Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-(2-aminomethylethyl)-.omega.-(2-aminomethylethoxy)-

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1979-01-17 - 1979-05-03

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Remarks:

However, limited details were provided on exposure conditions (i.e., particle size determination), test substance (i.e., purity), and animal husbandry. Only one concentration was used and exposure was for 8 hours without a justification provided.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

yes

Remarks:

Limited details were provided on exposure conditions (i.e., particle size determination), test substance (i.e., purity), and animal husbandry. Only one concentration was used and exposure was for 8 hours without a justification provided.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Test material form:

liquid

Details on test material:

- Physical state: liquid
- Storage condition of test material: Room temperature

Specific details on test material used for the study:

- Name as cited in study report: Poly[oxy(methyl-1,2-ethanediyl)], alpha-(2-aminomethylethyl)-omega-(2-aminomethylethoxy)
- Substance type: active
- Color: clear, amber
- Lot: Jefferson chemical company, sample no. AVS-0381, 4236-10-20a, SPC no. 1575

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 Breeding Laboratories, Wilmington, Massachusetts
- Weight at study initiation: 209-254
- Other: The animals were observed prior to exposure to assure that they were free from abnormalities.


IN-LIFE DATES: From: 1979-01-17 To: 1979-01-31

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

air

Remarks:

dry

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: A glass exposure chamber housed the animals.
- Exposure chamber volume: 26.5 liter
- Source and rate of air: 4.0 liters per minute
- Method of conditioning air: The test substance was placed in a 500 milliliter gas-washing bottle. Dry air, at the minimum chamber flow rate of 4.0 liters per minute, was passed through the test substance and the resultant vapor-laden air was directed, undiluted, into the exposure chamber housing the test animals.
- Temperature, humidity, pressure in air chamber: the chamber temperature during the exposure was 22 degrees C.
- Other: The flask containing the test substance, two glass tubes, and connectors were weighed before and after the exposure period. The difference in weight was equal to the amount of test substance volatilized during the exposure. The nominal concentration was calculated by dividing the weight loss by the total air flow through the chamber during the exposure period.

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

ca. 8 h

Concentrations:

0.74 mg/L (1.42 grams of test substance delivered in a total volume of 1920 liters of dry air)

No. of animals per sex per dose:

5 animals per sex

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for abnormal signs were recorded at 15 minute intervals for the first hour of exposure, hourly for the remaining seven hours of the exposure, upon removal from the chamber, at one hour post-exposure, and daily thereafter for 14 days. Individual body weights were recorded on day 0 (prior to exposure) and on Days 1, 2, 4, 7 and 14 (terminus) for all animals.
- Necropsy of survivors performed: yes; On Day 14 all animals were sacrificed (ethyl ether) and gross necropsy examinations were performed.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 0.74 mg/L air (nominal)

Based on:

test mat.

Exp. duration:

8 h

Remarks on result:

other: No mortality was observed at 0.74 mg/L

Mortality:

No mortalities occurred.

Clinical signs:

other: No abnormalities were observed in any animals during the exposure. Upon removal from the chamber, one animal was observed to have dry rales. At one-hour post-exposure dry rales was noted again in the same animal. During the 14-day observation period dr

Body weight:

Individual body weight data showed normal weight gains in all animals except one male, which showed a somewhat depressed weight gain pattern.

Gross pathology:

Necropsy examinations revealed lung discoloration in nine of ten animals and kidney discoloration in six of ten animals. The frequency of lung and kidney discoloration was higher than that normally observed in Sprague-Dawley rats in this type of exposure and may have been indicative of a response to the exposure.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

The acute inhalation toxicity of the test substance was evaluated in male and female rats. The LC50 was determined to be >0.74 mg/L.