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Diss Factsheets
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EC number: 235-730-0 | CAS number: 12627-14-4
- 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
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
While animal studies on skin sensitisation for silicic acid, lithium salt are lacking, reliable data for different structurally analogue test substances are available for assessment.
The dermal sensitisation potential of the read-across substance AgSil™ 25 Potassium Silicate Solution (active ingredient: 30%)
was determined in a Buehler test according to U.S. EPA Health Effect Test Guideline OPPTS 870.2600 (Durando, 2004). The undiluted test substance was topically applied to 20 guinea pigs, once a week for a three-week induction period. On day 28 the test animals as well as ten naïve control rabbits were treated with a 75% (w/w) challenge dose. Very faint erythema, which was not considered a positive reaction, was observed in some animals (test group: 8/20; naïve control group: 4/10) when examined 24 hours after the challenge application. Similar irritation persisted in one test animal through 48 hours, the naïve control animals were free of irritation by 48 hours after challenge application. Thus, based on the test results, the potassium silicate solution were not considered to be a skin sensitiser.
A local lymph node assay according to OECD Guideline 429 was conducted to determine the skin sensitisation potential of the read-across substance disodium metasilicate (Karrow et al., 2002). No significant effect on cell proliferation in the auricular lymph nodes was detected in female mice after treatment with 2, 4 and 6% test substance for 3 consecutive days.
In conclusion, based on the skin sensitisation tests performed on the read-across substances AgSil™ 25 Potassium Silicate Solution and disodium metasilicate and the many years of experience of lithium in bipolar disorder therapy, in which no sensitising potential for lithium have been noted, silicic acid, lithium salt is not considered to be a skin sensitiser.
Migrated from Short description of key information:
skin sensitisation (EPA OPPTS 870.2600, Bühler test): not sensitising (RA from AgSil™ 25 Potassium Silicate Solution)
Justification for classification or non-classification
Based on available data on skin sensitisation from read-across substances, silicic acid, lithium salt does not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC.
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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