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EC number: 249-385-9 | CAS number: 29043-70-7
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1998-12-09 to 1999-01-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- 1995
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Dimethylbis(octadecyloxy)silane
- EC Number:
- 249-385-9
- EC Name:
- Dimethylbis(octadecyloxy)silane
- Cas Number:
- 29043-70-7
- Molecular formula:
- C38H80O2Si
- IUPAC Name:
- dimethylbis(octadecyloxy)silane
- Test material form:
- other: solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Switzerland
- Age at study initiation: 6 weeks
- Weight at study initiation: males: 135 - 155 g; females: 109-127 g
- Fasting period before study: the animals were fasted for 18 hours before blood sampling, but water was available, ad libitum.
- Housing: in groups of 5 in Makrolon type-4 cages with wire mesh tops and softwood bedding
- Diet: pelleted standard rat maintenance diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 40- 70 %
- Air changes (per hr): 10-15 air changes/ hours
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
Test article formulations were prepared once a week. The test article was weighed and ground in a mortar. The test article was transferred in a beaker and the vehicle was added. The mixtures were prepared using an ultrasonic water bath and mixed with magnetic stirrer. The test article formulations were stored at room temperature. Homogeneity of the formulations was maintained using a magnetic stirrer.
VEHICLE
- Justification for use and choice of vehicle (if other than water): no information
- Lot/batch no. (if required): 8001-30-7 - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Concentration, homogeneity and stability of dose formulations were determined in samples taken during acclimatization and on day 1. Concentration and homogeneity of the dose formulations were determined in samples taken on week 4 of the treatment. The analyses were performed by RCC ltd. according to a GC method.
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- daily, 7 days a week
Doses / concentrationsopen allclose all
- Dose / conc.:
- 50 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 200 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:
- 5 males and 5 females per dose
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Dose selection rationale: a non-GLP 5-day dose-range finding study was performed, in which the test material was administered orally to 2 rats per group and sex. The highest dose administered with no signs of toxicity was 1000 mg/kg bw/day.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: once before commencement of administration, then twice daily on days 1-3, thereafter once daily on days 4-28.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Once before commencement of administration, then once weekly.
BODY WEIGHT: Yes
Time schedule for examinations: Body weights were recorded weekly during pretreatment and treatment, and before necropsy.
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes (see table 1)
- Time schedule for collection of blood: after week 4
- Anaesthetic used for blood collection: Yes, light ether anaesthesia
- Animals fasted: Yes, for 18 hours
- How many animals: all the animals
- Parameters checked in table [No.?] were examined.
CLINICAL CHEMISTRY: Yes (see table 1)
- Time schedule for collection of blood: after week 4
- Animals fasted: Yes, for 18 days
- How many animals: all the animals
- Parameters checked in table [No.?] were examined.
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: week 4
- Dose groups that were examined: all the animals
- Battery of functions tested: grip strength and motor activity
FOOD CONSUMPTION:
- Time schedule for examinations: once daily during the pretreatment, then weekly for the rest of the study period. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (see table 2)
HISTOPATHOLOGY: Yes (see table 2) - Statistics:
- - Dunnett-test: comparison of treated groups with the control group
- Steel-test: applied instead of Dunnett-test when data could not be assumed to follow a normal distribution
- Fisher's exact-test: applied to macroscopic findings
Results and discussion
Results of examinations
- 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):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY: all animals survived until scheduled death.
BODY WEIGHT AND WEIGHT GAIN: No changes in expected body weight gain were observed.
HAEMATOLOGY: No test article-related differences were noted. A few incidences of statistical significance noted were not dose-related and therefore were considered to be incidental.
CLINICAL CHEMISTRY: No test article-related differences were noted. A few incidences of statistical significance noted were not dose-related or restricted to only one sex and therefore were considered to be incidental.
NEUROBEHAVIOUR: No qualitative or quantitative differences were noted in any of the test animals when compared to the control group. The hindlimb grip strength of males and females, and the forelimb grip strength of females treated with 1000 mg/kg bw/day was significantly increased when compared with the control animals. This slight increase was not considered to be an adverse effect. Locomotor activity of females treated with 50 and 200 mg/kg bw/day were significantly more active when compared to the control group. These findings were considered to be incidental as no such observations were noted for females treated with 1000 mg/kg bw/day.
ORGAN WEIGHTS: No test article-related differences were noted. The mean relative and absolute thymus weights were reduced in males treated with 50 mg/kg bw/day. No such changes were noted in the animals treated with 200 and 1000 mg/kg bw/day.
GROSS PATHOLOGY: No treatment-related macroscopic changes were observed in any of the animals. The macroscopical findings were within the range of spontaneous alterations that can appear in rats at this age and strain. The abnormalities included: dilated renal pelvises, discoloured foci in various organs, dilated uterine horns with filled with fluid and size reduction of testes, epididymides and adrenal glands.
HISTOPATHOLOGY: NON-NEOPLASTIC: A number of microscopical findings were noted. The type, incidence and severity of these findings were not considered treatment-related.
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No treatment-related abnormalities were observed in any of the test animals.
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- In the 28-day oral study in rats the reported NOAEL value for dimethylbis(octadecyloxy)silane was ≥1000 mg/kg bw/day.
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