Registration Dossier

Diss Factsheets

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:
2010

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

Constituent 1
Chemical structure
Reference substance name:
3,3'-(1,4-Phenylene)bis(5,6-diphenyl-1,2,4-triazine)
EC Number:
700-823-1
Cas Number:
55514-22-2
Molecular formula:
C36H24N6
IUPAC Name:
3,3'-(1,4-Phenylene)bis(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

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:
No clinical signs at both doses
Body weight:
See in table 3 of attached study report
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.