Ephedrine hydrochloride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: BASF method, similar to OECD 423; non GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Principles of method if other than guideline:

Method: other: BASF test

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ephedrine hydrochloride

EC Number:

200-074-6

EC Name:

Ephedrine hydrochloride

Cas Number:

50-98-6

Molecular formula:

C10H15NO.ClH

IUPAC Name:

2-(methylamino)-1-phenylpropan-1-ol hydrochloride

Constituent 2

Reference substance name:

(-)-Ephedrin-Hydrochlorid

IUPAC Name:

(-)-Ephedrin-Hydrochlorid

Details on test material:

- Name:(-)-Ephedrin-Hydrochlorid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

0.5% aquaeous CMC solution

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

215; 316; 464; 681; 1000 mg/kg bw

No. of animals per sex per dose:

5 rats

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
weighing: before application; 2nd -4th day; 7th day and 13th day after application.
observations: < 15'; 15'; 30'; 1 h; 2 h; 4 h; 5 h after application.
Thereafter, at least once daily.
- Other examinations performed: clinical signs, body weight

Statistics:

LD50 value calculations based on method of "Finney, D.J., Probit Analysis, Cambridge University Press, 3. Aufl., 1971".

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

710 mg/kg bw

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

514 mg/kg bw

Effect levels 3

Sex:

female

Dose descriptor:

LD50

Effect level:

1 235 mg/kg bw

Mortality:

215 mg/kg bw dose level:
No mortalities among male and female rats.

316 mg/kg bw dose level:
1 male and 1 female rat died within the first day after application.

464 mg/kg bw. dose level:
1 male animal died within the first day after application.
No mortality among female rats was observed at this dose level.

681 mg/kg bw dose level:
4 Male rats died within 4 days after application.
No mortality among female rats was observed at this dose level.

1000 mg/kg bw dose level:
5 Male rats died within the first day after application.
3 Female rats died within 3 days after application.

Clinical signs:

other: The following signs were noted in animals of all dose groups: Dyspnoe, apathy, excitation, abnormal position, atonia, no pain reflex, no corneal reflex, exophthalmus, salivation, blood in the saliva, exsiccosis, clonic conculsions, piloerection.

Gross pathology:

Animals which died:
Heart: acute cardiac dilatation, acute hyperemia.
Lung: large infarctoide areas with high amount of blood, slight emphysem

Sacrificed animals were without findings.