Butanamine, N,N-dibutyl-, branched and linear, fluorinated

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 February 1969 to 12 March 1969

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted before the adoption of GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1969

Report date:

1969

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: internal protocol

Principles of method if other than guideline:

7 male and 7 female rats were whole-body exposed to the test article for 4 hours. The animals were observed for mortality and pharmacokinetic signs. After exposure a male and female rat were sacrificed and a gross necropsy of the lung tissue preformed. The remaining rats were observed for clinical signs of toxicity for 14 days following exposure after which they were sacrificed and grossly examined.

GLP compliance:

no

Test type:

fixed concentration procedure

Test material

Test material information

Constituent 1

Reference substance name:

FC-40

IUPAC Name:

FC-40

Details on test material:

- Name of test material (as cited in study report): FC-40
- Physical state: Liquid

Test animals

Species:

rat

Strain:

other: Charles River

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: "Young"
- Weight at study initiation: The average was 246 g
- Housing: Individually in stock cages
- Diet (e.g. ad libitum): Purina Rat Chow ad libitum
- Water (e.g. ad libitum): ad libitum
IN LIFE DATES: From: 26 February 1969 to: 12 March 1969

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Plexiglas inhalation chamber
- Exposure chamber volume: 70 L
- Method of holding animals in test chamber: Individually free in chamber
- Source and rate of air: 4.5 L/min
- Method of conditioning air: Air was bubbled through FC-40 and measured with a rotameter
- Temperature, humidity, pressure in air chamber: 29.92 inches Hg at 25 degrees celsius
TEST ATMOSPHERE
- Brief description of analytical method used: Calculated by dividing generator weight loss by total volume air used during tests

Analytical verification of test atmosphere concentrations:

yes

Remarks:

Concentrations were determined by measuring the amount of the test article lost from the generator through a known amount of air.

Concentrations:

41 mg/L

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:Weighed before exposure and after 14 day observation. Observations made at and following exposure as well as daily for 14 days following exposure.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

41 mg/L air

Exp. duration:

4 h

Remarks on result:

other: LC50 was higher than saturated vapor concentration. Only 1 dose tested (saturated air concentration).

Mortality:

Four rats, two of each gender, were sacrified immediately following exposure and necropsy performed. The remaining ten rats were returned to their cages and observed for 14 days until sacrifice and necropsy.

Clinical signs:

other: No deaths, untoward behavioral reactions, or adverse body weight effects were caused by the inhalation of the test article tested at a concentration of 41 mg/L for 4 hours.

Body weight:

Average weight gain was 68 grams which was within the normal range.

Gross pathology:

No gross pathologic alterations found in the tissues and organs examined.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The test article can be considered practically non-toxic by inhalation.

Executive summary:

Fourteen health albino rats (7 male, 7 female) were exposed to a nominal concentration of the test article at 41 mg per liter of air in a 70 liter Liter Plexiglas chamber for a period of four hours. During exposure the animals were observed for mortality and pharmacotoxic signs. Upon removal from the chamber 2 males and 2 females were sacrificed. Sections of their lungs, spleen, liver and kidneys were taken and placed in 10% formalin. The lung tissues were processed for histological evaluation. The remaining ten rats were observed for a period of 2 weeks, weighed, sacrificed and grossly examined. Results show that there were no deaths in the study. Weight gains were normal. At necropsy no grossly observable lesions were noted. The lung tissues examined microscopically, were normal. The test article can be considered practically non-toxic by inhalation.