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EC number: 937-913-7 | CAS number: -
- 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 irritation / corrosion, other
- Remarks:
- other: validated "in vitro" test method
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-02-07 to 2012-02-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study reliable without restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: EpiSkin™ corrosivity assay (Invittox 118)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD 431
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: EU test method B.40 bis
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of tri-µ-(2-ethylhexanoato-O)-bis(N,N',N''-trimethyl-1,4,7-triazacyclononane-N,N',N'')dimanganese and µ-(acetato-O)-di-µ-(2-ethylhexanoato-O)-bis(N,N',N''-trimethyl-1,4,7-triazacyclononane-N,N',N'')dimanganese
- EC Number:
- 700-806-9
- Molecular formula:
- C42H87Mn2N6O6 and C36H75Mn2N6O6
- IUPAC Name:
- Reaction mass of tri-µ-(2-ethylhexanoato-O)-bis(N,N',N''-trimethyl-1,4,7-triazacyclononane-N,N',N'')dimanganese and µ-(acetato-O)-di-µ-(2-ethylhexanoato-O)-bis(N,N',N''-trimethyl-1,4,7-triazacyclononane-N,N',N'')dimanganese
- Reference substance name:
- Reaction mass of tri- µ -(2-ethylhexanoato-O)-bis(N,N',N''-trimethyl-1,4,7-triazacyclononane-N,N',N'')dimanganese and µ -(acetato-O)-di- µ -(2-ethylhexanoato-O)-bis(N,N',N''-trimethyl-1,4,7-triazacyclononane-N,N',N'')dimanganese
- IUPAC Name:
- Reaction mass of tri- µ -(2-ethylhexanoato-O)-bis(N,N',N''-trimethyl-1,4,7-triazacyclononane-N,N',N'')dimanganese and µ -(acetato-O)-di- µ -(2-ethylhexanoato-O)-bis(N,N',N''-trimethyl-1,4,7-triazacyclononane-N,N',N'')dimanganese
- Details on test material:
- - Name of test material (as cited in study report): Manganese Octoate/Acetate - MeTACN complex
- Physical state: white solid
- Storage condition of test material: room temperature in the dark under nitrogen
- Lot/batch No.: 16D16603
Constituent 1
Constituent 2
Test animals
- Details on test animals or test system and environmental conditions:
- Not applicable - this is an in vitro study and no animals were used
Test system
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 20 mg of the solid test item was applied topically to the corresponding tissues ensuring uniform coverage of the tissues. 100 ul of 0.9% w/v sodium chloride solution was added for wetting of the test item. Duplicate tissues, treated with 50 ul of 0.9% wlv sodium chloride solution served as negative
controls. Duplicate tissues, treated with 50 ul of glacial acetic acid served as positive controls. - Duration of treatment / exposure:
- Duplicate tissues were treated with the test item for exposure periods of 3, 60 and 240 minutes.
Duplicate tissues were treated with the positive and negative control items for an exposure period of 240 minutes. - Observation period:
- not applicable
- Number of animals:
- not applicable
- Details on study design:
- Episkin™ model kit 0.38cm2 was supplied by Skinethic, Nice, France on 2012-02-07
EXPOSURE:
2.2 ml of assay medium, warmed to approximately 37°C, was pipetted into 2 wells of the second and third columns of the 12-well plate. The tissues were transferred into the second column.
Duplicate tissues were treated with the test item for exposure periods of 3, 60 and 240 minutes. Duplicate tissues were treated with the positive and negative control items for an exposure period of 240 minutes. 20 mg of the solid test item was applied topically to the corresponding tissues ensuring uniform coverage of the tissues. 100 ul of 0.9% w/v sodium chloride solution was added for wetting of the test item. Duplicate tissues, treated with 50 ul of 0.9% wlv sodium chloride solution served as negative controls. Duplicate tissues, treated with 50 ul of glacial acetic acid served as positive controls. The treated tissues were kept in a biological safety cabinet at room temperature for the appropriate exposure period.
REMOVAL OF TEST SUBSTANCE:
At the end of each exposure period, each tissue was removed from the well using forceps and rinsed using a wash bottle containing Phosphate Buffered Saline Dulbeccos (PBS) with Ca++ and Mg++. Rinsing was achieved by filling and emptying each tissue insert for approximately 40 seconds using a constant soft stream of PBS to gently remove any residual test item. Each rinsed tissue was placed into the third column of the 12—welI plate until all tissues were rinsed.
MTT ASSAY:
2.2 ml of a 0.3 mg/ml MTT solution, freshly prepared in assay medium, was pipetted into 2 wells of the fourth column of each 12 well plate. The tissues were transferred into the MTT filled wells. The tissues were incubated for 3 hours +/- 5 minutes at room temperature in a biological safety cabinet ensuring that the plates were protected from light. 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 using the Episkin™ biopsy punch. The epidermis was carefully separated from the collagen matrix using forceps and both parts (epidermis and collagen matrix) were placed into labelled 1.5 ml micro tubes containing 850 ul of acidified isopropanol. Each tube was plugged, mixed thoroughly and stored overnight at room temperature, protected from light, to extract formazan crystals out of the MITT—loaded tissues.
At the end of the formazan extraction period each tube was mixed thoroughly on a vortex mixer to produce a homogenous coloured solution. For each tissue, duplicate 200 ul samples were transferred to the appropriate wells of a pre-labelled 96-well plate. 200 ul 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 the Anthos 2001 microplate reader.
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 relative mean viabilities were calculated in the following way: Relative mean viability (%) = (mean ODM540 of test item)/(mean ODM540 of negative control) x 100
Classification of corrosivity potential was based on relative viabilities for each exposure time according to the following prediction model:
INTERPRETATION OF RESULTS:
The mean OD value obtained for the duplicate tissues per test item were used to calculate the percent viability relative to the negative control, which was arbitrarily set at 100%.
According to EU CLP Cat.1 and DSD (67/548/EEC):
The test item is considered to be corrosive to skin:
(1) if the viability after 3 minutes exposure is less than 50%, or
(2) 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 item is considered to be non-corrosive to skin:
(1) 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%.
ACCEPTABILITY OF THE ASSAY:
The absolute OD570 of the negative control tissues in the MTT-test is an indicator of tissue viability obtained in the testing laboratory after the shipping and storing procedure and under specific conditions of the assay. Tissue viability met the acceptance criterion if the mean OD570 of the two tissues in both treatment intervals was ≥ 0.8.
The assay met the acceptance criterion if mean relative tissue viability of the positive control was ≤ 30%.
No further information on the study design was stated.
SCORING SYSTEM:
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: relative viability (%)
- Basis:
- mean
- Time point:
- other: after 3 mins exposure
- Score:
- 85
- Irritation parameter:
- other: relative viability (%)
- Basis:
- mean
- Time point:
- other: after 60 mins exposure
- Score:
- 61.9
- Irritation parameter:
- other: relative viability (%)
- Basis:
- mean
- Time point:
- other: after 240 mins exposure
- Score:
- 80.4
- Irritant / corrosive response data:
- After exposure to the test item cobalt oxyhydroxide the relative absorbance values were unaltered at 106.9% after 3 minutes. After the 1 hour exposure relative absorbance values were reduced to 80.7%. Both values did not exceed the threshold for corrosivity of 50% for the 3 minutes exposure and 15% for the 1 hour exposure. Therefore, the test item was not considered to be corrosive.
Any other information on results incl. tables
Results
Item | Exposure Period | Mean OD540of duplicate tissues |
Relative mean viability (%) |
Negative Control Item | 240 Minutes | 0.260 | 100* |
Positive Control Item | 240 Minutes | 0.015 | 5.8 |
Test Item | 240 Minutes | 0.209 | 80.4 |
60 Minutes | 0.161 | 61.9 | |
3 Minutes | 0.221 | 85.0 | |
* The mean viability of the negative control tissues is set at 100% |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information not corrosive to the skin. Criteria used for interpretation of results: EU
- Conclusions:
- The test item was not corrosive to skin.
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