Registration Dossier
Registration Dossier
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EC number: 700-323-3 | CAS number: 908020-52-0
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- other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Kannami Laboratory, Bozo Research Center Inc
Test material
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Japanese white
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Japan Laboratory animals inc
- Age at study initiation: 17 or 18 weeks
- Weight at study initiation: 3.16 - 3.59 kg
- Housing: Aluminium cages (Nihon Cage Co Ltd) with wire mesh bottoms
- Diet (e.g. ad libitum): Free access to RC4 pelleted dies
- Water (e.g. ad libitum): Free access to tap water (Fujimi Water Union) via automatic water supply system
- Acclimation period: 12 - 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 24°C
- Humidity (%): 50 - 76%
- Air changes (per hr): 11 - 14
- Photoperiod (hrs dark / hrs light): 12 hours
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 3 minutes to 4 hours
- Observation period:
- up to 6 days
- Number of animals:
- 3
- Details on study design:
- In this study 0.5 g of the test substance was applied to a lint sheet (2.5 x 2.5 cm) and moistened by 0.5 ml of water for injection and then it was applied to the clipped dorsal skin of rabbits for 3 minutes, 1 hour or 4 hours. Animals were observed periodically for dermal reactions including the corrosion reactions according to the Draize method.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.2
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Basis:
- animal: 1101, 1102 and 1103
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal: 1101, 1102 and 1103
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no edema observed through observation period
- Other effects:
- None observed.
Applicant's summary and conclusion
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