Registration Dossier
Registration Dossier
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EC number: 231-131-3 | CAS number: 7440-22-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1993-07-29 to 1993-08-01
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: In principle well documented GLP-study, but no information on test item purity was provided.
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:
- yes
- Remarks:
- , no initial test was performed
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Silver
- EC Number:
- 231-131-3
- EC Name:
- Silver
- Cas Number:
- 7440-22-4
- Molecular formula:
- Ag
- IUPAC Name:
- Silver
- Details on test material:
- - Name of test material (as cited in study report): silver powder CAP 9
- Physical state: grey powder
- Storage condition of test material: room temperature, white plastic container
- Particle size: < 40 µm
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.09 - 2.52 kg
- Housing: The animals were individually housed in suspended metal cages.
- Diet: ad libitum (RABMA Rabbit Diet, Special Diet Services Ltd., Witham, Essex, U.K.)
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 62 - 75
- Air changes (per hr): 15
- Photoperiod: 12 hours dark/light cycle
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped free of fur from the dorsal flank area
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A quantity of 0.5 g of the test material, moistened with 0.5 mL of distilled water, was applied. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Approximately 1 hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined.
- Number of animals:
- 3 rabbits (2 females an 1 male animal)
- Details on study design:
- TEST SITE
- Area of exposure: On the day of the test a suitable test site was selected on the back of each rabbit.
- Type of wrap if used: Test material was introduced under a 2.5 x 2.5 cm gauze patch placed in position on the shorn skin. The patch was secured in position with a strip of surgical adhesive tabe. To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset.
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 hours after application the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in diethyl ether.
SCORING SYSTEM: After removal of the patches, the test sites were examined for evidence of primary irritation and scored according to the scale from DRAIZE (1959).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours after removal of the patches
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours after removal of the patches
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Very slight erythema was noted at two treated skin sites 1 hour after patch removal and persisted at one treated skin site at the 24 and 48 hours observations. All treated skin sites appeared normal at the 72-hour observation.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material did not produce positive criteria in any rabbit according to the EEC labelling regulations and was classified as non-irritant to rabbit skin.
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