Registration Dossier
Registration Dossier
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EC number: 209-676-3 | CAS number: 590-28-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984-08-18 to 1984-10-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1984
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Potassium cyanate
- EC Number:
- 209-676-3
- EC Name:
- Potassium cyanate
- Cas Number:
- 590-28-3
- Molecular formula:
- KOCN
- IUPAC Name:
- potassium cyanate
- Details on test material:
- Potassium cyanate 98 = minimum 98 % Potassium cyanate, up to 2 % Potassium carbonate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: White Russian
- Details on test animals or test system and environmental conditions:
- - Source: Asta-Werke, Bielefeld, Germany
- Age at study initiation: 4 - 5 months
- Weight at study initiation: 2.0 - 2.35 kg
- Housing: individually
- Diet: standardized feed (ssniff)
- Water: ad libitum
- Acclimation period: 1 day
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1
- Humidity (%): 50 - 60
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied:0.5 g of test item was moistened with 0.2 mL water. - Duration of treatment / exposure:
- The exposure period was 4 hours.
- Observation period:
- The observation period was 1, 24, 48 and 72 hours after removing of the bandage.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6.25 cm^2
- Type of wrap: The gauze patch was hold in contact with the skin by means of an occlusive dressing (Acrylastic)
OBSERVATION TIME POINTS
- 1, 24, 48 and 72 hours after exposure
SCORING SYSTEM:
- Method of calculation: Draize scheme
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:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 1/24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- none
- Other effects:
- - Other adverse systemic effects: none
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Potassium cyanate is considered to be not irritating to rabbit's skin.
- Executive summary:
The skin irritation/corrosion potential of the test item was investigated in primary dermal irritation study accordding to OECD Guideline 404 (1984). Three females of 4-5 month old White Russian rabbits were dermally exposed to 0.5 g (moistened with 0.2 mL water) of potassium cyanate for 4 hours to the animals back. Skin reactions were recorded after 24, 48 and 72 hours after exposure and evaluated according to the method of Draize. The erythema and edema score was 0 for each of the three animals. Furthermore, no systemic effects were observed after dermal application of the test item.
Thus, the test item is considered to be not irritating to rabbit’s skin.
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