Registration Dossier
Registration Dossier
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EC number: 428-320-1 | CAS number: 71308-16-2
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)
- Rationale for reliability incl. deficiencies:
- other: Guideline Study according to GLP principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals
- Species:
- rabbit
- Strain:
- other: White russian (Albino)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: males 40, 48 months; female 57 months
- Weight at study initiation: males 2.24, 2.34 kg; female 2.74 kg
- Housing: individually
- Diet: approx. 120 g/animal x day standard diet sniff K
- Water: ad libitum
- Acclimation period: 1 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.5-19.0°C
- Humidity (%): 54-72%
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 21.11.1995 To: 02.12.1995
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- The skin was moistened with water to ensure a tight contact with the skin.
- Controls:
- other: control site at the same animal
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours after removal of the patches
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6.25 cm2
- Type of wrap if used: 1. cellulose fabric coated with natural rubber 2. synthetic film glue
REMOVAL OF TEST SUBSTANCE
- Washing: test material was washed off as far as possible after time of exposure
- Time after start of exposure: 4 hours, obseration period 24, 48, and 72 h
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 1-3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal: 1-3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Other effects:
- During the observation period neither erythema nor edema could be detected.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- The substance is non-irritant in this test system.
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