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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 235-730-0 | CAS number: 12627-14-4
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08 - 23 Dec 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Groupe interministeriel des produits chimiques, France
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Silicic acid, lithium salt
- EC Number:
- 235-730-0
- EC Name:
- Silicic acid, lithium salt
- Cas Number:
- 12627-14-4
- Molecular formula:
- Li2O*2.8SiO2 - Li2O*6.3SiO2
- IUPAC Name:
- Silicic acid, lithium salt
- Details on test material:
- - Name of test material (as cited in study report): lithium silicate
- Physical state: white, granular
- Analytical purity: >99%
- Lot/batch No.: 009061957
- Expiration date of the lot/batch: 28 May 2010
- Storage condition of test material: room temperature
- Other:
Molar Ratio SiO2/Li2O: 4.8 (information provided in the product information sheet for Lithium polysilicate by the data owner)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage JANVIER (53940 Le Genest St Isle - France)
- Age at study initiation: 8 weeks
- Weight at study initiation: 189 - 203 g
- Fasting period before study: Food was removed at D-1 and then redistributed 4 h after test item administration
- Housing: by group of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid; each cage contains sawdust bedding which was changed at least 2 times a week; each cage was installed in conventional air conditioned animal husbandry.
- Diet: M20-rat/mouse maintenance (made from the formulation EXTRALABO from PIETREMENT) ad libitum
- Water: ad libitum tap water from public distribution system (microbiological and chemical analyses carried out every six months by the IPL, Santé, Environnement Durables - Atlantique)
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 21
- Humidity (%): 28 - 68
- Air changes (per hr): approx. 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12/12 (7:00 to 19:00)/(19:00-7:00)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- DMSO
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw
DOSAGE PREPARATION (if unusual): In each step of the study, 2 g of the test item was weighed and 10 mL DMSO was added in a volumetric flask. The preparation was magnetically stirred during 24 hours to obtain a homogenous white suspension.
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 exposed animals (3 animals in Step 1, 3 animals in Step 2), 3 control animals
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical observations were carried out 30 min, 1 h, 3 h, 4 h post-dose and daily thereafter; body weights were determined on D0 (just before administering the test substance), D2, D7 and D14
- Necropsy of survivors performed: yes; All animals found dead during the study were immediately necropsied.
On D14, all survivors were anaesthetised with sodium pentobarbital and administration continued to fatal levels.
Necropsy examinations: oesophagus, stomach, duodenum, jejunum, ileon, caecum, colon, rectum, spleen, liver, thymus, trachea, lungs, heart, kidneys, urinary bladder, ovaries, uterus, adrenals, pancreas
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 500 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: LD50 cut-off according to OECD 423
- Mortality:
- 2 of 6 animals were found dead during the study: one animal from step 1 died at 28 hours 55 minutes post-dose and one animal from step 2 died at 21 hours post-dose.
- Clinical signs:
- other: The mortalities were preceded by a decrease in spontaneous activity (2/2) and in body temperature (2/2), increased lachrymation (1/2), bradypnea (2/2), tremors (1/2), piloerection (1/2) and absence of righting reflex (1/2). In the survival animals (4/6),
- Gross pathology:
- The macroscopical examination of the dead animals revealed a thinning of the corpus associated with red spots (2/2) and a thinning of the forestomach (1/2).
The macroscopical examination of the survival animals at the end of the study did not reveal treatment-related changes.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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.