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Diss Factsheets
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EC number: 946-850-4 | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July - September 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction mass of 1,3-dimethyl-1,1,3,3-tetraphenyldisiloxane and 1,3,3,5-tetramethyl-1,1,5,5-tetraphenyltrisiloxane and 1,3,3,5,5,7-hexamethyl-1,1,7,7-tetraphenyltetrasiloxane
- IUPAC Name:
- Reaction mass of 1,3-dimethyl-1,1,3,3-tetraphenyldisiloxane and 1,3,3,5-tetramethyl-1,1,5,5-tetraphenyltrisiloxane and 1,3,3,5,5,7-hexamethyl-1,1,7,7-tetraphenyltetrasiloxane
- Test material form:
- liquid
- Details on test material:
- clear, colourless liquid
Production date: 14. Jan. 2018
Expiry date: 14. Jan. 2021
Storage: room temperature (20 ± 5 °C)
Batch no.: 701146_43343114
1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Velaz, Czech Republic
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 178 - 194 g
- Fasting period before study: yes
- Housing: housed in plastic cages suspended on stainless steel racks, up to 3 animals per cage in a room equipped with central air-conditioning
- Diet: laboratory food ssniff (Spezialdiäten GmbH, Germany), offered at recommended doses each day approximately at the same time
- Water (ad libitum): tap water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23.0 - 23.4
- Humidity (%): 54.7 ± 2.3
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 1.8 mL/kg
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 0.5, 1, 2, 4 h after administration + daily for the next 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no
- Clinical signs:
- other: no signs of intoxication, change of health, nor any other adverse reactions during 24 hours and 14-days observation period
- Gross pathology:
- no findings
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The LD50 of the test item is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.
The test item is classified in GHS Category 5/Unclassified with a LD50 cut off value equal to or greater than 5000 mg/kg body weight, after single oral administration to Wistar rats. - Executive summary:
The test item was administered to 6 female Wistar rats at a limit dose of 2000 mg/kg. All (6/6 females) animals survived the limit dose of 2000 mg/kg body weight.The limit dose did not cause death or evident signs of toxicity. During the follow up period, no other signs of intoxication, change of health, nor any other adverse reactions were displayed.The body weight of animals increased during the study.The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.
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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