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EC number: 801-072-3 | CAS number: 1052075-57-6
- 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:
- 23 July, 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Version / remarks:
- (2009)
- 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)
- Version / remarks:
- (2010)
- Deviations:
- no
- Principles of method if other than guideline:
- - The Ocular Toxicity Working Group (OTWG) of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and the National Interagency Centre for the Evaluation of Alternative Toxicological Methods (NICEATM), Background Review Document (BRD): current status of in vitro test methods for identifying ocular corrosives and severe irritants: The Bovine Corneal Opacity and Permeability (BCOP) Test Method, March 2006.
- In Vitro Techniques in Toxicology Database (INVITTOX) protocol 127. Bovine Opacity and Permeability (BCOP) Assay, 2006.
- Gautheron P., Dukic M., Alix D. and Sina J.F., Bovine corneal opacity and permeability test: An in vitro assay of ocular irritancy. Fundam Appl Toxicol 18:442-449, 1992. - GLP compliance:
- yes
Test material
- Reference substance name:
- 2-[3-(9-butyl-1,1,3,3,5,5,7,7,9,9-decamethylpentasiloxanyl)propoxy]ethyl methacrylate
- EC Number:
- 801-072-3
- Cas Number:
- 1052075-57-6
- Molecular formula:
- C23H54O7Si5
- IUPAC Name:
- 2-[3-(9-butyl-1,1,3,3,5,5,7,7,9,9-decamethylpentasiloxanyl)propoxy]ethyl methacrylate
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): KF-1622
- Description: Clear colourless liquid
Constituent 1
Test animals / tissue source
- Details on test animals or tissues and environmental conditions:
- ENVIRONMENTAL CONDITIONS
- Temperature (°C): 32 ± 1
Test system
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied (volume): approx. 750 µL per cornea
NEGATIVE CONTROL
- Amount applied (volume): 750 µL of physiological saline per cornea
POSITIVE CONTROL
Amount applied (volume): 750 µL per cornea
Concentration: 10% (w/v) Benzalkonium Chloride
- Duration of treatment / exposure:
- 10 minutes
- Details on study design:
- TEST SITE
- Isolated bovine cornea. Three corneas were selected at random for each treatment group.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 10 minutes
SCORING SYSTEM:
- After exposure the cornea is thoroughly rinsed to remove the test substance followed by immediate opacity measurement and permeability evaluation of the cornea.
- The mean opacity and mean permeability values (OD490) were used for each treatment group to calculate an in vitro score:
In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value).
TOOL USED TO ASSESS SCORE:
- opacitymeter and microplate reader
DATA EVALUATION:
A test substance that induces an IVIS ≥ 55.1 is defined as a corrosive or severe irritant
Results and discussion
In vivo
Results
- Irritation parameter:
- other: In vitro irritancy score (IVIS)
- Basis:
- mean
- Time point:
- other: 10 minutes
- Score:
- 0
- Remarks on result:
- other: The mean in vitro irritancy score of the negative control was 0 and that of the positive control (10% (w/v) Benzalkonium Chloride) was 145.
- Irritant / corrosive response data:
- The corneas treated with KF-1622 showed opacity values ranging from -1 to 1 and permeability values ranging from -0.001 to 0.002. The corneas were clear after the 10 minutes of treatment with KF-1622. No pH effect of the test substance was observed on the rinsing medium. Hence, the in vitro irritancy scores ranged from -1 to 1 after 10 minutes of treatment with KF-1622.
Any other information on results incl. tables
Historical control data were included. The negative control responses of the opacity and permeability values were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas.The mean IVIS of the positive control (10% (w/v) Benzalkonium Chloride) was 145 and within the historical positive control data range. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance KF-1622 is not irritant or corrosive in the Bovine Corneal Opacity and Permeability test performed according to OECD 437 guideline and GLP principles.
- Executive summary:
The substance KF-1622 was screened for the eye irritancy potential using the BCOP test performed according to OECD 437 guideline and GLP principles.
The negative control responses of the opacity and permeability values were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas.The mean IVIS of the positive control (10% (w/v) Benzalkonium Chloride) was 145 and within the historical positive control data range. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.
The substance did not induce ocular irritation through both endpoints, resulting in a mean IVIS of 0 after 10 minutes of treatment.
Based on the results it is concluded that the substance is not severe irritant or corrosive in the Bovine Corneal Opacity and Permeability test.
Acceptability test and interpretation results:
The BCOP test method is recommended by authorities to identify the eye hazard potential of a test chemical. This test method is also recommended to identify chemicals that do not require classification for eye irritation or serious eye damage, as defined by the UN GHS, in case IVIS ≤ 3.
As in the present study with KF-1622 an IVIS of 0 was obtained, indicating no irritating properties for KF-1622, further testing for eye irritating properties is considered redundant and ethically not justified.
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