1,3-Dioxolane, 4,5-dichloro-2,2,4-trifluoro-5-(trifluoromethoxy)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 1995 - september 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1981

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4,5-dichloro-2,2,4-trifluoro-5-(trifluoromethoxy)-1,3-dioxolane

EC Number:

605-262-5

Cas Number:

161611-73-0

Molecular formula:

C4F6Cl2O3 C4F6Cl2O3

IUPAC Name:

4,5-dichloro-2,2,4-trifluoro-5-(trifluoromethoxy)-1,3-dioxolane

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- batch No.of test material: 18852/2
- Expiration date of the lot/batch: July 1996
- Purity test date:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: no specific requirements

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Italia S.p.A.
- Age at study initiation: 7-9 weeks
- Weight at study initiation: males: 225 - 250 g / females: 200 - 225 g
- Fasting period: 16 hours
- Housing: 5 animals /sex/cage
- Diet: ad libitum (GLP 4RF2I top certificate pelleted diet)
- Water: ad libitum (municipal water main system)
Contaminants that might interfere with the objectives of the study were not expected to be present in diet or drinking water.
- Acclimation period: five days before the start of the test Animals were observed daily to ascertain their fitness for the study


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C+/-2
- Humidity (%): 55%+/-10
- Air changes (per hr): about 20/hour filtered on HEPA 99.97%
- Photoperiod (hrs dark / hrs light): 12 hour cycle (7 am - 7pm)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The test article was administered undiluted as supplied by the Sponsor. The volume of administration was 1.22 ml/kg in order to obtain the dose of 2000 mg/kg being the density 1.635 g/ml.
The volumes to be administered were measured with appropriately gauged plastic syringes The administration was done by gavage to rats which had been fasted about 16 hours

Doses:

2000 mg/Kg bw/day (limit test)

No. of animals per sex per dose:

2000 mg/Kg: 5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

- 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: twice pre-trial (at randomization and on day 1 just before administration) and on days 3, 8 and 14. On day I the animals were weighed after a 16-hour fasting. Volume of administration was based on day 1 body weight. Feed was returned to rats three hours after the test article administration.
- Gross pathology: on all animals (fasted overnight) killed by excision of the femoral arteries, after i.p overdosage anesthesia with 5% sodium pentobarbital, at the end of the observation period.
- Histologic examination was not performed

Initially a group of 5 male rats, randomly selected, was administered a dosage of 2000 mg/kg of the test article. Since no animals died after the 2000 mg/kg administration, a further group of 5 female rats was administered with the same dose.

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:

No animals died during the study.

Clinical signs:

other: No clinical signs or behavioral alterations were observed in any animal during the observation period.

Gross pathology:

At necropsy (at the end of the observation preiod) no appreciable macroscopic findings were evident in any treated rats

Any other information on results incl. tables

Initially a group of 5 male rats, randomly selected, was administered a dosage of 2000 mg/kg of the test article. Since no animals died after the 2000 mg/kg administration, a further group of 5 female rats was administered the same dosage.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No animals died during the study. The LD50 was therefore estiamted to be higher than 2000 mg/kg.

Executive summary:

The acute toxicity after oral exposure of rats to dichloro trifluoro methoxy dioxolane (CAS 161611 -73 -0) was investigated according to the OECD guideline 401 (1981) and EC B.1 (1982).

In this study, 10 Sprague Dawley rats (5 males and 5 females) received a single oral administration of the test item at the dosage of 2000 mg/kg bw/day (limit test). The test item was administered undiluted at the constant volume of 1.22ml/kg in order to give the dose of 2000 mg/kg being the density 1.635 g/ml. All rats were treated after a 16 hours fasting period. The animals were weighed twice before treatment (at randomization and on day 1 just before treatment) and on days 3, 8 and 14. They were observed for clinical signs for 14 days following the treatment. On day 15 all rats were killed (fasted overnight). and necropsied. Gross pthology examinations were performed but not histology.

No animals died during the study. All treated rats did not show any clinical signs or behavioral alterations during the post-treatment observation period.

Body weight resulted unaffected by treatment.

It was reported by the author that , at the autopsy carried out at the end of the observation period, no appreciable macroscopic findings were evident in any treated rat.