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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1972

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted prior to adoption of GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1972

Report date:

1972

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

GLP compliance:

no

Test type:

fixed dose procedure

Test material

Test material information

Constituent 1

Reference substance name:

FC-43

IUPAC Name:

FC-43

Details on test material:

- Name of test material (as cited in study report): T-457

Test animals

Species:

rat

Strain:

other: Sherman-Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 200-250 grams
- Fasting period before study: 24 hours without food (water still available)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

10 grams per kilogram bodyweight

No. of animals per sex per dose:

5 male, 5 female

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:Observations daily, weighed before oral gavage.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 other: g/kg bw

Remarks on result:

other: One dose was used for all study animals.

Mortality:

No mortality was seen in any animals during the 14 day observation period.

Clinical signs:

other: No data

Gross pathology:

There were no significant gross findings on autopsy.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Based on the results of the study the LD50 for the test article is greater than 10 grams per kilogram body weight.

Executive summary:

One group of ten albino rats (5 male and 5 female) of the Sherman-Wistar Strain were employed in this study. The rats were fasted 24 hours prior to dosing. Each animal was weighed and dosed by direct administration of the undiluted test article at 10 grams per kilogram body weight into the stomach by means of a syringe and dosing needle. Following administration the animals were allowed food and water ad libitum for the 14 day observation period during which time the rats were observed for signs of toxicity and mortalities. At day 14 each of the rats was sacrificed and subjected to gross necropsy. There were no significant gross findings on necropsy. Based on the results of the study the LD50 for the test article is greater than 10 grams per kilogram body weight.