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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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- 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
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Vehicle:
- propylene glycol
- Concentration:
- From 5% to 25% by weight of the test substance in propylene glycol
25 microlitres of the suspension were applied daily for three consecutive days - No. of animals per dose:
- Four mice per concentration
A control group of 4 mice were treated with propylene glycol alone - Positive control substance(s):
- other: phenylacetaldehyde CAS122-78-1
- Positive control results:
- At a concentration of 2.5% in propylene glycol, the positive test substance, phenylacetaldehyde, which had been applied to five mice, showed a stimulation index of 18.43 and is known to be a skin sensitiser.
- Parameter:
- SI
- Remarks on result:
- other: At 5%w/w in propylene glycol = 0.77 (negative result) At 10%w/w in propylene glycol = 0.56 (negative result) At 25%w/w in propylene glycol = 0.61 (negative result)
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test material was considered to be a non-sensitiser under the conditions of the test
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In addition to the negative test results, Laponite has been used for many years in personal care products at low concentrations to provide structure to formulations. In more than 30 years of use in these fields, no data has been found to indicate that this material leads to sensitisation in the general public.
Migrated from Short description of key information:
The study performed assessed the skin sensitisation potential of this substance in mice using the LLNA (Local Lymph Node Assay) to recommended guideline methodology. The test material was considered to be a non-sensitiser under the conditions of the test
Justification for classification or non-classification
Results of the skin sensitisation test (LLNA in mice) showed no indication that the material is a skin sensitiser.
Respirable exposure would not be an expected route for sensitisation for product uses and during the lifetime of the manufacturing facility where dust inhalation might be expected, there have been no incidences of operators developing respirable (or dermal) sensitisation to this substance.
Therefore it is concluded that this substance is not a sensitiser, neither dermal nor respirable.
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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