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EC number: 237-377-8 | CAS number: 13767-32-3
- 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:
- 08 May 2018 - 21 May 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- 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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Molybdenum zinc tetraoxide
- EC Number:
- 237-377-8
- EC Name:
- Molybdenum zinc tetraoxide
- Cas Number:
- 13767-32-3
- Molecular formula:
- MoO4Zn
- IUPAC Name:
- molybdenum(6+) zinc(2+) tetraoxidandiide
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Strain:
- other: Bos primigenius Taurus
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Müller Fleisch GmbH slaughterhouse. Enzstr. 2-4, 75217 Birkenfeld, Germany
- Characteristics of donor animals (e.g. age, sex, weight): The cattle were between 12 and 60 months old.
- Storage, temperature and transport conditions of ocular tissue: The eyes were transported to the test facility in Hanks’ Balanced Salt Solu-tion with 1% Penicillin-Streptomycin solution (Penicillin 100 U/mL, Streptomycin 100 μg/mL) in a suitable cooled container within 1 hour 20 minutes (exp. 1b) or 1 hour 5 minutes (exp. 1c).
- Time interval prior to initiating testing: Fresh bovine eyes were obtained on the day of the test
- indication of any existing defects or lesions in ocular tissue samples: No.
- Indication of any antibiotics used: No.
Test system
- Vehicle:
- Hank's balanced salt solution
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 μL
- Concentration (if solution): 20% concentration in HBSS. - Duration of treatment / exposure:
- 4 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
After the arrival of the corneas, they were examined and only corneas which were free from damages were used. The corneas were excised with a scalpel and cut from the globe with a 2-3 mm ring of sclera around the outside. Each cornea was transferred to a cornea holder in which pre-warmed cMEM (32 ± 1 °C) without phenol red was filled. The holders were then incubated for 1 hour in the incubation chamber at 32 ± 1 °C.
QUALITY CHECK OF THE ISOLATED CORNEAS
After the initial incubation, the medium was changed and the baseline opacity for each cornea was recorded. None of the corneas showed tissue damage; therefore, all corneas were used.
NUMBER OF REPLICATES : 3
SOLVENT CONTROL USED: Yes:
HBSS: Hank’s Balanced Salt Solution (HBSS) 10-fold concentrated, diluted in de-min. water (1:10), batch no.: 20180515 (exp. 1b) and 20180524 (exp. 1c)
POSITIVE CONTROL USED : Yes:
Imidazole solution: 20% C3H4N2 (CAS-No. 288-32-4), dissolved in HBSS, batch no.: 20180515 (exp. 1b) and 20180524 (exp. 1c)
APPLICATION DOSE AND EXPOSURE TIME :
TREATMENT METHOD: open chamber
The test item was given directly on the epithelium in such a manner that as much as possible of the cornea was covered with test item. Exposure time on the corneas was 4 hours at 32 ± 1 °C. After thorough rinsing with cMEM with phenol red and final rinsing with cMEM without phenol red, both chambers were filled with cMEM without phenol red, and the final opacity value of each cornea was recorded.
After the recording of the final opacity value, the cMEM without phenol red was removed from the front chamber, and 1 mL sodium fluorescein solution was added to the front chamber for the detection of permeability of the corneas. For the open chamber method, a sodium fluorescein solution with a concentration of 5 mg/mL was used. The chambers were then closed again and incubated for 90 minutes at 32 ± 1 °C. After incubation, the content of the posterior chamber was thoroughly mixed. Then, its optical density at 492 nm was measured with the microtiter plate photometer.
POST-INCUBATION PERIOD: No.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of microtiter plate reader (OD490).
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
IVIS = (opacity difference – mean opacity difference of the negative control) + [15 x (OD492 – mean OD492 of the negative control)]
DECISION CRITERIA:The decision criteria as indicated in the TG was used.
≤ 3 - No category
> 3 and ≤ 55 - No prediction can be made
> 55 - Eye damage Category 1
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 1a
- Negative controls validity:
- not valid
- Remarks on result:
- not determinable
- Remarks:
- Study invalid: opacity values of the negative control were too high
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 1b
- Value:
- 3.35
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 1c
- Value:
- 10.02
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: No.
DEMONSTRATION OF TECHNICAL PROFICIENCY: Annually, proficiency chemicals are tested in order to ensure the accuracy and reliability of the test method over time.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes. The mean IVIS of the negative control has to show an IVIS ≤ 3 (1.68 (exp. 1b) and 2.36 (exp. 1c)).
- Acceptance criteria met for positive control: Yes. IVIS of positive control 20% imidazole solution falled within two standard deviations of the current historical mean, i.e. between 69.37 – 157.73 (98.54 (exp. 1b) and 123.48 (exp. 1c)).
- Range of historical values if different from the ones specified in the test guideline:
Range of IVIS (validity) - Negative control HBSS: ≤ 3
Range of IVIS (validity) - Positive control 20% imidazole solution: 69.37 – 157.73
Range of opacity - Negative control HBSS: -1.86 – 4.08
Range of opacity - Positive control 20% imidazole solution: 41.72 – 133.11
Range of Permeability - Negative control HBSS: -0.02 – 0.10
Range of Permeability - Positive control 20% imidazole solution: 0.75 – 5.89
Any other information on results incl. tables
The first experiment was aborted during the second opacity measurement, because the opacity values of the negative control were too high. Therefore the experiment was declared invalid and repeated. The second experiment (experiment 1b) was valid, but the test item result was equivocal, because 2 of the 3 replicates gave discordant prediction from the mean. This is why a fur-ther run was performed (experiment 1c). As the result of experiment 1c corroborated the prediction of the experiment 1b (based upon the mean IVIS value), a final decision could be achieved without further testing.
Opacity and Permeability Values of Experiment 1b:
Illuminance values:
Parameter |
Negative Control |
Test Item |
Positive Control |
||||||
1. Rep. |
2. Rep. |
3. Rep. |
1. Rep. |
2. Rep. |
3. Rep. |
1. Rep. |
2. Rep. |
3. Rep. |
|
(I) Measured values before exposure |
1008 |
997 |
996 |
1015 |
1018 |
1013 |
1017 |
1015 |
1051 |
(I) Measured values after exposure |
958 |
975 |
974 |
953 |
853 |
927 |
326 |
356 |
421 |
Opacity values negative control:
Parameter |
Negative Control |
||
1. Rep. |
2. Rep. |
3. Rep. |
|
Opacity before exposure |
3.10 |
3.56 |
3.61 |
Opacity after exposure |
5.31 |
4.53 |
4.58 |
Opacity Difference |
2.22 |
0.97 |
0.97 |
Mean Opacity Difference |
1.39 |
Opacity values test item and positive control:
Parameter |
Test Item |
Positive Control |
||||
1. Rep. |
2. Rep. |
3. Rep. |
1. Rep. |
2. Rep. |
3. Rep. |
|
Opacity before exposure |
2.80 |
8.68 |
2.89 |
2.72 |
2.80 |
1.36 |
Opacity after exposure |
5.55 |
10.82 |
6.81 |
92.04 |
80.96 |
62.37 |
Opacity Difference |
2.75 |
8.14 |
3.92 |
89.32 |
78.16 |
61.02 |
Opacity Differencecorrected |
1.36 |
6.76 |
2.54 |
87.93 |
76.77 |
59.63 |
Mean Opacity Diff. corr. |
3.55 |
74.78 |
Optical density at 492 nm of Blank
Parameter |
cMEM without phenol red |
1. Measurement |
0.044 |
2. Measurement |
0.044 |
3. Measurement |
0.047 |
Mean |
0.045 |
Optical density at 492 nm of negative control, test item and positive control:
Parameter |
Negative Control |
Test Item |
Positive Control |
||||||
1. Rep. |
2. Rep. |
3. Rep. |
1. Rep. |
2. Rep. |
3. Rep. |
1. Rep. |
2. Rep. |
3. Rep. |
|
1. Measurement |
0.091 |
0.048 |
0.054 |
0.071 |
0.049 |
0.034 |
1.469 |
1.434 |
2.065 |
2. Measurement |
0.092 |
0.047 |
0.055 |
0.071 |
0.050 |
0.032 |
1.471 |
1.433 |
2.033 |
3. Measurement |
0.090 |
0.049 |
0.057 |
0.073 |
0.051 |
0.033 |
1.476 |
1.429 |
2.034 |
|
|||||||||
1. Measurement – blank |
0.0460 |
0.0030 |
0.0090 |
0.0260 |
0.0040 |
-0.0110 |
1.4240 |
1.3890 |
2.0200 |
2. Measurement – blank |
0.0470 |
0.0020 |
0.0100 |
0.0260 |
0.0050 |
-0.0130 |
1.4260 |
1.3880 |
1.9880 |
3. Measurement – blank |
0.0450 |
0.0040 |
0.0120 |
0.0280 |
0.0060 |
-0.0120 |
1.4310 |
1.3840 |
1.9890 |
Mean of each replicate |
0.0460 |
0.0030 |
0.0103 |
0.0267 |
0.0050 |
-0.0120 |
1.4270 |
1.3870 |
1.9990 |
Mean of the 3 replicates |
0.0198 |
-- |
-- |
||||||
Corrected |
-- |
-- |
-- |
0.0069 |
-0.0148 |
-0.0318 |
1.4072 |
1.3672 |
1.9792 |
Corrected mean of the 3 replicates |
-- |
-0.0132 |
1.5846 |
IVIS:
Test Group |
IVIS |
Mean IVIS |
Relative Standard Deviation IVIS |
Negative Control HBSS |
2.91 |
1.68 |
63.12% |
1.01 |
|||
1.13 |
|||
Test Item |
1.46 |
3.35 |
82.66% |
6.53 |
|||
2.06 |
|||
Positive Control solution |
109.04 |
98.54 |
10.07% |
97.28 |
|||
89.32 |
Opacity and Permeability Values of Experiment 1c:
Illuminance values:
Parameter |
Negative Control |
Test Item |
Positive Control |
||||||
1. Rep. |
2. Rep. |
3. Rep. |
1. Rep. |
2. Rep. |
3. Rep. |
1. Rep. |
2. Rep. |
3. Rep. |
|
(I) Measured values before exposure |
993 |
995 |
1024 |
996 |
1015 |
994 |
986 |
991 |
986 |
(I) Measured values after exposure |
919 |
972 |
997 |
732 |
823 |
815 |
308 |
319 |
302 |
Opacity values negative control:
Parameter |
Negative Control |
||
1. Rep. |
2. Rep. |
3. Rep. |
|
Opacity before exposure |
3.74 |
3.65 |
2.43 |
Opacity after exposure |
7.21 |
4.67 |
3.56 |
Opacity Difference |
3.48 |
1.02 |
1.13 |
Mean Opacity Difference |
1.88 |
Opacity values test item and positive control:
Parameter |
Test Item |
Positive Control |
||||
1. Rep. |
2. Rep. |
3. Rep. |
1. Rep. |
2. Rep. |
3. Rep. |
|
Opacity before exposure |
3.61 |
2.80 |
3.69 |
4.04 |
3.83 |
4.04 |
Opacity after exposure |
19.13 |
12.65 |
13.16 |
99.72 |
94.92 |
102.48 |
Opacity Difference |
15.52 |
9.85 |
9.47 |
95.67 |
91.10 |
98.44 |
Opacity Differencecorrected |
13.64 |
7.97 |
7.59 |
93.80 |
89.22 |
96.56 |
Mean Opacity Diff. corr. |
9.74 |
93.19 |
Optical density at 492 nm of Blank
Parameter |
cMEM without phenol red |
1. Measurement |
0.037 |
2. Measurement |
0.045 |
3. Measurement |
0.044 |
Mean |
0.042 |
Optical density at 492 nm of negative control, test item and positive control:
Parameter |
Negative Control |
Test Item |
Positive Control |
||||||
1. Rep. |
2. Rep. |
3. Rep. |
1. Rep. |
2. Rep. |
3. Rep. |
1. Rep. |
2. Rep. |
3. Rep. |
|
1. Measurement |
0.057 |
0.117 |
0.049 |
0.045 |
0.037 |
0.196 |
0.547 |
1.542 |
2.186 |
2. Measurement |
0.057 |
0.116 |
0.049 |
0.042 |
0.039 |
0.201 |
0.548 |
1.540 |
2.206 |
3. Measurement |
0.054 |
0.118 |
0.050 |
0.044 |
0.041 |
0.195 |
0.539 |
1.525 |
2.171 |
|
|||||||||
1. Measurement – blank |
0.0150 |
0.0750 |
0.0070 |
0.0030 |
-0.0050 |
0.1540 |
0.5050 |
1.5000 |
2.1440 |
2. Measurement – blank |
0.0150 |
0.0740 |
0.0070 |
0.0000 |
-0.0030 |
0.1590 |
0.5060 |
1.4980 |
2.1640 |
3. Measurement – blank |
0.0120 |
0.0760 |
0.0080 |
0.0020 |
-0.0010 |
0.1530 |
0.4970 |
1.4830 |
2.1290 |
Mean of each replicate |
0.0140 |
0.0750 |
0.0073 |
0.0017 |
-0.0030 |
0.1553 |
0.5027 |
1.4937 |
2.1457 |
Mean of the3 replicates |
0.0321 |
-- |
-- |
||||||
Corrected |
-- |
-- |
-- |
-0.0304 |
-0.0351 |
0.1232 |
2.4812* |
1.4616 |
2.1136 |
Corrected mean of the 3 replicates |
-- |
0.0192 |
2.0188 |
IVIS:
Test Group |
IVIS |
Mean IVIS |
Relative Standard Deviation IVIS |
Negative Control HBSS |
3.69 |
2.36 |
52.38% |
2.14 |
|||
1.24 |
|||
Test Item |
13.19 |
10.02 |
29.06% |
7.45 |
|||
9.44 |
|||
Positive Control solution |
131.02 |
123.48 |
8.72% |
111.14 |
|||
128.27 |
Applicant's summary and conclusion
- Interpretation of results:
- other:
- Conclusions:
- The calculated IVIS was 3.35 in experiment 1b and 10.02 in experiment 1c. Being >3 and ≤ 55, the substance is not classified as Eye damage Category 1 but no further predictions can be made.
- Executive summary:
An ex-vivo eye damage test was performed according to the OECD Guideline 437 (GLP study). Three experiments were performed. The first experiment was aborted during the second opacity measurement, because the opacity values of the negative control were too high. Therefore the experiment was declared invalid and repeated. The second experiment (experiment 1b) was valid, but the test item result was equivocal, because 2 of the 3 replicates gave discordant prediction from the mean. This is why a further run was performed (experiment 1c). The result of experiment 1c corroborated the prediction of the experiment 1b (based upon the mean IVIS value), and a a final decision could be achieved. In all experiments bovine corneas were used. They were collected from slaughtered cattle that were between 12 and 60 months old. The test item was brought onto the cornea of a bovine eye which had been previously incubated with cMEM without phenol red at 32 ± 1 °C for 1 hour and whose opacity had been measured. The test item was incubated on the cornea for 4 hours at 32 ± 1 °C. After removal of the test item, opacity and permeability values were measured. Hank’s Balanced Salt Solution (HBSS) was used as negative control. The negative control showed no irritating effect on the cornea and the calculated IVIS (In Vitro Irritancy Score) was 1.68 in experiment 1b and 2.36 in experiment 1c. 20% imidazole solution was used as positive control. The positive control induced serious eye damage on the cornea and was within two standard deviations of the current historical mean. The calculated IVIS was 98.54 in experiment 1b and 123.48 in experiment 1c. Under the conditions of this study, the test item showed effects on the cornea of the bovine eye in both valid experiments. The calculated IVIS was 3.35 in experiment 1b and 10.02 in experiment 1c. The calculated IVIS was 3.35 in experiment 1b and 10.02 in experiment 1c. Being >3 and ≤ 55, the substance is not classified as Eye damage Category 1 but no further predictions can be made.
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