2-nitropropane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1960

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study was conducted prior to GLP and Test Guidelines, but sufficient data is available for interpretation of results

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1960

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Oral LD50 test: Groups of rats were exposed to a single oral dose of 2-nitropropane (P-1357) and observed for a 7-day period. Mortality was recorded and the lethal concentration required to produce 50% mortality estimated (LD50).

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-nitropropane

EC Number:

201-209-1

EC Name:

2-nitropropane

Cas Number:

79-46-9

Molecular formula:

C3H7NO2

IUPAC Name:

2-nitropropane

Details on test material:

Purity of the material was not listed. The test material was assumed to be commercial grade. Therefore, it is assumed that it is of fairly high purity.

Test animals

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

Rats of unspecified strain and sex. Weight ranged from 150 to 180 grams.

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

water

Details on oral exposure:

100 and 400 mg/ml stock solutions were prepared in water.

Doses:

100, 200, 400, 800, and 1200 mg/kg bw

No. of animals per sex per dose:

5 rats of unspecified sex per dose

Control animals:

no

Details on study design:

Oral LD50 test: 5 rats/dose were orally administered 100, 200, 400, 800, and 1200 mg/kg of 2-nitropropane. The animals were observed for 7 days after dosing.
Based on the morality at different levels, the oral LD0, LD50 and confidence limit, and LD100 were estimated.

Statistics:

None

Results and discussion

Preliminary study:

No data

Effect levels

Sex:

not specified

Dose descriptor:

LD50

Effect level:

565 - 885 mg/kg bw

Mortality:

100 mg/kg group = 0/5, 200 mg/kg group = 0/5, 400 mg/kg group = 0/5, 800 mg/kg group = 3/5, and 1200 mg/kg group = 5/5

Clinical signs:

other: In-life observations were progressive unsteadiness, weakness, incoordination ending in ataxia. Narcotic action was noted.

Gross pathology:

Two hours after ingestion: 1 rat dosed at 800 mg/kg level, unable to move around in cage, breathing is irregular. Eighteen hours after ingestion: 1 dead. Post-mortem results: lungs = Hemorrhaged; liver = dark areas; spleen = has a large dark spot; kidneys = spotted; stomach = gassous and contains gray fluid; and intestines = have bloody fluid.
Two more deaths occurred after 48 hours. Post-mortem results, generally same as above.

Other findings:

None

Any other information on results incl. tables

mg/kg	No. of Rats	1	2	3	4	5	6	7
100	5	0/5	0/5	0/5	0/5	0/5	0/5	0/5
200	5	0/5	0/5	0/5	0/5	0/5	0/5	0/5
400	5	0/5	0/5	0/5	0/5	0/5	0/5	0/5
800	5	1/5	3/5	3/5	3/5	3/5	3/5	3/5
1200	5	5/5

Applicant's summary and conclusion

Interpretation of results:

other: Category 4

Remarks:

Criteria used for interpretation of results: other: EU GHS

Conclusions:

The oral LD50 in rats is 725 +/- 160 mg/kg/day

Executive summary:

Oral LD50 test: 5 rats/dose were orally administered 100, 200, 400, 800, and 1200 mg/kg of 2-nitropropane wtih water as the vehicle. The animals were observed for 7 days after dosing. Post-mortem examinations were performed.

Based on the morality at different levels, the oral LD0, LD50 and confidence limit, and LD100 were estimated. The LD0 was 400 mg/kg; the LD50 was approximately 725 +/- 160 mg/kg, and the LD100 was 1200 mg/kg