Ethanol

Acute Toxicity: other routes

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

Test material information

Constituent 1

Reference substance name:

Ethanol

EC Number:

200-578-6

EC Name:

Ethanol

Cas Number:

64-17-5

Molecular formula:

C2H6O

IUPAC Name:

ethanol

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 or test system 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 levels

Effect levels 1

Sex:

female

Dose descriptor:

LC50

Effect level:

9 450 mg/kg bw

95% CL:

> 8 450 - < 10 490

Effect levels 2

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.