Registration Dossier
Registration Dossier
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EC number: 250-063-5 | CAS number: 30125-47-4
Eye irritation
Administrative data
- Endpoint:
- eye 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:
- incomplete documentation, 50 mg application amount, number of animals
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 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- reduced application volume, 72 h scoring not performed, number of animals
- 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 / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: 2.91 kg (female), 2.51 kg (male)
ENVIRONMENTAL CONDITIONS: not reported
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: talcum (amorph) into the other eye
- Amount / concentration applied:
- 50 mg of test substance (100%)
- Duration of treatment / exposure:
- Single exposure without washing of the eyes
- Observation period (in vivo):
- 8 days (day 0, 1, 2, 5, 7 and 8)
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: No
SCORING SYSTEM: Evaluation was carried out according to the Draize scoring system
TOOL USED TO ASSESS SCORE: Fluorescein at the end of the observation period
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- (2 animals)
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- (2 animals)
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- (2 animals)
- Time point:
- 24/48 h
- Score:
- 0.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- (2 animals)
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- In the control eyes slight effects were seen, but these were fully reversible within 48 h
- Other effects:
- Yellow compound residues
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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