Registration Dossier
Registration Dossier
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EC number: 253-256-2 | CAS number: 36888-99-0
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 to guideline study with acceptable restrictions (incomplete documentation, 20 h occlusive treatment, 2 animals)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (occlusive treatment, 20 h treatment duration, 2 animals)
- Principles of method if other than guideline:
- standardized internal test method (BASF test)
- GLP compliance:
- no
Test material
- Reference substance name:
- 5,5'-(1H-isoindole-1,3(2H)-diylidene)dibarbituric acid
- EC Number:
- 253-256-2
- EC Name:
- 5,5'-(1H-isoindole-1,3(2H)-diylidene)dibarbituric acid
- Cas Number:
- 36888-99-0
- Molecular formula:
- C16H9N5O6
- IUPAC Name:
- 5,5'-(1H-isoindole-1,3(2H)-diylidene)dipyrimidine-2,4,6(1H,3H,5H)-trione
- Test material form:
- solid
- Details on test material:
- - Physical state: solid
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
-Source: Breeder
- Weight at study initiation: females: 3.21 and 3.22 kg
ENVIRONMENTAL CONDITIONS: not reported
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Concentration (if solution): 50 % aqueous solution - Duration of treatment / exposure:
- 20 h
- Observation period:
- 7 days
- Number of animals:
- 2
- Details on study design:
- Since irritation data are recommended for a 4 h skin exposition, results of the available 20 h exposition will serve as approximation.
TEST SITE
- Area of exposure: 2.5 x 2.5 cm (dorsal)
SCORING SYSTEM: Descriptive scores of the raw data have been converted to Draize numerical scores
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (2 animals)
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (2 animals)
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Other effects:
- orange substance residues (lasting 20 hrs)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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