Registration Dossier
Registration Dossier
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EC number: 947-995-6 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- An in vitro study was not performed as an in vivo test is already available
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 68439-64-5
- Test material form:
- solid: compact
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harald Schriever Kaninchenfarm, D-2740 Bremervörde
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: single caging in battery of cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C +- 2°C
- Humidity (%): 50 - 85 %
- Air changes (per hr): -
- Photoperiod (hrs dark / hrs light):12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 g
- Concentration (if solution): neat
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 24 h, 48 h, 72 h
- Number of animals:
- 6 rabbits
- Details on study design:
- TEST SITE
- Area of exposure: 6.25 cm²
- Type of wrap if used: rubber sleeve
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not specified
OBSERVATION TIME POINTS
(indicate if minutes, hours or days)
24 h, 48h, 72 h
On each rabbit two areas of the back were designated for the position of the patches. One of the areas was scarified by making epidermal incisions.
For evaluation the cumulative scores were averaged for both scarified and intact skin and were added together to calculate the primary irritation index.
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Rewopal V 2762 is not irritant to skin of rabbits.
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