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Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to guideline; under GLP conditions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPP 81-1 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1-(allyloxy)-2-methyl-1-oxopropan-2-yl 2-chloro-5-[3-methyl-2,6-dioxo-4-(trifluoromethyl)-3,6-dihydropyrimidin-1(2H)-yl]benzoate
EC Number:
603-837-5
Cas Number:
134605-64-4
Molecular formula:
C20H18ClF3N2O6
IUPAC Name:
1-(allyloxy)-2-methyl-1-oxopropan-2-yl 2-chloro-5-[3-methyl-2,6-dioxo-4-(trifluoromethyl)-3,6-dihydropyrimidin-1(2H)-yl]benzoate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Physical state: Solid (tan powder)
- Storage condition of test material: The test and control materials were stored at room temperature.

Test animals

Species:
rat
Strain:
other: Crl :CD®(SD)BR
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Recognised supplier.
- Age at study initiation: not reported
- Weight at study initiation: 208 to 232 g
- Fasting period before study: 17-20 hours prior to test material administration.
- Housing: the animals were separated by sex and group housed in screen-bottom stainless steel cages. (During the range-finding study, the animals were individually housed.)
- Diet (e.g. ad libitum): Certified diet from recognised supplier, provided ad libitum (except during fasting)
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 50 +/- 20%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 h light / 12 h dark

IN-LIFE DATES: From: To: 1995-07-06 to 1995-07-26

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: MC/T 80 [0.5% methylcellulose (w/v) and 0.1% Tween 80 (v/v)] to a concentration of 0.25 g/ml.
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.25 g/ml
- Amount of vehicle (if gavage): 20 ml/kg
- Justification for choice of vehicle: not reported
- Lot/batch no. (if required): not reported
- Purity: MC/T 80 [0.5% methylcellulose (w/v) and 0.1% Tween 80 (v/v)]

MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Starting dose selected based on the results of the range-finding test.
Doses:
Range-finding study: 500, 1000, 3000 and 5000 mg/kg of body weight.
Main test: 5000 mg/kg body weight.
No. of animals per sex per dose:
Range-finding study: 2
Main study: 10
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations and mortality checks for the definitive study animals were conducted at approximately 1, 2.5, and 4 hours after test or control material administration. Additional clinical observations and twice a day mortality checks (morning and afternoon) were conducted daily thereafter for 14 days. Body weights for both range-finding and definitive study animals were determined before test or control material administration (Day 0), at Day 7 and at termination of the in-life phase (Day 14).
- Necropsy of survivors performed: yes
Statistics:
No statistical analyses were performed.

Results and discussion

Preliminary study:
No mortalities were observed in the range-finding study and all animals exhibited the normal body weight gain.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities were observed.
Clinical signs:
All test animals appeared normal throughout the test period.
Body weight:
All animals exhibited normal body weight gain throughout the study.
Gross pathology:
There were no test material-related lesions observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: US EPA pesticides
Conclusions:
The acute oral median lethal dose (LD50) of the test material in male and female Crl :CD®(SD)BR strain of rat was estimated to be greater than 5000 mg/kg body weight.
Executive summary:

The study was performed to assess the acute oral toxicity of the test material in the Crl :CD®(SD)BR strain of rat. The study was performed to GLP and the method was designed to meet the requirements of EPA guideline 81-1. The test material was administered orally, after overnight fasting, once only by gavage, as a suspension in MC/T 80 [0.5% methylcellulose (w/v) and 0.1% Tween 80 (v/v)]. The test material concentration in the vehicle was 0.25 g/mL and the administered volume of suspension was 20 mL/kg body weight. Following a preliminary test in which an animal of each sex was dosed with the test material at 500, 1000, 3000 and 5000 mg/kg body weight, there was no mortality or signs of systemic toxicity. For the main test, 10 male and 10 female test animals were dosed at 0 and 5000 mg/kg body weight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy after an observation period of 14 days.

There were no deaths and no signs of systemic toxicity were observed. Animals showed expected gains in bodyweight during the study. No test-related abnormalities were noted at necropsy. The acute oral median lethal dose (LD50) of the test material in the male and female Crl:CD (SD) BR strain rat was estimated to be greater than 5000 mg/kg bodyweight.

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