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EC number: 235-310-7 | CAS number: 12163-26-7
- 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
Acute toxicity studies with magnesium diniobate are not available, thus the acute toxicity will be addressed with existing data on the dissociation products.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Version / remarks:
- 2008-10-03
- Deviations:
- yes
- Remarks:
- purity and stability not stated; observation period last 72 hours only; test item preparation missing; number of dead animals not reported; gross pathology not performed; sex and age of animals missing
- GLP compliance:
- not specified
- Remarks:
- not specified in the publication
- Test type:
- up-and-down procedure
- Limit test:
- no
- Specific details on test material used for the study:
- not specified
- Species:
- mouse
- Strain:
- Swiss
- Remarks:
- albino
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight: 20 - 35 grams
- Housing: housed in polypropylene cages
- Diet: standard pellet diet (Hindustan Lever, Bangalore, India)
- Water (ad libitum)
ENVIRONMENTAL CONDITIONS
- Temperature: 22 - 24°C
- Humidity: 75 %
- Photoperiod (hrs dark / hrs light): 14/10 - Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- The first animal receives a dose one step below the assumed estimate of the LD50. If the animal survives, the second animal receives a higher dose. If the first animal dies, the second animal receives a lower dose (Chen et al. (2006))*.
*Reference:
- Chen Z, Meng H, Xing G et al. Acute toxicological effects of copper NPs in vivo. Toxicol. Lett. 2006; 163: 109 - 120 - Doses:
- 1000 to 5000 mg/kg bw
- No. of animals per sex per dose:
- 10 mice
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 72 hours
- General examination: after administration of the test item, animals were examined daily for their survival, evident behavior or motor impairments and effect on their body weight.
- Behavioral changes: drowsiness, hyperactivity, moving of tail, scratching of body, loss of hair, texture of hair (smooth, or rough) etc were observed. - Statistics:
- LD50 was calculated using probit analysis (Randhawa (1944); Miller & Tainter (1944))*.
*References:
- Randhawa MA. Calculation of LD50 values from the method of Miller and Tainter, 1944. J Ayub Med Coll Abbottabad 2009; 21(3): 184-5
- Miller LC, Tainter ML. Estimation of the LD50 and its error by means of logarithmic probit graph paper. Proc Soc Exp Biol Med. 1944; 57:261–264. - Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 3 954 mg/kg bw
- Based on:
- test mat.
- Mortality:
- not specified
- Clinical signs:
- The mice exposed to the test item showed hyperactivity, moving of tail but the hair remained smooth.
- Body weight:
- not specified
- Gross pathology:
- not specified
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 (mice): 3954 mg/kg bw
According to the Regulation (EC) No 1272/2008 and subsequent adaptations, magnesium oxide is not acutely toxic via the oral route. - Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009-08-11 to 2009-08-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001-12-17
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2008-05-30
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 2009-04-06
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature - Species:
- rat
- Strain:
- other: Crl:WI(Han)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 10 weeks old
- Weight at study initiation: 162 - 181 g
- Fasting period before study: prior to the administration food was withheld for 16 to 19 hours (access to water was permitted) and food was provided again approx. 4 hours post dosing.
- Housing: kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding
- Diet (ad libitum): Altromin 1324 maintenance diet for rats and mice
- Water (ad libitum): tap water, sulfur acidified to a pH value of approx. 2.8
- Acclimation period: 13 or 14 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Relative humidity: 55 ± 10 %
- Air changes: 10 x/hour
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- other: deionised water
- Details on oral exposure:
- DOSAGE PREPARATION:
The test item was suspended in deionised water.
VEHICLE
- Justification for choice of vehicle: vehicle was chosen due to its non-toxic characteristics.
- Lot no.: 09/07/14
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 female rats (3 females/step)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were weighed on day 1 (prior to administration) and on day 8 and on day 15. A clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose) as well as once daily thereafter until the end of the observation period.
- Necropsy of survivors performed: yes, all animals were subjected to gross necropsy. - Statistics:
- not applicable
- Preliminary study:
- none
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study.
- Clinical signs:
- No signs of toxicity were observed.
- Body weight:
- None of the animals showed weight loss during the observation period .
- Gross pathology:
- With the exception of acute injection of blood vessels in the abdominal region, which is due to the euthanasia, no special gross pathological changes were recorded for any animal.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 (female rats) > 2000 mg/kg bw
According to the Regulation (EC) No 1272/2008 and subsequent adaptations, the substance is not acutely toxic via the oral route.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Signs of acute oral toxicity are not expected for magnesium diniobate, since the two constituents magnesium and niobium have not shown signs of acute oral toxicity in experimental testing (both LD50 > 2000 mg/kg bw). Under the assumption that the constituents of magnesium diniobate show their toxicological profile individually upon dissolution, the acute oral (systemic) toxicity of magnesium diniobate can be estimated using the equation given in Regulation (EC) 1272/2008, Annex I, Section 3.1.3.6.1; the oral LD50 for magnesium diniobate is > 2000mg/kg.
A study for acute toxicity via inhalation or the dermal route was not conducted with magnesium diniobate since it can safely be assumed to have a low potential for human inhalation hazard and a low potential for dermal absorption during handling or application as assessed in the corresponding derogation statements. Thus, acute toxic effects are not likely to occur during manufacture and handling of that substance.
Justification for classification or non-classification
The available information indicates that magnesium diniobate is not acutely toxic or harmful. The calculated oral LD50 for magnesium diniobate is > 2000mg/kg. Therefore, classification of magnesium diniobate for acute toxicity is not required according to Regulation (EC) 1272/2008.
The classification criteria according to Regulation (EC) 1272/2008 as specific target organ toxicant (STOT) – single exposure are not met since adverse health effects, including reversible and irreversible, were not observed immediately or delayed after exposure.
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