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EC number: 241-022-2 | CAS number: 16949-65-8
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Magnesium hexafluorosilicate hexahydrate
- Cas Number:
- 18972-56-0
- Molecular formula:
- MgSiF6·6H2O
- IUPAC Name:
- Magnesium hexafluorosilicate hexahydrate
- Test material form:
- other: crystalline powder
Constituent 1
Test animals / tissue source
- Species:
- other: bovine
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: bovine
- Eye transport solution: Hanks balanced salt solution (HBSS) Modified [Gibco Cat. no. 14025 (batch no. 1150029)] supplemented with Penicillin sulphate (Sigma batch no. BCBD3925V) and Streptomycin sulphate (Sigma batch no. 079K14102V) both at the final concentration of 100 IU/mL.
Complete EMEM* (also named: Minimum Essential Medium Eagle's (MEM) Modified or MEM or Eagle’s MEM.):
- without phenol red: EMEM* Gibco (Invitrogen) Cat. no. 51200 (batch no. 1150177) supplemented with 1% (v/v) Foetal Bovine Serum (FBS - ATCC - batch no. 30001205)
- with phenol red: EMEM* Gibco (Invitrogen) Cat. no. 21090 (batch no. 1098654) supplemented with 1% (v/v) Foetal Bovine Serum (FBS - ATCC - batch no. 30001205)
These media were prewarmed in a water bath at 32°C during the experimental procedure.
- Sodium fluorescein solution : Sigma Cat. no. F-6377 (batch no. 079K0141). This was formulated to give 5 mg/mL solutions in DPBS [Gibco Cat. No. 14190 (batch no. 1098734)].
- Transport condition: Maintained in eyes transport solution at approximately 4ºC
COLLECTION OF EYES
Slaughter house: Butcher Service s.r.l.- Mattatoio no. 2067 M St. Teverina Km. 7800 - 01100 Viterbo
Age of animals : 6-12 months
Killing time: From 9:00 to 11:30 in the morning.
Transport condition: Maintained in eyes transport solution at approximately 4°C.
Approximate test starting time: 13:50
PREPARATION AND SELECTION OF CORNEAS
Examination: Eyes were examined for the presence of any defects which could render the eye unsuitable for use (opacity, scratches or pitting of the corneal surface, vascularisation or pigmentation).
Cornea excision: Each cornea with 2-3 mm of surrounding sclera was dissected from the eye using a scalpel, scissors and forceps and placed into a Petri dish containing HBSS.
Mounting in the chamber: Each cornea was mounted into a prewarmed testing chamber (see Figure 1) with the endothelial surface of the cornea placed in contact with the O-ring of the posterior part of the chamber. Care was taken to ensure the correct position of the cornea minimizing the presence of pigmented area inside the O-ring and avoiding movements which would damage the cornea. The chamber was then filled with complete EMEM without phenol red maintained at 32 ± 1°C (posterior part of the chamber first to maintain convexity).
Equilibration: The corneas in their holders were incubated in a liquid bath at 32 ± 1°C at least for 1 hour to permit metabolic stabilisation. At the end of the pre-dose incubation period, the two chambers were drained (anterior first) and re-filled with complete EMEM without phenol red maintained at approximately 32°C (posterior first).
Selection: Basal opacity of corneas was determined by means of a calibrated meter, measuring difference in light transmission between the corneas placed into the beam paths versus air (Opacitometer). During measurement, attention was paid to keep corneas away from the bath for the minimal time needed.
Corneas with a basal value ≥ 7 arbitrary units are excluded from testing.
The mean opacity of the remaining corneas was determined. Corneas were distributed in treatment groups starting from those nearest to the mean value for the negative control group and trying to approximately maintain opacity values similar to the mean of the negative control group in the treatment and positive control groups.
Test system
- Vehicle:
- physiological saline
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Concentration (if solution): 20 % (w/v) being the test item a solid non surfactant
VEHICLE
- Concentration (if solution): 0.9%% NaCl (Physiological saline)
- batch no. (if required): 10I0208 - Duration of treatment / exposure:
- 4h +/- 10 min
- Observation period (in vivo):
- There was no post-exposure period.
- Number of animals or in vitro replicates:
- 9 corneas
- Details on study design:
- CONTROL ITEMS
Positive control item: 20% (w/v) Imidazole (Sigma Cat. no.: 56749; CAS: 288-32-4, batch no.: 0001422794) solution in physiological saline (Bieffe Medital, batch no. 10I0208), being the test item a solid. A certificate of analysis is presented in Addendum II.
Negative control item: Physiological saline (0.9% NaCl; BieffeMedital batch no. 10I0208) as a control of the test system.
Positive and negative control items were obtained commercially and characterised by their labelling. Determination of the stability and concentration of solutions of the positive control was not undertaken since it is sufficient to provide evidence for the correct expected response of the test system to it.
ANALYSIS OF DATA
For each test point, the mean value of opacity obtained after exposure was calculated. As appropriate, negative control was subtracted from the opacity of the test item or positive control.
The mean value of permeability, expressed as optical density units, was also calculated and corrected against the mean control value.
The in vitro irritancy score (IVIS) of the test item was calculated from these values in the following manner:
IVIS = mean opacity score + (15 x mean Permeability OD490 score)
Classification of the test item was performed according to the in vitro irritancy score:
Value Classification
> 55.1 Corrosive or severe irritant
In addition, the test item was evaluated also for the eye irritancy potential according to the criteria stated in the OECD Supplement to Test Guidelines nos. 437 and 438:
Value Classification
0-3 Non eye irritant
3.1-25 Mild eye irritant
25.1- 55 Moderate eye irritant
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: In vitro irritancy score (IVIS)
- Basis:
- mean
- Score:
- ca. 109.3
- Irritation parameter:
- other: OD490 (corneal permeability)
- Basis:
- mean
- Score:
- ca. 1.636
- Irritant / corrosive response data:
- According to OECD Guideline no. 437, the test item should be classified as corrosive or serverely irritant to eye.
Any other information on results incl. tables
PREPARATION OF CORNEAS
Once underwent the first examination, a total of 9 corneas were processed (out of 10 delivered) for a final selection of the 9 required corneas according to basal opacity.
The measured basal opacity values and assignment to treatment groups of the processed corneas are presented in Table 1.
Treatment Code |
Pre-test cornea number |
Basal opacity |
Mean group basal opacity |
N1 |
1 |
2 |
1.0 |
N2 |
2 |
1 |
|
N3 |
5 |
0 |
|
P1 |
3 |
1 |
1.0 |
P2 |
7 |
0 |
|
P3 |
10 |
2 |
|
C1 |
4 |
1 |
1.0 |
C2 |
6 |
1 |
|
C3 |
8 |
1 |
|
|
|
Mean: 1.0 ° |
|
OBSERVATIONS
Details of measurements carried out at the observations are reported in Table 2.
STUDY NO.: 93360
Treatment |
|
OPACITY |
MACROSCOPIC |
|
|
PERMEABILITY |
|||||||||
|
Basal Opacity |
Assay Opacity |
Value corrected (basal value) |
|
Value Corrected (negative control) |
|
|
|
OD490 |
Dilution factor |
Value Corrected (diluition factor) |
Value Corrected (negative control) |
|
||
N1 |
|
2 |
2 |
0 |
|
N/A |
|
No macroscopic changes |
|
|
0.013 |
1 |
0.013 |
N/A |
|
N2 |
|
1 |
2 |
1 |
|
N/A |
|
No macroscopic changes |
|
|
0.013 |
1 |
0.013 |
N/A |
|
N3 |
|
0 |
2 |
2 |
|
N/A |
|
No macroscopic changes |
|
|
0.016 |
1 |
0.016 |
N/A |
|
|
Mean |
|
|
1.0 |
|
|
|
|
|
Mean |
|
|
0.0140 |
|
|
|
SD |
|
|
1.0 |
|
|
|
|
|
SD |
|
|
N/A |
|
|
|
CV % |
|
|
100.0 |
|
|
|
|
|
CV % |
|
|
N/A |
|
|
IVIS: |
1.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
P1 |
|
1 |
47 |
46 |
|
45 |
|
Opacity |
|
|
1.148 |
1 |
1.148 |
1.134 |
|
P2 |
|
0 |
45 |
45 |
|
44 |
|
Opacity |
|
|
1.208 |
2 |
2.416 |
2.402 |
|
P3 |
|
2 |
35 |
33 |
|
32 |
|
Opacity |
|
|
1.387 |
1 |
1.387 |
1.373 |
|
|
Mean |
|
|
|
|
40.3 |
|
|
|
Mean |
|
|
|
1.636 |
|
|
SD |
|
|
|
|
7.2 |
|
|
|
SD |
|
|
|
0.674 |
|
|
CV % |
|
|
|
|
17.9 |
|
|
|
CV % |
|
|
|
41.18 |
|
IVIS: |
64.8 |
|
|
|
|
|
|
|
|
|
|
|
|
||
C1 |
|
1 |
116 |
115 |
|
114 |
|
Opacity |
|
|
0.003 |
1 |
0.000 |
-0.014 |
* |
C2 |
|
1 |
93 |
92 |
|
91 |
|
Opacity |
|
|
0.008 |
1 |
0.000 |
-0.014 |
* |
C3 |
|
1 |
125 |
124 |
|
123 |
|
Opacity |
|
|
0.010 |
1 |
0.000 |
-0.014 |
* |
|
Mean |
|
|
|
|
109.3 |
|
|
|
Mean |
|
|
|
0.000 |
|
|
SD |
|
|
|
|
16.5 |
|
|
|
SD |
|
|
|
N/A |
|
|
CV % |
|
|
|
|
15.1 |
|
|
|
CV % |
|
|
|
N/A |
|
IVIS: |
109.3 |
|
|
|
|
|
|
|
|
|
|
|
|
||
N/A:not applicable |
|
*assumed to be 0 for calculation |
|
|
|
|
|
|
|
|
|
The negative control treatments did not induce corrosion as the mean opacity and permeability values were homogeneous and in line with the expected values for this kind of control.
The test item induced opacity of the whole cornea surface, with a mean increase of the opacity value equal to 109.3. This was confirmed at the macroscopic observation in which the three corneas showed visible opacity.
With reference to the cornea permeability, this was not affected when compared to that of negative control.
The positive control induced opacity of the whole cornea surface with a mean increase of the opacity value equal to 40.3. Opacity was noted in the three replicates at the end of the 4-hour post-incubation period.
The corneal permeability was also increased. The calculated mean permeability OD490 value was 1.636.
IVIS CALCULATION
The IVIS was calculated as follows:
IVIStest item = 109.3
IVISpositive control = 64.8
The test is therefore considered as valid.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The potential of the test item, Magnesium Hexafluorosilicate hexahydrated (MgSiF6), to be severely irritant or corrosive to the eye, was measured by its ability to induce opacity and increase permeability in isolated bovine corneas.
Alterations of cornea opacity were recorded during the study when compared to those of negative control. No significant alterations of cornea permeability were noted. The negative and positive controls gave the expected results. The test is therefore considered as valid.
According to the OECD Guideline no. 437, the test item should be classified as corrosive or severely irritant to the eye. - Executive summary:
The potential of the test item, Magnesium Hexafluorosilicate Hexahydrated (MgSiF6·6H2O), to cause corrosion/severe irritation by using the Bovine Corneal Opacity and Permeability (BCOP) assay, was examined in agreement with OECD Guideline no. 437 (adopted on) and OECD Supplement to Test Guidelines nos. 437 and 438.
The test item was tested suspended at 20% (w/v) in physiological saline (being a solid non surfactant) on the epithelial surface of three idoneous bovine corneas, for an exposure period of 4 hours.
Positive and negative controls [a 20% (w/v) Imidazole solution in physiological saline and physiological saline alone, respectively] were concurrently tested in similar conditions.
The mean opacity detected with an opacitometer at the end of the test item exposure period was 109.3. After the determination of opacity, the epithelial surface was treated with a 0.5% solution of sodium fluorescein in DPBS for 90 minutes, to investigate alteration in cornea permeability. Mean OD490value of the corneas treated with the test item was unaffected by treatment, as well as the negative control. Negative and positive controls gave the expected results.
The results obtained indicate that the test item induced changes in cornea opacity, but not in permeability under the reported experimental conditions. The calculated in vitro irritancy score (IVIS) for the test item is 109.3.
According to the OECD Guideline no. 437, the test item should be classified as corrosive or severely irritant to the eye.
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