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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016-09-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- 2013-07-26
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Version / remarks:
- 2010
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Bovine Corneal Opacity and Permeability (BCOP) Assay, SOP of Microbiological Associates Ltd., UK, Procedure Details, April 1997
- Version / remarks:
- April 1997
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 2015-09-14
Test material
- Reference substance name:
- Magnesium diniobate
- EC Number:
- 235-310-7
- EC Name:
- Magnesium diniobate
- Cas Number:
- 12163-26-7
- Molecular formula:
- Mg.2NbO3
- IUPAC Name:
- Magnesium diniobate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Test Item: Magnesium diniobate
Molecular formula: MgNb2O6
Molecular weight: 306.11 g/mol
Appearance: White powder
Storage conditions: Ambient temperature, keep container tightly closed, dry
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
Test animals / tissue source
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: abattoir (Schlachthof Aschaffenburg, 63739 Aschaffenburg, Germany)
- Characteristics of donor animals: at least 9 month old donor cattle
- Storage, temperature and transport conditions of ocular tissue: isolated eyes were transported to the laboratory in Hank’s Buffered Salt Solution (HBSS) supplemented with streptomycin / penicillin at ambient temperature.
- Time interval prior to initiating testing: corneae were isolated and used on the same day after delivery of the eyes
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.75 mL
- Concentration: 20 % suspension (w/v) in vehicle - Duration of treatment / exposure:
- 240 minutes
- Observation period (in vivo):
- not applicable
- Duration of post- treatment incubation (in vitro):
- not required
- Number of animals or in vitro replicates:
- Number of bovine corneae per dose:
Test item: triplicates
Negative control: triplicates
Positive control: triplicates - Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
- all eyes were examined macroscopically for defects. Those presenting defects such as vascularization, pigmentation, opacity and scratches were discarded.
- cornea was removed from the eye.
- each cornea was mounted in a cornea holder according to the description given in OECD guideline 437, which consists of anterior and posterior compartments, which interface with the epithelial and endothelial sides of the cornea, respectively. Both compartments of the holder were filled with incubation medium (MEM*, equivalent to EMEM).
- for equilibration, the corneae in the holder were incubated in a vertical position for about one hour at 32 ± 1 °C in a water-bath.
*MEM supplemented with sodium bicarbonate, L-glutamine, penicillin/streptomycin, and 1% fetal calf serum
QUALITY CHECK OF THE ISOLATED CORNEAS
- at the end of the equilibration period, the basal opacity was determined (t0).
- each cornea with a value of the basal opacity > 7 was discarded.
APPLICATION DOSE / EXPOSURE TIME / REMOVAL OF TEST SUBSTANCE
- the anterior compartment received the test item suspension or negative or positive control at a volume of 0.75 mL each on the surface of the corneae.
- corneae were incubated in a horizontal position at 32 ± 1 °C in the water-bath (incubation time: 240 minutes).
- after the incubation period, the test item or control items, respectively, were rinsed off from the application side with saline
- fresh incubation medium was added into the anterior compartment and opacity was measured (t240).
- permeability of the cornea was determined
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: the opacitometer (OP_KiT opacitometer (Electro Design)) was calibrated and the opacity of each of the corneae was determined by reading each holder placed in the photoreceptor compartment for treated cornea.
Evaluation of opacity:
- the change of opacity value of each treated cornea or positive and negative control corneae is calculated by subtracting the initial basal opacity from the post treatment opacity reading (t240 – t0), for each individual cornea.
- the average change in opacity of the negative control corneae is calculated and this value is subtracted from the change in opacity of each treated cornea or positive control to obtain a corrected opacity.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of spectrophotometer (Versamax® Molecular Devices) (OD490).
- after the final opacity measurement was performed, the incubation medium was removed from the anterior compartment and replaced by a 0.5% (w/v) sodium fluorescein solution in HBSS.
- corneae were incubated again in a horizontal position for 90 ± 10 minutes in a water-bath at 32 ± 1 °C.
- incubation medium from the posterior compartment were removed, well mixed and transferred into a 96 well plate and the optical density at 490 nm (OD490) was determined with a spectrophotometer.
Evaluation permeability:
- the corrected OD490 value of each cornea treated with positive control and test item is calculated by subtracting the average negative control cornea value from the original
permeability value for each cornea.
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
The following formula was used to determine the IVIS of the negative control:
IVIS = opacity value + (15 x OD490 value)
The following formula was used to determine the IVIS of the positive control and the test item:
IVIS = (opacity value – opacity value mean negative control) + (15 x corrected OD490 value)
The mean IVIS value of each treated group was calculated from the IVIS values of each individual treatment and positive control cornea.
Depending on the score obtained, the test item was classified into categories according to OECD guideline 437 (table 1 in the field "Any other information on materials and methods incl. tables" below).
ACCEPTANCE CRITERIA:
The test was acceptable if
- the positive control gives an IVIS that falls within two standard deviations of the current historical mean (updated every three months), and if
- the negative control responses result in opacity and permeability values that are less than the established upper limits for background opacity and permeability values for bovine corneae treated with the respective negative control.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Remarks:
- (mean)
- Value:
- 2.97
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - with the negative control (saline) neither an increase of opacity nor permeability of the corneae could be observed (mean IVIS = 1.48).
- distinct opacity of the corneae leading to a mean IVIS of 110.15 was caused after treatment with the positive control (10% (w/v) Benzalkonium chloride in saline) corresponding to the classification Irreversible effects on the eye / serious eye damage (CLP (Cat 1)).
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: opacity and permeability of the negative control are less than the respective established upper limits for background opacity and permeability.
- Acceptance criteria met for positive control: the positive control falls within two standard deviations of the current historical mean.
Please refer to the field "Any other information on results incl. tables" below.
Any other information on results incl. tables
Table 1: Results after 240 minutes incubation time
Test Group |
Opacity value = Difference (t240-t0) of Opacity |
Permeability at 490 nm (OD490) |
IVIS |
Mean IVIS |
||
|
|
Mean |
|
Mean |
|
|
Negative Control |
0 |
0.33 |
0.079 |
0.077 |
1.19 |
1.48 |
1 |
0.076 |
2.14 |
||||
0 |
0.075 |
1.13 |
||||
Positive Control |
117.67* |
0.003* |
117.72 |
110.15 |
||
104.67* |
0.017* |
104.93 |
||||
107.67* |
0.009* |
107.81 |
||||
Magnesium diniobate |
2.67* |
0.005* |
2.75 |
2.97 |
||
2.67* |
0.016* |
2.91 |
||||
2.67* |
0.039* |
3.26 |
*corrected values
Table 2: Historical data
|
Positive Control |
Negative Control |
Mean IVIS |
122.01 |
1.32 |
Standard Deviation IVIS |
15.51 |
0.33 |
Range of IVIS |
98.49 – 167.85 |
0.73 – 2.04 |
Mean Opacity t240min |
120.03 |
0.17 |
Standard Deviation |
18.45 |
0.25 |
Range of Opacity t240min |
88.67 – 183.00 |
-.33 – 0.67 |
Mean Permeability |
0.147 |
0.184 |
Standard Deviation Permeability |
0.257 |
0.281 |
Range of Permeability |
0.000 – 1.438 |
0.055 – 1.100 |
Values of 32 studies with solid test items performed from February 2015 (calendar week 7) until October 2016 (calendar week 40)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, based on a valid OECD 437 test and under the experimental conditions reported, magnesium diniobate does not meet the requirements for classification as UN GHS Category 1 or 2 (2A or 2B) and is referred to as UN GHS No Category.
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