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EC number: 605-262-5 | CAS number: 161611-73-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
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
- 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
- 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
- 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 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) - 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:
- 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
- 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.
Reference
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.
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.
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