1,1,2,2-tetrafluoro-2-[(trifluorovinyl)oxy]ethanesulfonyl fluoride

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07-JAN-2000 to 21-MAR-2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This GLP-compliant study was conducted in accordance with OECD guideline 402 and EU method B.3.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,1,2,2-tetrafluoro-2-[(1,2,2-trifluoroethenyl)oxy]ethane-1-sulfonyl fluoride

EC Number:

608-369-5

Cas Number:

29514-94-1

Molecular formula:

C4F8O3S

IUPAC Name:

1,1,2,2-tetrafluoro-2-[(1,2,2-trifluoroethenyl)oxy]ethane-1-sulfonyl fluoride

Test material form:

other: liquid

Details on test material:

- Substance type: monoconstituent 
- Physical state: colourless liquid
- Analytical purity: 100%
- Density: 1.64
- Lot/batch No.: 6-99
- Manufacturing date: 24 May 1999
- Expiration date of the lot/batch: May 2001
- Storage condition of test material: at room temperature

Specific details on test material used for the study:

- Name of test material (as cited in study report): Perfluorosulfonyl vinyl-ether
- Impurities, purity test date: no data available
- Physical state: liquid
- Lot/batch No.: 6-99
- Manufacturing date: 24 May 1999
- Expiration date of the lot/batch: May 2001
- Storage condition of test material: at room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Sprague Dawley Crl: CD(SD) BR rat
- Source: Charles River Italia S.p.A. / Via Indipendenza. 11 - 23885 CALCO (Lecco) / ITALY
- Age at study initiation: no more than 3 months
- Weight at study initiation: 236-347 g for males and 209-226 g for females
- Fasting period before study: no data available
- Housing: animals were housed individually during the 24-hour treatment period and then 5 animals/cage per sex in grill cages (40.5x38.5x18h cm) with stainless steel feeder, in air-conditioned room.
- Diet: ad libitum, GLP 4RF21 top certificate pelleted diet (Charles River Italia’s feed licencee Mucedola S.r.l., Settimo Milanese) supplemented by the producer with vitamins and trace elements
- Water: ad libitum, filtered water from municipal water main system
- Acclimation period: more than 5 days before the start of the test

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2°C
- Humidity: 55 ± 10%
- Air changes: about 15-20 per hour filtered on HEPA 99.97%
- Photoperiod: 12 hrs dark / 12 hrs light (7 a.m. - 7 p.m.)

IN-LIFE DATES: From 07-JAN-2000 and 14-JAN-2000 to 28-JAN-2000 (females) and 04-FEB-2000 (males)

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: approximately 24 hours before the test, fur was clipped from the dorsal and ventral area of the trunk of the test. An area of about 6x5 cmq of the body dorsal surface was cleared for the application of the test article.
- % coverage: about 10% of the total body surface
- Type of wrap if used: the treated area was covered with the porous gauze dressing fixed to the skin with hypoallergenic non irritating tape. The test site was further covered in a suitable manner in order to ensure that the animals could not ingest the test substance.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the residual test article was wiped off with water.
- Time after start of exposure: at the end of the exposure period, i.e. 24 h

TEST MATERIAL
- Amount(s) applied: 1.22 mL/kg or 2000 mg/kg
- Concentration: not applicable
- Constant volume or concentration used: yes

VEHICLE
Not applicable

Duration of exposure:

ca. 24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation of clinical signs and mortality at 30 minutes, 2, 4 and 6 hours on the first day after the administration (day 1) and then twice a day up to termination of the observation period; body weight monitored twice pre-trial (at randomization and on day 1 just before administration) and on days 8 and 15. Volume of administration was based on day 1 body weight.
- Necropsy of survivors performed: yes, on all animals (fasted overnight) killed by excision of the femoral arteries, after intraperitoneal overdosage anaesthesia with 5% sodium pentobarbital, at the end of the 14-day observation period. Gross pathology performed

Statistics:

LD50 was not calculated.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No animals died during the study. The LD50 was not calculated; it was considered to be higher than 2000 mg/kg.

Clinical signs:

other: No general or local clinical abnormalities were seen in any animal.

Gross pathology:

No appreciable changes were evident in the treated animals of either sex at the autopsy carried out at the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In conclusion, the test article, when administered by dermal route to the rat, did not cause mortality or show appreciable toxic effects at the limit dose of 2000 mg/kg. The LD50 by dermal route was considered to be higher than 2000 mg/kg.

Executive summary:

The purpose of the study was to evaluate the acute dermal toxicity of the test article. The test method was in accordance with EU method B.3 and OECD guideline 402 and in compliance with good laboratory practices (GLP).

 

Male and female Sprague Dawley Crl:CD(SD) BR rats (5 per sex and group) received a single dermal administration of the test article at the dosage of 2000 mg/kg. The test article was applied uniformly onto the cleared dorsal and ventral area of rat trunk (fur was clipped 24 hours previously). A porous gauze was fixed to the area and remained there for about 24 hours. The individual dosages were based on body weight taken just before treatment.

The day of treatment was considered as day 1 of the study. Animals were weighed twice before treatment (at randomization and on day 1 just before treatment) and on days 8 and 15. They were clinically observed for 14 days after the 24-hour exposure period. On day 16 all rats were killed (fasted overnight) by excision of the femoral arteries after intraperitoneal overdosage anaesthesia with 5% sodium pentobarbital; animals were then submitted to a thorough autopsy.

 

No animals died and no general or local clinical signs or body weight abnormalities were observed in any treated rat during the observation period. No macroscopic findings were evident at the final autopsy.

 

In conclusion, the test article, when administered by dermal route to the rat, did not cause mortality or show appreciable toxic effects at the limit dose of 2000 mg/kg. The LD50 by dermal route was considered to be higher than 2000 mg/kg.