Registration Dossier
Registration Dossier
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EC number: 250-063-5 | CAS number: 30125-47-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- very brief documentation
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 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- application volume exceeds 20 mL/kg bw; 7 days observation period
- GLP compliance:
- no
- Remarks:
- performed prior to the implementation of GLP
- Test type:
- standard acute method
- Limit test:
- yes
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:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gassner
- Mean weight at study initiation: males: 229 g (208-246 g); females: 170 g (165-171 g)
ENVIRONMENTAL CONDITIONS: Not reported
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5% aqueous solution
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 35 % suspension in 0.5 % aqueous CMC solution - Doses:
- 10000 mg/kg bw (28.5 mL/kg bw)
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of weighing: day 1, 5 and 8
- Observation of clinical signs: on the day of administration and once daily afterwards (on working days)
- Necropsy of survivors performed: yes - Statistics:
- not performed
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality occurred.
- Mortality:
- No mortality was observed
- Clinical signs:
- other: Yellow faeces
- Gross pathology:
- No abnormalities were observed
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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