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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
Description of key information
The registered substance is not classified as a skin irritant or an eye irritant.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted by GLP compliant laboratory using OECD Testing Guideline 404.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: Japanese white
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- yes
- Amount / concentration applied:
- 0.4 ml
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 24, 48 and 72 hours
- Number of animals:
- 6
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0.17
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0.03
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance was not found to be a skin irritant with a mean erythema score of 0.17, a mean oedema score of 0 and a mean overall irritation score of 0.03 recorded 48 hours after application of the substance. The substance is therefore not considered a skin irritant.
- Executive summary:
The skin irritation potential of the substance was determined in accordance with the OECD Guideline for Testing of Chemiclas 404. The substance was applied in semi-occlusive coverage to the clipped skin of rabbits. After 48 hours a mean erythema score of 0.17, a mean oedema score of 0 and a mean overall irritation score of 0.03 was recorded. The substance is not classified as a skin irritant according to EU CLP criteria.
Reference
4 hours after application of the test material, erythema grade one was observed. This had disappeared 24 hours after application.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- 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:
- The study meets generally accepted scientific standards, is sufficiently documented, and is considered acceptable for assessment. The study was conducted according to Federal Hazardous Substances Act Section 191.12 (1973). 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.
- Qualifier:
- according to guideline
- Guideline:
- other: Fed. Hazardous Substance Act Section 191.12 (1973)
- Deviations:
- not specified
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
- Observation period (in vivo):
- 24, 48, and 72 hours following application.
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- Comment: not rinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: 24 h
- Score:
- 3.3
- Max. score:
- 20
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: Based on the effects of redness (A), swelling (B) and discharge (C) with (A+B+C)x2/number of animals = 3.3
- Irritant / corrosive response data:
- Only on day 1, transient slight erythema and edema were noted in all animals (effect score 1), in one animal score 2 for erythema; cornea and iris remained unaffected. No irritating effects any more after 48 h.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The conjunctivae score (mean of 6 animals) was found to be 3.3, with effects fully reversible within 48 hours. The substance is therefore not classified as an eye irritant according to EU CLP criteria.
- Executive summary:
The eye irritation potential of the test substance was determined in accordance with the test guideline outlined in the Federal Hazardous Substances Act Section 191.12 (1973). 100 mg of the test substance was applied to rabbit eyes and observations made 24, 48 and 72 hours after application. The conjunctivae score (mean of 6 animals) was found to be 3.3, with effects fully reversible within 48 hours. The substance is therefore not classified as an eye irritant according to EU CLP criteria. 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
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
A study was conducted on the registered substance to determine the skin irritation potential of the substance. The skin irritation potential of the substance was determined in accordance with the OECD Guideline for Testing of Chemiclas 404. The substance was applied in semi-occlusive coverage to the clipped skin of rabbits. After 48 hours a mean erythema score of 0.17, a mean oedema score of 0 and a mean overall irritation score of 0.03 was recorded. The substance is not classified as a skin irritant according to EU CLP criteria.
A study was conducted on a structurally similar substance to determine the eye irritation potential of the substance. The eye irritation potential of the test substance was determined in accordance with the test guideline outlined in the Federal Hazardous Substances Act Section 191.12 (1973). 100 mg of the test substance was applied to rabbit eyes and observations made 24, 48 and 72 hours after application. The conjunctivae score (mean of 6 animals) was found to be 3.3, with effects fully reversible within 48 hours. The substance is therefore not classified as an eye irritant according to EU CLP criteria.
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.
Justification for selection of skin irritation / corrosion endpoint:
Study was conducted on the registered substance according to GLP standards and using OECD Testing Guideline 404.
Justification for selection of eye irritation endpoint:
Study was conducted on the substance silicic acid, aluminium, sodium salt, which is structurally similar to the registered substance, thereby justifying read-across of results. The study was conducted using the testing guideline included in the Federal Hazardous Substance Act Section 191.12 (1973).
Justification for classification or non-classification
No irrititation potential was found in either the skin or eye irritation studies.
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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