Registration Dossier
Registration Dossier
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EC number: 434-080-7 | CAS number: 208343-47-9
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
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: Elevage Scientifique des Dombes, Chatillon sur Chalaronne / France
- Age at study initiation: 15 weeks (male), 16 weeks (females)
- Weight at study initiation: 2793 g (male), 2722 g (female), 2716 g (female)
- Housing: individually
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 65/99).
- Water (e.g. ad libitum): Community tap water from FuUinsdorf, ad libitum
- Acclimation period: al least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 hours / 12 hours
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 h
- Observation period:
- through 72 hours after treatment
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin was flushed with lukewarm tap water
SCORING SYSTEM: Draize Scoring System
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No signs of irritation were observed after 24 h, 48 h and 72 h of semiocclusice dermal application of the test substance onto the shaved skin of New Zealand White rabbits.
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