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Diss Factsheets
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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated 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:
- other: see 'Remark'
- Remarks:
- Study was conducted using OECD Testing Guideline 414 and meets generally accepted scientific standards. Basic data given (e.g. results tables are provided), considered acceptable for assessment. 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.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- not specified
- 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:
- FDA-Compound 71-45 ("sodium silicoaluminate")
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- 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 data
- Fasting period before study: no
- Housing: single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Photoperiod (hrs dark / hrs light): no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: water suspension
VEHICLE
- Justification for use and choice of vehicle (if other than water): used as dispersant
- Concentration in vehicle: maximum 1500-1600 mg NAS/6.4 ml water => 10 ml suspension/kg bw
- Amount of vehicle (if gavage): adjusted to the dose, from 1 ml water/kg bw to 6.4 ml water/kg bw - Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: no data
- Length of cohabitation: no data
- Proof of pregnancy: vaginal plug referred to as day 0 of pregnancy - Duration of treatment / exposure:
- From day 6 to day 15 of gestation
- Frequency of treatment:
- Once per day
- Duration of test:
- Gestation day 20: sacrifice of all dams by Caesarian section
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0 mg/kg bw/day (as aqueous suspension)
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
16 mg/kg bw/day (as aqueous suspension)
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
74 mg/kg bw/day (as aqueous suspension)
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
350 mg/kg bw/day (as aqueous suspension)
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
1600 mg/kg bw/day (as aqueous suspension)
Basis:
nominal conc.
- No. of animals per sex per dose:
- 21 - 23 pregnant female rats
- Control animals:
- yes, concurrent vehicle
- other: positve control dosed with Aspirin (250 mg/kg bw)
- Details on study design:
- - Dose selection rationale: no data
Examinations
- Maternal examinations:
- BODY WEIGHT: Yes
- Time schedule for examinations: gestation day 0, 6, 11, 15, and 20
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes (not documented)
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 20
- Organs examined: in particular urogenital tract
- Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes (neonatal pup weight)
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of resorptions: Yes
- Number of early resorptions: No data
- Number of late resorptions: No data - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: 1/3 per litter
- Skeletal examinations: Yes: 2/3 per litter
- Head examinations: Yes - Statistics:
- No data
- Historical control data:
- No data
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Remarks:
- (highest dose tested)
- Effect level:
- 1 600 mg/kg bw/day
- Based on:
- no data
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Remarks:
- (highest dose tested)
- Effect level:
- 1 600 mg/kg bw/day
- Based on:
- no data
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
The administration of up to 1600 mg/kg (body weight)
of the test material to pregnant rats for 10 consecutive days had
no clearly discernible effect on nidation or on maternal or
fetal survival. The number of abnormalities seen in either
soft or skeletal tissues of the test groups did not differ
from the number occurring spontaneously in the sham-treated controls.
Applicant's summary and conclusion
- Conclusions:
- The NOAEL for both maternal toxicity and teratogenicity was 1600 mg/kg bw/day i.e. no dose related effects were seen at the maximum dose used in the test. The administration of up to 1600 mg/kg (body weight) of the test material to pregnant rats for 10 consecutive days had no clearly discernible effect on nidation or on maternal or fetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls.
- Executive summary:
The developmental toxicity and teratogenicity of the test substance was determined in accordance with the OECD Guideline for Testing of Chemicals 414. Doses of 0 - 1600 mg/kg bw/day were administered to pregnant female rats for 10 consecutive days via oral (gavage) exposure. The NOAEL for both maternal toxicity and teratogenicity was 1600 mg/kg bw/day i.e. no dose related effects were seen at the maximum dose used in the test. The administration of up to 1600 mg/kg (body weight) of the test material to pregnant rats for 10 consecutive days had no clearly discernible effect on nidation or on maternal or fetal survival. The number of abnormalities
seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls. The substance is not considered to cause developmental or teratogenic effects in rats. 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.
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.
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