Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 701-366-0 | CAS number: -
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- 2009-03-09 to 2009-12-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The experimental study on the supporting substance is guideline-conform under GLP without deviations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- cC6O4 ammonium salt
- IUPAC Name:
- cC6O4 ammonium salt
- Reference substance name:
- Acetic acid, 2,2-difluoro-2-[[2,2,4,5- tetrafluoro-5-(trifluoromethoxy)-1,3- dioxolan-4-yl]oxy]-, ammonium salt (1:1)
- IUPAC Name:
- Acetic acid, 2,2-difluoro-2-[[2,2,4,5- tetrafluoro-5-(trifluoromethoxy)-1,3- dioxolan-4-yl]oxy]-, ammonium salt (1:1)
- Reference substance name:
- Reaction mass of ammonium difluoro {[(4S,5R)-2,2,4,5-tetrafluoro-5-(trifluoromethoxy)-1,3-dioxolan-4-yl]oxy}acetate, ammonium difluoro {[(4R,5S)-2,2,4,5-tetrafluoro-5-(trifluoromethoxy)-1,3-dioxolan-4-yl]oxy}acetate, ammonium difluoro {[(4S,5S)-2,2,4,5-tetrafluoro-5-(trifluoromethoxy)-1,3-dioxolan-4-yl]oxy}acetate and ammonium difluoro {[(4R,5R)-2,2,4,5-tetrafluoro-5-(trifluoromethoxy)-1,3-dioxolan-4-yl]oxy}acetate
- EC Number:
- 682-238-0
- Cas Number:
- 1190931-27-1
- Molecular formula:
- C6H4F9NO6
- IUPAC Name:
- Reaction mass of ammonium difluoro {[(4S,5R)-2,2,4,5-tetrafluoro-5-(trifluoromethoxy)-1,3-dioxolan-4-yl]oxy}acetate, ammonium difluoro {[(4R,5S)-2,2,4,5-tetrafluoro-5-(trifluoromethoxy)-1,3-dioxolan-4-yl]oxy}acetate, ammonium difluoro {[(4S,5S)-2,2,4,5-tetrafluoro-5-(trifluoromethoxy)-1,3-dioxolan-4-yl]oxy}acetate and ammonium difluoro {[(4R,5R)-2,2,4,5-tetrafluoro-5-(trifluoromethoxy)-1,3-dioxolan-4-yl]oxy}acetate
- Details on test material:
- - Name of test material (as cited in study report): cC6O4 (DRY SALT)
- Molecular formula (if other than submission substance): C6H4F9NO6
- Molecular weight (if other than submission substance): 357
- Smiles notation (if other than submission substance): [NH4+].FC1(F)OC(F)(OC(F)(F)C([O-])=O)C(F)(OC(F)(F)F)O1
- InChl (if other than submission substance): no data
- Structural formula attached as image file (if other than submission substance): see Fig.1 (C6O4 Structural formula)
- Substance type: organic
- Physical state: Hygroscopic, off-white/cream, granules
- Analytical purity: 96.2% in terms of dry salt
- Impurities (identity and concentrations): NH4F=0.021% (w/w), NH4Cl=0.31% (w/w), H2O=0.328% (w/w), the organic impurities are dioxolan based and represent the 0.8% by mol on total mol of organic phase of sample
- Purity test date: not reported
- Lot/batch No.: 150/31
- Expiration date of the lot/batch: 31 December 2020
- Stability under test conditions: not reported
- Storage condition of test material: Ambient condition
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Italy S.r.l., 33049 San Pietro al Natisone (UD), Italy
- Age at study initiation: 6 to 8 weeks old
- Weight at study initiation: 183.7 to 194.1 grams
- Fasting period before study: Overnight prior to dosing (Day –1)
- Housing: Polycarbonate cages measuring 59x38.5x20 cm, with stainless steel mesh lid and floor
- Diet (e.g. ad libitum): 4 RF 18 ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 2°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): Approximately 15 to 25 air changes per hour
- Photoperiod (hrs dark / hrs light): Artificial (fluorescent tubes), daily light/dark cycle of 12/12 hours
IN-LIFE DATES: From: 2009-02-26 To: 2009-03-26
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 2.5x2.5 cm
- % coverage: 10%
- Type of wrap if used: A strip of synthetic film was placed over the treated site and the whole assembly held in place by encircling the trunk of the animal with a length of elastic adhesive bandage, this forming a semi-occlusive barrier.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treatment area was cleaned by gentle swabbing of the skin with cotton wool soaked with lukewarm water.
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 367.4 mg - 388.2 mg of dry salt
- Concentration (if solution): n.a.
- Constant volume or concentration used: yes
- For solids, paste formed: A volume of 0.5 ml or 1.0 ml of sterile water was added and mixed to a paste at the dosing procedure
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 ml or 1.0 ml of sterile water
- Concentration (if solution): n.a.
- Lot/batch no. (if required): n.a.
- Purity: distilled water - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Allocation (Day-1), Days 1, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- no statistics applied
Results and discussion
- Preliminary study:
- not applicable
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- none observed
- Clinical signs:
- No systemic toxic effect were observed in male or female animals during the observation period. External examination of the treated site showed a slight oedema on Day 2 in all animals. Recovery from this sign occurred in all animals by Day 3. Desquamation of the treated skin was recorded in a single female from Day 3 to Day 7. Recovery occurred in this animal by Day 8.
- Body weight:
- A very slight body weight loss was recorded in a single female animal on Day 8 and in another female on Day 15. These losses are not believed to have any toxicological significance. Changes in body weight were within the expected range for this species and age of animal at the end of the study.
- Gross pathology:
- No abnormalities were found in any animals at necropsy performed at termination of the study.
- Other findings:
- none reported
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- These results indicate that the test item, cC6O4 ammonium salt, has no toxic effect on the rat following dermal exposure over a 24 hour period at a level of 2000 mg/kg. The lack of mortality demonstrates the LD50 to be greater than 2000 mg/kg.
Considering the similarity of chemical structure between cC6O4 ammonium salt and F-DIOX potassium salt, the same degree of acute toxicity of cC6O4 ammoium salt is expected for F-DIOX ammonium salt. - Executive summary:
In order to evaluate the potential dermal acute toxicityof F- Diox potassium salt it was deemed appropriate to use the Read Across approach based on the experimental study performed on cC6O4 ammonium salt by virtue of similarity of chemical structure between F- Diox potassium salt and cC6O4 ammonium salt (CAS no: 1190931-27-1).
F-Diox potassium salt and cC6O4 ammonium salt are two salts of the same carboxylic acid, they differ only for the cationic part (K+ in F-Diox potassium salt and NH4+ in cC6O4 ammonium salt). Considering the similarity of chemical structure a similar biological behaviour is expected.
The acute toxicity of cC6O4 ammonium salt was investigated following administration of a single dermal dose to the rat. No mortality occurred following dosing and no significant clinical signs were observed. These results indicate that the test item, cC6O4 ammonium salt, has no toxic effect on the rat following dermal exposure over a 24 hour period at a level of 2000 mg/kg. The lack of mortality demonstrates the LD50 to be greater than 2000 mg/kg. European Directives concerning the classification, packaging and labelling of dangerous substances and preparations (Regulation (EC) no. 1907/2006, 67/548/EEC and subsequent revisions) would indicate the following for cC6O4 ammonium salt:
Classification : Not required
Signal word : None indicated
Hazard statement : None indicated
Considering the similarity of chemical structure between cC6O4 ammonium salt and F-DIOX potassium salt above discussed, the same degree of dermal acute toxicity of cC6O4 ammonium salt is expected for F-DIOX potassium salt.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.