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EC number: 950-463-6 | 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Minor deviations were noted however these did not have any impact on the study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Minor deviations were noted but these did not have any impact on the study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- same as above
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- yes
- Remarks:
- same as above
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction mass of Methacryloxypropyl (tris(trialkylsiloxy)silylethyl dimethylsiloxy) silane and oligomers
- EC Number:
- 950-463-6
- Molecular formula:
- C(33-81)H(86-214)O(11-25)Si(11-28)
- IUPAC Name:
- Reaction mass of Methacryloxypropyl (tris(trialkylsiloxy)silylethyl dimethylsiloxy) silane and oligomers
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
HES10108 (supplied as Dow Corning BY 16-122B
- Expiration date of the lot/batch:
25-August-2017 / Lot number 0008624816
- Purity test date:
-14-April-2016
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
0°C -32 °C, protected from light. Do not store with strong
oxidising agents
- Stability under test conditions:
the liquid test item was tested undiluted
- Solubility and stability of the test substance in the solvent/vehicle:
not applicable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:
not applicable
Other
- Physical state - liquid
- Color - colorless
- Active components - 95%: 3-Methacryloxypropyltris {[tris(trimethylsiloxy) silyl]
ethyldimethylsiloxy} silane
- Purity - 99.3% (non-volatile content)
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand Black
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, 97633 Sulzfeld, Germany
- Age at study initiation: approximately 19-20 weeks old
- Weight at study initiation: > 2.0 kg
- Housing: Housed in ABS-plastic or Noryl rabbit cages, floor 4200 cm 2
- Diet (e.g. ad libitum): Free access autoclaved hay and to Altromin 2123 maintenance diet for rabbits, rich in crude fibre
- Water (e.g. ad libitum): Free access to tap water (drinking water, municipal residue control, microbiological controls at
regular intervals)
- Acclimation period: Adequate acclimatisation period (at least 5 days) under laboratory conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3°C
- Humidity (%): 55 ± 10%
- Air changes (per hr): Air change: at least 10 x / hour
- Photoperiod (hrs dark / hrs light): Artificial light, sequence being 12 hours light, 12 hours dark
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- A dose of 0.1 mL of the test item was applied to the test site
- Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- The animals were observed for 72 hours after dosing
- Duration of post- treatment incubation (in vitro):
- not applicable
- Number of animals or in vitro replicates:
- 3 rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eye was not rinsed after the application
SCORING SYSTEM: The eyes were examined for signs of irritation throughout the observation period. The eye irritation was scored and recorded according to the Draize grades
TOOL USED TO ASSESS SCORE: At the end of the observation period the treated eyes were examined with the aid of a fluorescein solution. The eyes were rinsed with physiological saline 0.9% NaCI after the examination.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other:
- Remarks:
- not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other:
- Remarks:
- not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other:
- Remarks:
- not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0.33 - 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within:
- Remarks:
- 72 hours
- Remarks on result:
- probability of weak irritation
- Irritant / corrosive response data:
- After the application into the eyes of three male NZW rabbits the test item produced slight irritant effects in all animals, which were fully reversible within 48 hours in animals no. 1 and no. 2 and 72 hours in animal no. 3. No corrosive effects were observed in any animals. Upon fluorescein examinations at the end of the observation period of 72 hours no corneal lesions were found in any animal
- Other effects:
- Neither mortalities nor significant clinical signs of toxicity but local effects were observed
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present study, a single ocular application of the test item HES10108 (Supplied as DOW CORNING® BY 16-122 B) to rabbits at a dose of 0.1 mL produced slight irritant effects, which were fully reversible within 48 hours in animals no. 1 and no. 2 and within 72 hours in animal no. 3. Neither mortalities nor significant clinical signs of toxicity were observed.
According to Annex I of Regulation (EC) 1272/2008 [9], the test item HES10108 (Supplied as DOW CORNING® BY 16-122 B) has no obligatory labelling requirement for eye irritation and according to GHS (Globally Harmonized Classification System) [10] the test item HES1 01 08 (SuJJJJlied as DOW CORNING® BY '16-'122 B) has no obligatory labelling requirement for eye irritation , - Executive summary:
In this eye irritation/corrosion study (conducted according to OECD Guideline 405, EU Method B.5 and EPA OPPTS 870.2400 and in accordance with GLP), three rabbits were administered a single ocular application of HES10108 (Supplied as DOW CORNING® BY 16 -122 B) at a dose of 0.1 ml and evalauted for ocular irritation/corrosion effects.
Under the conditions of the present study, a single ocular application of the test item HES10108 (Supplied as DOW CORNING® BY 16-122 B) to rabbits at a dose of 0.1 mL produced slight irritant effects, which were fully reversible within 48 hours in animals no. 1 and no. 2 and within 72 hours in animal no. 3. Neither mortalities nor significant clinical signs of toxicity were observed.
According to Annex I of Regulation (EC) 1272/2008 [9], the test item HES10108 (Supplied as DOW CORNING® BY 16-122 B) has no obligatory labelling requirement for eye irritation and according to GHS (Globally Harmonized Classification System) [10] the test item HES1 01 08 (SuJJJJlied as DOW CORNING® BY '16-'122 B) has no obligatory labelling requirement 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.
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