Registration Dossier
Registration Dossier
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EC number: 250-063-5 | CAS number: 30125-47-4
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:
- comparable to guideline study with acceptable restrictions
- Remarks:
- occlusive, 20 h treatment, 2 animals, diluted substance (50%)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
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
- Remarks:
- performed prior to the implementation of GLP
Test material
- Reference substance name:
- 3,4,5,6-tetrachloro-N-[2-(4,5,6,7-tetrachloro-2,3-dihydro-1,3-dioxo-1H-inden-2-yl)-8-quinolyl]phthalimide
- EC Number:
- 250-063-5
- EC Name:
- 3,4,5,6-tetrachloro-N-[2-(4,5,6,7-tetrachloro-2,3-dihydro-1,3-dioxo-1H-inden-2-yl)-8-quinolyl]phthalimide
- Cas Number:
- 30125-47-4
- Molecular formula:
- C26H6Cl8N2O4
- IUPAC Name:
- 4,5,6,7-tetrachloro-2-[2-(4,5,6,7-tetrachloro-1,3-dioxo-2,3-dihydro-1H-inden-2-yl)quinolin-8-yl]-1H-isoindole-1,3(2H)-dione
- Test material form:
- solid: nanoform
- Details on test material:
- - Physical state/ appearance: solid / yellow
- Shape of particles: spherical
- Aspect ratio: 1.5
- Particle size distribution: 62.7 nm
- Crystal structure: crystalline
- Surface area of particles: 29.6 m^2/g
- Surface treatment: no
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
-Source: Gaukler
- Weight at study initiation: female: 3.17 kg, male: 3.68 kg
ENVIRONMENTAL CONDITIONS: not reported
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- other: untreated site of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Concentration (if solution): 50 % aqueous solution
- Amount applied: no data
VEHICLE
- dest. water - Duration of treatment / exposure:
- 20 h
- Observation period:
- 8 days (24, 48 and 72 h and day 6 and 8 after exposure)
- Number of animals:
- 2
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: cotton pad
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water (possibly containing mild detergent)
- Time after start of exposure: 20 h
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:
- erythema score
- Basis:
- mean
- Remarks:
- (2 animals)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (2 animals)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Other effects:
- Yellow substance residues after 24 h and 8 days in both animals. Slight scaling was observed in one animal during observation period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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