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Diss Factsheets
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EC number: 910-245-3 | CAS number: -
- 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
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
For sodium silicate:
In a 4-generation study with rats, the total number of offspring born at 79 mg/kg bw/d was reduced to 67% of offspring weaned to 46% of the control, respectively (Smith et al., 1973). The NOAEL for parental animals was determined to be > 159 mg/kg bw/day. For the F1 generation no NOAEL was identified. Severe limitations of the study and inter-current deaths, including controls make it however difficult to draw any firm conclusion from this study.
In addition, in oral repeated dose toxicity studies with rats and dogs, the macroscopic and microscopic examination of reproductive organs did not reveal any treatment-related effects (Newberne and Wilson, 1970). The NOAEL for rats and dogs was > 2400 mg/kg bw/day.
Kamboj and Kar (1964) did not find testicular effects of sodium silicate injected either subcutaneously or intratesticularly in male rats. The NOAEL was determined to be > 8 mg/kg bw.
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
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
This substance is a multi-constituent substance consisting of sodium hydroxide (215-185-5, 1310-73-2) and disodium metasilicate (229-912-9, 6834-92-0). It is the by-product of a reaction between Zircon (EC no 239-019-6) and sodium hydroxide; after hydrolysis, this substance is the water-soluble fraction. The OECD SIDS Initial Assessment Report for SIAM 18 Paris, France 20-23 April, 2004 reported that a mixture of silicic acid, sodium salt (215-687-4) and sodium polyphosphate (OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test) did not demonstrate genetic toxicity (No significant increase of chromosomal aberrations compared to negative control even at dosage levels exceeding the M.T.D. of 940 mg/kg bw.). Sodium hydroxide does not have the potential to be a genetic toxin based on the presence of only a sodium anion. The REACH text states:
8.4.2. The study does not usually need to be conducted — if adequate data from an in vivo cytogenicity test are available, or
►M3 — the substance is known to be carcinogenic category 1A or 1B or germ cell mutagenic category 1A, 1B or 2.◄
8.4.3. The study does not usually need to be conducted if adequate data from a reliable in vivo mammalian gene mutation test are available.
8.4. Appropriate in vivo mutagenicity studies shall be considered in case of a positive result in any of the genotoxicity studies in Annex VII or VIII.
Sodium Hydroxide: Source - the sodium hydroxide summary risk assessment report JRC EC 2008
No valid studies were identified regarding effects on fertility or developmental toxicity in animals after oral, dermal or inhalation exposure to NaOH. NaOH is not expected to be systemically available in the body under normal handling and use conditions and for this reason it can be stated that the substance will not reach the foetus nor reach male and female reproductive organs. Therefore, a specific study to determine the reproduction toxicity is not necessary.
Based on these data sets, no further testing is required for the reaction mass of disodium metasilicate and sodium hydroxide and no additional test is proposed.
The above should be considered as an expert statement to fulfil the REACH registration requirements under Annex VIII for endpoint 8.4.2, 8.4.3 and 8.4.4.
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.
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