero". One animal showed dry skin at 72 hours after patch removal.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Potassium sorbate is not irritating to the skin.