Propylene carbonate

Acute Toxicity: other routes

Administrative data

Endpoint:

acute toxicity: other routes

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study is presented in a Japanese journal with english abstract. Handwritten translation included. Journal not identified.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1972

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The LD50 in rats and mice after a single subcutaneous injection of the test substance was determined.

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Propylene carbonate

EC Number:

203-572-1

EC Name:

Propylene carbonate

Cas Number:

108-32-7

Molecular formula:

C4H6O3

IUPAC Name:

4-methyl-1,3-dioxolan-2-one

Test material form:

liquid

Specific details on test material used for the study:

- Name of test material (as cited in study report): propylene carbonate
- Stability under test conditions: Forms a stable solution in water
- Other: Colorless (transparent)

Test animals

Species:

other: Mouse and rat

Strain:

other: dd-strain mice and Wistar strain rats

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: Approximately 20 g (mice); 180 g (rats)
- Diet: Properly fed for 7 days. During the experiment, food was provided ad libitum.
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23-27 C

Administration / exposure

Route of administration:

subcutaneous

Vehicle:

unchanged (no vehicle)

Details on exposure:

Animals were given one injection and observed for 72 hours after treatment.

Doses:

- Mice: 9.6, 11.6, 13.9, 16.7, or 20.0 mL/kg
- Rats: 6.7, 8.0, 9.6, 11.6, 13.9, 16.7, or 20.0 mL/kg

No. of animals per sex per dose:

10 males/dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 72 hours
- Necropsy of survivors performed: yes

Statistics:

LD50 was calculated according to the method of Van der Waerden.

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

15.8 mL/kg bw

95% CL:

14.6 - 17.2

Remarks on result:

other: Mice

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

11.1 mL/kg bw

95% CL:

10.3 - 11.9

Remarks on result:

other: Rats

Mortality:

Mice: No animals in the 9.6 or 11.6 mL/kg groups died. In the 13.9 mL/kg group, 3 animals died, all at 12 hours. In the 16.7 mL/kg group, 1 animal died at hour 1 and 4 more died at hour 12. In the high dose group (20.0 mL/kg), all animals died, 4 at hour 1 and the remaining 6 animals at hour 12.
Rats: No animals died in the 6.7 and 8.0 ml/kg groups. In the 9.6, 11.6, 13.9, and 16.7 ml/kg groups, 1, 8, 9, and 10 animals, respectively, died at hour 12; no additional deaths occurred. In the high dose group (20.0 mL/kg), 2 animals died at hour 1 and the remaining 8 died at hour 12.

Clinical signs:

Decreased activity was generally observed

Applicant's summary and conclusion

Conclusions:

The male rat subcutaneous LD50 was determined to be 11.1 mL/kg.
The male mouse subcutaneous LD50 was determined to be 15.8 mL/kg.