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Diss Factsheets
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EC number: 939-487-8 | 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
Endpoint summary
Administrative data
Description of key information
In the key 90-day repeated dose oral (gavage) study conducted to OECD Test Guideline 408 and to GLP (Dow Corning Corporation, 1995), no adverse systemic effects attributable to treatment with phenyl silsesquioxanes were observed at doses up to 1000 mg/kg bw/day (the highest dose tested).
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- no neurobehavioural tests included
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Fischer 344N
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Raleigh, NC
- Age at study initiation: approx. 7 weeks
- Weight at study initiation: Males 77-93 g Females 75-103 g on arrival
- Fasting period before study: no
- Housing: individually in stainless steel wire mesh cages
- Diet: Purina Rodent Chow 5002 Meal ad libitum except prior to necropsy
- Water: Reverse osmosis purified from local supply ad libitum
- Acclimation period: 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 23-61
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: 07 December 1993 to 09 March 1994 - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
Twice weekly
VEHICLE
- Concentration in vehicle: 0, 5, 30, 90, 200 mg/mL
- Amount of vehicle: 5mL/kg
- Lot/batch no.: Sigma Chemical Co. 42H0864 and 43H0315 - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Samples of the dosing formulations (approximately 20 or 40 ml each), including undiluted vehicle, used during treatment weeks l-2, 2-3, 6-7 and
l0-l I were taken for concentration analysis - Duration of treatment / exposure:
- 91 or 92 days
- Frequency of treatment:
- Once daily
- Dose / conc.:
- 25 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 150 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 450 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- yes, sham-exposed
- Details on study design:
- Not stated
- Positive control:
- No
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: once or twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: weekly
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION: Yes
- Time schedule: weekly
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/animal/week: Yes
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: pre-treatment and Week 12
- Dose groups that were examined: All
HAEMATOLOGY: Yes
- Time schedule for collection of blood: day 92 or 93
- Anaesthetic used for blood collection: Yes (sodium pentobarbital)
- Animals fasted: Yes / No / No data
- How many animals: All
- Parameters in table 1 were examined.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: day 92 or 93
- Animals fasted: Yes
- How many animals: All
- Parameters in table 2 were examined.
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- ORGAN WEIGHTS: Yes (see table 3)
GROSS PATHOLOGY: Yes (see table 4)
HISTOPATHOLOGY: Yes (see table 4) - Statistics:
- Data was analysed by analysis of variance (ANOVA) followed by Duncan's multiple range comparison test.
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- Absolute and relative liver weights showed statistically significant increase in all treated groups, however, no underlying histopathology noted to support the organ weight change.
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: No effects attributable to treatment at doses up to 1000 mg/kg/day
- Critical effects observed:
- no
- Conclusions:
- In a 90-day repeated oral gavage study conducted to OECD Test Guideline 408 and to GLP (reliability score 1), no changes attributable to treatment at doses up to 1000 mg/kg bw/day (the highest dose tested) silsesquioxanes, phenyl, were observed in rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The key study is the only repeated dose toxicity study available for phenyl silsesquioxanes (Dow Corning Corporation, 1995). In the study F344 rats were given the test substance by oral gavage at doses of 25, 150, 450 or 1000 mg/kg bw/day (controls received corn oil only) for 91 or 92 consecutive days. Absolute and relative liver weights showed statistically significant increase in all treated groups; however, no underlying histopathology was observed to support the organ weight change. Therefore the NOAEL for this study was ≥1000 mg/kg bw/day.
Justification for classification or non-classification
Based on the 90-day oral repeated dose toxicity study, phenyl silsesquioxanes does not require classification for adverse effects following repeated exposures according to Regulation (EC) No 1272/2008.
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