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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Referenceopen allclose all

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”.

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.