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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:
supporting study
Study period:
1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, study with sufficient basic documentation to demonstrate that study meets basic scientific principles and contains enough detail to be able to judge the results reliable as a supporting study.

Data source

Reference
Reference Type:
publication
Title:
The lethal effects of ethanol and cocaine and their combination in mice: implications for cocaethylene formation.
Author:
Schechter, M. and Meehan, S.
Year:
1995
Bibliographic source:
Pharmacol Biochem Behav 52(1):245-248.

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The study examined the lethal effects of ethanol and cocaine and their use in combination by using percent mortality and the resultant LD50's as a measure of acute toxicity. The ethanol groups were the controls for the main experiment.
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): No data

Test animals

Species:
mouse
Strain:
other: HS
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 25 - 30 days old.
- Housing: Plexiglass cages with aspen shavings in a climate controlled room.
- Diet: ad libitum except during 2hr period post dosing.
- Water: ad libitum except during 2hr period post dosing.

ENVIRONMENTAL CONDITIONS
- Temperature and humidity climate controlled but not specified
- Photoperiod: 12 hour light/12 hour dark

NOTE: This strain is regarded as particularly suitable for testing with cocaine.

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
physiological saline
Doses:
- Doses: 6, 8 and 10 g/kg in 20% w/v solution in 0.9% physiological saline. A second injection of saline only was given immediately afterwards into the contralateral location (5ml/kg). This dose acted as the vehicle only control for the main experiments using cocaine.
- Doses per time period: One
- Exposure duration: not applicable.
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- After injection, animals monitored for 2 hours for indications of toxicity and lethality for close observation before returning to home cages. Death defined as an absence of respiration for 30s or more.
- Duration of observation period following administration: 24 hours before sacrifice.
Statistics:
Calculation of LD50 using a computerised version of the Litchfield-Wilcoxon analysis (

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LC50
Effect level:
9 450 mg/kg bw
95% CL:
> 8 450 - < 10 490
Sex:
male
Dose descriptor:
LD50
Effect level:
9 710 mg/kg bw
95% CL:
> 8 380 - < 11 270
Mortality:
All deaths occurred within 30 minutes. Individual times of death were not given.
Clinical signs:
Description, severity, time of onset and duration of clinical signs at each dose level were not described.
Other findings:
- Potential target organs: not discussed.
- Necropsy findings, included doses affected, severity and number of animals affected: not done.

Any other information on results incl. tables

The LD50 values were 838 to 1127 (9.71 g/kg) in males and 8.45 to 1049 g/kg (9.45 g/kg) in females.

Applicant's summary and conclusion

Executive summary:

A study established that the LD50 of ethanol in mice when given by the ip route is 9710mg/kg for males and 9450mg/kg for females.