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Diss Factsheets
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EC number: 285-349-9 | CAS number: 85085-18-3
- 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
- Study period:
- 1988
- 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
- Justification for type of information:
- See Document "Laponite Analog justification-BL_6_30_2020.pdf" in Section 13.2 - Toxicokinetic assessment for Synthetic fluorohectorites for justification of read-across.
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:
- Synthetic hectorite
- Details on test material:
- Read-across: Laponite Type 1 (Silicate(2-), hexafluoro-, disodium, reaction products with lithium magnesium sodium silicate) and Laponite Type 2 (silicic acid, lithium magnesium sodium salt) in this case the read across substance, are essentially the same structure except that Type 1 has fluoride incorporated in the structure. They both behave in a similar way in powder form and also when dispersed in water, forming a colloidal gel. At skin pH values of essentially neutral, no hydrolysis from the clay type structure would occur and it would not be expected for there to be any difference in the dermal effect than there is for Laponite T2 .
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"
- Executive summary:
Laponite Type 2 (EC 258-476-2) is not irritating to skin of rabbits under the conditions of this test. This test substance is a "read-across" for Laponite Type 1 (EC 285-349-9), their structures being essentially identical with the exception of some ionic substitution within the clay lattice. It is therefore concluded that Laponite Type 1 will not be a skin irritant to rabbits in the same way as for Laponite type 2.
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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