Triethylamine

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1994-09-14 to 1994-11-22

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted according to EPA and OECD guideline, described in sufficient detail and well documented.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: EPAOTS 798.1150 (Acute Inhalation Toxicity) and OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

not specified

GLP compliance:

yes

Test type:

other: acute inhalation method (OECD 403)

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Triethylamine

EC Number:

204-469-4

EC Name:

Triethylamine

Cas Number:

121-44-8

Molecular formula:

C6H15N

IUPAC Name:

triethylamine

Details on test material:

- Name of test material (as cited in study report): triethylamine
- Physical state: Liquid
- Purity test date: no data
- Stability under test conditions: Stable
- Storage condition of test material: Avoid Heat, Flame, containers should be grounded before product is transferred to reduce chance of spark by static electricity
- Other: strong odor; source: provided by the Sponsor Air Products and Chemicals; Specific Gravity, 20/20 oC: 0.726 to 0.730; Distillation Range, oC: 85.0 to 91.0; safety precautions: toxic, severe irritant, corrosive, flammable

Test animals

Species:

rat

Strain:

other: Sprague Dawley derived Crl:CD BR VAF/Plus

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, 9801 Shaver Road; Portage, Michigan 49081
- Age at study initiation: between 49 and 58 days of age
- Weight at study initiation: male weights ranged from 203 - 289 grams and females ranged from 172 - 218 grams on the day of exposure
- Housing: Individual stainless steel wire mesh cages
- Diet (e.g. ad libitum): Certified Rodent Chow # 5002, Purina Mills, Inc., St. Louis, Missoui, freely available except during exposure
- Water (e.g. ad libitum): water freely available except during exposure
- Acclimation period: Conditioned for a period of at least 7 days prior to exposure
- Method of identification: ear tag

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
group 1: mean: 21; S.D.: 0.0
group 2: mean: 21; S.D.: 0.0
group 3: mean: 23; S.D.: 1.0
group 4: mean: 21; S.D.: 0.0
- Relative Humidity (%):
group 1: mean: 8; S.D.: 1.4
group 2: mean: 11; S.D.: 2.2
group 3: mean: 19; S.D.: 2.0
group 4: mean: 19; S.D.: 0.6
- Air changes (per L/min):
group 1: mean: 122; S.D.: 0.0
group 2: mean: 122; S.D.: 0.0
group 3: mean: 122; S.D.: 0.0
group 4: mean: 122; S.D.: 0.0
The low relative humidities were due to the dry compressed air used to generate the vapor. The measured oxygen content during all exposured was 20.9%.
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

other: no data

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: stainless steel and glass exposure chamber
- Exposure chamber volume: 160 liter
- Method of holding animals in test chamber: individual stainless steel wire mesh cages
- Source and rate of air: the test material was metered via a liquid pump (Fluid Metering Inc., model RPG) to a glass vaporization column (2.5 cm diameter x 22 cm height) filled to a height of 18 cm with glass beads ranging from 4-6 mm in diameter. The 1/8" tubing from the FMI pump to the column is designed to deliver the test article to the approximate center of the glass bead layer. Air entering the column base at 70 L/min , measured by a flow meter (Fischer & Porter, FP-1-27-G-10/55), facilitates vaporization.
- Method of conditioning air: air entering the column base at 70 L/min, measured by a flow meter (Fischer & Porter, FP-1-27-G-10/55)
- System of generating particulates/aerosols: the test material vapor is swept through a condensation trap and into the exposure chamber. Additional dilution air entering the vapor stream prior to the exposure chamber (measured by a flowmeter, Fischer & Porter, FP-3/4-21-G-10-55) was used to decrease the vapor concentration to the desired level. The test atmosphere was exhausted to a fume hood.
- Method of particle size determination: according to the protocol aerosol particle size measurements will not be required as the test animals are exposed to vapor

- Temperature, humidity:
- Temperature (°C):
group 1: mean: 21; S.D.: 0.0
group 2: mean: 21; S.D.: 0.0
group 3: mean: 23; S.D.: 1.0
group 4: mean: 21; S.D.: 0.0
- Relative Humidity (%):
group 1: mean: 8; S.D.: 1.4
group 2: mean: 11; S.D.: 2.2
group 3: mean: 19; S.D.: 2.0
group 4: mean: 19; S.D.: 0.6

TEST ATMOSPHERE
- Brief description of analytical method used:
Actual exposure concentrations were measured by IR. The test material, Triethylamine, was used to develop a calibration curve relating known concentrations of Triethylamine to recorder chartlines. The calibration curve was prepared by making closed-loop injections of the test material into the IR. In the closed-loop calibration method, a known volume of the liquid test material vaporizes and recirculates through the IR cell until the instrument response has plateaued. This method assures complete vaporization of the liquid material. When sampling from an exposure chamber, the exposure atmosphere is drawn through the IR, analyzed and returned to the chamber exhaust.
- Samples taken from breathing zone: yes

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

1 h

Concentrations:

2450 (group 2), 3200 (group 3), 4000 (group 4) and 5050 (group 1) ppm

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice daily, once for pharmacotoxic signs and once for mortality only
- Necropsy of survivors performed: yes
- Other examinations performed: pharmacotoxic signs, body weight

Statistics:

Statistical method was mentioned in the protocol as 'when appropriate, the concentration mortality data may be statistically analyzed for the LC50 and its confidence limits'

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

3 496 ppm

95% CL:

>= 3 257 - <= 3 752

Exp. duration:

1 h

Remarks on result:

other: 99.8% pure

Mortality:

Group 1: 10 death/10 on study
Group 2: 0 death/10 on study
Group 3: 2 death/10 on study
Group 4: 9 death/10 on study

Clinical signs:

other: Immediately upon removal of the exposure chamber Group 2: laborated breathing: 5 of 5 males; 5 of 5 females tremors: 1 of 5 males; 1 of 5 females Increased salivation: 5 of 5 males; 5 of 5 females Group 3: Labored Breathing: 5 of 5 males; 3 of 5 females

Body weight:

Group 1: not applicable (no animals survived beyond the exposure)
Group 2:
male: 279 g (7 days post-exposure) and 325 g (14 days post-exposure)
female: 208 g (7 days post-exposure) and 237 g (14 days post-exposure)
Group 3:
male: 284 g (7 days post-exposure) and 326 g (14 days post-exposure)
female: 222 g (7 days post-exposure) and 241 g (14 days post-exposure) -> 3 females survivors
Group 4:
male: NA
female: 198 g (7 days post-exposure) and 269 g (14 days post-exposure) -> one female survivor

Gross pathology:

At the necroscopy, no abnormal macroscopic observations were recorded for either Groups 1 or 2. One male in Group 3 had bilateral corneal opacity. Four males and four females had discolored lungs in Group 4.

Other findings:

One male from group 3 developed corneal opacity in both eyes on post-exposure day 7 that remained to the end of the 14-day post-exposure period. The one surviving animal from group 4 judged normal by post-exposure day 3 but wheezing was noted for one day on post-exposure day 6 and corneal opacity developed in one eye on post-exposure day 13.

Applicant's summary and conclusion

Interpretation of results:

other: for detailed interpretation refer to Chemical Safety Report

Remarks:

Criteria used for interpretation of results: expert judgment

Conclusions:

The 1-hr rat LC50 for triethylamine (98% pure) is 3496 ppm with 95% confidence limits of 3257-3752 ppm.

Executive summary:

The acute inhalation toxicity study in rats to triethylamine was conducted according to the OECD Guideline 403 and is GLP compliant.

The purpose of this study was to determine the 1 -hour rat inhalation LC50 for the test material.

Four measured exposure concentrations were used: 2,450, 3,200, 4,000, and 5,050 ppm. Rats showed labored breathing and tremors at all exposure levels; some also showed increased salivation and (at 3,200 ppm) excessive lacrimation. After 2,450 ppm all rats (5 male and 5 female) returned to normal by post-exposure day 5. At 3,200 ppm two female rats died immediately post-exposure, but the other 3 females and all 5 males returned to normal by post-exposure day 6. At 4,000 pm 9/10 rats died immediately after exposure, and at 5,050 ppm all 10 died immediately.

Mean body weight gains were normal after 2,450 ppm (for both male and female rats) and for female rats after 3,200 ppm. Male body weight gains were depressed during the first week after 3,200 ppm exposure, but all returned to normal by day 14.

At necropsy, no macroscopic abnormalities were recorded for either the lowest or the highest exposure groups. At 3,200 ppm one male rat had bilateral corneal opacity. Four males and four females had discolored lungs after 4,000 ppm