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EC number: 439-510-7 | CAS number: 149048-48-6
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Version / remarks:
- 2013
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 439-510-7
- EC Name:
- -
- Cas Number:
- 149048-48-6
- Molecular formula:
- Constituent 1: C14H26N2O3Si Constituent 2: C13H22N2O2Si
- IUPAC Name:
- 1-(3-{13-[3-(aminomethyl)phenyl]-6,6,8,8-tetramethoxy-7-oxa-2,12-diaza-6,8-disilatridecan-1-yl}phenyl)methanamine; 1-[3-({[3-(trimethoxysilyl)propyl]amino}methyl)phenyl]methanamine
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature container flushed with nitrogen
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: The test material was applied undiluted.
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test material was applied undiluted.
- Preliminary purification step (if any): No correction was made for the purity/composition of the test item.
- Final dilution of a dissolved solid, stock liquid or gel: not applicable
- Final preparation of a solid: not applicable
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Vitelco, 's Hertogenbosch, The Netherlands
- Number of animals:
- Characteristics of donor animals (e.g. age, sex, weight): young cattle
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions): Eyes were collected and transported in physiological saline in a suitable container under cooled conditions.
- Time interval prior to initiating testing:
- indication of any existing defects or lesions in ocular tissue samples: The eyes were checked for unacceptable defects, such as opacity, scratches, pigmentation and neovascularization by removing them from the physiological saline and holding them in the light. Those exhibiting defects were discarded.
- Indication of any antibiotics used: none specified
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750µl
- Concentration (if solution): not applicable
- Duration of treatment / exposure:
- 10 +/- 1 minutes at 32 +/- 1°C
- Duration of post- treatment incubation (in vitro):
- 120 +/- 10 minutes at 32 +/- 1°C
- Number of animals or in vitro replicates:
- Three corneas per treatment group.
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS: The eyes were checked for unacceptable defects, such as opacity, scratches, pigmentation and neovascularization by removing them from the physiological saline and holding them in the light. Those exhibiting defects were discarded. The corneas were incubated with cMEM for the minimum of 1 hour at 32 +/- 1°C.
QUALITY CHECK OF THE ISOLATED CORNEAS: After the incubation period, the medium was removed from both compartments and replaced with fresh cMEM. Opacity determinations were performed on each of the corneas using an opacitometer. The opacity of each cornea was read against a cMEM filled chamber, and the initial opacity reading thus determined was recorded. Corneas that had an initial opacity reading higher than 7 were not used. Three corneas were selected at random for each treatment group.
NUMBER OF REPLICATES: Three corneas per group
NEGATIVE CONTROL USED: Yes, physiological saline
SOLVENT CONTROL USED (if applicable): not applicable
POSITIVE CONTROL USED: Yes, ethanol
APPLICATION DOSE AND EXPOSURE TIME: 750µl for 10 +/- 1 minutes at 32 +/- 1°C
TREATMENT METHO: not specified
POST-INCUBATION PERIOD: No
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: After the incubation the solutions were removed and the epithelium was washed with MEM with phenol red (Earle’s Minimum Essential Medium) and thereafter with cMEM
- POST-EXPOSURE INCUBATION: 120 +/- 10 minutes at 32 +/- 1°C
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: diminution of light passing through the cornea
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of microtiter plate reader (OD490)
- Others (e.g, pertinent visual observations, histopathology):
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: The decision criteria as indicated in the TG was used.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- treatment with 100% test material for 10 min
- Value:
- > 186 - <= 304
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- ranged from -2.2 to -1.0
- Positive controls validity:
- valid
- Remarks:
- ranged from 51 to 71
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- treatment with 100% test material for 10 min
- Value:
- 228
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: none reported
DEMONSTRATION OF TECHNICAL PROFICIENCY: The negative control responses for opacity and permeability 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 in vitro irritancy score of the positive control (Ethanol) was 61 and within two standard deviations of the current historical positive control mean (Appendix 3). It was therefore concluded that the test conditions were adequate and that the test system functioned properly.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes, within historical control ranges
- Acceptance criteria met for positive control: Yes, within historical control ranges
- Range of historical values if different from the ones specified in the test guideline: Not different
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- In the Bovine Corneal Opacity and Permeability test, conducted according to an appropriate OECD guideline and in compliance with GLP, the test material was reported to induce an IVIS score greater than 55 and to be irritating to bovine corneas.
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