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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 701-065-4 | CAS number: -
- 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)
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 July 1989 to 9 August 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- In accordance with REACH Annex XI, testing is not scientifically necessary as studies on synthetic amorphous magnesium silicate have been conducted by Dallas Group of America and show no acute toxicity via the dermal route. The particle size analysis performed on the Dallas and PQ corporation material show that they are sufficiently similar. The only difference between the materials are the molar ratios. The molar ratio of the tested Dallas material is within the range of the PQ Corporation registered substance. No additional testing is therefore required.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- other: FHSA 16 CFR 1500
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Silicic acid, magnesium salt
- EC Number:
- 215-681-1
- EC Name:
- Silicic acid, magnesium salt
- Cas Number:
- 1343-88-0
- Molecular formula:
- MgO.xSiO2, the molar ratio SiO2:MgO typically ranges from 1.4-4
- IUPAC Name:
- Synthetic amorphous magnesium silicate, with molar ratio (SiO2:MgO) range of 1.4-4
- Details on test material:
- The test material, Magnesium Silicate was a fine white powder.
Constituent 1
- Specific details on test material used for the study:
- The test material, Magnesium Silicate was a fine white powder.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: U.S.D.A. supplier
- Weight at study initiation: 2.3-3.0 kg
- Housing: individually in wire mesh suspension cages
- Diet : Purina Laboratory Rabbit Chow available ad libitum
- Water : available ad libitum
- Acclimation period: Four days
Animals were housed in a temperature and humidity controlled environment with 12 hours light/12 hours dark cycle.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- physiological saline
- Details on dermal exposure:
- Prior to dosing, hair was removed from the trunk of each rabbit so that approximately 10% of the body surface area was exposed. For half of the treated rabbits (2 males and 3 females), the surface ofthe test site was abraded , for the remaining animals the test site was left intact. The sample, moistened with saline, was applied to the test site at a dose of 2 g/kg bw. The sample was introduced onto a sleeve of rubber dental dam which was wrapped around the truck of the animal and secured with staples.
At the end of the 24 hour exposure period, the wrapping was removed and any residual test material was removed by gentle sponging using a towel moistened with water. - Duration of exposure:
- 24 hours
- Doses:
- The dose level applied was 2 g/kg
- No. of animals per sex per dose:
- Ten rabbits (five female/five male)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: checked daily for clinical signs and weighedon day of dosing and at termination
- Necropsy of survivors performed: yes
The test material moistened with an appropriate volume of physiological saline was administered to five male and five female rabbits at a dose level of 2 g/kg.
Each animal was observed daily for viability. Observations of any toxicologic signs were taken after dosing and daily thereafter for 14 days. Skin reactions or any evidence of irritation were noted.
Body weights were measured for each animal on the day of dosing and at the time of necropsy.
A gross necropsy was performed on each animal at the end of the 14 day observation period - Statistics:
- Not applicable for a limit test
Results and discussion
- Preliminary study:
- No preliminary study performed.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No deaths occurred during the observation period.
- Clinical signs:
- other: Exposed area appeared dry, no other clinical changes recorded.
- Gross pathology:
- No gross changes observed.
- Other findings:
- No other findings to report.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal LD50 value was found to be greater than 2.0 g/kg in male and female New Zealand White rabbits. The test material is not classified as toxic or harmful by dermal application.
- Executive summary:
The acute dermal toxicity of magnesium silicate was evaluated by the addition of 2 g/kg to an area of skin for 24 hours on ten New Zealand white rabbits. The animals were observed for 14 days. The acute dermal LC50 was found to be greater than 2.0 g/kg. The test substance was found to be not toxic or harmful by dermal application. No classification is required under existing DPD (Directive 67/548/EEC, as subsequently amended) or GHS (Regulation 1271/2008) legislation.
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)