Registration Dossier
Registration Dossier
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EC number: 940-265-8 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989-08-08 to 1989-08-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant; Guideline Study (OECD 404; adopted 1981). deviation from OECD Guideline adopted 2002: occlusive treatment. This deviation has no influence on the reliability of the study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- May 12, 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- April 25, 1984
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Details on test material:
- - Physical properties: solid;
- Storage conditions: room temperature;
Constituent 1
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; D-7950 Biberach/Riss
- Age at study initiation: approx. 12 - 14 weeks;
- Weight at study initiation: 2550 - 2750 gr;
- Housing: individually in metal cages;
- Diet: standard rabbit pellet diet - Nafag No. 814, Gossau, Switzerland; ad libitum;
- Water: fresh water ad libitum;
- Acclimation period: at least 5 days;
ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 3 °C;
- Humidity: relative humidity of 30-70 %
- Air changes (per hr): no information available;
- Photoperiod: 12 hours light cycle per day.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: moistened with water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g;
VEHICLE
- Patches were moistened with distilled water before application; - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours (skin reactions were scored at 1, 24, 48 and 72 hours after patch removal)
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 12 - 16 cm² at the flank of the animals
- Type of wrap: patch covered with aluminium foiul and hold in place with adhesive plast (Isoplast) wrapping
REMOVAL OF TEST SUBSTANCE
- Washing: none
SCORING SYSTEM: OECD guideline No. 404
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:
- Because no reactions were observed at 24 hours to 72 hours after removing the bandages, the test was ended after the 72 hours evaluation.
It can be concluded that the test item has no primary skin irritant potency in albino rabbits.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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