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EC number: 700-823-1 | CAS number: 55514-22-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study not performed according to GLP, but carried out in a quality environment and in repect of internal standard operating procedures, checked by regular Quality Assurance audits, and according to OECD 423 guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- But audited by Quality Assurance
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 3-[4-(5,6-diphenyl-1,2,4-triazin-3-yl)phenyl]-5,6-diphenyl-1,2,4-triazine
- EC Number:
- 700-823-1
- Cas Number:
- 55514-22-2
- Molecular formula:
- C36H24N6
- IUPAC Name:
- 3-[4-(5,6-diphenyl-1,2,4-triazin-3-yl)phenyl]-5,6-diphenyl-1,2,4-triazine
- Details on test material:
- - Name of test material (as cited in study report): WP30
- Substance type: monoconstituent substance
- Physical state: powder
- Analytical purity: 99.6 % by HPLC
- Purity test date: 23rd December 2009
- Lot/batch No.: LP110
- Stability under test conditions: stable
- Storage condition of test material: room temperature, in a dark and dry place
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
Nulliparous and not pregnant female rats
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: between 8 and 12 weeks
- Weight at study initiation: 193 to 214 g
- Fasting period before study: overnight (at least 17 hours)
- Housing: 3 rats per cage from allocation to each step
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 30 to 70 %
- Air changes (per hr): at least 10 full air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: a solution of substance was obtained
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: 300 mg/kg was chosen according to OECD guideline, in absence of data - Doses:
- 300 mg/kg
2000 mg/kg - No. of animals per sex per dose:
- 3 females per dose and per step (2 steps at 300 mg/kg, 2 steps at 2000 mg/kg)
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Morbidity and mortality: twice from day 1 to the end of the observation period
Clinical signs: at least after 30 min, 1h, 3h, 4h, 6h, and then twice daily for 14 days
Body weight: day 1 before dosing and then on days 3, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: thoracic, abdominal (particularly the stomach) and pelvic cavities examination, with their associated organs and tissues
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No effect so no statistics
- Mortality:
- No mortality observed at 300 and 2000 mg/kg bw
- Clinical signs:
- other: No clinical signs at both doses
- Gross pathology:
- None
- Other findings:
- None
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Since no dose resulted in mortality, the LD50 was estimated to be higher than 2500 mg/kg.
- Executive summary:
The objective of the study was to evaluate the potential acute toxicity of WP30 when administered once orally, by gavage in female Wistar rats followed by 14 days of observation.
A stepwise procedure was used, with a maximum of 2 steps per dose-level; each step using 3 animals aged 8 to 12 weeksat the time of dosing. The starting dose was fixed at 300 mg/kg; 2000 mg/kg was then tested because of absence of mortality at 300 mg/kg. For both dose-levels, 2 steps were performed.
WP30 was mixed with corn oil and administered at a dosing volume of 10 mL/kg.
Parameters evaluated included mortality, and clinical signs which were recorded twice daily. Body weights were measured on days 1, 3, 8 and 15, and necropsy findings noted for all animals on day 15.
No mortality occured and no abnormal clinical sign was observed at either dose-leveel.
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