Registration Dossier
Registration Dossier
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EC number: 414-310-2 | CAS number: 191358-81-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991-12-12 to 1992-02-19
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline Study (OECD 404 adopted 1981), GLP compliant. Acceptable deviations from OECD Guideline 404 adopted 2002: occlusive treatment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 1981
- Deviations:
- no
- GLP compliance:
- yes
Test material
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS AND ENVIRONMENTAL CONDITIONS
- Source: Dr. K. Thomae GMBH; Chemisch-pharmazeutische Fabrik; D-7 950 Biberach/Riss;
- Acclimatisation: at least 5 days;
- Weight: 2410 to 2660 g
- Housing: the animals were housed individually in metal cages, identified by ear tattoo
- Temperature: 20 +/- 3 °C
- Humidity: 30-70 %
- Photoperiod: 12 hours light cycle day
- Diet: rabbits received ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland - and fresh water.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80.
- Controls:
- no
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours (reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches )
- Number of animals:
- 3 male rabbits
- Details on study design:
- TEST SITE
- Area of exposure: An area of at least 36 cm² was shaved on both flanks of the animals approximately 24 hours before treatment.
- Coverage: A gauze patch (approx. 12-16 cm² ) bearing 0.5 g of the test article was applied to the right flank of each animal. A control gauze patch was applied to the contralateral flank. Both patches were moistened before application with 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80.
- Type of wrap: The patches were loosely covered with an aluminum foil (approx. 36 cm² ) and held in place for 4 hours by an adhesive tape.
SCORING SYSTEM
According to the OECD scoring system.
OTHER
The animals were checked daily for systemic symptoms and mortality.
The bodyweight was recorded at start and on day 3 of the test.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No skin reactions were noted.
- Other effects:
- One hour after patch removal the application area was stained with the dark red test article.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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