1,1,2,2,3,3,4,4,4-nonafluorobutane-1-sulphonic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Potassium 1,1,2,2,3,3,4,4,4-nonafluorobutane-1-sulphonate

EC Number:

249-616-3

EC Name:

Potassium 1,1,2,2,3,3,4,4,4-nonafluorobutane-1-sulphonate

Cas Number:

29420-49-3

Molecular formula:

C4HF9O3S.K

IUPAC Name:

potassium 1,1,2,2,3,3,4,4,4-nonafluorobutane-1-sulfonate

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Lot Number 2

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature, protected from light

FORM AS APPLIED IN THE TEST (if different from that of starting material): The test material was dissolved in 1% carboxymethylcellulose (CMC) in deionized water.

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Inc.
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: Six to eight weeks
- Weight at study initiation: Males 271.6 +/- 8.7g, females 183.6 +/- 8.7g
- Fasting period before study: Feed held over night prior to dosing
- Housing: The animals will be individually housed in stainless steel cages. The cages conform to standards set forth in the Guide for the Care and Use of Laboratory Animals, National Academy Press, Washington, D.C., 1996.
- Diet (e.g. ad libitum): Tekiad Certified Rodent Diet #8728 will be provided ad libitum. This diet is routinely analyzed by the manufacturer for nutritional components and environmental contaminants. Results of the manufacturer's analyses are on file at Primedica Redfleid.
- Water (e.g. ad libitum): Filtered tap water will be provided ad libitum. Samples of the water are analyzed for total dissolved solids, hardness, specified microbiological
content, and for environmental contaminants. Results of these analyses are on file at Primedica Redfield.
- Acclimation period: Animals will be acclimated for a minimum of seven days prior to the study start.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-26C
- Humidity (%): 30-70%
- Air changes (per hr): 10 or greater per hour
- Photoperiod (hrs dark / hrs light): 12:12 hour light:dark cycle

IN-LIFE DATES: From: 25 May 2000 To: 8 June 2000

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Lot/batch no. (if required): 69H0028

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Lot/batch no. (if required): 69H008

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

DOSAGE PREPARATION (if unusual): The vehicle was prepared to a concentration of 1% by mixing 10 grams of powdered medium viscosity carboxymethylcellulose with deionized water using a Waring blender. Additional deionized water was added to yield 1000 mL of prepared vehicle. The vehicle was stored refrigerated when not in use. The test material was dissolved in the prepared vehicle to the appropriate concentration and stirred on a magnetic stir plate.

Doses:

2000 mg/kg

No. of animals per sex per dose:

5/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Pretest and on study days 1, 8, and 15
- Necropsy of survivors performed: Yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Observations for mortality and moribundity were recorded twice daily (a.m. and p.m.) with no incidence of either occurring throughout the study.

Clinical signs:

other: Clinical observationswere recorded predose and approximately hourly for four hours postdose on the day of dosing then daily thereafter for at least 14 days. Clinical observations included male localized alopecia, urine-stained abdominal fur, and one femal

Gross pathology:

On Study Day 15, all animals (non-fasted) were humanely euthanized via carbon dioxide asphyxiation followed by exsanguination and submitted for a complete necropsy examination. Necropsy examination failed to reveal any adverse findings with the exception of a single male and a single female with dilatation of the right kidney. Dilatation of the kidney is usually induced by hydronephritis of the kidney and this condition is not uncommon in rats. Therefore, these findings are not considered related to the test material.

Any other information on results incl. tables

Based on the results of the study, the rat oral LD50 of T-7485 is >2000 mg/kg.

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of the study, the rat oral LD50 of T-7485 is >2000 mg/kg.

Executive summary:

The acute oral lethality of T-7485 was determined in rats. Crl:CD®(SD) IGS BR stock albino rats (5/sex/dose) received 2000 mg/kg T-7485 dissolved in carboxymethylcellulose via oral gavage. Observations for mortality and morbundity (twice daily), body weights (pretest and day 1, 8, and 15), clinical signs (predose and approximately hourly for 4 hours postdose on day 1 and daily thereafter for at least 14 days), and macroscopic examination (at necropsy). At 2000 mg/kg all animals survived. Clinical observations included male localized alopecia, urine-stained abdominal fur, and one female had liquid feces at three and four hours post dose. These clinical observations did not appear to be related to the test material exposure. Mean body weights increased in males (114.1 g) and females (49.4 g) between study day 1 and day 15, however, no record of body weight loss occurred during the study in either sex suggesting no adverse effect of a single 2000 mg/kg T-7485 dose. On study day 15 all animals (non-fasted) were euthanized and necropsied. Necropsy failed to reveal any adverse findings with the exception of dilation of the right kidney in one male and one female, however, this effect is usually induced by hydronephritis of the kidney and is not uncommon in rats; these findings were not considered related to the test material. Based on the results of the study, the rat oral LD50 of T-7485 is >2000 mg/kg.