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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1981
Deviations:
no
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

Constituent 1
Chemical structure
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.