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Toxicological information

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:
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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
In-life observations were progressive unsteadiness, weakness, incoordination ending in ataxia. Narcotic action was noted.
Body weight:
Body weight not reported
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
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  0/5   0/5   0/5   0/5   0/5   0/5   0/5 
 800  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