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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key 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 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

no

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 moistened with 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 240.0 +/- 5.8g, females 167.6 +/- 2.1g
- Fasting period before study: Not fasted
- 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 Laboratoy Animals, National Academy Press, Washington, D.C.,1996.
- Diet (e.g. ad libitum): Teklad 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 Redfield.
- Water (e.g. ad libitum): Filtered tap water will be provided ad libitum. Samples of the water are analyzed for total dissoNed solids, hardness, specified microbiological content, and for environmental contaminants. Results of these analyses aare on file at Primedica Redfield.
- Acclimation period: Animals will be acclimated for a minimum of seven days prior to the study start. During the acclimation period, the animals were habituated to collars used during the study.

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

IN-LIFE DATES: From: 27 July 2000 To: 11 August 2000

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

CMC (carboxymethyl cellulose)

Details on dermal exposure:

TEST SITE
- Area of exposure: Dorsal area of the trunk
- % coverage: Approximately 10% of the body surface area
- Type of wrap if used: Porous gauze dressing with non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Test material removed with warm water and gauze
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg wetted to a paste with medium viscosity carboxymethylcellulose
- For solids, paste formed: Yes

VEHICLE
- Lot/batch no. (if required): 69H0028

Duration of exposure:

24 hours

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 day 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:

Treatment with T-7485 produced no test material-related mortalities, but there was one procedural death that resulted in the replacement of a male rat.

Clinical signs:

other: Clinical observations included red material around the eyes, nose, and mouth. These observations were not present after Study Day 2 and were not considered test material-related.

Gross pathology:

There were no adverse gross findings recorded for either male or female rats treated with 2000 mg/kg T-7485 with the exception of one male (this male was replaced) which died due to procedural complications.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

No mortality occurred and no clinical signs of toxicity were observed.

Conclusions:

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

Executive summary:

The acute dermal lethality of T-7485 was determined in rats. Sprague-Dawley rats (5/sex/dose) received 2000 mg/kg T-7485 mixed with enough carboxymethylcellulose in water to for form a paste to the dorsal area of the trunk (approximately 10% of the body surface area). Observations for mortality and morbundity (recorded twice daily), body weights (pretest and day 1, 8, and 15), clinical signs (predose and approximately hourly for four hours postdose on study day 1 and once daily thereafter for at least 14 days), and macroscopic examination (at necropsy). At 2000 mg/kg all animals survived; one male rat died due to procedural complications and was replaced. Clinical observations included red material around the eyes, nose and mouth, however, these were not present after day 2 of the study and were not considered to be related to test material exposure. No adverse effects on body weights or body weight changes were seen. When compared to Study Day 1, Study Days 8 and 15 male mean body weights were increased 17% and 40%, respectively. Likewise, female mean body weights were increased 8% and 19%, respectively. On Study Days 1 through 15, male mean body weight change was increased 96.6g while bodyweight change in the females was increased 31.6g. No adverse gross findings were recorded for either sex with the exception of one male rat (previously stated) which died due to procedural complications. Based on the results of the study, the rat dermal LD50 of T-7485 is >2000 mg/kg.