Perfluamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24 February 1994

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: no data on if this study was conducted using GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

T-5912

IUPAC Name:

T-5912

Details on test material:

- Name of test material (as cited in study report): T-5912
- Substance type: clear, colorless liquid.
- Physical state: liquid
- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

other: albino Crl:CD (SD) BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Inc., Portage, MI
- Weight at study initiation: 261-286 grams
- Fasting period before study: overnight
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): not stated, but controlled
- Humidity (%): not stated, but controlled
IN-LIFE DATES: From: 30 March 1994 To: April 5 1994

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2.78 mL/kg of body weight (based on the density of the test article at 1.80 g/mL.

Doses:

1

No. of animals per sex per dose:

5/sex/dose

Control animals:

no

Details on study design:

Duration of observation: 14 days
- Frequency of observations and weighing:
- Necropsy of survivors performed: Yes
- Other examinations performed: clinical signs, body weight, gross pathology

Statistics:

None

Results and discussion

Effect levels

Dose descriptor:

approximate LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

No mortality occured.

Clinical signs:

other: All animals appeared clinically normal throughout the study.

Gross pathology:

No visible lesions were observed, with the exception of one female animal; both mandibular lymph nodes were large (15 x 10 x 5 mm). This effect was considered incidental and unrelated to the test material.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information

Conclusions:

The estimated oral LD50 for male and female albino rats is greater than 5000 mg/kg of body weight.

Executive summary:

The acute oral toxicity of T-5912 in albino rats was assessed using OECD 401 guidelines. Young animals were treated with 5000 mg/kg bodyweight of the undiluted test article via oral gavage. Mortality, clinical observations, body weight and gross pathology was observed. There was no mortality and bodyweights and clinical observations were normal during the study. In one female animal, an increased size of mandibular lymph nodes were enlarged. Those effects were considered not related to the treatment of the test article. The estimated oral LD50 for male and female albino rats is greater than 5000 mg/kg of body weight.