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EC number: 215-684-8 | CAS number: 1344-00-9
- 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: In none of the studies in the test substance Silicic acid, aluminum sodium salt (CAS 1344-00-9, NAS) and structurally related Silicic acid, aluminum magnesium sodium salt (CAS 12040-43-6, SMAS) mortality was observed. In the only reliable study in the test substance two nanoforms of Silicic acid, aluminum sodium salt (CAS 1344-00-9, NAS) were tested at doses of 5000 mg/kg bw without mortality or gross pathological abnormalities. Therefore, no hazard was identified in the assessment of the test substance Silicic acid, aluminum sodium salt (CAS 1344-00-9, NAS).
Inhalation: Only one study in Silicic acid, aluminum sodium salt (CAS 1344-00-9, NAS) is available (all other studies are in read-across substances). In this study, according to the OECD TG 436, the acute lethal dose for inhalation route could not be determined for the tested nanoform of Silicic acid, aluminum sodium salt (CAS 1344-00-9, NAS), since no mortality or any toxic event could be registered at an actual dose level of 65.9 mg/m³. Thus, the test item showed an acute inhalation LC50 cut-off greater than 85.6 mg/m³. This was the only dose tested.
A much higher concentration was employed in a study with the read-across substance Silicic acid, aluminum magnesium sodium salt (CAS 12040-43-6, SMAS), here, a LC50 of > 5221 mg/l was assessed with no mortality observed.
Dermal: Only one study in Silicic acid, aluminum sodium salt (CAS 1344-00-9, NAS) is available (the others are in read-across substances). In this study, no mortality was observed up to 5000 mg/kg bw. The same result was attained in all other studies (in read-across substances): No mortality was observed up to the highest dose level.
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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- other: U.S. Fed. Hazardous Substance Act, Section 101.1 (f)
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- Zeolex 23A & Zeolex 7
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- average body weight of 210 grams
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- Aqueous slurries (50% w/v) of each of the test materials were prepared for use in the acute oral toxicity evaluations.
- Doses:
- 5 g/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- The procedure outlined in the Federal Hazardous Substances Act, Section 101.1 (f) (1) was followed. Groups of ten animals (5 male and 5 female) each were fasted approximately 18 hours but given water ad libitum prior to dosing. Each animal received 5 grams of assigned test material per kilogram of body weight (10 ml/kg) by gastric intubation. All animals were observed frequently for mortality and signs of toxicity during the 14-day observation period. Necropsies were performed on all surviving animals 14 days following dose administration.
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 5 000 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No deaths attributed to oral dosing with any of the test materials were recorded during the 14-day post-dosing observation period.
- Clinical signs:
- other: not specified
- Gross pathology:
- At autopsy of surviving animals, no grossly abnormal lesions were seen.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- None of the materials tested were orally toxic when administered to rats at a dose level of five grams per kilogram of body weight.
- Executive summary:
The acute toxicity of Zeolex 23A and Zeolex 7 were studied in rats. No mortality occurred in these studies.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD0
- Value:
- >= 5 000 mg/kg bw
- Quality of whole database:
- reliablity 2
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:
- experimental phase (acute & sub-acute study): Jun. 5, 2018 - Apr. 17, 2019
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class Method)
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- Test item identification: Sodasil P95
Description: Amorphous silicate of sodium and aluminum
Formula/Chemical group: Nanosilicates
Chemical Abstract No.: 1344-00-9
EINECS No.: 215-684-8
Aspect: White powder
Storage condition: Room temperature - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Age (at treatment start): 10 weeks old
Body-weight range(at treatment start): 206.9 – 277.8 g (females) and 314.7 – 490.9 g (males)
Temperature: 20.0ºC – 24.0ºC (Mean 22.0ºC)
Humidity: 40.0% – 80.0% (Mean 60.0%)
Room air renovation cycles: 30
Photoperiod: 12 hours of light: 12 hours of darkness
Feeding: Irradiated certified laboratory dry diet RM1 (P) QC Reference 831193 (batch number 3077, Dietex SDS) was offered with unlimited supply.
Drinking: Autoclaved mineral water was offered ad libitum. - Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: 0.05% BSA (CAS No. 9048-46-8), 30 μL of absolute alcohol and sterile water
- Mass median aerodynamic diameter (MMAD):
- ca. 392.8 nm
- Geometric standard deviation (GSD):
- 14.8
- Remark on MMAD/GSD:
- Mass dispersion and particle sizes, as well as concentration in the inhalatory air were measured by ITENE, by using an optical particle sizer OPS-TSI 3330, at least in one occasion for each study. In parallel, samples of solutions for administration and from the air in the inhalation chamber were also collected and measured by using a nanosizer.
- Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- theoretical (cut-off) dose: 85.6 mg/m³
actual dose: 65.9 mg/m³ - No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- After the acclimatization period of 5 days, a randomly selected animal was marked with a number at the base of the tail with a permanent marker in order to identify the animal.
The dose was prepared immediately before administration, different batches of 6-mL of a solution integrated by 0.05% BSA, 30 μL of absolute alcohol and sterile water (q.s.) to 6 mL and with Sodasil P95 at concentration of 2.567 mg/mL was used. It was not possible to assess higher concentrations or dose levels without affect dispersion and homogeneity feasible for inhalation. The solution is sonicated for 12 minutes at 31-36 mJ/m³ at 20% amplitude in an ultrasound bath.
The animals were exposed to the inhalation procedure at 0.1 mL/min of test item solution and at 3 L air/min for 4 hours (acute toxicity).
The animals were weighed and observed daily for the assessment of toxic effects for 14 days (acute toxicity). Throughout the study periods, food and water were also weighed regularly to monitor changes in food and water intake.
Clinical findings were checked daily by observing any toxic effects. They were graded and recorded according to a scale based on the basic animal welfare supervision protocol proposed by Morton and Griffiths. - Statistics:
- For continuous data, a parametric analysis was performed to assess if variables follow a normal distribution and variances are homogeneous. If so, a one-way analysis of variance (ANOVA) followed by Dunnett’s test was performed. On the contrary, the Kruskal-Wallis ANOVA followed by the Mann-Whitney U-test was applied if Kolmogorov-Smirnov normality test was significant.
For organ weight data, parametric statistical comparison was done with absolute organ weights and those rated by the terminal body weight of each animal, unless non-parametric methods are applied when normality and variances homogeneity is not reached. - Sex:
- male/female
- Dose descriptor:
- LC0
- Effect level:
- >= 65.9 mg/m³ air (analytical)
- Exp. duration:
- 4 h
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50 cut-off
- Effect level:
- > 85.6 mg/m³ air
- Exp. duration:
- 4 h
- Mortality:
- No mortality was observed in animals treated with Sodasil P95 at an actual dose level of 65.9 mg/m³.
- Clinical signs:
- bodyweight loss
- Remarks:
- Cf. below on body weight loss. No other clinical signs were observed.
- Body weight:
- Only a very weak and temporary decrease in female body weight could be seen for 2–3 days after inhalation, but this effect is commonly related to the exposure conditions. No effects could be seen on food and water intake.
- Gross pathology:
- No macroscopic alterations were observed in animals treated with Sodasil P95.
- Conclusions:
- According to the OECD TG 436, the acute lethal dose for inhalation route could not be determined for Sodasil P95, since no mortality or any toxic event could be registered at theoretical dose level of 85.6 mg/m³ (LC50 cut-off) and an actual one of 65.9 mg/m³. Therefore, the LC50 cut-off is greater than 85.6 mg/m³ and the LC0 at least 65.9 mg/m³.
- Executive summary:
The aim of this study was to assess the acute and subchronic systemic toxicity following acute (4-hour exposure) and subacute inhalation (4-hour exposure daily for 5 days) of Sodasil P95 in Wistar rats. Only the acute experiment is documented here, the subacute one is found in chapter 7.5.2. No mortality was observed in both studies.
Reference
According to the OECD TG 436, the acute lethal dose for inhalation route could not be determined for Sodasil P95, since no mortality or any toxic event could be registered at a theoretical dose level of 85.6 mg/m³ (LC50 cut-off) and an actual one of 65.9 mg/m³.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- > 85.6 mg/m³ air
- Physical form:
- inhalation: aerosol
- Quality of whole database:
- reliability: 1
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific asnd national standards, limited documentation, acceptable for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- 24-exposure, abraded and intact skin
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- Zeolex 23A
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- not specified
- Vehicle:
- water
- Duration of exposure:
- 24 h
- No. of animals per sex per dose:
- 4
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights - Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Dose descriptor:
- LD0
- Effect level:
- >= 5 000 mg/kg bw
- Mortality:
- none: 0/16 (0/4 per each dose group)
- Clinical signs:
- other: no data
- Gross pathology:
- No pathological findings
- Other findings:
- Dermal reactions were limited to slight erythema and edema.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD0
- Value:
- >= 5 000 mg/kg bw
- Quality of whole database:
- reliabilty: 2
Additional information
Justification for classification or non-classification
As no mortality was observed in any study, there is no need for classification.
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