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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
Study period:
From 7 MAR 1986 to 7 MAY 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
Principles of method if other than guideline:
Method:
acute inhalation toxicity
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): Tri-n-butylamine
- Analytical purity: purity 98.5%, not further specified

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River UK Ltd.
- Females (if applicable) nulliparous and non-pregnant: no data
- Age at study initiation: no data
- Weight at study initiation: ca. 200 g
- Fasting period before study: no
- Housing: 5 per sex per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-24
- Humidity (%): 43-49
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: air
Details on inhalation exposure:
TEST ATMOSPHERE
- Brief description of analytical method used:
Sampling: 5 samples were withdrawn through an acetone-containing absorption trap. 
Analysis: GC-FID analysis
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
Test concentrations (analytical): 0.35, 0.51, 0.73, and 2.27 mg/l (45.5, 66, 95, and 295 ppm)
Test concentrations (nominal): 0.46, 0.77, 1.02, 4.93 mg/l ( 60, 100, 133, 640 ppm)
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: continuously during exposure, at least twice daily during the observation period
- Frequency of weighing: daily
- Necropsy of survivors performed: yes
Statistics:
LC50 was calculated by the log probit method of Miller and Tainter.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
0.5 mg/L air
Exp. duration:
4 h
Mortality:
see table
Clinical signs:
other: - abnormal breathing, restlessness, signs of irritation, closure of  eyelids, excessive salivation, whole-body tremor, clonic convulsions,  death  - No symptoms were observed any more in surviving animals after 4 days.
Gross pathology:
- In deceased animals: hyperemic congestion of the lung.
- Surviving animals: no particular findings.

Any other information on results incl. tables

MORTALITY
               male      female
====================================
   0 mg/l    0/5          0/5   
0.35 mg/l    0/5          0/5
0.51 mg/l    4/5          2/5 (within 3 - 24 h)
0.73 mg/l    5/5          5/5 (within 2.5 - 4 h)
2.27 mg/l    5/5          5/5 (within 1 h)
====================================
LC50 = 0.5 mg/l (66 ppm)

Applicant's summary and conclusion

Interpretation of results:
Category 1 based on GHS criteria
Conclusions:
Acute inhalation toxicity was tested for the test item (Tri-n-butylamine). Inhalation of 0.51 mg/L of test substance (tributylamin) vapour for 4 hours resulted in the death of 4 out of 5 male and 2 out of 5 female rats, resulting in a LC50 = 0.5 mg/L air.
Executive summary:

Male and female rats (5 rats/sex/dose) were subjected to test acute inhalation toxicity. The animals were exposed (whole body) to vapour at analytical dose levels of 0.35, 0.51, 0.73, and 2.27 mg/L test item (purity 98.5%) for 4 h and were observed for further 14 days.

The animals showed abnormal breathing, restlessness, signs of irritation, closed eyelids, excessive salivation, whole body tremor and clonic convulsions, yet no symptoms were observed any more in surviving animals after 4 days. At a concentration of 0.51 mg/L air 4 out of 5 male and 2 out of 5 female rats died within 3 to 24 h.

The results obtained thus led to a LC50 = 0.5 mg/L air (Pennwalt Corp./HRC, 1987).

This acute inhalation study is performed comparable to guideline studys (OECD TG 403), thus it can be juged reliable (RL 1).