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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 482-280-8 | 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 May 2018 - 16 May 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 482-280-8
- EC Name:
- -
- Cas Number:
- 449177-94-0
- Molecular formula:
- C8H11F5O2
- IUPAC Name:
- 3-methyl-3-[(2,2,3,3,3-pentafluoropropoxy)methyl]oxetane
- Test material form:
- liquid
- Details on test material:
- Lot No: 2231AM-68E
Expiry date: 01 January 2019
Storage conditions: room temperature in the dark
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Eyes from adult cattle (typically 12 to 60 months old) were obtained from a local abattoir as a by-product from freshly slaughtered animals.
Immediately after slaughter, the eyes were placed in Hanks' Balanced Salt Solution (HBSS) supplemented with antiobiotics (penicillin at 100 IU/mL and streptomycin at 100 µg/mL). They were transported to the test facility over ice packs and refrigerated upon arrival. They were used within 24 hours of receipt.
All eyes were macroscopically examined before and after dissection. Only corneas free of damage were used.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 0.75 mL of test item or control item was directly applied. The holders were gently tilted back and forth to ensure a uniform application of the item over the entire cornea.
- Duration of treatment / exposure:
- The corneas were Incubated at 32 ± 1 °C for 10 minutes.
- Duration of post- treatment incubation (in vitro):
- The holders were incubated, anterior chamber facing forward at 32 ± 1 °C for 120 minutes following the treatment.
- Details on study design:
- A pre-treatment opacity reading was taken for each cornea using a calibrated opacitometer.
The test item or control were applied directly to the corneas and incubated for 10 minutes at 32 ± 1 °C.
At the end of the exposure period, the test item and control items were removed from the anterior chamber and the cornea was rinsed 3 times with fresh complete EMEM containing phenol red before a final rinse with complete EMEM without phenol red. A post-treatment opacity reading was taken and each cornea was visually observed.
The holders were incubated, anterior chamber facing forward at 32 ± 1 °C for 120 minutes.
After incubation. the holders were removed from the incubator and the medium replaced with fresh EMEM. A final opacity reading was taken and each cornea visually inspected.
Following the final opacity measurement the permability of the corneas to sodium fluorescein was evaluated by incubation with 1mL of sodium fluorescein solution (4 mg/mL) at 32 ± 1 °C for 90 minutes.
After incubation, the medium in the posterior chamber of each holder was decanted and retained. 360 µL of media representing each cornea was dispensed into the appropriate wells of pre-labeled 96-well plate. The optical density was measured at 492 nm (without a reference filter) using the Labtech LT-4500 microplate reader.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Overall score (mean of 3 values)
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Overall Score
- Value:
- 0.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- - Sodium chloride 0.9% w/v was used for the negative control. The test was considered acceptable if the negative control produced an opacity value of <3.0 and a permeability of <0.077.
The values obtained for the negative control did meet the acceptance criterion at 0.78 for opacity and 0.060 for permeability.
- Neat ethanol was used for positive control purposes. The test was considered acceptable if the positive control produced an In Vitro Irritancy score between the range of 31.6 to 58.7. The In Vitro Irritancy Score obtained for the positive control was 45.3 and is therefore considered acceptable.
The condition of each cornea were also noted. The corneas treated with the test item were clear post treatment and post incubation. The corneas treated with the negative control item were clear post treatment and post incubation. The corneas treated with the positive control item were cloudy post treatment and post incubation.
Any other information on results incl. tables
Table 1: Individual and Mean Corneal Opacity and Permeability Measurements
Treatment |
Cornea Number |
Opacity |
Permeability (OD492) |
In Vitro Irritancy Score |
|||||
Pre-Treatment |
Post-Treatment |
Post Incubation |
Post-Incubation minus Pre-Treatment |
Corrected value |
|
Corrected value |
|||
Negative Control |
2 |
3 |
3 |
4 |
1 |
|
0.014 |
|
|
3 |
6 |
5 |
6 |
0 |
|
0.015 |
|
|
|
6 |
2 |
2 |
3 |
1 |
|
0.152 |
|
|
|
|
|
|
|
0.7* |
|
0.060# |
|
1.6 |
|
Positive Control |
7 |
5 |
35 |
35 |
30 |
29.3 |
1.735 |
1.675 |
|
10 |
5 |
27 |
26 |
21 |
20.3 |
1.505 |
1.445 |
|
|
11 |
4 |
33 |
30 |
26 |
25.3 |
1.010 |
0.950 |
|
|
|
|
|
|
|
25.0• |
|
1.356• |
45.3 |
|
Test Item |
12 |
4 |
4 |
3 |
-1 |
0.0 |
0.015 |
0.000 |
|
14 |
2 |
3 |
2 |
0 |
0.0 |
0.052 |
0.000 |
|
|
15 |
2 |
2 |
2 |
0 |
0.0 |
0.072 |
0.012 |
|
|
|
|
|
|
|
0.0• |
|
0.004• |
0.1 |
OD = Optical density * = Mean of post incubation – pre-treatment •= Mean corrected value # = mean permeability
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The in vitro irritancy score for the test item was determined to be 0.1 and therefore the test item does not require classification for eye irritation.
- Executive summary:
The purpose of this test was to identify whether the test item would induce serious eye damage upon application to the eye using the Bovine Corneal Opacity and Permeability (BCOP) test method.
The test item along with a positive (ethanol) and negative (Sodium chloride 0.9% w/v) control were applied directly to the eye and the opacity and permeability recorded. The test results obtained for the negative and positive control were within the limits stated and therefore considered acceptable.
The in vitro irritancy score for the test item was determined to be 0.1 and therefore it can be concluded that the test item does not require classification for eye irritation.
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.