Tributylamine

Acute Toxicity: inhalation

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

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

Test material information

Constituent 1

Reference substance name:

Tributylamine

EC Number:

203-058-7

EC Name:

Tributylamine

Cas Number:

102-82-9

Molecular formula:

C12H27N

IUPAC Name:

tributylamine

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 or test system 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Sampling: 5 samples were withdrawn through an acetone-containing absorption trap.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).