Ethyldimethylamine

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: Acceptable, well documented report which meets basic scientific principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

BASF Test

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ethyldimethylamine

EC Number:

209-940-8

EC Name:

Ethyldimethylamine

Cas Number:

598-56-1

Molecular formula:

C4H11N

IUPAC Name:

ethyldimethylamine

Details on test material:

- Name of test material (as cited in study report): Dimethylaethylamin

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, France
- Weight at study initiation: 200 - 300 g
- Housing: 2 animals per cage
- Diet: HERILAN, MRH-Haltungsdiaet, ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 7 days.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 55 ± 10 %
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure chamber volume: 28.5 L


TEST ATMOSPHERE
- Brief description of analytical method used: H2SO4-method
- Samples taken from breathing zone: yes

Analytical verification of test atmosphere concentrations:

yes

Remarks:

gas chromatography

Duration of exposure:

1 h

Concentrations:

Actual: 2.3 and 15.4 mg/L
Nominal: 3.5 and 21.2 mg/L

No. of animals per sex per dose:

10 per sex per dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: day 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 2.3 - < 15.4 mg/L air

Based on:

test mat.

Exp. duration:

1 h

Mortality:

See details in remarks on results

Clinical signs:

other: During exposure: 2.3 mg/L air: slight increased salivation; 15.4 mg/L air: decreased respiratory rate, gasping, slight apathy, eyelid closure, increased salivation, nasal secretion; furthermore, decreased response to touch, decreased reflex reactions (pai

Body weight:

The surviving animals gained weight - see details in remarks on results.

Gross pathology:

Dying animals: 11 out of 18 animals showed diffuse aleolar emphysema; 1 animal with atelectasis.
Sacrificed animals: in the low dose group 9/20 animals showed a grey-red discoloration of the lung and sporadic patechia were seen.

Any other information on results incl. tables

Mortality:

Dose (mg/L air)	Gender	15 min	30 min	24 h	14 days
2.3	male	0/10	0/10	0/10	0/10
2.3	female	0/10	0/10	0/10	0/10
15.4	male	7/10	10/10	10/10	10/10
15.4	female	3/10	8/10	8/10	8/10

All death occured during exposure.

Weight:

Dose (mg/L air)	Gender	day 0	day 7	day 14
2.3	male	215	261	287
2.3	female	178	196	218
15.4	male	196	-	-
15.4	female	162	178	196

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

Based on the results of this study, the LC50 for 1-hour exposure to DMEA was between 2.3 and 15.4 mg/l air.

Executive summary:

The acute inhalation toxicity of Dimethylethylamine (DMEA) was evaluated in a 1-hour, single-exposure study in rats. DMEA was initially administered to a single group of 10 male and 10 female Sprague Dawley rats via whole-body vapor exposure at concentrations between 2.3 and 15.4 mg/l. Mortality and clinical signs were evaluated daily over a 14-day observation period. Animals were weighted on days 0, 7 and 14.

Mortality was 0/20 at 2.3mg/l and 18/20 (10 males and 8 females) at 15.4 mg/l.All death occurred during exposure. During the 1-hour exposure, animals exposed to 2.3 mg/l air showed a slight increased salivation. Animals exposed to 15.4 mg/l air showed a decreased respiratory rate, gasping, slight apathy, eyelid closure, increased salivation, nasal secretion; furthermore, decreased response to touch, decreased reflex reactions (pain and auricle reflex), overall a poor general state was observed. In female rats trembling of the whole body and hunched posture were observed.

During observation period, 1 male exposed to 2.3 mg/l air showed alopecia after 13 days of observation.

After exposure to 15.4 mg/L air, surviving animals displayed gasping, slight apathy, lid closure, slight increased salivation, reduced pain reflex, tremor and twitching, piloerection. After 6 days they were without symptoms.

11 out of 18 dying animals showed diffuse alveolar emphysema; 1 animal presented atelectasis.

At necropsy, in the low dose group 9/20 animals showed a grey-red discoloration of the lung and sporadic paetechia were seen.

Based on the results of this study, the LC50 for 1-hour exposure to DMEA was between 2.3 and 15.4 mg/l air.