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EC number: 215-685-3 | CAS number: 1344-01-0
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 21 May - 07 June 1979
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Screening study/limited examination: meets generally accepted scientific standards, sufficiently documented, database insufficient for complete assessment. No study guideline provided. Read-across from the results on the test substance has been made to the registered substance based on the similar structure of the two substances.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Method: screening/range-finding for 90-d study: Reduced number of animals; no comprehensive examinations in haematology/clinical chemistry/urinalysis/limited histopathology (only high-dose and control group: 3 animals each).
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Silicic acid, aluminum sodium salt
- EC Number:
- 215-684-8
- EC Name:
- Silicic acid, aluminum sodium salt
- Cas Number:
- 1344-00-9
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): Sodium Aluminosilicate
- Substance type: inorganic
- Physical state: solid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Lot/batch No.: B71778
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no indivual data available / mean weights 179 - 184 g (male); 153 - 156 g (female)
- Fasting period before study: none
- Housing: 5/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 17 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +-1 (Report 74 +-2 °F)
- Humidity (%): 50 +-5
- Air changes (per hr): 10 - 15x
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- not specified
- Details on oral exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): 1x/week
- Mixing appropriate amounts with (Type of food): NIH-07 Rat and Mouse Ration Mash - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 14 d
- Frequency of treatment:
- continuous
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0.625%
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
1.25%
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
2.5%
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
5%
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
10%
Basis:
nominal in diet
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- Post-exposure period: 1 d (day 15)
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: day 0, 7, and 14
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Mean weekly food consumption of each group is given after week 1 and 2 (Tab. 4)
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: No
CLINICAL CHEMISTRY: No
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes, on 10% of the animals (6/60), 2 female and 1 male each from the control and the 10% group
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Male rats of the highest-dosed group showed a significantly lower bw gain (-39 %), which may be considered to be treatment-related.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- BODY WEIGHT AND WEIGHT GAIN:
Male rats of the highest-dosed group showed a significantly lower body weight gain (-39%), which may be considered to be treatment-related.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Remarks:
- 5% dietary level
- Effect level:
- ca. 4 750 mg/kg bw/day (nominal)
- Sex:
- male
- Basis for effect level:
- other: body weight
- Dose descriptor:
- NOAEL
- Remarks:
- 10% dietary level
- Effect level:
- ca. 7 000 mg/kg bw/day (nominal)
- Sex:
- female
- Basis for effect level:
- other: overall effects
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The NOAEL (5% dietary level) was 4750 mg/kg bw/day in male rats (based on body weight). Male rats in the highest-dosed group showed a significantly lower body weight gain (-39%), which may be considered to be treatment-related. The NOAEL (10% dietary level) was 7000 mg/kg bw/day in female rats (based on overall effects). No clinical signs or mortality was recorded. There were no effects reported during gross pathology or histopathological investigation.
- Executive summary:
The repeated dose toxicity of the test substance was determined, with no test guideline provided. The method followed involved a screening/range-finding test for 90-day study. The method used a reduced number of animals; there were no comprehensive examinations in haematology/clinical chemistry/urinalysis/limited histopathology (only high-dose and control group: 3 animals each). The study investigated the toxicity of repeated oral exposure of the test substance to male and female rats. Animals were exposed to 0.625 -10% doses, as part of the diet, for 14 days. The NOAEL (5% dietary level) was 4750 mg/kg bw/day in male rats (based on body weight). Male rats in the highest-dosed group showed a significantly lower body weight gain (-39%), which may be considered to be treatment-related. The NOAEL (10% dietary level) was 7000 mg/kg bw/day in female rats (based on overall effects). No clinical signs or mortality was recorded. There were no effects reported during gross pathology or histopathological investigation. The test susbtance is not considered to be toxic to rats via repeated oral exposure. The structure of both silicic acid, aluminium, sodium salt and silicic acid, aluminium, calcium, sodium salt are macromolecular skeletons of silicon and oxygen with the metal cations binding ionically to negatively charged oxygens in the structure. In the silicic acid, aluminium, calcium, sodium salt the metal cations bind ionically to negatively charged oxygens in the structure. The inclusion of calcium salts to the structure of silicic acid, aluminium, sodium salt would not be expected to change the toxicity of the substance.
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