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Toxicological information

Acute Toxicity: inhalation

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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

Reference
Name:
Unnamed
Type:
Constituent
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 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
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.