Registration Dossier
Registration Dossier
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EC number: 413-920-6 | CAS number: 88949-33-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and OECD testing guideline compliant study with well characterized test material.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Details on test material:
- - Substance type: Organic
- Physical state: Solid
- Lot/batch No.: Z-2281/1,2,4,5
- Expiration date of the lot/batch: April 01, 1997
- Storage condition of test material: at room temperature in the dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: Approx. 12 weeks
- Weight at study initiation: 2287 - 2600 grams
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: At least 5 days before start of treatment.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Humidity (%): 55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1992-11-24 To: 1992-11-27
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: contralateral flanks of the trated aninals
- Amount / concentration applied:
- 0.5g
- Duration of treatment / exposure:
- 4h
- Observation period:
- 4 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE
Approximately 24 hours before treatment, the dorsal fur was shaved with
electric clippers
- Area of exposure: approximately 150 square centimeters (10 cm X 15 cm).
- % coverage:
- Type of wrap if used: moistened Scotchpak-non-woven patch, mounted on Micropore tape. The dressing was wrapped around the abdomen
and secured with an elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): tissue moistened with tap-water
- Time after start of exposure: 4h
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1h, 24h, 48h, 72h
- Score:
- 0
- Max. score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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