Registration Dossier
Registration Dossier
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EC number: 402-400-4 | CAS number: 54660-00-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant OECD Guideline Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted May 12, 1981
- GLP compliance:
- yes
- Remarks:
- Research & Consulting Company AG, Itingen, Switzerland
Test material
- Details on test material:
- - Physical state: solid
- Analytical purity: commercial grade
- Lot/batch No.: Op. 10002
- Stability under test conditions: stable for at least 2 hours
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, Fuellinsdorf, Switzerland
- Age at study initiation: 15 - 16 weeks
- Weight at study initiation: 2.7 - 3.0 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitium
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: Polyethylenglykol 400
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g
- Concentration (if solution): moistened with PEG 400 - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, and 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: dorsal
- Type of wrap if used: 3.0 cm x 3.0 cm patch of surgical gauze. The gauze was covered with aluminum foil and then covered with an occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with luke warm water
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to the OECD Guidelines for Testing of Chemicals, Section 4, number 404, pp. 3-4.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Other effects:
- In the area of application a clear visible orange discoloration of the skin was observed which could be related to effects of the test article.
No corrosive effect had occurred on the skin at each measuring interval.
The body weight gain of all rabbits was similar.
No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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