Registration Dossier
Registration Dossier
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EC number: 429-600-4 | CAS number: 1026988-42-0
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 guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): Basazol Gelb 8511
- Physical state: powder
- Analytical purity: 96 %
- Lot/batch No.: 6123 V. 6781
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Savo; Med Versuchstierzuchten GmbH; Kisslegg
- Weight at study initiation: 2.2 (female) - 2.41(male) kg
- Housing:cage made of stainless steel with wire mesh walk floor; floor area 40 cm X 51 cm
- water:250 ml/d tap water
- Acclimation period: at least 8 days before the beginning of the study; same housing conditions as during the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): central air conditioning guaranteed a range of 20 -24 degrees celsius
- Humidity (%): 30 - 70 % relative humidity
- Photoperiod (hrs dark / hrs light): 12 h/12 h (6.00 - 18.00 hours/ 18.00 - 6.00 hours)
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin sites of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied : 0.5 ml
- Duration of treatment / exposure:
- Exposure period: 4 h
- Observation period:
- 72 h
- Number of animals:
- 2 male; 1 female
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): at the end of th exposure period with Lutrol and Lutrol/water (1:1)
SCORING SYSTEM:
OECD Draize Score
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 4- 24- 48 - 72 h
- Score:
- 0.1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 4 - 24 -48 - 72 hours
- Score:
- 0
- Max. score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Classification: not irritating
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