Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- other: discussion in comparison with naturally occurring structurally related hectorite
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to other study
Reference
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1973-4
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Work carried out by recognised toxicology laboratory by qualified laboratory personnel using calibrated equipment and recognised methods of test. But the work was done in 1974 and not to GLP standards at that time
- 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.
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- 100 rats, 50 of each gender divided into four groups, were orally dosed by intubation with a dispersion concentration of 10ml/kg of the test material in deionised water over a period of 100 consecutive days. The rats were grouped by weight and dosed according to a recorded schedule. Group 1 was the control group and had just distilled water administered. Group 2 had a low dose (5mg/kg), group 3 had a medium dose (50mg/kg) and group 4 had a high dose (500mg/kg). The rats were observed daily for signs of toxicity and mortality. All rats were weighed on day 1 and weekly thereafter and at sacrifice. Blood analysis was carried out after 6 weeks and at the end of the test period. All organs were examined after sacrifice
- GLP compliance:
- no
- Limit test:
- no
- Species:
- rat
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- The rats were 28 days old when received for the start of the testing.
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- not specified
- Sacrifice and pathology:
- Opthalmology, blood analysis, hematology, biochemistry and urinalsysis testing were carried out
- Other examinations:
- Rats were weighed at day 1 and then weekly thereafter and at sacrifice
- Key result
- Dose descriptor:
- dose level:
- Effect level:
- >= 50 - <= 500 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 500 mg/kg bw/day (actual dose received)
- System:
- gastrointestinal tract
- Organ:
- oesophagus
- stomach
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- no
- Executive summary:
This study, carried out in 1973, was designed to evaluate the repeat dose oral toxicity of Laponite on rats over a period of 3 months. The material was dispersed in deionised water and the rats were fed by intubation. The rats were split into four groups, even numbers of male/female. Group 1 was the control group, (just water), group 2 was low dose (5mg/kg bw), group 3 was medium dose (50mg/kg bw) and group 4 was high dose (500mg/kg bw). The high dose group saw some premature deaths and these were found to be due to the fact that the Laponite forms a gel at high dose and this had accumulated in the animals digestive system and had not been digested. This level of dosing would not be permitted under today's controls. For surviving rats at necropsy, there were no signs of abnormalities relating to the oral dosing of the Laponite. The high dosage group resulted in half of the rats failing to survive to completion of the test but all rats in the other two groups (with the exception of 1 in the low dose group whose death was not attributed to the treatment) all survived. No systemic toxic effect as ascertained by blood analysis and histopathological examination were observed, even in the high dose rats
- Reason / purpose for cross-reference:
- other: see Remarks
- Remarks:
- general substance background and toxicokinetics summary
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Biodegradable polymer-nanoclay composites as intestinal sleeve implants installed in digestive tract for obesity and type 2 diabetes treatment
- Author:
- Hsu, Wei-Hsin; Lee, Ya-Lun; Prasannan, A.; Hu, Chien-Chieh; Wang, Jun-Shen
- Year:
- 2 020
- Bibliographic source:
- Hsu, Wei-Hsin, et al., Biodegradable polymer-nanoclay composites as intestinal sleeve implants installed in digestive tract for obesity and type 2 diabetes treatment. 2020/05/01 Materials Science and Engineering: C 10.1016/j.msec.2020.110676
- Reference Type:
- publication
- Title:
- Silicon and bone health
- Author:
- Jugdaohsingh R.
- Year:
- 2 007
- Bibliographic source:
- Jugdaohsingh R. Silicon and bone health. J Nutr Health Aging. 2007;11(2):99–110.
- Reference Type:
- publication
- Title:
- STUDIES ON THE SIZE AND SHAPE OF CLAY PARTICLES IN AQUEOUS SUSPENSION
- Author:
- Kahn, A.
- Year:
- 1 957
- Bibliographic source:
- Kahn, A. Clays Clay Miner. (1957) 6: 220
- Reference Type:
- publication
- Title:
- Machado-VThe role of lithium in the treatment of bipolar disorder: convergent evidence for neurotrophic effects as a unifying hypothesis
- Author:
- Machado-Vieira R, Manji HK, Zarate CA Jr.
- Year:
- 2 009
- Bibliographic source:
- Machado-Vieira R, et. al. The role of lithium in the treatment of bipolar disorder: convergent evidence for neurotrophic effects as a unifying hypothesis. Bipolar Disord. 2009;11 Suppl 2(Suppl 2):92–109. doi:10.1111/j.1399-5618.2009.00714.x
- Reference Type:
- publication
- Title:
- National InstitutMagnesium Fact Sheet for Health Professionals
- Author:
- National Institute of Health (NIH)
- Year:
- 2 019
- Bibliographic source:
- National Institute of Health (NIH) Magnesium Fact Sheet for Health Professionals https://ods.od.nih.gov/factsheets/Magnesium-HealthProfessional/ 10.11.2019
- Reference Type:
- publication
- Title:
- Injectable nanoclay gels for angiogenesis.
- Author:
- Page DJ, Clarkin CE, Mani R, Khan NA, Dawson JI, Evans ND.
- Year:
- 2 019
- Bibliographic source:
- Page DJ, Clarkin CE, Mani R, Khan NA, Dawson JI, Evans ND. (2019) Injectable nanoclay gels for angiogenesis. Acta Biomater. 2019 Dec;100:378-387. doi: 10.1016/j.actbio.2019.09.023. Epub 2019 Sep 19.
- Reference Type:
- publication
- Title:
- Critical review of any new evidence on the hazard profile, health effects, and human exposure to fluoride and the fluoridating agents of drinking water.
- Author:
- Scientific Committee on Health and Environmental Risks (SCHER).
- Year:
- 2 011
- Bibliographic source:
- Scientific Committee on Health and Environmental Risks (SCHER). Critical review of any new evidence on the hazard profile, health effects, and human exposure to fluoride and the fluoridating agents of drinking water. Report date: 16.5.2011
- Title:
- Bentonite, kaolin, and selected clay minerals
- Author:
- World Health Organization (WHO)
- Year:
- 2 005
- Bibliographic source:
- World Health Organization (WHO). Bentonite, kaolin, and selected clay minerals. Environmental Health Criteria 231, 2005
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- discussion in comparison with naturally occurring structurally related hectorite
- GLP compliance:
- no
Test material
- Reference substance name:
- Silicate(2-), hexafluoro-, disodium, reaction products with lithium magnesium sodium silicate
- EC Number:
- 285-349-9
- EC Name:
- Silicate(2-), hexafluoro-, disodium, reaction products with lithium magnesium sodium silicate
- Cas Number:
- 85085-18-3
- Molecular formula:
- Na0.7[Mg5.3Li0.7Si8O20(OH)0.0F4.0]
- IUPAC Name:
- Synthetic fluorohectorite
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Laponite Type Type 1
Date of manufacture 31/05/2009
Batch Number 09-2151-1
Constituent 1
Test animals
- Species:
- rat
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
- Remarks on result:
- other: see Remarks
- Remarks:
- see Any Other Information on Results
Results (fetuses)
Effect levels (fetuses)
- Remarks on result:
- other: see Remarks
- Remarks:
- see Any Other Information on Results
Overall developmental toxicity
- Developmental effects observed:
- no
Any other information on results incl. tables
There is no evidence that the substance is absorbed through ingestion, dermal contact or inhalation None of the ions present are known to have effects on fertility or reproduction.No effects were observed in the 90-day study on a similar read-across material (Laponite type 2) to indicate effects on gonads. It is not considered justified to perform further animal testing on this class of substance.
Laponite is a synthetically manufactured layered silicate similar to a naturally occurring smectite clay: Hecotorite. Laponite, a Silicate(2-), hexafluoro-, disodium, reaction products with lithium magnesium sodium silicate, (EC no 285-349-9) is a monoconstituent substance and is an inorganic layered silicate structure with a unit cell of the following composition: Na0.7[Mg5.3Li0.7Si8O20(OH)0.0F4.0]. Hectorite is a trioctahedral, magnesium based smectite clay with a unit cell of the following composition: H2LiMgNaO12Si4-2. The unique properties of the naturally occurring hectorite active mineral are very small platelet size, an elongated platelet structure with an inherent negative charge counterbalanced by exchangeable sodium (Na+) ions, light color with low iron content and high viscosifying ability in water.
Na, Mg, Li and Si are already widely found in the environment both in waters and soils / sediments. If released to the environment, the substance is expected to combine indistinguishably with the soil or sediment due to its similarity with inorganic soil/sediment matter and will be subjected to natural processes under environmental conditions (cation exchange, dissolution, sedimentation). Furthermore the potential human exposure to laponite is negligible in comparison to the release by natural deposits or alteration of naturally occurring clays with similar compositions.
Laponite is not expected to pose serious risk via the systemic absorption route. Lithium is the only metal that is less common from natural exposures. A review of publicly available information has indicated that lithium is not expected to bioaccumulate and its human and environmental toxicity are low. Large doses of lithium (up to 10 mg/L in serum) are given to patients with bipolar disorder. A provisional recommended daily intake of 14.3 μg/kg body weight lithium for an adult has been suggested. Lithium does not accumulate in the body since daily doses are required to maintain effect and has been utilized as a pharmacological treatment for over 60 years (Machado-Vieira et al. 2009). Excreted lithium from human use will find its way into the environment naturally. Accumulating evidence over the last 30 years strongly suggest that dietary silicon is beneficial to bone and connective tissue health and there are strong positive associations between dietary silica intake and bone mineral density. Dietary intake of silica is between 20-50 mg Si/day for most Western populations (Jugdaohsingh, 2007). Mg and Na are abundant minerals in the body, they are naturally present in many foods, added to other food products, available as a dietary supplement, and present in some medicines (such as antacids and laxatives). Magnesium is a cofactor in more than 300 enzyme systems that regulate diverse biochemical reactions in the body, including protein synthesis, muscle and nerve function, blood glucose control, and blood pressure regulation (NIH 2019). In humans and animals, ingested fluoride occurs as hydrogen fluoride (HF) in the acidic environment of the stomach and is effectively absorbed from the gastrointestinal tract, although there is no proved absorption from the oral cavity. Once absorbed, fluoride is rapidly distributed throughout the body via the blood. Approximately 99% of the fluoride in the human body is found in bones and teeth. Renal excretion is the major route of fluoride removal from the body.
None of the ions present are known to have effects on fertility or reproduction. No effects were observed in the 90 day study to indicate effects on gonads. No significant differences we observed in the contents of magnesium, sodium in the brain, kidney, liver, or tibia from pregnant SD rats dosed with 2% sodium montmorillonite or calcium montmorillonite clay compared with animals fed the basal diet. (WHO, 2005)
Laponite exhibited no toxicity in acute testing (oral, dermal, inhalation), mutagenicity and cytogenicity (See submitted studies) or any other toxicological relevant pathway. In addition Laponite is currently being explored as a potential drug delivery mechanism for angiogenesis (Page DJ., 2019), in implantable medical devices (Hsu, 2020). Laponite is a synthetic clay based on hectorite a naturally occurring clay mineral. There have been no epidemiological or toxicologically relevant studies on hectorite that found potential risk from hectorite exposure. Laponite is a synthetic clay with the same functional chemical composition as hectorite. Any nanoform exposures from laponite would be comparable to background exposure from the nanoform compartment of hectorite (Kahn, 1957).
Applicant's summary and conclusion
- Conclusions:
- There is no evidence that the substance is absorbed through ingestion, dermal contact or inhalation
None of the ions present are known to have effects on fertility or reproduction so further animal testing is not warranted based on animal welfare reasons. - Executive summary:
There is no evidence that the substance is absorbed through ingestion, dermal contact or inhalation
None of the ions present are known to have effects on fertility or reproduction so further animal testing is not warranted based on animal welfare reasons.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)