Registration Dossier
Registration Dossier
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EC number: 939-698-5 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions. Lack of details of test material.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- lack of details on test material
- GLP compliance:
- no
Test material
- Details on test material:
- - Name of test material (as cited in study report): trade name
- Physical state: liquid
- Analytical purity: no data
- Lot/batch No.: no data
- Storage conditions: no data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach/Main, Germany
- Weight at study initiation: 3.63 kg (males) and 3.25 kg (females)
- Housing: animals were housed individually in stainless steel cages with shelves
- Diet: Ovator Solikanin 4 mm (Muskator-Werke, Düsseldorf, Germany), 130 g/d for each animal
- Water: VE water (tap water at the weekend), 250 mL/d for each animal
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 8 days
Reading time points: 30-60 min, 24, 48, 72 and 8 days - Number of animals:
- 2 males and 1 female
- Details on study design:
- TEST SITE
- Area of exposure: 6.25 cm²
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test substance was removed with lutrol and lutrol/water (1:1)
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- No skin reactions were observed during the study period.
- Other effects:
- No further local or systemic effects were observed.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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