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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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:
- There were no deviations from the study plan
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 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The closed patch test for delayed-type hypersensitivity is performed on the guinea pig. It has been the animal of choice for predictive sensitisation tests for several decades. The assessment of the test item to produce skin sensitisation is achieved through multiple exposures under standardised conditions. Animals of either sex are acceptable for use according to DECO 406.
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)
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Crl: HA - Guinea Pigs (full barrier)
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: approximately 4 weeks old
- Weight at study initiation: 329-360 g
- Housing: The animals were kept in groups in Terluran - cages on Altromin saw fibre
bedding
- Diet (e.g. ad libitum): Free access to autoclaved hay and to Altromin 3122 maintenance diet for guinea pigs, 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 lp.aRt fivp. clays)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): at least 10 x / hour
- Photoperiod (hrs dark / hrs light): Artificial light, sequence being 12 hours light, 12 hours dark
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 ml
- Day(s)/duration:
- once a week at the same test srea at weekly intervals for 3 weeks
- Adequacy of induction:
- not specified
Challenge
- No.:
- #20
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 ml of the test substance
- Day(s)/duration:
- 14 days after the last induction, dermal application for 6 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- Number of animals in the preliminary test: 2
Number of animals in the test group: 20
Number of animals in the negative-control group: 10 - Details on study design:
- RANGE FINDING TESTS: Before the initiation of the preliminary test, a solubility test was performed to define the maximum concentration which is technically applicable to the animals. Solubility was found for the vehicle acetone at a concentration of 75%.
Two different concentrations of the test item (100%, undiluted and 75%, diluted with the vehicle acetone) were applied topically to the flanks of the animals for 6 hours using occlusive dressings to determine the concentrations for the main study.
2 animals were treated topically with a concentration of 100% of the undiluted test item on the left flank and with a concentration of 75% of the test item (dissolved in acetone, Sigma, lot no. MKBN6172V, expiry date: 01/2017) on the right flank for 6 hours. A Hill Top Chamber® was loaded with 0.5 mL of the prepared test substance. The chamber was applied to the test area of approximately 2.5 x 2.5 cm and was held in contact with the help of an occlusive dressing. Based on the results of this preliminary test the following concentrations were chosen for the main test:
a concentration of 100% for the dermal inductions
a concentration of 100% for the challenge application
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours/day - once a day/week for 3 consecutive weeks
- Test groups: 20 animals
- Control group: 10 animals
- Site: The left flank was cleared of hair (close-clipped) prior to the first application and again prior to further applications during Induction I, 2 and 3
- Frequency of applications: This procedure was repeated once a week at the same test area at weekly intervals for 3 weeks.
- Duration: 6 hours/day - once a day/week for 3 consecutive weeks
- Concentrations: 0.5 ml of undiluted test substance
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after last induction
- Exposure period: 6 hours under occlusive conditions
- Test groups: 20 animals
- Control group: 10 animals
- Site: both flanks were cleared of hair (close-clipped) prior to challenge application
- Concentrations: 0.5 ml of undiluted test substance
- Evaluation (hr after challenge): approximately 21 hours after removing the Hill Top Chamber, the challenge area was cleaned and cleared of hair by the use of depilatory cream. Approximately 24 and 48 hours after removing the patch the skin reaction was observed and scored accordingly - Challenge controls:
- Test Group and Negative Control Group:
Both flanks were cleared of hair (close-clipped) prior to the challenge application. 14 days after the last induction application 0.5 mL of the test substance were loaded on a Hill Top Chamber®, applied to an area of approximately 2.5 x 2.5 cm on the right flank and held in contact with the help of an occlusive dressing for 6 hours. A dry Hill Top Chamber® was applied to an area of approximately 2.5 x 2.5 cm on the left flank at an untreated site (intraspecific control) and was held in contact with the help of an occlusive dressing for 6 hours - Positive control substance(s):
- yes
- Remarks:
- Positive-Control Substance: mercaptobenzothiazole, purity> 98%, Aldrich, lot no.: BCBC5206V, expiry date: 03/2019
Results and discussion
- Positive control results:
- The sensitisation rate after application of the positive-control substance mercaptobenzothiazole (25% in vaseline) was 85%, confirming the reliability of the test
system.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- All animals of both groups survived throughout the test period. No signs of toxicity were recorded .Neither erythema nor oedema was observed in any animal at any time of observation.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- same as above
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- same as above
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- same as above
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
All animals of both groups survived throughout the test period. No signs of toxicity were recorded .Neither erythema nor oedema was observed in any animal at any time of observation. There was no evidence of sensitisation and the percentage of sensitised animals was 0%.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present study it can be stated that the test item HES10108 (Supplied as DOW CORNING® BY 16-122 B) caused no reactions identified as sensitisation at the tested concentration.
According to Commission Regulation (EU) No 286/2011 as well as OECD-GHS (Globally Harmonized Classification System) the test item HES10108 (Supplied as DOW CORNING® BY 16-122 B) has no obligatory labelling requirement for skin sensitisation and is unclassified. - Executive summary:
In a test for delayed-type hypersenitivity in guinea pigs (closed patch test according to Buehler) conducted according to OECD Guidelines 406, EU Method EC 440/2008 and EPA OPPTS 870.2600 and in accordance with the Principles of GLP, groups of guinea pigs were exposed dermally to HES10108 (Supplied as DOW CORNING® BY 16-122 B).
Under the conditions of the present study it can be stated that the test item HES10108 (Supplied as DOW CORNING® BY 16-122 B) caused no reactions identified as sensitisation at the tested concentration.
According to Commission Regulation (EU) No 286/2011 as well as OECD-GHS (Globally Harmonized Classification System) the test item HES10108 (Supplied as DOW CORNING® BY 16-122 B) has no obligatory labelling requirement for skin sensitisation and is unclassified.
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