Registration Dossier
Registration Dossier
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EC number: 275-639-3 | CAS number: 71566-54-6
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- (only four rats used (2 male/2 female animals), no data on body weight gain)
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Diisopropyl 3,3'-[(2,5-dichloro-1,4-phenylene)bis[iminocarbonyl(2-hydroxy-3,1-naphthylene)azo]]bis[4-methylbenzoate]
- EC Number:
- 275-639-3
- EC Name:
- Diisopropyl 3,3'-[(2,5-dichloro-1,4-phenylene)bis[iminocarbonyl(2-hydroxy-3,1-naphthylene)azo]]bis[4-methylbenzoate]
- Cas Number:
- 71566-54-6
- Molecular formula:
- C50 H42 Cl2 N6 O8
- IUPAC Name:
- diisopropyl 3,3'-[(2,5-dichloro-1,4-phenylene)bis[iminocarbonyl(2-hydroxy-3,1-naphthylene)azo]]bis[4-methylbenzoate]
- Test material form:
- solid
- Details on test material:
- The test material is identified by its trade name.
Constituent 1
- Specific details on test material used for the study:
- - No. of test material (as cited in study report): 21825
- Physical state: maroon powder
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: in-house breeding
- Age at study initiation: 5-6 weeks
- Weight at study initiation: male average: 174 g, female average: 133 g
- Fasting period before study: 18 hours
- Housing: singly
- Diet (ad libitum): Labsure CRM rat and mouse diet
- Water (ad libitum): filtered water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25 %
- Amount of vehicle (if gavage): 20 ml/kg bw - Doses:
- 5 g/kg bw/day
- No. of animals per sex per dose:
- 2
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: neither mortality nor clinical signs indicative of toxicity were observed during the 14-day observation period.
- Mortality:
- No mortality occured.
- Clinical signs:
- other: Piloerection was seen in one female between 3 and 6 hours after compound administration. Red staining of the faeces was seen in all animals between 24 and 72 hours after administration. No abnormalities were noted from day 4 onwards.
- Gross pathology:
- No abnormalities were noted at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
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