[1,2,4]Triazolo[1,5-a]pyrimidine-2-sulfonamide, N-(2,6-difluorophenyl)-5-methyl-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 20 June 1988 to 5 August 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPP 81-1 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-(2,6-difluorophenyl)-5-methyl-[1,2,4]triazolo[1,5-a]pyrimidine-2-sulfonamide

EC Number:

619-383-6

Cas Number:

98967-40-9

Molecular formula:

C12H9F2N5O2S

IUPAC Name:

N-(2,6-difluorophenyl)-5-methyl-[1,2,4]triazolo[1,5-a]pyrimidine-2-sulfonamide

Constituent 2

Reference substance name:

N-(2',6'-difluorophenyl)-5-methyl[1,2,4]triazolo[1,5-a]pyrimidine-2-sulfonamide

IUPAC Name:

N-(2',6'-difluorophenyl)-5-methyl[1,2,4]triazolo[1,5-a]pyrimidine-2-sulfonamide

Details on test material:

- Name of test material (as cited in study report): XRD-498

- Physical state: white powder
- Analytical purity: 99.6%

- Lot/batch No.: AGR 240043

Test animals

Species:

rat

Strain:

Fischer 344

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratories Inc., Kingston, New York

- Fasting period before study: fasted the night before treatment
- Housing: two or three per cage
- Diet (e.g. ad libitum): Purina certified rodent chow #5002, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: one week

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: corn oil:acetone

Details on oral exposure:

5 rats per sex received 5000 mg of test material per kg body weight by single dose gavage. The test material was administered as a 50% suspension in corn oil:acetone (9:1). All animals were fasted the night before treatment. Feed was provided to all rats following administration of the test material.

Doses:

5000 mg of test material per kg body weight

No. of animals per sex per dose:

5 rats per sex received 5000 mg of test material per kg body weight by single dose gavage

Control animals:

not specified

Details on study design:

Five rats per sec recieved 5000 mg of test material per kg body weight by single-dose gavage. The test material was administered as a 50% suspension in corn oil:acetone. All animals were fasted the night before treatment. Feed was provided to all rats following administration of the test material. Careful clinical observations were made once each working day, and recorded. Each animal was weighed the day of treatment and on test days 2, 8, and 15.

Statistics:

Means and standard deviations of body weights were calculated, and statistical outliers were evaluated.

Results and discussion

Preliminary study:

no information

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality.

Clinical signs:

other: All rats were in apparent good health throughout the study.

Gross pathology:

No gross pathologic changes in any of the rats at necropsy

Other findings:

no information

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: US EPA pesticides

Conclusions:

Under conditions of this study, the acute oral LD50 of XRD-498 was greater than 5000 mg/kg. Based on these results, the acute oral toxicity of XRD-498 was categorized as extremely low.

Executive summary:

XRD-498 was evaluated for acute oral toxicity in Fischer 344 rats. Five rats per sex recieved 5000 mg/kg of XRD-498 by single dose gavage. Parameters examined during the two week observation period included body weights and in-life clinical observations. All animals were examined for gross pathologic observations. All animals survived the 5000 mg/kg limit test established by the guidelines and therefore no other dose level was tested. All animals were in apparent good health throughout the study termination. There were no gross pathologic changes in any of the rats at necropsy. Under the conditions of this study, the acute oral LD50 or XRD-498 was greater than 5000 mg/kg. Based on these results, the acute oral toxicity of XRD-498 was categorized as extremely low.