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EC number: 229-912-9 | CAS number: 6834-92-0
- 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
oral: LD50 (rat) = 1152 - 1349 mg/kg bw
inhalation: LC50 (rat) > 2.06 g/m3
dermal: LD50 (rat) > 5000 mg/kg bw
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to basic scientific principles, study report provides only summary of data, with no/very few tables with data from individual animals. There were discrepancies between the study report and the abstract (Ito, 1986).
- Principles of method if other than guideline:
- Standard acute oral toxicity
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- mouse
- Strain:
- other: T23-48:ddy
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS:
- Source: Sankyo Laboratory Service
- Age: 4 weeks - Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- - Volume administered or concentration: 0.05-0.19 ml/10g for males, 0.05-0.14 ml/10g for females
- Doses:
- 500-1920.8 mg/kg (males), 500-1372 mg/kg (females)
- Control animals:
- not specified
- Details on study design:
- - Post dose observation period: seven days
EXAMINATIONS: mortality, clinical symptoms, histopathology - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 770 - 820 mg/kg bw
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 661.5 - 896.3 mg/kg bw
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 666.7 - 1 008.6 mg/kg bw
- Remarks on result:
- other: 66.7-1087.6 mg/kg is reported in Ito, 1986
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to basic scientific principles, study report provides only summary of data, with no/very few tables with data from individual animals.
- Principles of method if other than guideline:
- Standard acute oral toxicity
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS:
- Source: Nippon Kurea
- Age: 4 weeks - Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- - Volume administered or concentration: 0.265-1 ml/100 g for males, 0.455-1.3 ml/100g for females
- Doses:
- 538-2000 (males), 910-2600 (females)
- No. of animals per sex per dose:
- 110 in total
- Control animals:
- not specified
- Details on study design:
- - Post dose observation period: seven days
EXAMINATIONS: mortality, clinical symptoms, histopathology - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 152 - 1 349 mg/kg bw
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 189.6 - 1 530 mg/kg bw
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 994.7 - 1 335.9 mg/kg bw
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Too little data available.
- Principles of method if other than guideline:
- Standard acute oral toxicity method
- GLP compliance:
- no
- Test type:
- standard acute method
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Vehicle:
- not specified
- Doses:
- no data
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 750 mg/kg bw
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Too little data available.
- Principles of method if other than guideline:
- Standard acute oral toxicity test
- GLP compliance:
- no
- Test type:
- standard acute method
- Species:
- mouse
- Sex:
- male
- Vehicle:
- not specified
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 200 - 1 700 mg/kg bw
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only secondary literature available (review).
- Principles of method if other than guideline:
- Standard acute oral toxicity
- GLP compliance:
- no
- Test type:
- standard acute method
- Species:
- rat
- Dose descriptor:
- LD50
- Effect level:
- 800 mg/kg bw
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only secondary literature available (review).
- Principles of method if other than guideline:
- Standard acute oral toxicity
- GLP compliance:
- no
- Test type:
- standard acute method
- Species:
- rat
- Dose descriptor:
- LD50
- Effect level:
- 600 mg/kg bw
Referenceopen allclose all
MORTALITY:
- Time of death: 4 hrs - 5 days
CLINICAL SIGNS:
2 minutes after administration males and
females became lethargic and had a hunched posture. Tear
flow increased with dose level. Surviving animals recovered
within 2-4 days. The animals that died were lethargic, did
not react to external stimuli, had hanging eyelids,
paralysis of hind legs, clonicity and tonic cramps, followed
by cyanosis and respiratory paralysis.
NECROPSY FINDINGS:
the following symptoms increased with
increasing dose: localised bleeding in the mucous membranes
of the "glandular stomach", duodenum, mucous membranes of
the central part of the "small gut", capillary dilation,
rarefaction of the stomach lining, clear liver lobules,
faded colour of the liver rim, redness of the gall. Animals
dosed 1372 mg/kg and above had bleeding and inflammation
extending from the "glandular stomach"to the central part of
the "small gut". In surviving animals the liver lobules
looked slightly clearer and the spleen showed slight
rubefaction, compared to control group animals.
POTENTIAL TARGET ORGANS: stomach, liver, gut.
MORTALITY:
- Time of death: 30 min - 96 h
CLINICAL SIGNS:
lethargy, increased breathing frequenc
immediately after dosing, 20 minutes later the animals
became lethargic, cyanosis and platycoria was observed. At
30 min the first animals developed clonicity and tonic
cramps, dying of respiratory paralysis. The symptoms
increased in intensity, had an earlier onset, and were
observed in a higher number of animals in the group with
increasing dose level.
NECROPSY FINDINGS:
the animals that died had localised
bleeding at the rim of the "glandular stomach", which partly
depended on the dose, and bleeding and rubefaction in the
duodenum. Some animals in the high dosage group had
considerable stomach bleeding. Surviving animals had no
significant changes.
POTENTIAL TARGET ORGANS: stomach
RS-Freetext:
MORTALITY:
- Time of death: from 3 hours up until 2 days after exposure
- Number of deaths at each dose: Not reported
CLINICAL SIGNS: Apathy, staggering gait, dyspnoea,
piloerection and abdominal discomfort
NECROPSY FINDINGS: Not reported
POTENTIAL TARGET ORGANS: Not reported
RS-Freetext:
MORTALITY: Not reported
CLINICAL SIGNS: "uncharacteristic" according to the authors
of the study report
NECROPSY FINDINGS: Not reported
POTENTIAL TARGET ORGANS: Not reported
RS-Freetext:
MORTALITY: Not reported
CLINICAL SIGNS: Not reported
NECROPSY FINDINGS: Not reported
POTENTIAL TARGET ORGANS: Not reported
SEX-SPECIFIC DIFFERENCES: Not reported
RS-Freetext:
MORTALITY: Not reported
CLINICAL SIGNS: Not reported
NECROPSY FINDINGS: Not reported
POTENTIAL TARGET ORGANS: Not reported
SEX-SPECIFIC DIFFERENCES: Not reported
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 Oct 2004 - 16 Dec 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Meets national standard methods; GLP
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1300 (Acute inhalation toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Product Safety Laboratories
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Sprague-Dawley derived albino
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals, Inc., Boyertown
- Age at study initiation: 8 - 9 weeks
- Weight at study initiation: 255 - 285 g (males) and 180 - 205 g (females)
- Housing: singly in stainless steeel cages
- Diet (e.g. ad libitum): Purina Rodent Chow #5012
- Water (e.g. ad libitum): tap wter
- Acclimation period: 9 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 21 Oct To: 4 Nov 2004 - Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: filtered air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: whole body plexiglas chamber
- Exposure chamber volume: 150 L
- Method of holding animals in test chamber: cages
- Source and rate of air: air compressor, total airflow 45.7 L per minute
- System of generating particulates/aerosols: The test atmosphere was generated using a 1/4 inch JCO atomizer, FC3 fluid cap and 70SS air cap. Compressed air was supplied. The test substance was metered to tthe atomization nozzle through size 14 tygon tubing using a peristaltic pump.
- Method of particle size determination: eight stage Andersen cascade impactor
- Temperature, humidity, pressure in air chamber:
TEST ATMOSPHERE
- Brief description of analytical method used: Gravimetric samples were collected with filter papers which were wighed before and after collection to determine the mass collected. This value was devided by the total vlume of air sampled to determine the chamber concentration. Sample airflows were measured using a Mass Flowmeter.
- Samples taken from breathing zone: yes
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: 9 µM: 4%, 5.8 µm: 8.3%, 4.7 µm: 11.1%, 3.3 µm: 12%, 2.1 µm: 32%, 1.1 µm: 22.6%, 0.7 µm: 7.4%, 0.4 µm: 2.6%
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 2.7 µm/1.96 - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- see above
- Duration of exposure:
- 4.4 h
- Concentrations:
- 2.06 ± 0.19 mg/L
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: in chamber animal observations and at least daily following exposure; body weights were recorded prior to exposure and again on days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: - Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 2.06 mg/L air (analytical)
- Exp. duration:
- 4 h
Reference
During exposure, animals showed hunched posture and hypoactivity. All animals recovered from the above clinical signs upon removal from the exposure chamber and appeared healthy and active over the 14 -day observation period. All animals survived exposure to the test atmosphere and gained body weight over the 14 -day period. No gross abnormalities were noted for any of the animals at terminal necropsy.
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 Oct 2004 - 16 Dec 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Meets national standard methods; GLP
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Product Safety Laboratories
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Sprague-Dawley derived albino
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals Inc., Boyertown
- Age at study initiation: 8 -9 weeks
- Weight at study initiation: 251 - 280 g (males) and 175 - 210 g (females)
- Housing: sngly in stainless steel cages
- Diet (e.g. ad libitum): Purina Rodent Chow #5012
- Water (e.g. ad libitum): filtered tap water
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 20 Oct To: 3 Nov 2004 - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal area and the trunk
- % coverage: 10 (2 inches x 3 inches)
- Type of wrap if used: Durapore tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test sites were gently cleansed
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.71 - 1.1 mL depending on body weight
- Concentration (if solution): 30% - Duration of exposure:
- 24 h
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: frequently during the first sevral hours after application and at least once daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
Reference
All animals survived, gained body weight and appeared healthy and active. Apart from the dermal irritation (erythema) and alopecia noted at the application site of five animals (4 females and 1 male) between days 1 and 8, there were no other signs of toxicity. No gross lesions were observed at final necropsy in any animal.
Additional information
Various concentrations (10 ¿ 99%) of disodium metasilicates have been tested using oral administration in rats and mice. The majority of test results are cited as secondary literature only (Schleyer and Blumberg, 1982), but several study reports are available, although in limited detail (Ito et al. 1986, Saiwai et al. 1980, Gloxhuber 1973, Gloxhuber and Potokar 1971). Clinical symptoms observed in a dose-dependent manner consisted of apathy, ataxia and respiratory paralysis. Histopathology revealed acute gastro-enteritis, mottled livers as well as chemical irritation and/or corrosion of the viscera. All symptoms are indicative of effects due to high alkalinity.
Limit tests were performed with potassium silicate for the inhalative and dermal exposure route. No deaths occurred. Only clinical signs caused by irritation (hunched posture, hypoactivity and erythema), which were all reversible, were observed.
Justification for classification or non-classification
Disodium metasilicate is not classified as harmful if swallowed. All symptoms of acute toxicity are due to high alkalinity.
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