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EC number: 603-401-4 | CAS number: 1302-88-1
- 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:
- chronic toxicity: oral
- Remarks:
- combined repeated dose and carcinogenicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted using a method equivalent to OECD Testing Guideline 453 and meets acceptable scientific standards.
Data source
Reference
- Reference Type:
- publication
- Title:
- Oral ingestion of syloid to mice and rats and its chronic toxicity and carcinogenicity.
- Author:
- Takizawa, Y. et al.
- Year:
- 1 988
- Bibliographic source:
- Acta Medica et Biologica 36(1): 27-56
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies)
- Deviations:
- yes
- Remarks:
- no urinalysis was performed
- GLP compliance:
- no
- Limit test:
- yes
Test material
- Reference substance name:
- Silicon dioxide
- EC Number:
- 231-545-4
- EC Name:
- Silicon dioxide
- Cas Number:
- 7631-86-9
- Molecular formula:
- O2Si
- IUPAC Name:
- dioxosilane
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Substance name: Syloid 244
- Supplier: Fuji Davison Chemical Ltd, Japan
- Lot/batch No.: JC-2108
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Funabashifarm Animal Co. Ltd., Japan
- Age at study initiation: 3 weeks
- Weight at study initiation: male: 117g to 150g; female: 92.0g to 126g
- Fasting period before study: Not provided
- Housing: 2 animals per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature: 23 +/- 1°C
- Humidity: 50 +/- 10%
- Air changes (per hr): Not provided
- Photoperiod: 10 hrs dark / 14 hrs light
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): weekly - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- Duration: 103 weeks. Some specimens were sacrificed after 6 and 12 months.
- Frequency of treatment:
- Continuous administration through diet.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1.25, 2.5 and 5 %
Basis:
nominal in diet
- No. of animals per sex per dose:
- 40 animals per sex for 1.25%, 2.5%, and the control. 41 animals per sex for 5%.
- Control animals:
- yes, plain diet
Examinations
- Observations and examinations performed and frequency:
- Physical examinations and observations:
- Survival: daily
- Body weights: weekly for the first 55 weeks then biweekly
- Food consumption: weekly
- Unusual signs: routinely
- Other: some specimen were sacrificed to collect experimental data after 26 and 52 weeks.
Clinical laboratory procedure:
- Haematology: Erythrocytes, haemoglobin, leukocytes, and haematocrit at termination
- Clinical chemistry: aspartate transaminase, alanine transaminase, serum inorganic phosphorus, total protein, albumin, lactic dehydrogenase, alkali phosphatase, total bilirubin, total cholesterol, high density lipoprotein cholesterol, low density lipoprotein cholesterol, triglyceride, , blood urea nitrogen, uric acid, creatinine, and calcium on serum separated from the blood after clotting at termination - Sacrifice and pathology:
- - Sacrifice: by etherization after overnight fasting.
- Gross examination: lungs, bronchus, heart, kidneys, liver, spleen, brain, stomach, colon, intestines, pancreas, adrenal glands, pituitary, thyroid, salivary glands, thymus, testes, prostate, bladder, ovaries, uterus, oviducts, femoral bones, mammary glands, skin, and subcutis.
- Microscopic examination: liver, kidneys, spleen, heart, and brain fixed in cold, neutrally-buffered solution of formalin, embedded in paraffin, sectioned, and stained with hematoxylin-eosin - Statistics:
- Significance of differences tested by using Student's t-analysis variance test.
Chi-square test of significance (p<0.05) by Mantel-Hanszel was employed to compare the survival date exclusive of sacrificed specimens.
Prevalence rates expressed as percentages of tumor groups and non-tumor groups.
Significance of differences between means of prevalence tested by using Fischer's exact test.
Percentages of frequencies of tumor analyzed by using the Cochran-Armitage test for trend in proportion.
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):
- no effects observed
- 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):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY
- Deaths in male groups compared to control group (non-significant)
- Highest survival rates in the 5% group (non dose-related)
FOOD CONSUMPTION AND COMPOUND INTAKE
Mean cumulative intake of the substance at the end of the 103 weeks:
- 1.25%: 143.46g (male) and 107.25g (female)
- 2.5%: 179.55g (male) and 205.02g (female)
- 5%: 581.18g (male) and 435.33g (female)
HAEMATOLOGY
- Sporadic variations in haematologic profiles observed in the treated groups (non-significant)
CLINICAL CHEMISTRY
- Changes observed in aspartate transaminase, albumin, alanine transaminase, lactic dehydrogenase, total protein, total bilirubin, low-density lipoprotein cholesterol, and triglyceride (non biologically significant)
- No changes observed in creatinine, urea, and bilirubin.
ORGAN WEIGHTS
- Lower liver weight noted from 52 weeks to 103 weeks in female rats compared with treated groups dosed at 2.5% and 5% (non sex or dose-related)
- No sex or dose-related hypertrophy or atrophy.
HISTOPATHOLOGY: NEOPLASTIC
- Greatest tumor incidence in genital organs (non significant)
- Relatively low incidence in other organs (non significant)
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Remarks:
- highest dose evaluated
- Effect level:
- ca. 1 700 - ca. 3 000 mg/kg bw/day (actual dose received)
- Sex:
- male
- Basis for effect level:
- other: highest dose evaluated: 5% concentration in diet
- Dose descriptor:
- NOAEL
- Remarks:
- highest dose evaluated
- Effect level:
- ca. 1 700 - ca. 3 000 mg/kg bw/day (actual dose received)
- Sex:
- female
- Basis for effect level:
- other: highest dose evaluated: 5% concentration in diet
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The NOAEL was 5% of the substance in diet, which corresponds to a dose between 1700 and 3000 mg/kg bw/day for both male and female and is the highest concentration evaluation during this study.
- Executive summary:
Chronic toxicity of the read-across substance silicon dioxide branded as Syloid 244 following an oral exposure was determined according to a method similar to the OECD Guideline for Testing of chemicals 453. Syloid 244 was orally administrated in diet to Fisher rats - which is the preferred species for this study - for 103 weeks at dose levels of 0, 1.25, 2.5, and 5%. Clinical observations were performed routinely throughout the study. Body weight were calculated weekly for the first 55 weeks then biweekly. Food consumption was determined weekly. Haematology and clinical chemistry was performed at termination.
Lungs, bronchus, heart, kidneys, liver, spleen, brain, stomach, colon, intestines, pancreas, adrenal glands, pituitary, thyroid, salivary glands, thymus, testes, prostate, bladder, ovaries, uterus, oviducts, femoral bones, mammary glands, skin, and subcutis were extracted for gross examination. Microscopic examination was performed on liver, kidneys, spleen, heart, and brain.
Animals were sacrificed after 6 and 12 months to obtain additional intermediate data.
No significant or dose-related alterations were observed in food consumption, body and organ weights, haematology, clinical chemistry, and during the histopathology.
The NOAEL was 5% of the substance in diet, which corresponds to a dose between 1700 and 3000 mg/kg bw for both male and female and is the highest concentration evaluation during this study.
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