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Diss Factsheets
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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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- 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
- Justification for type of information:
- not applicable
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 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- Some minor deviations were noted but these did not have an impact on the overall conduct of the study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- Some minor deviations were noted but these did not have an impact on the overall conduct of the study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- Some minor deviations were noted but these did not have an impact on the overall conduct of the study
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- 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
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 week sold
- Weight at study initiation: Step 1 - 200 - 201 grams and Step 2 - 153 - 181 grams
- Fasting period before study: Prior to the administration food was withheld from the test animals for 16 to 19 hours (access to water was permitted).
- Housing: The animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding
- Diet (e.g. ad libitum): Free access to Altromin 1324 maintenance diet for rats and mice
- Water (e.g. ad libitum): Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water,
municipal residue control, microbiological controls at regular intervals)
- Acclimation period: Adequate acclimatisation period (at least five days) under laboratory conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 10%
- Air changes (per hr): 10 x / hour
- Photoperiod (hrs dark / hrs light): Artificial light, sequence being 12 hours light, 12 hours dark
IN-LIFE DATES: From: 25-Aprill-2016 To: 25-April-2016
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- CLASS METHOD
- Rationale for the selection of the starting dose: The starting dose was selected to be 2000 mg/kg body weight. No compound-related mortality was recorded for any animal of step 1 or 2. Based on these results and according to the acute toxic class method regime no further testing was required . - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3 female rats/step
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed for 14 days after dosing for general clinical signs , morbidity and mortality. The animals were weighed on day 1 (prior to the administration) and on days 8 and 15.
- Necropsy of survivors performed: yes - Statistics:
- not applicable
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 - 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other:
- Remarks:
- Under the conditions of the present study, a single oral application of the test item HES10108 to rats at a dose of 2000 mg/kg body weight was associated with no signs of toxicity or mortality. The median lethal dose of HES10108 after a single oral administration to female rats, observed over a period of 14 days is: LD50 cut-off (rat): > 2000 5000 mg/kg bw
- Mortality:
- The test item showed no mortality and no other acute oral toxicity characteristics after a single dose administration
- Clinical signs:
- other: The test item showed no other acute oral toxicity characteristics after a single dose administration
- Gross pathology:
- No specific findings were noted
- Other findings:
- not applicable
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present study, a single oral application of the test item HES10108 to rats at a dose of 2000 mg/kg body weight was associated with no signs of toxicity or mortality. The median lethal dose of HES1 01 08 after a single oral administration to female rats, observed over a period of 14 days is: LD50 cut-off (rat): > 2000 5000 mg/kg body weight
- Executive summary:
In this acute oral study (conducted according to OECD Guideline 423, OPPTS 870.1100 and EU Method B.1 (tris) and GLP), two groups, each of three female Wistar Crl: WI (Han) rats, were treated with the HES10108 (Dow Corning BY 16 -122B) by oral gavage administration at a dosage of 2000 mg/kg body weight, in a stepwise manner. The test item was administered undiluted according to body weight.
All animals survived until the end of the study without showing any test-item related signs of toxicity. Throughout the 14-day observation period, the body weight gain of the test animals was within the normal range of variation for this strain. At necropsy, no treatment-related macroscopic findings were observed in any animal of any step.
Under the conditions of the present study, a single oral application of the test item HES10108 (Dow Corning By 16 -122B) to rats at a dose of 2000 mg/kg body weight was associated with no signs of toxicity or mortality. The median lethal dose of HES1 0108 after a single oral administration to female rats, observed over a period of 14 days was:
L050 cut-off (rat): > 2000 -5000 mg/kg bw
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