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Toxicological information

Acute Toxicity: other routes

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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 levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
15.8 mL/kg bw
95% CL:
14.6 - 17.2
Remarks on result:
other: Mice
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.