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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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Link to relevant study records
- Endpoint:
- toxicity to reproduction
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Reproductive effects observed:
- not specified
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
This study was waived, it is not justified to conduct further animal testing based on the low toxicological activity of the substance and the lack of systemic absorption via relative routes of exposure and the natural abundance of silicates. This is in accordance with REACH Annex X, Column 2.
Short description of key information:
This study was waived in accordance with column 2 of REACH X (required for section 8.7.3) of REACH Regulation 1907/2006: no additional study indicated, based on the low toxicological activity of the substance, the lack of systemic absorption via relative routes of exposure and the natural abundance of silicates. It is therefore not justified to conduct animal testing.
Justification for selection of Effect on fertility via oral route:
It is not justified to conduct further animal testing based on the low toxicological activity of the substance and the lack of systemic absorption via relative routes of exposure and the natural abundance of silicates. This is in accordance with REACH Annex X, Column 2.
Justification for selection of Effect on fertility via inhalation route:
It is not justified to conduct further animal testing based on the low toxicological activity of the substance and the lack of systemic absorption via relative routes of exposure and the natural abundance of silicates. This is in accordance with REACH Annex X, Column 2.
Justification for selection of Effect on fertility via dermal route:
It is not justified to conduct further animal testing based on the low toxicological activity of the substance and the lack of systemic absorption via relative routes of exposure and the natural abundance of silicates. This is in accordance with REACH Annex X, Column 2.
Effects on developmental toxicity
Description of key information
A developmental toxicity / teratogenicity study was conducted on pregnant rats, mice, rabbits and hamsters. The results consistantly gave a maternal toxicity and a teratogenicity NOAEL of 1600 mg/kg bw/day.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting 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.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- not specified
- GLP compliance:
- no
- Limit test:
- no
- Species:
- hamster, Syrian
- Strain:
- other: (outbred)
- 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
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Photoperiod (hrs dark / hrs light): no data - 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: 1/1
- Length of cohabitation: no data
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy - Duration of treatment / exposure:
- From day 6 to day 10 of gestation
- Frequency of treatment:
- Once per day
- Duration of test:
- Day 14: sacrifice of dams by Caesarian section
- Remarks:
- Doses / Concentrations:
0 mg/kg bw/day
Basis:
nominal conc. - Remarks:
- Doses / Concentrations:
16 mg/kg bw/day
Basis:
nominal conc. - Remarks:
- Doses / Concentrations:
74.3 mg/kg bw/day
Basis:
nominal conc. - Remarks:
- Doses / Concentrations:
345 mg/kg bw/day
Basis:
nominal conc. - Remarks:
- Doses / Concentrations:
1600 mg/kg bw/day
Basis:
nominal conc. - No. of animals per sex per dose:
- 22 pregnant hamsters
- Control animals:
- yes, concurrent vehicle
- other: Positive control receiving Aspirin, 250 mg/kg bw/day
- Details on study design:
- - Dose selection rationale: no data
- Maternal examinations:
- BODY WEIGHT: Yes
- Time schedule for examinations: gestation day 0, 6, 8, 10, and 14
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: no data
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 14
- 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: 1/3 per litter
- Head examinations: No data - Statistics:
- No data
- Historical control data:
- No data
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
- Dose descriptor:
- NOAEL
- Remarks:
- (Maximum dose tested)
- Effect level:
- 1 600 mg/kg bw/day
- Based on:
- no data
- Basis for effect level:
- other: maternal toxicity
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
- Dose descriptor:
- NOAEL
- Remarks:
- (maximum dose tested)
- Effect level:
- 1 600 mg/kg bw/day
- Based on:
- no data
- Basis for effect level:
- other: teratogenicity
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
- 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 hamsters for 5 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 hamsters for 5 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 hamsters for 5 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 occuring 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.
Reference
The administration of up to 1600 mg/kg (body weight)
of the
test material to pregnant hamsters for 5 consecutive days
had no clearly discernible effect on nidation or on maternal
or fetal survival. The number of abnormalities seen in either soft
of skeletal tissues of the test groups did not differ from
the number occuring spontaneously in the sham-treated controls.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 600 mg/kg bw/day
- Species:
- rat
- Quality of whole database:
- A developmental toxicity / teratogenicity study was conducted on pregnant rats, mice, rabbits and hamsters. The results consistantly gave a maternal toxicity and a teratogenicity NOAEL of 1600 mg/kg bw/day.
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
A developmental toxicity / teratogenicity study was conducted on pregnant rats, mice, rabbits and hamsters. The results consistantly gave a maternal toxicity and a teratogenicity NOAEL of 1600 mg/kg bw/day.
The tested substance was silicic acid, aluminium, sodium salt. 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. The registered substance is not considered to be a developmental toxin or a teratogen.
Justification for selection of Effect on developmental toxicity: via oral route:
The chosen study was conducted in accordance with OECD Testing Guideline 414.
Justification for classification or non-classification
Additional information
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.