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EC number: 949-694-5 | 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
Endpoint summary
Administrative data
Description of key information
Studies of the sub-chronic oral toxicity of the structurally-similar substance, magnesium aluminium silicate, are available in two species: rats and dogs.
Albino rats were fed a diet supplemented with 2%, 5%, 10% or 20% of VEEGUM (magnesium aluminium silicate) for 90 days. Growth was diminished slightly, but with statistical significance, in animals of both sexes at the highest dose. There were no gross pathological or histopathological findings reported, and the haematological and biochemical parameters measured were within normal levels. The NOAEL for VEEGUM (magnesium aluminium silicate) was determined to be 10% in the diet (100,000 ppm, equating to approximately 5000 mg/kg bw/day).
The repeated-dose oral toxicity of the same substance was also assessed in mongrel dogs fed a diet supplemented with 10% of the test material for 90 days. No adverse effects were reported. The NOAEL for VEEGUM (magnesium aluminium silicate) was determined to be 10% in the diet (100,000 ppm, equating to approximately 2500 mg/kg bw/day).
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- Not specified.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- A full justification for the use of data on magnesium aluminium silicate as read-across for this substance, magnesium potassium fluoride silicate (Mg2.7K0.7Si4O10F2), is attached to Section 13 of this dossier.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- - Principle of test: 90-day feeding study using rats.
- Short description of test conditions: Albino rats (10/sex/test group, 25/sex/control group) were fed commercial diet supplemented with 2%, 5%, 10% or 20% VEEGUM (magnesium aluminium silicate), or unmodified (control group) for 90 days.
- Parameters analysed / observed: Body weight and feed intake were recorded daily. Haematological examinations were made at 6 and 12 weeks on half of the test group. Blood sugar and non-protein nitrogen determinations and urinalysis were also completed. Liver, kidneys, spleen, heart and adrenal gland weights were determined post-mortem. Microscopic examination of the liver, kidneys, spleen, and portions of the GI tract of four rats/sex in the control, 10% and 20% groups was carried out. - GLP compliance:
- no
- Remarks:
- Study pre-dates introduction of GLP.
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 90 days
- Dose / conc.:
- 20 000 ppm
- Remarks:
- Reported as 2%
- Dose / conc.:
- 50 000 ppm
- Remarks:
- Reported as 5%
- Dose / conc.:
- 100 000 ppm
- Remarks:
- Reported as 10%
- Dose / conc.:
- 200 000 ppm
- Remarks:
- Reported as 20%
- No. of animals per sex per dose:
- 10/sex/treated group.
25/sex/control group. - Control animals:
- yes, plain diet
- Observations and examinations performed and frequency:
- Body weight and feed intake recorded daily and efficiency of feed utilisation (EFU, g bw gained/100 g feed consumed) calculated.
Haematological examinations, blood sugar, non-protein nitrogen and urinalysis at 6 and 12 weeks in half of the test group. - Sacrifice and pathology:
- All animals were killed at the end of the 90-day period.
Liver, kidneys, spleen, heart and adrenal weights were recorded from all animals.
Microscopic examination of the liver, kidneys, spleen and portions of the GI tract were carried out on 4 animals/sex in the control, 10% and 20% groups. - Clinical signs:
- not specified
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- One (male) in the 2% group and one/sex in the 10% group died during the study. "These rats had fibrinous exudates in the thorax, haemorrhagic lungs, and evidence of respiratory infection at necropsy."
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Average body weights and net body weight gains were not adversely affected up to 10%. "Growth was diminished slightly but with statistical significance when 20% VEEGUM was fed to both sexes"
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- effects observed, treatment-related
- Description (incidence and severity):
- Only the 20% dose significantly lowered the observed EFU value.
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 100 000 ppm
- Based on:
- test mat.
- Remarks:
- Nominal concentration in the diet; reported as 10%
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- Dose descriptor:
- NOAEL
- Effect level:
- 5 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Remarks:
- Assuming that 1 ppm in the diet corresponds to an average 0.05 mg/kg bw/day consumption of the test material.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- Key result
- Critical effects observed:
- no
- Conclusions:
- In a 90-day study, rats were fed a diet supplemented with up to 20% VEEGUM (magnesium aluminium silicate), a substance closely structurally-related to magnesium potassium fluoride silicate (Mg2.7K0.7Si4O10F2). Animals in the high-dose group displayed a slightly (but statistically significantly) reduced body weight gain. No other adverse effects were reported. The NOAEL was determined to be 10% in the diet (100,000 ppm or 5000 mg/kg bw/day).
- Executive summary:
The repeated-dose oral toxicity of VEEGUM (magnesium aluminium silicate), a substance closely structurally-related to magnesium potassium fluoride silicate (Mg2.7K0.7Si4O10F2), was assessed in albino rats fed a diet supplemented with 2%, 5%, 10% or 20% of the test material for 90 days. Growth was diminished slightly, but with statistical significance, in animals of both sexes at the highest dose. There were no gross pathological or histopathological findings reported, and the haematological and biochemical parameters measured were within normal levels. The NOAEL for VEEGUM (magnesium aluminium silicate) was determined to be 10% in the diet (100,000 ppm, equating to approximately 5000 mg/kg bw/day). Consequently, the target substance magnesium potassium fluoride silicate (Mg2.7K0.7Si4O10F2) is considered to be non-toxic with regard to its repeated-dose oral toxicity.
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- Not specified.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- A full justification for the use of data on magnesium aluminium silicate as read-across for this substance, magnesium potassium fluoride silicate (Mg2.7K0.7Si4O10F2), is attached to Section 13 of this dossier.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- - Principle of test: 90-day feeding study using rats.
- Short description of test conditions: Mongrel dogs (2/sex/group) were fed commercial diet supplemented with 10% VEEGUM (magnesium aluminium silicate), or unmodified (control group) for 90 days. - GLP compliance:
- no
- Remarks:
- Study pre-dates introduction of GLP.
- Limit test:
- no
- Species:
- dog
- Strain:
- other: Mongrel
- Sex:
- male/female
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 90 days
- Dose / conc.:
- 100 000 ppm
- Remarks:
- Reported as 10%
- No. of animals per sex per dose:
- 2/sex/group.
- Control animals:
- yes, plain diet
- Observations and examinations performed and frequency:
- Complete blood counts, blood sugar and non-protein nitrogen were analysed at 6 and 12 weeks. Urine specimens were examined at 12 weeks for acidity, sugar, albumin, and microscopic elements in the sediment.
- Sacrifice and pathology:
- All animals were killed at the end of the 90-day period and subjected to necropsy. [extent of examination not specified]
- Clinical signs:
- not specified
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- "Body weight did not change despite a depression of appetite with the addition of VEEGUM"
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Two of the test animals had slightly increased blood sugar at the end of the testing period.
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 100 000 ppm
- Based on:
- test mat.
- Remarks:
- Nominal concentration in the diet; reported as 10%
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Dose descriptor:
- NOAEL
- Effect level:
- 2 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Remarks:
- Assuming that 1 ppm in the diet corresponds to an average 0.025 mg/kg bw/day consumption of the test material.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Key result
- Critical effects observed:
- no
- Conclusions:
- In a 90-day study, dogs were fed a diet supplemented with 10% VEEGUM (magnesium aluminium silicate), a substance closely structurally-related to magnesium potassium fluoride silicate (Mg2.7K0.7Si4O10F2). No adverse effects were reported. The NOAEL was therefore determined to be 10% in the diet (100,000 ppm or 2500 mg/kg bw/day).
- Executive summary:
The repeated-dose oral toxicity of VEEGUM (magnesium aluminium silicate), a substance closely structurally-related to magnesium potassium fluoride silicate (Mg2.7K0.7Si4O10F2), was assessed in mongrel dogs fed a diet supplemented with 10% of the test material for 90 days. No adverse effects were reported. The NOAEL for VEEGUM (magnesium aluminium silicate) was determined to be 10% in the diet (100,000 ppm, equating to approximately 2500 mg/kg bw/day). Consequently, the target substance magnesium potassium fluoride silicate (Mg2.7K0.7Si4O10F2) is considered to be non-toxic with regard to its repeated-dose oral toxicity.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 5 000 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Additional information
Justification for classification or non-classification
The only adverse effect observed, a slight (but statistically-significant) reduction in body weight gain, occurred only at a dose far above the threshold for classification. Thus, no classification for repeated-dose systemic toxicity is required.
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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