Nitrapyrin

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

26 January 1962 to 09 February 1962

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Study conducted to sound scientific principles with a sufficient level of detail to assess the quality of the submitted data. The data have been assigned a reliability score of 4 since the study was conducted with a non-standard species.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Remarks:

Study pre-dates GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Nitrapyrin

EC Number:

217-682-2

EC Name:

Nitrapyrin

Cas Number:

1929-82-4

Molecular formula:

C6H3Cl4N

IUPAC Name:

2-chloro-6-(trichloromethyl)pyridine

Test material form:

not specified

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Fasting period before study: animals were deprived of food for 15 hours prior to test material administration

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

TEST MATERIAL ADMINISTRATION
Animals received a single dose of test material by oral gavage. The test material was delivered using a calibrated syringe and a suitable rubber catheter.

VEHICLE
Test material was administered as a 39.8 % solution in the vehicle.

Doses:

252, 500, 1000, 2000, 3980 mg/kg

No. of animals per sex per dose:

5 males per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were weighed before dosing, the following day and at weekly intervals for two weeks thereafter. They were observed periodically for signs of toxicity. Pathological observation is made on representative animals.
- Necropsy of survivors performed: no

Statistics:

The LD50 was calculated by the Weil modifications of the method of Thompson (Weil, C.S. Biometrics, 8:343, 1952)

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

< 252 other: mg/kg

Based on:

test mat.

Mortality:

3 of the 5 animals dosed with 252 or 500 mg/kg test material and all animals dosed with 1000, 2000 or 3980 mg/kg test material died within the first week following test material administration.

Clinical signs:

other: No signs of toxicity were noted.

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

Under the conditions of the study, the acute oral LD50 of the test material was determined to be less than 252 mg/kg when dosed to male Hartley guinea pigs.

Executive summary:

The acute oral toxicity of the test material was investigated in a study which was conducted to a method largely relating to that which is outlined in the standardised guideline OECD 401.

During the study, groups of 5 male Hartley guinea pigs received a single dose of test material, by gavage, as a 39.8 % solution in corn oil. Dosage levels were 252, 500, 1000, 2000 and 3980 mg/kg. Animals were weighed before dosing, the following day and weekly thereafter. They were also observed periodically, over the two weeks post-test material administration, for signs of toxicity.

3 of the 5 animals dosed with 252 or 500 mg/kg test material and all animals dosed with 1000, 2000 or 3980 mg/kg test material died within the first week following test material administration. No signs of toxicity were noted.

Under the conditions of the study, the acute oral LD50 of the test material was determined to be less than 252 mg/kg when dosed to male Hartley guinea pigs.