Reaction mass of copper oxide and manganese dioxide

Endpoint summary

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

Reference

Reference 1

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”.

Reference 2

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”.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

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”.

Reference 2

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”.

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.