Ephedrine hydrochloride

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

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 403; 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 403 (Acute Inhalation Toxicity)

Principles of method if other than guideline:

Method: BASF test (inhalation risk test)

GLP compliance:

no

Test type:

other: similar to 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

Test material form:

aerosol dispenser: not specified

Remarks:

migrated information: aerosol

Details on test material:

- Name of test material: (-)-Ephedrin Hydrochlorid
- substance number: 80/198
- physical state: white powder
- purity: 100 %

Test animals

Species:

rat

Strain:

other: Sprague-Dawley; strain: Caw-Ico-Wiga

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Firma Wiga Versuchstierzuchtanstalt, Sulzfeld;
- Age at study initiation: 7 - 11 weeks old
- Weight at study initiation: 185 +/- 15 g
- Housing: groups in 5 cages
- Diet: Herilan MRH; H. Eggersmann 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: nose-head inhalation systen
- System of generating particulates/aerosols: dust-generator
- Method of particle size determination: gravimetric


TEST ATMOSPHERE
- Brief description of analytical method used: gravimetric
- Samples taken from breathing zone: yes


TEST ATMOSPHERE
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 2.76 µM / 1.58

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

5.2 mg/L

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Weighing before, on days 7 and 14 after inhalation. Observation of clinicla symptoms daily.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights

Statistics:

Statistical analysis according to binomialtest (Wittig, H.: Mathematische Statistik 1974, page 32 - 35).
Determination of the paticle size according to mathematical and graphical methods for paticle measurement (Silverman, L.: Particle Size Analysis in Industrial Hygiene, 1971, S. 235 - 259).

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.2 mg/L air

Exp. duration:

4 h

Mortality:

No mortality was observed.

Clinical signs:

other: Attemps to escape, pronounced irritation of the skin on the noses, corneal opacity, accelerated respiration and hyperactivity were observed.One female rat showed alopezia on the back. All animals appeared normal again after day 13.

Body weight:

The mean body weight of the test groups increased throughout the study period within the normal range.

Gross pathology:

Sacrificed animals were without findings.