Registration Dossier
Registration Dossier
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EC number: 432-690-8 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Analogue substance tested; GLP study using standard method
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: 92/69/EEC, B4
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:D. Percival, Mosto Cheshire, UK
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2,53 -2,88 kg
- Housing:individual
- Diet (e.g. ad libitum): ad- lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: >5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-21 C
- Humidity (%): 49-69
- Air changes (per hr) : 15
- Photoperiod (hrs dark / hrs light): 12 /12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- Substance applied as supplied moistened with distilled water
- Controls:
- not required
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 3 d
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6,25 cm²
- Type of wrap if used: cotton gauze + surgical adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 4h
SCORING SYSTEM: Draize scale (Draize J.H. "Dermal and eye toxicity tests" In: Principles and procedures for evaluating the toxicity of household substances, National academy of sciences, Washington D.C.; USA 1977, p. 31)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Other effects:
- no
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information not classified Criteria used for interpretation of results: EU
- Conclusions:
- An analogue substance did not produce significant irritation responses in rabbits, Thus, the substanceis not expected to cause skin irritation.
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