Registration Dossier
Registration Dossier
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EC number: 461-670-1 | 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:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- and EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Breeder: CEGAV, Saint Mars d'Egrenne, France
- Age at study initiation: 2 - 4 months
- Weight at study initiation: 2.5 ± 0.3 kg
- Housing: individually in polystyrene cages
- Diet (e.g. ad libitum): ad libitum, 110 pelleted diet (SAFE, villemoisson, Epinay-sur-Orge, France)
- Water (e.g. ad libitum): ad libitum, drinking water (filtered)
- Acclimation period: 5 days (at least)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 12 cycles
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
VEHICLE
- Amount(s) applied (volume or weight with unit): no vehicle was applied - Duration of treatment / exposure:
- 3 minutes and 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: flanks
- Type of wrap if used: gauze pad (moistened with purified water) , held in contact with the skin by means of an adhesive
hypoallergenic aerated semi-occlusive dressing and a restraining bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): removal of residual test item: by using a dry cotton pad (no washing)
- Time after start of exposure: 3 minutes and 4 hours first on one animal and 4 hours for the further two animals
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- for each animal
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: Max. score: 1 (one animal, 24 h, erythema)
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- for each animal
- Time point:
- other: 48 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: Max. score: 1 (one animal, 24 h, erythema)
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- for each animal
- Time point:
- other: 72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: Max. score: 1 (one animal, 24 h, erythema)
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- for each animal
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: Max. score: 1 (one animal, 24 h, erythema)
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- for each animal
- Time point:
- other: 48 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: Max. score: 1 (one animal, 24 h, erythema)
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- for each animal
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: Max. score: 1 (one animal, 24 h, erythema)
- Irritant / corrosive response data:
- very slightly irritant
- Other effects:
- Very slight erythema on day 1 two animals. Persisting on day 2 for one rabbit.
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Not classified.
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