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EC number: 234-919-5 | CAS number: 12040-43-6
- 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
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics in vivo
- Type of 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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Test material ist different from reference substance but comparable, see chapter 13, attachment 'Analogue Approach Justification'
- Reason / purpose for cross-reference:
- read-across: supporting information
- Objective of study:
- excretion
- Principles of method if other than guideline:
- The rate of sodium silicate excretion was obtained from data on urinary excretion in rats after single oral administration of sodium aluminosilicate, Zeolite A, sodium silicate and magnesium trisilicate. Only data for sodium aluminosilicate were described in this entry.
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): sodium aluminosilicate, tradename: Zeolex (Huber Corporation)
- Analytical purity: no data
- Other: Huber Corporation specified that this compound met all the purity and quality specifications of the Food Chemicals Codex; the analyses showed that it contained 30 % silicon and 5.4% aluminium. - Radiolabelling:
- no
- Species:
- rat
- Strain:
- other: Sprague Dawley Cox
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 240-260 g
- Diet (e.g. ad libitum): Purina Rat Chow (1500-2000 ppm silicon)
- Water (e.g. ad libitum): tap water; ad libitum
- Acclimation period: 4-5 days - Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: All suspensions were prepared in quartz-distilled water which contained < 0.5 ppm silicon and aluminium. Concentrations (w/w) of dosing materials were adjusted so that all groups received the same dosage volume (10 mL/kg). The acutal weights administered were calculated by difference.
- Duration and frequency of treatment / exposure:
- no data
- Remarks:
- Doses / Concentrations:
40, 200 and 1000 mg/kg bw - No. of animals per sex per dose / concentration:
- 4
- Control animals:
- yes, plain diet
- Positive control reference chemical:
- yes, 4 control animals received 10 mL of quartz-distilled water.
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: urine
- Other: - Details on excretion:
- At the 40 mg/kg level 12.4 % of administered sodium aluminosilicate was excreted in the urine, elevated levels of Si in the urine were observed only in the first 24 h after oral dosing. At the 200 and the 1000 mg/kg level 5.2 % and 1.3 % of the total administered test substance was excreted in the urine. The urinary excretion half-life for ingested sodium aluminosilicate was calculated to be 38 h. No significant increase in urinary aluminium was detected. Daily urinary aluminium excretion averaged 17.7 ± 3.2 µg for control rats and 15.1 ± 4.3 µg for sodium aluminosilicate treated rats. The excretion rate was independent of the doses applied indicating that the limiting factor is the rate of production of soluble or absorbable silicon in the gastrointestinal tract.
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
The half life time was 38 h. - Endpoint:
- basic toxicokinetics in vivo
- Type of 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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Test material ist different from reference substance but comparable, see chapter 13, attachment 'Analogue Approach Justification'
- Reason / purpose for cross-reference:
- read-across: supporting information
- Objective of study:
- toxicokinetics
- Principles of method if other than guideline:
- The purpose of the study was to comparable the bioavailabilty of silicon and aluminium from sodium aluminosilicate, Zeolite A, magnesium trisilicate and aluminium hydroxide. Only data for sodium aluminosilicate were described in this entry.
- GLP compliance:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): magnesium trisilicate
- Analytical purity: no data - Species:
- dog
- Strain:
- Beagle
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 10-13 months
- Weight at study initiation: 7.3-11.6 kg
- Housing: The dogs were individually housed in stainless steel cages and maintained in an environmentally controlled room.
- Diet (e.g. ad libitum): Diet was available for approx. 3 hours per day and was provided at approximately 4 hours after dosing for 3 hours on the days of dosing.
- Water (e.g. ad libitum): water, ad libitum - Route of administration:
- oral: capsule
- Vehicle:
- other: empty clear gelatin capsules
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Dosing was equimolar based upon silicon content and adjusted to each dog´s body weight. Empty clear gelatin capsules were used.
- Duration and frequency of treatment / exposure:
- single administration
- Remarks:
- Doses / Concentrations:
20 mg/kg - No. of animals per sex per dose / concentration:
- 3
- Control animals:
- no
- Positive control reference chemical:
- no
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: blood
- Time and frequency of sampling: 0 (prior to dosing), 0.5, 1, 1.5; 2, 3, 4, 6, 8, 12 and 24 hours after dosing - Details on absorption:
- The mean plasma silicon AUC value was 8.8 ± 3.0 mg*h/L, the mean plasma silicon Cmax value was 0.75 ± 0.31 mg/L and the mean Tmax estimates for plasma silicon was 6.9 ± 6.3 hours.
The mean plasma aluminum AUC value was 315 ± 69 µg*h/L, the mean plasma silicon Cmax value was 24 ± 5 µg/L and the mean Tmax estimates for plasma aluminium was 5.7 ± 7.3 hours. - Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- study initiation date: 23rd March 2016, experimental phase: 11th April - 23rd May 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 428 (Skin Absorption: In Vitro Method)
- Version / remarks:
- 2004
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Sylodent VP5 (SAS)
Supplier: Grace GmbH & Co. KG
Appearance: white paste
SAS content: 10% w/w - Radiolabelling:
- no
- Species:
- pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- Back/flank skin from suckling pigs (aged 6 - 8 weeks) was obtained from a food source abattoir. Prior to them being scalded, samples of whole skin were excised from the trunk area of each animal and the samples clipped to remove excess hair. Skin membranes were cut from the clipped samples at a thickness setting of 400 µm using an electric dermatome.
Each membrane was given an identifying number and stored frozen, at approximately -20°C, on aluminium foil until required for use. - Type of coverage:
- open
- Vehicle:
- other: oil in water emulsion (formula no. 659/001/003)
- Duration of exposure:
- 24 h
- Doses:
- 2 mg / cm² (= 200 µg SAS/cm²)
- No. of animals per group:
- 6 skin membrances per test substance (from at least four different animals)
- Control animals:
- yes
- Details on study design:
- The application rates (2 mg/cm²) and exposure conditions (24 hour) used in this study were designed to simulate predicted normal human exposure to the test material.
- Signs and symptoms of toxicity:
- no effects
- Dermal irritation:
- not examined
- Absorption in different matrices:
- There was no detectable penetration of SAS through dermatomed pig skin using both AF4 and ICP methods.
- Conclusions:
- There was no detectable penetration of Syloid VP 5 (a SAS) through dermatomed pig skin using both AF4 and ICP methods. Quantification of SAS by either method was not possible in the presence of the contaminants that were already present in the test system.
- Executive summary:
The purpose of this study was to investigate the in vitro percutaneous penetration of four synthetic amorphous silica (SAS) formulations prepared as ‘oil in water' (O/W) emulsions through pig dermatomed skin following a 24 hour exposure. Only the results of the examinations in Syloid VP 5 are documented here. An untreated control group and a group of skin samples treated with the ‘oil in water' emulsion were also included.
- Endpoint:
- basic toxicokinetics in vivo
- Type of 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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Test material ist different from reference substance but comparable, see chapter 13, attachment 'Analogue Approach Justification'
- Reason / purpose for cross-reference:
- read-across: supporting information
- Objective of study:
- excretion
- Principles of method if other than guideline:
- The rate of sodium silicate excretion was obtained from data on urinary excretion in rats after single oral administration of sodium aluminosilicate, Zeolite A, sodium silicate and magnesium trisilicate. Only data for sodium aluminosilicate were described in this entry.
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): magnesium trisilicate
- Origin: Mallinkrodt Chemical Company (St. Louis, USA)
- Analytical purity: no data
- Other: analysis showed that it contained 20.2 % silicon. - Radiolabelling:
- no
- Species:
- rat
- Strain:
- other: Sprague Dawley Cox
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 240-260 g
- Diet (e.g. ad libitum): Purina Rat Chow (1500-2000 ppm silicon)
- Water (e.g. ad libitum): tap water; ad libitum
- Acclimation period: 4-5 days - Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: All suspensions were prepared in quartz-distilled water which contained < 0.5 ppm silicon and aluminium. Concentrations (w/w) of dosing materials were adjusted so that all groups received the same dosage volume (10 mL/kg). The acutal weights administered were calculated by difference.
- Duration and frequency of treatment / exposure:
- no data
- Remarks:
- Doses / Concentrations:
40, 200 and 1000 mg/kg bw - No. of animals per sex per dose / concentration:
- 4
- Control animals:
- yes, plain diet
- Positive control reference chemical:
- yes, 4 control animals received 10 mL of quartz-distilled water.
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: urine
- Other: - Details on excretion:
- The urinary silicon excretion half life times, determined by the method of Barr et al. (1976), were 16-20 hours. They were independent of dose within the 40 to 1000 mg/kg bw dosage range.
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
The half life time was 16-20 h. - Endpoint:
- basic toxicokinetics in vivo
- Type of 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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Test material ist different from reference substance but comparable, see chapter 13, attachment 'Analogue Approach Justification'
- Reason / purpose for cross-reference:
- read-across: supporting information
- Objective of study:
- toxicokinetics
- Principles of method if other than guideline:
- The purpose of the study was to comparable the bioavailabilty of silicon and aluminium from sodium aluminosilicate, Zeolite A, magnesium trisilicate and aluminium hydroxide. Only data for sodium aluminosilicate were described in this entry.
- GLP compliance:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): sodium aluminosilicate
- Analytical purity: no data - Species:
- dog
- Strain:
- Beagle
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 10-13 months
- Weight at study initiation: 7.3-11.6 kg
- Housing: The dogs were individually housed in stainless steel cages and maintained in an environmentally controlled room.
- Diet (e.g. ad libitum): Diet was available for approx. 3 hours per day and was provided at approximately 4 hours after dosing for 3 hours on the days of dosing.
- Water (e.g. ad libitum): water, ad libitum - Route of administration:
- oral: capsule
- Vehicle:
- other: empty clear gelatin capsules
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Dosing was equimolar based upon silicon content and adjusted to each dog´s body weight. Empty clear gelatin capsules were used.
- Duration and frequency of treatment / exposure:
- single administration
- Remarks:
- Doses / Concentrations:
16 mg/kg - No. of animals per sex per dose / concentration:
- 3
- Control animals:
- no
- Positive control reference chemical:
- no
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: blood
- Time and frequency of sampling: 0 (prior to dosing), 0.5, 1, 1.5; 2, 3, 4, 6, 8, 12 and 24 hours after dosing - Details on absorption:
- The mean plasma silicon AUC value was 7.7 ± 1.6 mg*h/L, the mean plasma silicon Cmax value was 0.67 ± 0.27 mg/L and the mean Tmax estimates for plasma silicon was 5.8 ± 4.6 hours.
The mean plasma aluminum AUC value was 338 ± 167 µg*h/L, the mean plasma silicon Cmax value was 27 ± 14 µg/L and the mean Tmax estimates for plasma aluminium was 4.2 ± 4.3 hours. - Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Jan, 20 - Oct. 13, 2011; experimental phase: Jan. 26 - May 3, 2011
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Reason / purpose for cross-reference:
- reference to same study
- Objective of study:
- absorption
- distribution
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- This study is a further investigation of an OECD-guideline (407) repated dose oral one. It was performed for the chemical analysis of
silicon concentration (blood analysis) and the transmission of silicon particles in organ samples examined by electron microscopy. - GLP compliance:
- no
- Remarks:
- The main study was performed under GLP conditions except for the chemical analysis of silicon concentration and the transmission electron microscopy of silicon particles in organ samples documented in this endpoint.
- Specific details on test material used for the study:
- supplied by JRC, Ispra, on behalf of the sponsor, CEFIC, The European Chemical Industry Council
- Radiolabelling:
- no
- Species:
- rat
- Strain:
- Wistar
- Details on species / strain selection:
- purchased from: Charles River Deutschland, Sulzfeld, Germany
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Animals were housed in groups of 5 per cage in Makrolon Type IV cages in animal room T1.044 in the conventional area. Absorbent softwood was used as bedding material in the cages (Lignocel BK 8-15, ssniff GmbH, Soest, Germany). Drinking water from the Hannover city water supplier was offered fresh weekly, in Makrolon bottles (approximately 300 ml), ad libitum. Food was offered ad libitum fresh weekly. The diet used (ssniff R/M-H) was supplied by ssniff GmbH, Soest, Germany. The temperature in the animal room was set at 22 ± 2oC and the rel. humidity at 30 - 70%. The animal room lighting was a 12-hour light/dark cycle controlled by an automatic timing device.
- Route of administration:
- oral: gavage
- Vehicle:
- other:
- Duration and frequency of treatment / exposure:
- 28 d, daily exposure
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose / concentration:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- s. below
- Statistics:
- Differences between groups were considered case by case as statistically significant for p<0.05. Data were analyzed using analysis of variance. If the group means differed significantly according to the analysis of variance, the means of the treatment groups were compared with the means of the control group, using DUNNETT's modification of the t-test. Kruskal-Wallis ANOVA and Mann-Whitney U-test were applied in the case of non-homogeneous data. The statistical evaluation of the histopathological findings was done with the two-tailed FISHER test using the PROVANTIS system. For comparisons of semiquantitative data, the Chi-square test was used.
- Details on absorption:
- Transmission electron microscopy (non-GLP) found electron dense structures composed of irregular homogenous to fine granular material in the cytoplasm of mesenteric lymph nodes cells, liver cells and kidney cells of all animals from the control and from the high dose group. The granular structures measured only few nanometer. However, these structures did not have the shape or appearance of amorphous material such as amorphous silica.
- Details on distribution in tissues:
- Determination of Silicon Ion Concentration
The results of the chemical analysis of silicon ion concentration are presented in Table 19. In summary, the ion concentrations in kidney, liver and blood were comparable in control animals (group 1) and high dose animals (group 4) and no treatment related changes were observed.
Determination of Silicon Particles
For electron microscopical investigation two samples per organ of the mesenteric lymph nodes, kidney as well as liver of all high dose group animals (group 4) were used. Vehicle treated animals served as controls (group 1).
To achieve better visibility of possible nanoparticles in comparison to the biological background composed of the organic structure, ultrathin sections have not been contrasted using uranyl acetate and lead citrate.
Mesenteric lymph node: Occasionally, cells of the mesenteric lymph node of all animals of the untreated group (group 1) and of the amorphous silica treated group (group 4) showed electron dense structures. Theses electron dense structures were found intracytoplasmatically in vacuoles and were characterized by irregular homogenous to fine granular material.
Liver: Occasionally, liver cells of all animals of the untreated group (group 1) and of all animals of the amorphous silica treated group (group 4) showed electron dense structures. Theses electron dense structures were found intracytoplasmatically in vacuoles and were characterized by irregular homogenous to fine granular material.
Kidney: Occasionally, kidney cells of all animals of the untreated group (group 1) and of all animals of the amorphous silica treated group (group 4) showed electron dense structures. Theses electron dense structures were found intracytoplasmatically in vacuoles and were characterized by irregular homogenous to fine granular material. - Conclusions:
- Toxicological analysis of silica ion concentrations in blood, kidney and liver tissue did not reveal differences between the control and the dose group. This result is most likely due to the naturally occurring high background values of silica.
- Executive summary:
This is a toxicokinetic examination of an oral 28-day study in rats. It showed, that silicon is naturally absorbed by the body, as shown by its presence in blood, kidneys and liver of treated as well as untreated animals.
Referenceopen allclose all
The results suggest that single oral administration of magnesium trisilicate yields to low absorption of silicon.
According to the analytical laboratory, due to the contamination of the receptor fluid with very small skin debris and very small oil aerosols that have diffused from the skin samples into the receptor medium, a clear signal for silica particles could not be obtained. The situation was not improved by washing the receptor fluid with organic solvents to remove the oil aerosols due to the fact that the contamination was much higher than expected. The pre-testing with a pure receptor fluid spiked with a very low concentration of nano SAS particles (Colloidal Silica) demonstrated that the method was capable of detecting extremely low mass concentrations of SAS. Even using the blind sample to define the background and subtract the background of skin debris and oil aerosols from the test results did not provide any meaningful results.
ICP data did not present any evidence that silica was present in the receptor fluid samples and there was no indication that SAS was present in the noise scattering.
Asymmetric flow field-flow fraction (AF4) and multi angle light scattering is a viable option for analysing SAS particles in liquid media such as skin penetration receptor fluids. This was demonstrated by the Fraunhofer Institute using spiked receptor fluids. Contamination by skin debris and oil aerosols from the test materials and the test skin appeared to be very high in concentration and no meaningful results using the AF4 method could be obtained without removing the contaminants e.g. by washing or filtering. Analysis by ICP did not provide any evidence for penetration of SAS through dermatomed pig skin.
There was no detectable penetration of SAS through dermatomed pig skin using both AF4 and ICP methods. Quantification of SAS by either method was not possible in the presence of the contaminants that were already present in the test system.
The results suggest that single oral administration of sodium aluminosilicate yields to low absorption of silicon and only poorly absorption of aluminium.
Description of key information
Referring to the toxicokinetic properties of structurally related compounds, no risk potential is expected for SMAS.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
See basic toxicokinetics.
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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.