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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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 401 and EU method B.1.

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 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

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: colourless 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: 241-329 g for males and 216-226 g for females
- Fasting period before study: about 16 hours before exposure; feed was returned to rats about 3 hours after the test article administration.
- Housing: 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: at least 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 or 14-JAN-2000 to 27-JAN-2000 (females) and 03-FEB-2000 (males)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
Not applicable

MAXIMUM DOSE VOLUME APPLIED: 1.22 mL/kg

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 3, 8 and 14. On day 1 the animals were weighed after a 16-hour fasting period.
- 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 death occurred during the study period. The LD50 was not calculated; it was considered to be higher than 2000 mg/kg.

Clinical signs:

other: Diarrhea and piloerection were observed between 4 and 24 hours after dosing. No clinical abnormalities were seen afterwards.

Gross pathology:

At the necroscopy carried out at the end of the observation period, no appreciable macroscopic findings were evident in the rats.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In conclusion, the LD50 of the test article, when administered to rats as a single dose by oral route, was higher than 2000 mg/kg. At this dose, the test substance induced transient diarrhoea in the treated rats.

Executive summary:

The purpose of the study was to evaluate the acute oral toxicity of the test article. The test method was in accordance with EU method B.1 and OECD guideline 401 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 oral administration of the test article at the dosage of 2000 mg/kg. The test article was administered undiluted as supplied by the Sponsor. The volume of administration was 1.22 mL/kg (the density of the test article is 1.64 g/mL).

All rats were treated after a 16-hour fasting period. 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 3, 8 and 14. They were clinically observed for 14 days following the treatment. On day 15, rats were killed (fasted overnight) by excision of the femoral arteries after intraperitoneal overdosage anaesthesia with 5% sodium pentobarbital; then, animals were subjected to a thorough necroscopy.

 

No deaths occurred in any animal. Transient diarrhoea was seen in animals. No effects on body weight growth were seen in rats during the study. At the autopsy carried out at the end of the observation period, no appreciable macroscopic findings were evident in rats.

 

In conclusion, the LD50 of the test article, when administered to rats as a single dose by oral route, was higher than 2000 mg/kg. At this dose, the test substance induced transient diarrhoea in the treated rats.