Registration Dossier
Registration Dossier
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EC number: 229-388-1 | CAS number: 6505-28-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- The publication by MHLW does not contain the GLP statement.
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 2,2'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-N-phenylbutyramide]
- EC Number:
- 229-388-1
- EC Name:
- 2,2'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-N-phenylbutyramide]
- Cas Number:
- 6505-28-8
- Molecular formula:
- C34H32N6O6
- IUPAC Name:
- 2,2'-[(3,3'-dimethoxybiphenyl-4,4'-diyl)didiazene-2,1-diyl]bis(3-oxo-N-phenylbutanamide)
- Test material form:
- solid: particulate/powder
- Details on test material:
- Pigment orange 16 (hereinafter abbreviated as PO16) was used as a test substance. It is also called “Disazo orange” and its name in English is C. I. Pigment Orange 16 having CAS No. 6505-28-8, molecular weight 620.66 and molecular formula C34H32N6O6.
Purity: 99 wt% or higher
The provided test substance contained a water-soluble compound (NaCl) 0.18% as impurity
For this specific material, a particle size characterization is not available.
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Pigment Orange 16
- Physical state: orange powder
- Analytical purity: > 99 wt %
- Impurities (identity and concentrations): 0.18 % NaCl
- Storage condition of test material: at room temperature
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Tsukuba Breeding Center, Charles River Laboratories Japan Inc.
- Age at study initiation: 5 weeks
- Weight at study initiation: males: 119.3 - 132.8 g; females: 109.4 - 119.2 g
- Fasting period before study: yes, food was withdrawn ca. 18 hours before start of administration.
- Housing: individually in metal wire-mesh flooring cage (220 w x 270 d x 190 h mm)
- Diet: ad libitum (CE-2, Clea Japan, Inc.)
- Water: ad libitum (tap water supplied by Hadano City Waterworks Bureau)
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23.5 - 25
- Humidity (%): 51 - 65
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 10 w/v %
- Amount of vehicle (if gavage): 20 mL/kg
- Justification for choice of vehicle:
- Lot no.: V8P7069
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- not needed
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality was observed.
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: No clinical findings were observed.
- Gross pathology:
- No effects were found on autopsy findings.
- Other findings:
- Mucous feces attributable to the administration of corn oil were observed in controls on the administration day and orange colored feces in both sexes of the treated group on the next day.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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