Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 May 2018 - 17 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- 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
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- This study was performed in order to evaluate the skin corrosion potential of Zinc molybdate to human skin in an in vitro study. The principle of the human skin model assay is based on the hypothesis that corrosive chemicals are able to penetrate the stratum corneum by diffusion or erosion and are cyto-toxic to the underlying cell layers and its use is recommended by the relevant OECD guideline for corrosion testing (OECD No. 431).
- Vehicle:
- water
- Remarks:
- Demineralised water
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDermTM
- Tissue batch number(s): 28610
- Production date: MatTek In Vitro Life Science Laboratories, Brati-slava
- Delivery date: 15 May 2018
- Date of initiation of testing: 15 May 2018
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 ± 1°C (and 5.0 ± 0.5% CO2)
- Temperature of post-treatment incubation: 37 ± 1°C (and 5.0 ± 0.5% CO2)
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: DPBS, once
- Observable damage in the tissue due to washing: No.
- Modifications to validated SOP: No.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 300 μL (1 mg/mL in DPBS)
- Pre-incubation time: 1h
- Incubation time: Treatment: 3 minutes, 1 hour.
- MTT incubation time: 3h
- Spectrophotometer: Microtiter plate photometer
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
The values for negative control and for positive control were within the range of historical data of the test facility.
NUMBER OF REPLICATE TISSUES: 2
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE : No interference was detected.
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50%, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%.
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%. - Control samples:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
Tissue 1: 25.1 mg (3 min); 27.1 mg (1h)
Tissue 2: 25.7 mg (3 min); 27.2 mg (1h)
- Concentration (if solution): 25 μL demineralised water.
VEHICLE
- Amount(s) applied (volume or weight with unit): 50 μL
- Lot/batch no. (if required): Batch no: 20180221
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 μL
- Concentration (if solution): Solution in demineralised water (8 M) - Duration of treatment / exposure:
- 3 minutes and 1 hour.
- Duration of post-treatment incubation (if applicable):
- 3 hours
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min
- Value:
- 102.2
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: mean value of 2 tissues
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 hour
- Value:
- 98.2
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: mean value of 2 tissues
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: No.
- Direct-MTT reduction: No.
- Colour interference with MTT: No.
DEMONSTRATION OF TECHNICAL PROFICIENCY: Yes.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes. The criterion for optical density of the negative control (≥ 0.8 and ≤ 2.8) was fulfilled: optical density was 1.7 (3 minutes) and 1.6 (1 hour).
- Acceptance criteria met for positive control: Yes . The positive control showed clear corrosive effects. The mean value of relative tissue viability was 6.7% (1 h).
- Acceptance criteria met for variability between replicate measurements: Yes. The RSD were 0.9% (3 min treatment) and 0.0% (1h treatment), being <30%.
- Range of historical values:
Optical density negative control - 3 min: 1.197 - 3.077
Optical density negative control - 1 h: 1.377 - 2.571
% Tissue variability positive control 3 min: 9.6 - 57.3%
% Tissue variability positive control 1h: 4.1 - 24.2%
Any other information on results incl. tables
Absorbance values (OD 570 nm):
Incubation |
Negative Control |
Test Item |
Positive Control |
|||
|
Tissue 1 |
Tissue 2 |
Tissue 1 |
Tissue 2 |
Tissue 1 |
Tissue 2 |
3 min |
1.694 |
1.691 |
1.726 |
1.707 |
0.427 |
0.407 |
1.686 |
1.695 |
1.741 |
1.720 |
0.430 |
0.409 |
|
1.688 |
1.678 |
1.740 |
1.713 |
0.433 |
0.411 |
|
1 h |
1.723 |
1.643 |
1.652 |
1.647 |
0.141 |
0.154 |
1.707 |
1.661 |
1.658 |
1.665 |
0.141 |
0.156 |
|
1.744 |
1.644 |
1.660 |
1.661 |
0.145 |
0.155 |
Mean absorbance values - 3 minutes:
Designation |
Negative Control |
Test Item |
Positive Control |
Mean – blank (tissue 1) |
1.651 |
1.697 |
0.391 |
Mean – blank (tissue 2) |
1.649 |
1.675 |
0.370 |
Mean |
1.650 |
1.686 |
0.381 |
RSD |
0.1% |
0.9% |
3.9% |
Mean absorbance values - 1 hour:
Designation |
Negative Control |
Test Item |
Positive Control |
Mean – blank (tissue 1) |
1.686 |
1.618 |
0.104 |
Mean – blank (tissue 2) |
1.611 |
1.619 |
0.116 |
Mean |
1.648 |
1.619 |
0.110 |
RSD |
3.2% |
0.0% |
8.1% |
Tissue viability:
Test Item |
Positive Control |
Incubation |
102.2% |
23.1% |
3 min |
98.2% |
6.7% |
1 h |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- After 3 minutes and 1 hour treatment, the mean values of relative tissue viability of the test item were increased to 102.2% and 98.2%, respectively. These values value are well above the threshold for corrosivity (50%) and therefore, the test item is considered as non-corrosive to skin.
- Executive summary:
An in-vitro skin corrosion test was performed according to the OECD Guideline 431 (GLP study). Two tissues of the human skin model EpiDermTM were treated with the test item for 3 minutes and 1 hour, respectively. The test item was applied to each tissue and spread to match the tissue size. Demineralised water was used as negative control and 8 M KOH was used as positive control. After treatment, the respective substance was rinsed from the tissues. Then, cell viability of the tissues was evaluated by addition of MTT, which can be reduced to a blue formazan. Formazan production was evaluated by measuring the optical density (OD) of the resulting solution. The criterion for optical density of the negative control (≥ 0.8 and ≤ 2.8) was fulfilled: optical density was 1.7 (3 minutes) and 1.6 (1 hour). The positive control showed clear corrosive effects. The criterion for the viability of the 1 hour experiment, expressed as % of the negative control (< 15%), was fulfilled, too. The mean value of relative tissue viability was 6.7%. The values for negative control and for positive control were within the range of historical data of the test facility. The mean value of relative tissue viability of the test item was increased to 102.2% after 3 minutes treatment. This value is above the threshold for corrosivity (50%). After 1 hour treat-ment, the mean value of relative tissue viability of the test item was reduced to 98.2%, lying above the threshold for corrosivity (15%). Therefore, the test item is considered as non-corrosive to skin.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.