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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From August 24, 2011 to September 9, 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to OECD Guideline 425 and OPPTS 870.1100, in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
up-and-down procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-phenyl-5-(2-thienyl)-1,2,4-oxadiazole
EC Number:
810-533-8
Cas Number:
330459-31-9
Molecular formula:
C12H8N2OS
IUPAC Name:
3-phenyl-5-(2-thienyl)-1,2,4-oxadiazole
Test material form:
other: Cream coloured solid
Details on test material:
- Name of test material (as cited in study report): MON 102100

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories
- Age at study initiation: 9 weeks
- Weight at study initiation: 160-171 grams
- Fasting period before study: Fasted overnight
- Housing: Singly housed in suspended stainless steel caging with mesh floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 or 9 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23°C
- Humidity (%): 57-85%
- Air changes (per h): 15
- Photoperiod (h dark / h light): 12 h light/dark cycle

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 30% w/w
- Preliminary solubility testing indicated that mixtures in excess of 30% (i.e., 40 to 80%) were too viscous to be administered properly
Doses:
5,000 mg/kg
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Individual body weights of the animals were recorded on Days 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: All animals were observed for mortality, signs of gross toxicity, and behavioural changes during the first several hours post-dosing and at least once daily thereafter for 14 d after dosing. Observations included gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, and coma. All rats were euthanized via CO2 inhalation at the end of the 14 d observation period. Gross necropsies were performed on all animals. Tissues and organs of the thoracic and abdominal cavities were examined

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed
Clinical signs:
No signs of gross toxicity, adverse pharmacologic effects, or abnormal behaviour were observed.
Body weight:
All animals survived test substance administration gained body weight.
Gross pathology:
No gross abnormalities were noted for any of the animals when necropsied.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, the acute oral LD50 of the test substance was >5,000 mg/kg bw in female rats.
Executive summary:

A study was conducted to assess the acute oral toxicity of the test substance in rats according to OECD Guideline 425 and OPPTS 870.1100. The test substance was administered by gavage to overnight fasted female rats. An initial limit dose of 5,000 mg/kg was administered to one healthy animal. Due to the absence of mortality in this animal, two additional animals received the same dose level, simultaneously. Since these animals survived, no additional animals were tested. All animals were observed for mortality, signs of gross toxicity, and behavioural changes at least once daily for 14 d after dosing. Body weights were recorded prior to test substance administration and then on Day 7 and 14 (termination). Necropsies were performed at terminal sacrifice. All animals survived, gained body weight and appeared active and healthy during the study. There were no signs of gross toxicity, adverse pharmacologic effects, or abnormal behaviour. No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14 d observation period. Based on the results of the study, the acute oral LD50of the test substance was >5,000 mg/kg bw in female rats (Durando J, 2011a).