Registration Dossier
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. Manganese dioxide gave negative test results when studied in a local lymp node assay in mice (OECD TG 429). Even though copper (II) oxide produced some positive skin reaction at the 24 hour reading in a guinea pig maimixation assay (OECD TG 406), it was concluded not to be a skin sensitiser based on the reversibility of the effects at the 48 hour reading.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- 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
- Parameter:
- EC3
- Remarks on result:
- other: no EC3 value was determined as values obtained never exceeded the 3fold stimulation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this in vivo guideline study no skin sensitising potential was found for the tested material MnO2.
- Executive summary:
The skin sensitisting potential of MnO2 was investigated in vivo in a study which was conducted under GLP conditions and in accordance with the standardised guidelines OECD 429. During the study the stimualtion index never exceeded the 3fold increase value. No signs of systemic toxicity or excessive skin irritation were noted at any of the observation points. The test material was therefore concluded to be a non-sensitiser.
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 sensitisation: in vivo (non-LLNA)
- 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
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Discrete or patchy erythema was seen at the topical challenge sites of 4 test group animals at the 24 hour observation.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Discrete or patchy erythema was seen at the topical challenge sites of 2 test group animals at the 24 hour observation.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No reactions were observed at the 48 hour observation.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No reactions were observed at the 48 hour observation.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this in vivo guideline study no skin sensitising potential was found for the tested material copper (II) oxide.
- Executive summary:
For copper (II) oxide a study which was conducted under GLP conditions and in accordance with the standardised guidelines OECD 406 and EU Method B.6 (guinea pig maximisation assay, GPMT) was
performed. Under the conditions of this study the test material was concluded to be a non sensitiser, even though there were some skin reactions in animals at the 24 hour readings, but not at the 48 hour readings in both treatment groups. Negative and positive control perforemed adequately.
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 sensitising)
- Additional information:
The skin sensitisation potential of the manganese dioxide was was investigated in a study which was conducted under GLP conditions and in accordance with the standardised guidelines OECD 429 and EU Method B.42 (local lymph node assay in mice). Under the conditions of the study the test material was concluded to be a non sensitiser (stimulation index never exceeded factor of three, thus no EC3 value was calculated).
For copper (II) oxide a study which was conducted under GLP conditions and in accordance with the standardised guidelines OECD 406 and EU Method B.6 (guinea pig maximisation assay, GPMT) was performed. Under the conditions of this study the test material was concluded to be a non sensitiser, even though there were some clearly positive animals at the 24 hour readings, but not at the 48 hour readings in both treatment groups. However these effects have been analysed in detail already by the Committee for Risk Assessment (RAC) in the Opinion proposing harmonised classification and labelling at EU level of Copper(II) oxide (CAS number: 1317-38-0; CLH-O-0000001412-86-45/F). In this opinion it is stated that:
" A substance is considered to be a skin sensitiser if, in a GPMT, a positive response is observed in at least 30% of the treated animals at an intradermal induction concentration of ≤0.1%. The result at 24h following the 10% (w/w) challenge concentration, with 4/10 (40%; net incidence) animals positive for erythema (no scores given), fulfils this criterion. The erythema in these animals had reversed by 48h (net incidence 0%). The rapid reversion could point to primary irritation rather than sensitisation, but it is noted that no erythema (or oedema) was observed in the acute dermal toxicity test and in the skin irritation test with copper(II) oxide. There are no indications in the CLP criteria/guidance on a possible effect of reversibility on the classification, so in principle the GPMT is considered positive, albeit weakly. When considering the human evidence for skin sensitisation due to copper compounds, the few individual cases of allergic reactions reported indicate that this is a relatively rare finding, and thus insufficient to warrant classification. After weighing all available information, RAC supports the conclusion of the dossier submitter that classification of copper(II) oxide as skin sensitiser is not warranted."
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
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 skin sensitisation.
There are no studies available dealing with respiratory sensitisation, therefore no firm conclusion can be drawn for this endpoint.
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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