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EC number: - | 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:
- August 2019 to September 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
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)
- Version / remarks:
- 09 October 2017
- 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:
- Reaction mass of (Tetramethylcyclotetrasiloxane propylether) prop-1-enylether bisphenol A and Di(tetramethylcyclotetrasiloxane propylether) bisphenol A
- Cas Number:
- 203874-34-4
- Molecular formula:
- (OSiHxCH3)4-CH2-CH2 -CH2- O-C6H4-C(CH3)2-C6H4-0-CH2-CH2-CH2-(SiHxCH3O)4
- IUPAC Name:
- Reaction mass of (Tetramethylcyclotetrasiloxane propylether) prop-1-enylether bisphenol A and Di(tetramethylcyclotetrasiloxane propylether) bisphenol A
- Test material form:
- liquid
- Details on test material:
- Appearance: Pale yellow liquid
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Characteristics of donor animals: adult cattle (typically 12 to 60 months old)
- Storage, temperature and transport conditions of ocular tissue: The eyes were excised by an abattoir employee after slaughter, and were placed in Hanks’ Balanced Salt Solution (HBSS) supplemented with antibiotics (penicillin at 100 IU/mL and streptomycin at 100 µg/mL). They were transported to the test facility over ice packs on the same day of slaughter. The corneas were prepared immediately on arrival.
- Indication of any existing defects or lesions in ocular tissue samples: Only corneas free of damage were used.
- Indication of any antibiotics used: penicillin at 100 IU/mL and streptomycin at 100 µg/mL
- Selection and preparation of corneas: All eyes were macroscopically examined before and after dissection. Only corneas free of damage were used.
The cornea from each selected eye was removed leaving a 2 to 3 mm rim of sclera to facilitate handling. The iris and lens were peeled away from the cornea. The isolated corneas were immersed in a dish containing HBSS until they were mounted in Bovine Corneal Opacity and Permeability (BCOP) holders.
The anterior and posterior chambers of each BCOP holder were filled with complete Eagle’s Minimum Essential Medium (EMEM) without phenol red and plugged. The holders were incubated at 32 ± 1 ºC for 60 minutes. At the end of the incubation period each cornea was examined for defects. Only corneas free of damage were used.
The medium from both chambers of each holder was replaced with fresh complete EMEM.
A pre-treatment opacity reading was taken for each cornea using a calibrated opacitometer.
Three corneas were randomly allocated to the negative control. Three corneas were also allocated to the test item and three corneas to the positive control item.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 0.75 mL
- Duration of treatment / exposure:
- 10 minutes
- Duration of post- treatment incubation (in vitro):
- 120 minutes
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- APPLICATION DOSE AND EXPOSURE TIME
0.75 mL of the test item or control items were applied to the appropriate corneas. The holders were gently tilted back and forth to ensure a uniform application of the item over the entire cornea. Each holder was incubated, anterior chamber uppermost, at 32 ± 1 ºC for 10 minutes.
POST-INCUBATION PERIOD: 120 minutes.
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: After the exposure period, the cornea was rinsed 3 times with fresh complete EMEM containing phenol red before a final rinse with complete EMEM without phenol red. The anterior chamber was refilled with fresh complete EMEM without phenol red.
- POST-EXPOSURE INCUBATION: The holders were incubated, anterior chamber facing forward, at 32 ± 1ºC for 120 minutes.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: A post-treatment opacity reading was taken and each cornea was visually observed in addition to a final opacity reading after the post-incubation period.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of Labtech LT-4500 microplate reader, at 492 nm (without a reference filter)
- Histopathology :The corneas were retained after testing for possible conduct of histopathology. Each cornea was placed into a pre-labeled tissue cassette fitted with a histology sponge to protect the endothelial surface. The cassette was immersed in 10% neutral buffered formalin.
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA:
The test item was classified according to the following prediction model:
IVIS UN GHS
< = 3 No Category
>3; = 55 No prediction can be made
> 55 Category 1
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean of 3
- Value:
- 0.4
- Vehicle controls validity:
- valid
- Remarks:
- 0.0
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks:
- 53.7
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- The positive control In Vitro Irritancy Score was within the acceptance range. The positive control acceptance criterion was therefore satisfied.
The negative control gave opacity and permeability values below the established upper limits. The negative control acceptance criteria were therefore satisfied.
individual measurements are summarized below.
Any other information on results incl. tables
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 - Pre-Treatment | Corrected Value |
| Corrected Value | |||
Negative Control | 2 | 4 | 4 | 4 | 0 | - | 0.001 | - | - |
3 | 3 | 3 | 3 | 0 | - | 0.003 | - | - | |
6 | 6 | 5 | 5 | 0 | - | 0.003 | - | - | |
- | - | - | - | 0.0* | - | 0.002♦ | - | 0.0 | |
Positive Control | 9 | 5 | 34 | 33 | 28 | 28.0 | 2.165 | 2.163 | - |
11 | 5 | 26 | 29 | 24 | 24.0 | 1.645 | 1.643 | - | |
12 | 3 | 28 | 29 | 26 | 26.0 | 1.745 | 1.743 | - | |
- | - | - | - | - | 26.0• | - | 1.849• | 53.7 | |
Test item | 14 | 3 | 4 | 4 | 1 | 1.0 | 0.006 | 0.004 | - |
15 | 4 | 4 | 4 | 0 | 0.0 | 0.003 | 0.001 | - | |
16 | 3 | 3 | 3 | 0 | 0.0 | 0.012 | 0.010 | - | |
- | - | - | - | - | 0.3• | - | 0.005• | 0.4 |
OD = Optical density , * = Mean of the post-incubation − pre-treatment values , ♦ = Mean permeability , • = Mean corrected value
Table 2: Corneal Epithelium Condition Post Treatment and Post Incubation
Treatment | Cornea Number | Observation | |
Post Treatment | Post Incubation | ||
Negative Control | 2 | Clear | Clear |
3 | Clear | Clear | |
6 | Clear | Clear | |
Positive Control | 9 | Cloudy | Cloudy |
11 | Cloudy | Cloudy | |
12 | Cloudy | Cloudy | |
Test item | 14 | Clear | Clear |
15 | Clear | Clear | |
16 | Clear | Clear |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the experiment results, the test item is not irritant for eyes.
- Executive summary:
An ex vivo eye irritation test was performed according to OECD/EC guidelines and under GLP principles. Isolated bovine corneas were treated with the negative control, positive control and test item (0.75 mL each) for exposure period 10 minutes followed by an incubation period of 120 minutes. Negative and positive control items were tested concurrently. The two endpoints, decreased light transmission through the cornea (opacity) and increased passage of sodium fluorescein dye through the cornea (permeability) were combined in an empirically derived formula to generate an In Vitro Irritancy Score (IVIS). The In Vitro Irritancy Scores were 0.0, 53.7 and 0.4 for the vehicle control, the positive control and for the test item, respectively. The criteria required for acceptance of results in the test were satisfied.
This data indicates that the test item does not have eye irritation properties.
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