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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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Inhalation Toxicology of Trimethylamine
Author:
Kinney L.A., Burgess, B. A., Chen, H. C. and Kennedy, G. L.
Year:
1990
Bibliographic source:
Inhalation Toxicology, 2, 41-51, (1990)

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test:
2 groups of 6 male Crl:CD(SD)BR rats were exposed for single, 4h periods. The rats were observed and weighed daily for 14 d, at which time the surviving rats were sacrificed (without pathologic examination).
GLP compliance:
not specified
Test type:
fixed concentration procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: supplied by the Chemicals and Pigments Department, E. I. du Pont de Nemours and Company, Inc., Belle, W.V.
- Impurities: 0.06% dimethylamine, 0.01 % monomethylamine, and 0.17% water
- Expiration date of the lot/batch: no data
- Purity test date: no data

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratory, Kingston, N.Y.
- Age at study initiation: 7-8 wk old
- Weight at study initiation: between 234 and 293 g
- Fasting period before study: not specified
- Housing: in 8 x 14 x 8 in. suspended, steel-mesh cages
- Diet: Purina Certified Rodent Chow 5002 ad libitum
- Water: ad libitum
- Acclimation period: quarantined for 1 wk prior to testing

ENVIRONMENTAL CONDITIONS
- Temperature: 23 ± 2°C
- Humidity: 50 ± 10%
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): timer-controlled 12/12-h light/dark cycle.

IN-LIFE DATES: no data

Administration / exposure

Route of administration:
inhalation: gas
Type of inhalation exposure:
not specified
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
no additional information

TEST ATMOSPHERE
no analysis
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
4 h
Concentrations:
2000 ppm and 3500 ppm
No. of animals per sex per dose:
six males per group
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: no
Statistics:
not applicable

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LC0
Effect level:
2 000 ppm
Based on:
test mat.
Exp. duration:
4 h
Sex:
male
Dose descriptor:
LC50
Effect level:
ca. 3 500 ppm
Based on:
test mat.
Exp. duration:
4 h
Mortality:
No deaths occurred following a 4-h exposure to 2000 ppm TMA, whereas 3 of 6 rats exposed to 3500 ppm died during the exposure period.
Surviving rats showed lung noise from 1 to 9 d postexposure. Rats exposed to 3500 ppm also had dry red nasal and ocular discharge during the early stages of the post exposure period.
Clinical signs:
other: During exposure, all rats showed labored breathing, nasal and oral discharges, and neither moved nor responded to sound.
Body weight:
Surviving rats showed moderate to severe weight losses 1-2 d post exposure.
Gross pathology:
not examined

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
A 4-hour LC50 (gas) of ca. 8.58 mg/L was determined (equivalent to 3500 ppm).
Executive summary:

In an acute inhalation study, 2 groups of 6 male Crl:CD(SD)BR rats were exposed for single, 4h periods. The tested concentrations were 2000 ppm and 3500 ppm The rats were observed and weighed daily for 14 d, at which time the surviving rats were sacrificed (without pathologic examination).

No deaths occurred following a 4h exposure to 2000 ppm TMA whereas 3 of 6 rats exposed to 3500 ppm died during the exposure period. During exposure, all rats showed labored breathing, nasal and oral discharges, and neither moved nor responded to sound. Surviving rats showed moderate to severe weight losses 1-2 d postexposure and lung noise from 1 to 9 d postexposure. Rats exposed to 3500 ppm also had dry red nasal and ocular discharge during the early stages of the postexposure period.