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Diss Factsheets
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EC number: 237-623-4 | CAS number: 13870-28-5
- 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:
- sub-chronic toxicity: oral
- 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: see 'Remark'
- Remarks:
- Only two standard parameters were studied: body weight and survival. Background concentration in the diet varied between 0.1 and 1.0% of SiO2 (w/w). Nitrogen and phosphorous retention/excretion was measured only in the males at the end of the exposure period. For justification of read across see endpoint summary.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Effects of soluble silica on growth, nutrient balance and reproductive performance of albino rats.
- Author:
- Smith, G. S. et al.
- Year:
- 1 973
- Bibliographic source:
- J. Animal Sc. 36|(2), 271-278.
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Oral exposure of weanling rats via drinking water for 180 days.
The study was conducted to assess the influence of silica in the diet on growth and nutrient balance. - GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Silicic acid, sodium salt
- EC Number:
- 215-687-4
- EC Name:
- Silicic acid, sodium salt
- Cas Number:
- 1344-09-8
- IUPAC Name:
- sodium hydroxy(oxo)silanolate
- Details on test material:
- SOURCE: Diamond Alkali Company, Cleveland, Ohio, USA
PURITY: Not indicated
IMPURITY/ADDITIVE/ETC.: Not indicated
ANY OTHER INFORMATION: Molar ratio 3.2. Background concentration in the diet varied between 0.1 and 1.0% of SiO2 (w/w). Test substance Sodium Silicate was used.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS
- Age: Weanling
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 180 d (m-f) + 17 days (m)
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
789.5 and 1587 mg sodium silicate/L
Basis:
nominal in water
- Remarks:
- Doses / Concentrations:
600 and 1200 mg SiO2/l
Basis:
- No. of animals per sex per dose:
- 6
- Control animals:
- yes
- Details on study design:
- Post-exposure period: no
Examinations
- Observations and examinations performed and frequency:
- CLINICAL OBSERVATIONS AND FREQUENCY:
- Mortality: registered with unknown frequency
- Body weight: registered every week
- Urinalysis: nitrogen and phosphorous registered daily from day 181-197 in males. - Other examinations:
- Analysis of faeces: nitrogen and phosphorous registered daily from day 181-197 in males.
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 specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- TOXIC RESPONSE/EFFECTS BY DOSE LEVEL:
- Mortality and time to death: None
- Clinical signs: no effects
- Body weight gain: Some statistically significant differences in body weight between experimental groups and controls were registered, but these were small (6% or less), not consistent and not dose related.
- Urinalysis: significant, but not dose-related effects on nitrogen and phosphorus retention (p<0.05)
- Other: In the male low dose group nitrogen retention was 50% lower that in the control group, while in the high dose group no such difference was observed. In a repeat experiment no clear and significant differences in nitrogen retention were found. In both experiments phosphorous retention seemed somewhat increased in the male high dose groups (approximately 12%), while in the low dose groups no effect of treatment was seen.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- > 159 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no effects observed
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The NOAEL in rats after repeated oral administration of sodium silicate over 180 days was dertemined to be > 159 mg/kg bw/day.
- Executive summary:
In a subchronic toxicity study sodium silicate was administered to 6 Sprague-Dawley rats /sex/dose in drinking water at dose levels of 79 and 159 mg/kg bw/day.
TOXIC RESPONSE/EFFECTS BY DOSE LEVEL:
- Mortality and time to death: None
- Clinical signs: no effects
- Body weight gain: Some statistically significant differences in body weight between experimental groups and controls were registered, but these were small (6% or less), not consistent and not dose related.
- Urinalysis: significant, but not dose-related effects on nitrogen and phosphorus retention (p<0.05)
- Other: In the male low dose group nitrogen retention was 50% lower that in the control group, while in the high dose group no such difference was observed. In a repeat experiment no clear and significant differences in nitrogen retention were found. In both experiments phosphorous retention seemed somewhat increased in the male high dose groups (approximately 12%), while in the low dose groups no effect of treatment was seen.
The NOAEL is > 159 mg/kg bw/day.
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