Registration Dossier
Registration Dossier
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EC number: 211-162-9 | CAS number: 631-61-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 1990-06-03 to 1990-06-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to OECD guideline, with GLP compliance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Potassium acetate
- EC Number:
- 204-822-2
- EC Name:
- Potassium acetate
- Cas Number:
- 127-08-2
- Molecular formula:
- C2H4O2.K
- IUPAC Name:
- potassium acetate
- Details on test material:
- - Name of test material (as cited in study report): Safeway KA, LP 1848 (50 % water solution of Potassium acetate)
- Molecular formula (if other than submission substance): CH3COO-K+
- Molecular weight (if other than submission substance): 1,28 kg/L
- Analytical purity: 50,1% Potassium acetate
- Impurities (identity and concentrations): 0,10% Tolyltriazol; 0,05% H3PO4; rest water till 100%.
- Purity test date: 1990-07-16
- Lot/batch No.: Hoe CG 0255 OA ZD50 0001
- Storage condition of test material: 20 ºC
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,
- Age at study initiation: 3-5 months
- Weight at study initiation: 3.4 - 4.5 kg
- Water (e.g. ad libitum): deionized chlorinated water from automatic watering, ad libitum
- Housing:in fully air-condition, spaces in single cages
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 ºC
- Humidity (%): 50 +/- 20%
- Photoperiod (hrs dark / hrs light): 12 hours
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL of test substance Safeway KA - Duration of treatment / exposure:
- Approximately 24 hours prior to the experiment start, 3 rabbits in the dorsal area of the fuselage, were depilated with an electric hair clipper with an area of approximately 25 cm2.
The exposure time: 4 hours. - Observation period:
- Observations were made: were made 30 - 60 minutes and 24, 48 and 72 hours after.
- Number of animals:
- Three (female).
- Details on study design:
- TEST SITE
- Area of exposure: 25 cm2
- Type of wrap if used: wound plaster ( Beiersdorf AG, Hamburg)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with water
- Time after start of exposure: 4 hours
SCORING SYSTEM:
Erytrema:
0. No erythema
1. Very slight erythema (barely perceptible)
2. Clearly circumscribed erythema
3. Medium to severe erythema,
4. Severe erythema (intense redness to slight eschar) (deep
Injuries)
* Can not be assessed.
Edema:
0. No edema
1. Very slight edema (hardly noticeable)
2. Slight edema (edges of the body are characterized by a distinct swelling clearly defined)
3. Edema (swelling of about 1 mm }....
4. Severe edema (swelling of more than 1 mm and the exposure area)
* Can not be assessed.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
Any other information on results incl. tables
Throughout the trial period there were no symptoms of skin irritation.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Throughout the trial period there were no symptoms of skin irritation.
- Executive summary:
An dermal irritation test (72 hours) using 3 rabbits has been performed on the test substance LP 1848 (50 % water solution of Potassium acetate) in accordance with guideline OECD Guideline 404 (Acute Dermal Irritation / Corrosion).
Throughout the trial period there were no symptoms of skin irritation.In this test, the control parameters were within the recommended ranges.
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