Ephedrine

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP, similar to guideline study, available as unpublished report, limitations in design and/or reporting but otherwise adequate for assessment

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 403 (Acute Inhalation Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ephedrine

EC Number:

206-080-5

EC Name:

Ephedrine

Cas Number:

299-42-3

Molecular formula:

C10H15NO

IUPAC Name:

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

Details on test material:

- Name of test material (as cited in study report): (-)-Ephedrin, wasserhaltig
- Physical state: white powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Firma WIGA Versuchstierezuchtanstalt, Sulzfeld
- Age at study initiation: 7 - 11 weeks
- Weight at study initiation: 185 ± 15 g
- Housing: 5 per cage Type D III or MD III, without bedding
- Diet: Herilan MRH (Firma H.Eggermann KG, Rinteln/Weser), ad libitum
- Water: tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose/head only

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Head-nose inhalation system
- Method of holding animals in test chamber: the animals were places in tubes and with their snouts in the inhalation chamber
- By means of an exhaust air system the pressure ratios in the inhalation system were adjusted in such a way that the amount of exhaust air was about 10% lower. This ensured that the mixture of test substance and air was not diluted with laboratory air in the breathing zones of the animals.
- System of generating particulates/aerosols: dustgenerator
- Method of particle size determination: a sample was taken after 1 hour of exposure. A pre-weighed glass fibre disk and particle filter were placed in the impactor (Stack Sampler Mark III, Andersen). A 9 L sample was taken. The contents of the preimpactor as well as on the walls of the impactor and the probed deposited were determined.

TEST ATMOSPHERE
- Brief description of analytical method used: Gravimetric determination of the concentration of the inhalation atmosphere, loadspeed of 1.25 m/s, 1 L test sample, One sample per hour.
- Samples taken from breathing zone: yes

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

5.4 mg/L

No. of animals per sex per dose:

10

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs and mortality were checked daily; body weights were determined prior to the study, after 7 days and at the end of the follow-up period
- Necropsy of survivors performed: yes

Statistics:

The statistical evaluation of the study was carried out in according to the Binomialtest (Wittig, H: Mathematische Statistik 1974, page 32-35) according to the table work of BASF's data center.
The particle size determination was based on mathematical and graphical analysis methods for particle measurements (Silverman, L: Particle Size Analysis in Industrial Hygiene, 1971, page 253-259) in the Department of Industrial Hygiene and Toxicology of BASF.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.4 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Mortality:

No mortality observed in all animals exposed.

Clinical signs:

other: No clinical signs were observed in all exposed animals.

Body weight:

Body weight and body weight changes were comparable between animals from the exposure group and animals from the control group.

Gross pathology:

No effects observed.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information

Conclusions:

Under the conditions of this test, the LC50 was determined to be >5.4 mg/L.

Executive summary:

Ten Sprague-Dawley rats per sex were exposed in a study performed according to OECD 403 study by inhalation to 5.4 mg/L air dust aerosols of the substance for 4 hours. After an observation period of 14 days surviving animals were necropsied. No mortality or treatment related effects were observed during and after exposure. The LC50 was determined to be >5.4 mg/L air.