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Description of key information

One study is available (Tos, 1995). In this test Sprague-Dawley of both sexes were exposed to a limit dose of 2000 mg/kg). The study was performed according to OECD 401 and under GLP principles. No mortality and no clinical signs were observed. No gross pathological findings were reported. The LD50 was estimated to be > 2000 mg/kg.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1981
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes
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


Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals 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)
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.
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:
No clinical signs or behavioral alterations were observed in any animal during the observation period.
Body weight:
Body weight resulted unaffected by treatment.
Gross pathology:
At necropsy (at the end of the observation preiod) no appreciable macroscopic findings were evident in any treated rats

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.

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Justification for classification or non-classification

Based on the results of an acute oral toxicity study (Tos, 1995) in rats performed according OECD 401, the LD50 of dichloro trifluoro methoxy dioxolane is > 2000 mg/kg.

Based on the results of the above mentioned study and according to Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures, ECHA Guidance on the Application of the CLP Criteria (June 2015) and ECHA guidance Chapter R.7a: Endpoint specific guidance Version 4.1 – October 2015, no classification is needed for dichloro trifluoro metoxy dioxolane.