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EC number: 237-997-9 | CAS number: 14154-09-7
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-10-23 to 2012-10-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- 2004-04-13
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method 40 bis: In vitro skin corrosion: human skin model test
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 2012-11-30
Test material
- Reference substance name:
- Trimanganese bis(orthophosphate)
- EC Number:
- 237-997-9
- EC Name:
- Trimanganese bis(orthophosphate)
- Cas Number:
- 14154-09-7
- Molecular formula:
- Mn3O8P2
- IUPAC Name:
- trimanganese bis(orthophosphate)
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): trimanganese bis(orthophosphate)
- Physical state: pink cristalline solid
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage conditions: room temperature in the dark
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: human-derived epidermal keratinocytes
- Cell source:
- other: not specified
- Source strain:
- not specified
- Details on animal used as source of test system:
- not applicable
- Justification for test system used:
- Validation studies have shown that tests employing human skin models are able to discriminate between known skin corrosives and non-corrosives.
- Vehicle:
- other: 0.9% w/v sodium chloride solution
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiSkin TM tissues (purchased from SkinEthic Laboratories, Lyon, France)
- Batch No.: 13-EKIN-039
- Delivery date: 2012-10-23
- Date of initiation of testing: 2012-10-24 (following overnight pre-incubation)
TEMPERATURE USED FOR TEST SYSTEM
- Temperature of pre-incubation: approx. 37 °C (incubated overnight)
- Temperature used during treatment / exposure: approx. 37 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
At the end of the exposure period the tissues were removed from the the plate and rinsed with DPBS with Ca++ and Mg++. Rinsing was achieved by filling and emptying each tissue insert for approximately 40 seconds.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.3 mg/mL MTT solution (2.0 mL/well)
- Incubation time: 3 hours
At the end of the 3-hour incubation period each tissue was placed onto absorbent paper to dry. A total biopsy of the epidermis was taken uand the epidermis was separated from the collagen matrix. Both parts (epidermis and collagen matrix) were placed into micro tubes containing acidified isopropanol. Each tube was plugged, mixed thoroughly and stored overnight at room temperature, protected from light, to extract formazan crystals out of the MTT-loaded tissues.
At the end of the formazan extraction period each tube was mixed to produce a homogenous coloured solution. For each tissue, duplicate 200 μL samples were transferred to the appropriate wells of a pre-labelled 96-well plate. 200 μL of acidified isopropanol alone was added to the two wells designated as ‘blanks’. The optical density was measured (quantitative viability analysis) at 540 nm (without a reference filter) using a microplate reader.
TEST FOR DIRECT MTT REDUCTION
The test item should be evaluated for their potential to interfere with MTT assay. 20 mg of the test item was added to 2.2 mL of a 0.3 mg/mL MTT solution freshly prepared in assay medium. The solution was incubated in the dark at room temperature for 3 hours. Untreated MTT solution was used as a control. If the MTT solution containing the test item turns blue relative to the control, the test item was presumed to have reduced the MTT.
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Barrier function: tissues pass analysis for tissue functionality
- Contamination: absence of bacteria, fungus and mycoplasma as well as absence of HIV1 antibodies, HIV2 antibodies, Hepatitis B antigen, Hepatitis C antibodies
Please also refer to the field "Attached background material" below.
QUANTITATIVE MTT ASSESSMENT
The corrosivity potential of the test item was predicted from the relative mean tissue viabilities obtained after the 3, 60 and 240-Minute exposure periods, compared to the mean of the negative control tissues (n=2) treated with 0.9% w/v sodium chloride solution.
The remative mean viabilities were calculated in the following way: relative mean viability (%) = (mean OD540 of test item / mean OD540 of negative control) x 100
PREDICTION MODEL / DECISION CRITERIA
Classification of corrosivity potential was based on relative viabilities for each exposure time according to the prediction model as shown in the field "Any other information on materials and methods incl. tables" below (Table 1). - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 20 mg of the solid test item
VEHICLE
- Amount(s) applied: 100 μl of 0.9% w/v sodium chloride solution
NEGATIVE CONTROL
- Amount(s) applied: 50 µL of 0.9% w/v sodium chloride solution
POSITIVE CONTROL
- Amount(s) applied: 50 µL of glacial acetic acid - Duration of treatment / exposure:
- 3, 60 and 240 minutes
- Duration of post-treatment incubation (if applicable):
- not applicable
- Number of replicates:
- Test item: duplicate
Negative control: duplicate
Positive control: duplicate
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- (mean)
- Run / experiment:
- 3 minute exposure
- Value:
- 115.8
- Vehicle controls validity:
- not examined
- Negative controls validity:
- not examined
- Positive controls validity:
- not examined
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- (mean)
- Run / experiment:
- 60 minute exposure
- Value:
- 102.1
- Vehicle controls validity:
- not examined
- Negative controls validity:
- not examined
- Positive controls validity:
- not examined
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- (mean)
- Run / experiment:
- 240 minute exposure
- Value:
- 102.1
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS
- Direct MTT reduction: the MTT solution containing the test item did not turn blue. This was taken to indicate the test item did not reduce MTT.
ACCEPTANCE OF RESULTS
- Acceptance criteria met for positive control: the relative mean tissue viability for the positive control treated tissues was 2.5% relative to the negative control treated tissues following the 240-Minute exposure period (acceptibility criteria: relative mean tissue viability for the positive control should be 0 to 20 % relative to the negative control following 240 minute exposure).
- Acceptance criteria met for negative control: the mean OD540 for the negative control treated tissues was 0.812 (acceptability criteria: ≥ 0.600 and ≤ 1.500).
Any other information on results incl. tables
Table 3: Results after treatment with trimanganese bis(orthophosphate) and the controls
Dose Group |
Exposure Interval |
Mean OD540 of individual tissue 1 |
Mean OD540 of individual tissue 2 |
Mean Absorbance (OD540) of duplicate tissues |
Rel. mean viability (%) |
Test Item |
3 minutes |
0.955 |
0.925 |
0.940 |
115.8 |
Test Item |
60 minutes |
0.800 |
0.858 |
0.829 |
102.1 |
Negative Control |
240 minutes |
0.767 |
0.856 |
0.812 |
100* |
Positive Control |
0.015 |
0.025 |
0.020 |
2.5 |
|
Test Item |
0.846 |
0.811 |
0.829 |
102.1 |
* The mean viability of the negative control tissues is set at 100%.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is not corrosive to the skin.
According to the Regulation (EC) No 1272/2008 and subsequent regulations, the test item is not corrosive to the skin.
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