Registration Dossier
Registration Dossier
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EC number: 414-940-8 | CAS number: -
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)
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 (incl. QA statement)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Test article: CGA 224443 tech.
- Batch No.: P. 810012
- Purity: 92,6 %
- Test material received: March 6, 1990
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Chemisch-pharmazeutische Fabrik
- Age at study initiation: 9 - 13 weeks
- Weight at study initiation: 2460 - 2820 g
- Housing: individually in metal cages
- Indentification: by ear tattoo
- Diet (e.g. ad libitum): standard rabbit pellet - Nafag No. 814 and fresh water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): constant room temperatur, 20 °C +/- 3
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- other: loosly covered with an aluminium foil
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: control gauze patch was applied to the contralateral flank
- Amount / concentration applied:
- A gauze patch (approx. 12 - 16 cm²) bearing 0,5 ml of the test article was applied to the right flank of each animal
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours after removing
- Number of animals:
- 3 male rabbits
- Details on study design:
- An area of at least 36 cm² was shaved on botch flanks approx. 24 hours before treatment.
A gauze patch (approx. 12 - 16 cm²) bearing 0,5 ml of the test article was applied to the right flank of each animal.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72
- Score:
- 1.67
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- classified as non-irritant in albino rabbits
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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