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EC number: 215-202-6 | CAS number: 1313-13-9
- 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:
- 2009-10-13 to 2009-10-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
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:
- Manganese dioxide
- EC Number:
- 215-202-6
- EC Name:
- Manganese dioxide
- Cas Number:
- 1313-13-9
- Molecular formula:
- MnO2
- IUPAC Name:
- dioxomanganese
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material : MnO2
- Appearance: Black powder
- Physical state: Solid
- Storage condition of test material: Room temperature in the dark
Constituent 1
Test animals
- Species:
- other: Reconstituted Human Epidermal Model
- Strain:
- other: SkinEthic
- Details on test animals or test system and environmental conditions:
- - Supplier: SkinEthic Laboratories, Nice, France
- Date received : 13 October 2009
- Pre-incubation: Tissues were aseptically transferred into 6-well plates containing 1 mL maintenance medium at room temperature (Each tissue was inspected for any air bubble between the agarose gel and the tissue culture prior to transfer). The 6-well plated containing the tissues were placed into an incubator overnight at 37 °C, 5 % CO2 in air.
- Medium: Produced in serum-free SkinEthic maintenance medium
Test system
- Type of coverage:
- other: Topical treatment
- Preparation of test site:
- other: Tissues on polycarbonate inserts.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Positive and negative controls
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied : 20 mg
- Preparation of test material : Used as received
CONTROL
- Negative control: 40 µL of sterile distilled water
- Positive control : 40 µL of 8.0 N potassium hydroxide (used as supplied) - Duration of treatment / exposure:
- 3 or 60 minutes
- Observation period:
- 3 hours
- Number of animals:
- All tests were performed in duplicate
- Details on study design:
- TEST SITE
- Area of exposure: Tissue surface area
- Wetting : 20 µL of sterile distilled water was used for wetting the test material to ensure adequate contact with the tissue surface.
REMOVAL OF TEST SUBSTANCE
- Washing : At the end of each exposure period, each tissue was removed from the well of the treatment plate using forceps and rinsed using a wash bottle containing DPBS (Dulbecco's Phosphate Buffered Saline). Rinsing was achieved by filling and emptying each tissue insert with a constant soft stream of DPBS for approximately 40 seconds to gently remove any residual test material. Excess DPBS was removed by blotting the bottom of the tissue culture insert with absorbent paper.
- Time after start of exposure: 3 or 60 minutes.
SCORING SYSTEM: Corrosivity was determined by measuring the absorbency at 540 nm (OD 540) after treatment with MTT. The scoring system used is detailed in table 1.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean of two tissues. Time point: 3 minutes.
- Value:
- 95.7
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean of two tissues. Time point: 60 minutes.
- Value:
- 83
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- The OD540 for the 3 and 60 minute exposure of the SkinEthic model to MnO2 were 1.189 and 1.146, respectively.
The relative mean viability of cell cultures compared to negative control tissues were calculated as follows:
Relative mean viability (%) = ((mean OD540 of test material)/(mean OD540 of negative control)) x 100
The test material was found not to directly reduce MTT.
Any other information on results incl. tables
Table 2: Mean OD540 Values and Percentage Viabilities for the Negative Control Material, Positive Control Material and Test Material
Material |
Exposure Time |
Mean OD5401 |
Relative Mean Viability (%) |
Negative control |
3 Minute |
1.243 |
100* |
60 Minute |
1.381 |
100* |
|
Positive control |
3 Minute |
0.058 |
4.7 |
60 Minute |
0.048 |
3.5 |
|
Test Material |
3 Minute |
1.189 |
95.7 |
60 Minute |
1.146 |
83.0 |
|
1Mean of SkinEthic tissues tested in duplicate *Mean percentage viability of the negative control tissue is set at 100 %. |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified according to EU criteria.
- Conclusions:
- The test material was not corrosive in vitro using human skin.
- Executive summary:
The skin corrosion potential of the test material was investigated in vitro in a study which was conducted under GLP conditions and in accordance with the standardised guideline OECD 431.
Under the conditions of the study the test material was considered not to have the potential to be corrosive.
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