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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 234-426-5 | CAS number: 12003-38-2
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1958
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study is cited in a monograph. Not all study details are available. GLP was not yet available at the time of the study period.
Data source
Reference
- Reference Type:
- publication
- Title:
- Final Report on the Safety Assessment of Aluminum Silicate, Calcium Silicate, Magnesium Aluminum Silicate etc.
- Author:
- Elmore A.R, CIR Expert panel
- Year:
- 2 003
- Bibliographic source:
- Int. J. Toxicol., 2003, 22 Suppl. 1, 37-102 (Cosmetic Ingredient Review)
Materials and methods
Test guideline
- Deviations:
- not applicable
- Remarks:
- - no information provided
- Principles of method if other than guideline:
- Information on a guideline followed are not available.
- GLP compliance:
- no
- Remarks:
- GLP regulations didn't exist in 1958
- Limit test:
- no
Test material
- Reference substance name:
- Magnesium Aluminum Silicate
- IUPAC Name:
- Magnesium Aluminum Silicate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Name: Magnesium Aluminum Silicate
Commercial Name: VEEGUM
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- no information provided
Administration / exposure
- Route of administration:
- oral: feed
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
2%; 5%; 10%; and 20% = 20,000 ppm; 50,000 ppm, 100,000 ppm; and 200,000 ppm
Basis:
nominal in diet
- No. of animals per sex per dose:
- control group: 25 males + 25 females
Dose groups: 10 males + 10 females - Control animals:
- yes, plain diet
Examinations
- Observations and examinations performed and frequency:
- Body weight and feed intake were recorded daily. Hematological examinations were made at 6 and 12 weeks on half of the test group. Blood sugar and nonprotein nitrogen determinations and urine analyses were also completed.
- Sacrifice and pathology:
- All animals were killed at the end of the 90-day period. Liver, kidneys, spleen, heart, and adrenal glands weights were determined. Microscopic examination of the liver, kidneys, spleen, and portions of the gastrointestinal tract of four rats of each sex and control, 10% and 20% groups were carried out.
- Other examinations:
- The efficiency of feed utilization was calculated.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- Mortalities observed are not test item-related
- Mortality:
- no mortality observed
- Description (incidence):
- Mortalities observed are not test item-related
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- No effects up to 10%. Gowth was diminished slightly but with statistical significance (p=0.05) when 20% VEEGUM was fed to both sexes.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- effects observed, treatment-related
- Description (incidence and severity):
- Only the 20% VEEGUM dose significantly lowered the food efficiency
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- Blood sugar and nonprotein nitrogen were within normal limits.
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 100 000 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Nominal conc. in the diet
- Dose descriptor:
- NOAEL
- Effect level:
- 5 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Calculated from the NOAEL of 100000 ppm (assuming that 10 ppm in food equals 0.5 - 0.6 mg/kg bw/day).
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Based on a 90-day feeding study in rats, no adverse effects have been observed up to a test item concentration of 10% in the diet. The highest dose administered (= 200000 ppm) interfered with normal nutrition balance and, thus, can't be used to assess the toxicity of the test item.
- Executive summary:
The toxicity of magnesium aluminum silicate, a compound very similar to Fluorphlogopite, has been investigated in a 90 -day feeding study in rats. 4 Groups of animals (10 males and 10 females) received feed supplemented with the test material at 2% (20000 ppm), 5% (50000 ppm), 10% (100000 ppm) and 20% (200000 ppm), respectively. Control animals (25 males and 25 females) received the unmodified diet.
No effects on the body weight and feed uptake were observed up to 10% test material. In the high dose animals (20%), body weight development was slightly diminished, however, the high test material content in the feed interfered with normal nutritional balance. Therefore, the body weight changes are considered of no toxicological relevance. Mortalities observed during the studies are considered not test item-related. No effects have been observed on organ weights, hematology, clinical chemistry and urinalysis. Histopathological examination revealed no abnormalities.
Based on the results of this study, a NOAEL of 100000 ppm can be deduced (assuming that 10 ppm in food equals 0.5 - 0.6 mg/kg bw/day, the NOAEL can be calculated to be 5000 - 6000 mg/kg bw/day).
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.