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Diss Factsheets
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EC number: 215-264-4 | CAS number: 1317-34-6
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009-10-28 to 2009-12-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- manganese oxide
- IUPAC Name:
- manganese oxide
- Reference substance name:
- 1344-43-0
- Cas Number:
- 1344-43-0
- IUPAC Name:
- 1344-43-0
- Reference substance name:
- Manganese oxide
- EC Number:
- 215-695-8
- EC Name:
- Manganese oxide
- IUPAC Name:
- 215-695-8
- Details on test material:
- - Name of test material: MnO
- Substance type: Green powder
- Physical state: Solid
- Impurities (identity and concentrations): MnO2 0.46%, Fe 56 ppm, Ins. ac. 15 %, H2O at 105 °C 0.01%
- Composition of test material, percentage of components: Mn 77.8%
- Purity test date: 24/09/08
- Lot/batch No.: 104833-06
- Storage condition of test material: Room temperature in the dark
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Limited, Hillcrest, Belton, Loughborough, UK
- Age at study initiation: 12 to 20 weeks old
- Weight at study initiation: 2.31 to 2.79 kg
- Housing: Individually housed in suspended cages.
- Diet: 2030 Teklad Global Rabbit diet (Harlan Teklad, Blackthorn, Bicester, Oxon, UK) available ad libitum.
- Water: Mains drinking water available ad libitum.
- Acclimation period: Minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23 °C
- Humidity (%): 30 to 70 %
- Air changes (per hr): A minimum of 15 changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hour cycle
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g (moistened sufficiently with 0.5 mL of distilled water to achieve a paste). - Duration of treatment / exposure:
- Animal were exposed for 4 hours.
- Observation period:
- Animals were observed for 72 hours for skin reactions.
- Number of animals:
- 3 animals in total (1 animal used in the initial test, with further 2 animals in the main test)
- Details on study design:
- TEST SITE
- Area of exposure: The test material was introduced a 2.5 cm x 2.5 cm cotton gauze patch
- Type of wrap if used: The trunk of each rabbit was wrapped in an elasticated corset.
REMOVAL OF TEST SUBSTANCE
- Washing: Any residual test material was removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4 hours post administration of test material.
SCORING SYSTEM: Draize J.H. (1959) “Dermal Toxicity” In: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. Associations of Food and Drug Officials of the United States, Austin, Texas p.46-59; see Table 1 in box 'Any other information on materials & methods incl. tables'.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No irritation was observed in any of the animals.
For individual results see Table 2 in box 'Any other information on results incl. tables'.
Any other information on results incl. tables
Table 2: Individual Skin Reactions
Skin Reaction |
Observation Time (Following Patch Removal) |
Individual Scores – Rabbit Number and Sex |
Total |
||
68627 Male |
68626 Male |
68662 Male |
|||
Erythema/Eschar Formation |
Immediately |
0 |
0 |
0 |
0 |
1 Hour |
0 |
0 |
0 |
0 |
|
24 Hours |
0 |
0 |
0 |
0 |
|
48 Hours |
0 |
0 |
0 |
0 |
|
72 Hours |
0 |
0* |
0* |
0 |
|
Oedema Formation |
Immediately |
0 |
0 |
0 |
0 |
1 Hour |
0 |
0 |
0 |
0 |
|
24 Hours |
0 |
0 |
0 |
0 |
|
48 Hours |
0 |
0 |
0 |
0 |
|
72 Hours |
0 |
0* |
0* |
0 |
* = measurement performed at approximately 68 hours post dosing.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the test, the test material was found to be a non-irritant to rabbit skin.
- Executive summary:
In a primary dermal irritation study according to guideline OECD 404, three young adult New Zealand White rabbits were dermally exposed to 0.5% manganese oxide (77% Mn content) in water for 4 hours to 2.5 x 2.5 cm of the body surface area. Animals then were observed for 72 hours. Irritation was scored by the method of Draize. No irritation was observed in any of the animals. In this study, manganese oxide is not a dermal irritant.
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.
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