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Registration Dossier
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Diss Factsheets
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EC number: 910-356-7 | 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
Endpoint summary
Administrative data
Description of key information
No data are available for the registration substance. However adequate and reliable studies performed with each of the two constituents of the registration substance are at hand. No irritating effects on the skin of rabbits were found when testing manganese dioxide or copper (II) oxide. Both constituents produced very mild and reversible irritating effects when instilled into the rabbits eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- For details on endpoint specific justification please see read-across report in section 13 or find a link in cross-reference “assessment report”
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- assessment report
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this in vivo guideline study no skin irritation potential was found for the tested material MnO2.
- Executive summary:
The skin irritation potential of MnO2 was investigated in vivo in a study which was conducted under GLP conditions and in accordance with the standardised guidelines OECD 404 and EU Method B.4. During the study no signs of skin irritation were noted at any of the observation points. The test material was therefore concluded to be a non-irritant.
Results of the source compound were considered applicable to the target compound. Justification and applicability of the read-across approach (structural analogue) is outlined in the read-across report in section 13 or find a link in cross-reference “assessment report”.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- For details on endpoint specific justification please see read-across report in section 13 or find a link in cross-reference “assessment report”.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- for 3 animals
- Time point:
- other: 1, 24, 48 and 72 hours.
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable as no erythema was observed during the study
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- for 3 animals
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable as no edema was observed during the study
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this in vivo guideline study no skin irritation potential was found for the tested material copper (II) oxide.
- Executive summary:
The skin irritation potential of the copper (II) oxide was investigated in vivo in a study which was also conducted under GLP conditions and in accordance with the standardised guidelines OECD 404 and EU Method B.4. During the study no signs of skin irritation were noted at any of the observation points. The test material was therefore concluded to be a non-irritant.
The study used as source investigated copper oxide.The study results of the source compound were considered applicable to the target compound. Justification and applicability of the read-across approach (structural analogue) is outlined in the read-across report in section 13 or find a link in cross reference “assessment report”.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- For details on endpoint specific justification please see read-across report in section 13 or find a link in cross-reference “assessment report”
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- assessment report
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effect
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this in vivo guideline study no eye irritation potential was found for the tested material MnO2.
- Executive summary:
The eye irritation potential of MnO2 was investigated in vivo in a study which was conducted under GLP conditions and in accordance with the standardised guidelines OECD 405 and EU Method B.5. During the study no corneal or iridial effects were noted. Moderate conjunctival irritation was noted in all treated eyes one hour after treatment with minimal conjunctival irritation noted at the 24-hour observation (score of 1 for conjunctival redness and chemosis, respectively). All treated eyes appeared normal at the 48-hour observation. Therefore, under the conditions of the study the test material was determined to be not irritating to eyes.
Results of the source compound were considered applicable to the target compound. Justification and applicability of the read-across approach (structural analogue) is outlined in the read-across report in section 13 or find a link in cross-reference “assessment report”.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- For details on endpoint specific justification please see read-across report in section 13 or find a link in cross-reference “assessment report”.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- Irritation parameter:
- cornea opacity score
- Remarks:
- (Degree of opacity)
- Basis:
- mean
- Remarks:
- of animals #1 and #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility criteria not applicable
- Irritation parameter:
- cornea opacity score
- Remarks:
- (Degree of opacity)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of animals #1 and #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility criteria not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- (Redness)
- Basis:
- mean
- Remarks:
- of animals #1 and #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- (Redness)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of animals #1 and #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility criteria not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the study the test material, copper (II) oxide, was determined to be not irritating to eyes.
- Executive summary:
The irritancy potential of copper (II) oxide to the eye of the New Zealand White rabbit was investigated in a GLP study conducted according to OECD TG 405 and EU Method B.5. Application of the test material to the non-irrigated eye of three rabbits resulted in scattered or diffuse corneal opacity in one treated eye up to the 72-hour observation time point (maximum score observed during study degree of corneal opacity 1), as well as iridial inflammation up to the 48 -hour observation time point (Score 1). Moderate conjunctival irritation was noted in all treated eyes 1-hour after treatment (conjunctival redness maximum score observed 2 (in one animal); chemosis score 2 (in one animal); all effects fully reversible). Over all these mild irritating effects were reversible within 48 hours for two animals and within 7 days for the remaining animal, the test material is assessed to be not irritating to the eyes.
The study used as source investigated copper oxide.The study results of the source compound were considered applicable to the target compound. Justification and applicability of the read-across approach (structural analogue) is outlined in the read-across report in section 13 or find a link in cross reference “assessment report”.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin
The skin irritation potential of the manganese dioxide was investigated in vivo in a study which was conducted under GLP conditions and in accordance with the standardised guidelines OECD 404 and EU Method B.4. During the study no signs of skin irritation were noted at any of the observation points. The test material was therefore concluded to be a non-irritant.
The skin irritation potential of the copper (II) oxide was investigated in vivo in a study which was also conducted under GLP conditions and in accordance with the standardised guidelines OECD 404 and EU Method B.4. During the study no signs of skin irritation were noted at any of the observation points. The test material was therefore concluded to be a non-irritant.
Eyes
The eye irritation potential of manganese dioxide was investigated in vivo in a study which was conducted under GLP conditions and in accordance with the standardised guidelines OECD 405 and EU Method B.5. No corneal or iridial effects was noted during the study. Moderate conjunctival irritation was noted in all treated eyes one hour after treatment with minimal conjunctival irritation noted at the 24-hour observation. All treated eyes appeared normal at the 48-hour observation. Therefore, under the conditions of the study the test material was determined to be not irritating to eyes.
The irritancy potential of copper (II) oxide to the eye of the New Zealand White rabbit was investigated in a GLP study conducted according to OECD TG 405 and EU Method B.5. Application of the test material to the non-irrigated eye of three rabbits resulted in scattered or diffuse corneal opacity in one treated eye up to the 72-hour observation time point (maximum score observed during study degree of corneal opacity 1), as well as iridial inflammation up to the 48 -hour observation time point (Score 1). Moderate conjunctival irritation was noted in all treated eyes 1-hour after treatment (conjunctival redness maximum score observed 2 (in one animal); chemosis score 2 (in one animal); all effects fully reversible). Over all these mild irritating effects were reversible within 48 hours for two animals and within 7 days for the remaining animal, the test material is assessed to be not irritating to the eyes.
Justification for classification or non-classification
Based on the lack of relevant effects observed in reliable studies performed with both of the constituents of the registration substance and in accordance with criteria for classification as defined in Regulation (EC) No. 1272/2008, the registration substance does not require classification with respect to either skin or eye irritation.
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.