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EC number: 682-238-0 | CAS number: 1190931-27-1
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009-03-26 to 2009-06-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Guideline-conform study 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:
- other: The Bovine Corneal Opacity and Permeability Assay (BCOP) will be performed according to the INVITTOX (UK) protocol no. 98 "The Bovine Corneal Opacity and Permeability Assay", dated February 1994.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Bovine Corneal Opacity and Permeability (BCOP) Assay, SOP of Microbiological Associates Ltd., UK, Procedure Details, April 1997.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Draft OECD Guideline for Testing of Chemicals: The Bovine Corneal Opacity and Permeability (BCOP) Test Method for Identifying Ocular Corrosives and Severe Irritants (December, 2008).
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hessisches Ministerium für Umwelt, Energie, Landwirtschaft und Verbraucherschutz
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:
- ammonium 2,2-difluoro-2-{[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:
- ammonium 2,2-difluoro-2-{[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): cC604
- Substance type: pure substance
- Physical state: solid
- Analytical purity: 96.2%
- 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
- Composition of test material, percentage of components: not reported
- Isomers composition: not reported
- Purity test date: not reported
- Lot/batch No.: 150/31
- Expiration date of the lot/batch: 31 December 2020
- Stability under test conditions: Stable in water and saline for days
- Storage condition of test material: At room temperature
Constituent 1
Constituent 2
Constituent 3
Test animals / tissue source
- Species:
- other: in vitro test, using bovine cornea
- Strain:
- other: in vitro test, using bovine cornea
- Details on test animals or tissues and environmental conditions:
- not applicable, in vitro test
Test system
- Vehicle:
- physiological saline
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): approx. 100 mg at a volume of 1.0 mL on the surface of the corneas
- Concentration (if solution): 100 g/l
VEHICLE
- Amount(s) applied (volume or weight with unit): 1.0 ml per applicatiom
- Concentration (if solution): 0.9% (w/v)
- Lot/batch no. (if required): no data
- Purity: no data - Duration of treatment / exposure:
- 240 minutes (± 5 minutes)
- Observation period (in vivo):
- not applicable to in vitro testing
- Number of animals or in vitro replicates:
- Not applicable to in vitro testing; three bovine corneas used for each test item, negative and positive controls
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): After incubation, test medium was rinsed off from the application side by changing cMEM buffer
- Time after start of exposure: 240 min
SCORING SYSTEM:
The following formula was used to determine the in vitro score of the negative control:
In vitro Score = opacity value + (15 x OD490 value)
The following formula was used to determine the in vitro score of the positive control and the test item:
In vitro Score = (opacity value – opacity valuenegative control + (15 x corrected OD490 value)
The in vitro score was calculated for each individual treatment and positive control cornea.
The mean in vitro score value of each treated group was calculated from the individual in vitro score values.
In vitro score Proposed in vitro irritation scale
0-3 non eye irritant
3.1-25 mild eye irritant
25.1-55 moderate eye irritant
55.1-80 severe eye irritant
>80.1 very severe eye irritant
TOOL USED TO ASSESS SCORE: This test is designed to measure the opacity of the cornea by quantifying the ability of light of pass through it. The permeability, as a result of the irritation potential of the test item, is determined using Na-fluorescein solution.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 183.46
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: very severe irritant
- Other effects / acceptance of results:
- The mean "in vitro irritation score" was 183.46, thus much above the score of 80.1, which represents the minimum score for the data interpretation "very severe irritating".
Any other information on results incl. tables
Table 1: Results after 240 Minutes Incubation Time
Test Group | Opacity value = Difference (t240-t0) of Opacity * | Permeability at 490 nm (OD490)* | In vitro Score | Mean in vitro Score | Proposed in vitro Irritation Scale |
Negative control (mean of 3 tests) | 0 | 0.143 | 2.15 | No eye irritant | |
Positive Control | 104 | -0.063 | 103.05 | ||
Positive Control | 113 | -0.034 | 112.49 | 105.73 | Very severe eye irritant |
Positive Control | 101 | 0.044 | 101.66 | ||
cC6O4 | 214 | 1.985 | 243.77 | ||
cC6O4 | 130 | 2.232 | 163.48 | 183.46 | Very severe eye irritant |
cC6O4 | 109 | 2.276 | 143.14 |
*corrected values
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item cC6O4 ammonium salt is considered to be a very severe eye irritant. As the observed effects caused by the test item exceeded by far the effects caused by the positive control substance, a worst case classification is suggested, i.e. CLP classification H318, eye damage 1.
- Executive summary:
This in vitro study was performed to assess the corneal irritation and damage potential of cC6O4 ammonium salt by means of the BCOP assay using fresh bovine corneas.
After a first opacity measurement of the fresh bovine corneae (t0), about 100 mg of the test item cC6O4 ammonium salt, the positive, and the negative controls were applied to corneas and incubated for 240 minutes at 32 ± 2 °C in complete medium. After the incubation phase the test item, the positive, and the negative controls were each rinsed from the corneas and opacity was measured again (t240). After the opacity measurements permeability of the corneas was determined while application of 1 mL of a fluorescein solution for 90 minutes at 32 ± 2 °C in a horizontal position. The coming out liquid was measured spectrophotometrically.
With the negative control (0.9% NaCl solution) neither an increase of opacity nor permeability of the corneas could be observed. The in vitro score was calculated as 2.15. The positive control (10% (v/v) Benzalconium chloride) showed clear opacity and distinctive permeability of the corneas and therefore, is classified as very severe eye irritant. The in vitro score was calculated as 105.73. The test item cC6O4 ammonium salt caused opacity and permeability of the corneas compared with the results of the negative control. The calculated in vitro score was 183.46 and therefore, the test item was classified as very servere eye irritant.
As the observed effects caused by the test item exceeded by far the effects caused by the positive control substance, a worst case classification is suggested, i.e. CLP classification H318, eye damage 1.
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