2-nitropropane

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was comparable to a guideline but was non-GLP.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Comparable to a guideline. Groups of mice and rats were exposed for a-single six hour period to various vapor concentrations of 2-nitropropane (P-1357) and observed for a 14-day period. Mortality was recorded and the lethal concentration required to produce 50% mortality estimated (LC50).

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 commercial grade. Therefore, it is assumed that it is of fairly high purity.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Animals: Sprague-Dawley rats (145-194 g) were used in the study. Food and water were supplied ad libitum (except for during exposure, when they were withheld).

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

The test material was vaporized at ambient temperature. Nitrogen was passed through a scintered glass sparger into a tube containing the test material (30 ml) at a variable rate (100-250 cc/min). The stream was admixed with "breathing air" (6.2 liters/min) and passed to a 36.2 liter, glass inhalation chamber. Vapor concentration was monitored continuously using an infrared spectrophotometer.

Analytical verification of test atmosphere concentrations:

yes

Remarks:

Vapor concentration was monitored continuously using an infrared spectrophotometer.

Duration of exposure:

6 h

Concentrations:

Concentrations tested in groups of 8 males were 367, 405, 461 and 574 ppm. Groups of 10 females were exposed to 370, 416, 464, 602 and 805 ppm.

No. of animals per sex per dose:

8 males and 10 females, controls (8/sex)

Control animals:

yes

Details on study design:

The animals were exposed to test material for 6 hours and observed for a period of 14 days. Concentrations tested in groups of 8 males were 367, 405, 461 and 574 ppm. Groups of 10 females were exposed to 370, 416, 464, 602 and 805 ppm. Groups of control animals (N= 8 for both sexes) were exposed similarly, with the exception that water was substituted for test material in the vaporizer tube. Deaths were recorded daily and signs of toxicity were recorded at unlisted intervals. Survivors were euthanized at 14 days. Necropsies were performed on animals (including those that died prematurely). The LC50 value was estimated using the method of Miller and Tainter (Proc. Soc. Exper. Biol. Med. 57:261, 1944).

Statistics:

None

Results and discussion

Preliminary study:

None

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LC50

Effect level:

400 ppm

Exp. duration:

6 h

Effect levels 2

Sex:

female

Dose descriptor:

LC50

Effect level:

720 ppm

Exp. duration:

6 h

Mortality:

Males: None of the controls or males exposed to 367 (+/- 6) ppm died. Five males exposed to 405 (+/- 11) ppm died (3 on day 2 and 2 on day 3). Seven males exposed to 461 (+/- 13) ppm died by day 2. All eight males exposed to 574 +/- 28 ppm died within 2 days.

Females: None of the controls or animals exposed to 370 +/- 10, 416 +/- 29, 464 +/- 22, or 602 +/- 11 ppm died. Eight out of 10 rats exposed to 805 +/- 37 ppm died within 2 days.

Clinical signs:

other: Males: Animals moved about the chambers immediately upon exposure, followed by slight depression and hyperventilation. Cyanosis was observed in animals exposed to concentrations > = 405 ppm. Females: Animals moved about the chambers immediately upon ex

Body weight:

Males: Weight gain of survivors did not appear to be affected by treatment.
Females: Weight gain of animals exposed to concentrations < = 602 ppm did not appear to be affected by treatment. The females that survived exposure to 805 ppm did not gain weight over the course of the study.

Gross pathology:

Males and females- Necropsies were unremarkable.

Other findings:

Males: The LC50 value was 400 +/- 38 ppm.
Females: The LC50 value was 720 +/- 46 ppm.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category II

Remarks:

Migrated information Based on LC50 value for males (400 ppm vapor or 1.5 mg/L). Criteria used for interpretation of results: other: EU GHS

Conclusions:

The LC50 value for male and female rats was 400 +/- 38 ppm and 720 +/- 46 ppm, respectively.

Executive summary:

None