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Diss Factsheets
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EC number: 946-797-7 | 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
- Objective of study:
- absorption
- distribution
- excretion
- toxicokinetics
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Dodecamethylpentasiloxane
- EC Number:
- 205-492-2
- EC Name:
- Dodecamethylpentasiloxane
- Cas Number:
- 141-63-9
- Molecular formula:
- C12H36O4Si5
- IUPAC Name:
- dodecamethylpentasiloxane
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- 14C-Dodecamethylpentasiloxane
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: Approximately 225 g when purchased.
- Fasting period before study: None
- Housing: No data
- Individual metabolism cages: yes/no
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Seven days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22± 2
- Humidity (%): approximately 45%
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: No data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Duration and frequency of treatment / exposure:
- Single oral dose
Doses / concentrations
- Dose / conc.:
- 600 mg/kg bw/day
- No. of animals per sex per dose / concentration:
- 2 males only
- Control animals:
- no
- Positive control reference chemical:
- None
- Details on study design:
- - Dose selection rationale: None given
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion); After dosing animals were immediately placed in a Roth-type glass metabolism cage.
- Tissues and body fluids sampled: urine, faeces, plasma, other organs/tissues, expired air.
- Time and frequency of sampling: samples of excreta and expired air collected for 96 hours after dosing. Animals euthanised after 96 hours and blood and tissues removed for determination of 14C, and examinations.
METABOLITE CHARACTERISATION STUDIES: not conducted - Statistics:
- None described.
Results and discussion
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- Approximately 25% of the administered dose was absorbed from the gastrointestinal tract.
- Type:
- distribution
- Results:
- Trace amounts of 14C activity were detected in various organs and tissues at the time of necropsy (96 hours after administration).
- Type:
- metabolism
- Results:
- Not investigated.
- Type:
- excretion
- Results:
- Approximately 74% of the dose was recovered from the faeces, while 23% was eliminated through the expired air. Only 2.2% was recovered in urine.
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Based on total recovery in the urine, expired air and tissues, and assuming no biliary excretion, approximately 25% of the administered dose was absorbed from the gastrointestinal tract.
- Details on distribution in tissues:
- Trace amounts of 14C activity were detected in various organs and tissues (primarily those involved in excretion of the test substance) at the time of necropsy (96 hours after administration). No 14C was detected in plasma at the time of necropsy (96 hours). The liver and lungs had the highest 14C activity, which the authors concluded was equivalent to 73 and 16 µg of dodecamethylpentasiloxane equivalent per wet weight of tissue. The kidneys had the next highest concentration at 8 µg of dodecamethylpentasiloxane equivalent per wet weight of tissue. Overall recovery from tissues and organs was 0.09% of the administered dose.
- Details on excretion:
- Approximately 74% of the dose was recovered from the faeces, while 23% was eliminated through the expired air. Only 2.2% was recovered in urine. About 65 and 97% of the applied dose was eliminated within 24 and 48 hours, respectively. Therefore elimination was rapid.
Metabolite characterisation studies
- Metabolites identified:
- not measured
Any other information on results incl. tables
There were no signs of toxicity and no gross pathological findings relating to treatment.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: no bioaccumulation potential based on study results
In a toxicokinetic study that investigated the oral absorption, distribution and elimination of dodecamethylpentasiloxane in two male rats following a single gavage dose, the absorption was found to be approximately 25% of the administered dose (reliability score 2). Elimination was rapid (65 and 97% by 24 and 48 hours, respectively), so by 96 hours after dosing there were only trace amounts of the test substance in tissues and organs (0.09% of administered dose across all tissues and organs). Approximately74% of the administered dose was found in faeces, 23% in expired air and 2.2% in urine.
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