Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 215-199-1 | CAS number: 1312-76-1
- 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

Endpoint summary
Administrative data
Description of key information
oral: LD50 (rat, female) > 5000 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
- 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 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Product Safety Laboratories
- Test type:
- up-and-down procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Sprague-Dawley derived albino
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals, Inc., Boyertown
- Age at study initiation: 10 weeks
- Weight at study initiation: 179 - 190 g
- Fasting period before study: overnight
- Housing: singly in suspended stainless steel cages
- Diet (e.g. ad libitum): Purina Rodent Chow #5012
- Water (e.g. ad libitum): filtered tap water
- Acclimation period: 15 - 16 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 20 Oct To: 4 Nov 2004 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: frequently during the first several hours and daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Remarks on result:
- other: No effects on body weight. All animals were active and healthy throughout the experiment. At necropsy, no gross abnormalities were found.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test procedure according to national standards; report with limited detail.
- Principles of method if other than guideline:
- Standard acute oral toxicity test (partly in agreement with OECD 401). Only survivors were macroscopically examined upon autopsy. The report is very limited in detail.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Cpb:Wu, Wistar Random
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS:
- Source: Central Institute for the Breeding of Laboratory Animals TNO, Zeist, Netherlands
- Age: "Young adult albino rats"
- Weight at study initiation: 234-314 g (males) and 132-204 g (females) - Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Doses:
- 2.50, 3.00, 3.60, 4.32, 5.20 mL/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 5 700 mg/kg bw
Referenceopen allclose all
MORTALITY:
- Time of death: deaths occured between 2 hours and 2 days after dosing
- Number of deaths at each dose: 1 at dose 2.50 ml/kg, 2 at
dose 3.00 ml/kg, 2 at dose 3.60 ml/kg, 3 at dose 4.32 ml/kg
and all 10 at dose 5.20 ml/kg.
CLINICAL SIGNS:
Sedation and signs of discomfort were
observed within few hours after treatment and later on
sluggishness and unconsciousness were frequently observed.
The effects were reversible in the recovery period of the
surviving animals.
NECROPSY FINDINGS:
No treatment-related gross alterations
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
Potassium silicates of varying
concentrations have been tested in rats for their acute toxicity.
Clinical effects observed in the above mentioned studies included
sedation, signs of irritation (only after dermal and inhalation
exposure) and sluggishness. All effects were reversible. No
treatment-related gross alterations were found at necropsy. The LD50(oral
and dermal route) was above 5000 mg/kg bw. The LC50was > 2.06
mg/m3.
The studies on potassium silicate fit well into the toxicity pattern of the sodium silicates: Inverse correlation of acute oral toxicity of soluble silicates to the molar ratio SiO2/Na2O. Toxicity decreases in rats with increasing molar ratio from LD50 of 500 mg/kg bw for molar ratio 0.5 to 8650 mg/kg bw for 3.38.
Justification for classification or non-classification
The available data is conclusive but not sufficient for classification.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
