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Registration Dossier
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EC number: 258-476-2 | CAS number: 53320-86-8
- 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

Skin irritation / corrosion
Administrative data
- 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: Test carried out by GLP compliant laboratory to recognised validated methods by trained personnel
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Draize Test Dermal Toxicity FDA 1975
- Deviations:
- yes
- Remarks:
- Modified Draize test
- GLP compliance:
- yes
Test material
- Reference substance name:
- Silicic acid, lithium magnesium sodium salt
- EC Number:
- 258-476-2
- EC Name:
- Silicic acid, lithium magnesium sodium salt
- Cas Number:
- 53320-86-8
- Molecular formula:
- Na0.7[Li0.3Mg5.5Si8O20(OH)4]
- IUPAC Name:
- magnesium(2+) lithium(1+) sodium bis(oxosilanebis(olate))
- Details on test material:
- Optigel SH is another commercial name for Laponite T2 and is the same test substance
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Animals were acclimated at least 4 days prior to test. Housed in galvanised or s.s cages and kept in a 12hr day/night cycle. Room temperaturs kept between 65-75 deg F. Fed and watered. 24 hours prior to test the animals were re-examined. Any with skin problems or in poor health were not used.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: two sites per animal, one shaved only, the other shaved and abraded
- Vehicle:
- physiological saline
- Controls:
- not required
- Amount / concentration applied:
- 0.5 g of test material moistened with saline were applied to each test site
- Duration of treatment / exposure:
- Wrapping and test article removed after 24 hours. Remaining test article was gently washed from the skin with water and dried with paper towel.
- Observation period:
- Test sites were examined after 24 and 72 hours
- Number of animals:
- Six
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 hours and 72 hous after application
- Score:
- 0.18
- Reversibility:
- no data
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- This substance is not a primary dermal irritant to rabbits under the consition of the test. A score in the range 0.1-0.9 is classed as "potential for slight irritation, rarely irritating to people - no warning required"
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