Registration Dossier
Registration Dossier
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EC number: 246-376-1 | CAS number: 24634-61-5
Skin irritation / corrosion
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:
- 1 987
- Report date:
- 1987
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 1984
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 1981-05-12
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Potassium (E,E)-hexa-2,4-dienoate
- EC Number:
- 246-376-1
- EC Name:
- Potassium (E,E)-hexa-2,4-dienoate
- Cas Number:
- 24634-61-5
- Molecular formula:
- C6H8O2.K
- IUPAC Name:
- potassium (E,E)-hexa-2,4-dienoate
- Details on test material:
- - Name of test material: Potassium sorbate
- Physical state: colourless powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system 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:
- 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
- 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
- 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.
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