Registration Dossier
Registration Dossier
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EC number: 235-049-9 | CAS number: 12062-81-6
Endpoint summary
Administrative data
Description of key information
Valid studies for skin irritation/corrosion and eye irritation are available for (Fe,Mn)3O4 (CAS 68186-94-7) as a surrogate for (Fe,Mn)2O3.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: as reported in source record
- Justification for type of information:
- see attachment "Endpoint-specific read-across justification for the iron oxide category" in IUCLID section 13.2.
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 h not determined; after 24 h and 48 h and on days 5, 6, and 7 no effects
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Remarks:
- 48 and 72 h not determined; after 24 h and on days 4, 5, 6, and 7 no effects
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Remarks:
- 48 and 72 h not determined; after 24 h and on days 4, 5, 6, and 7 no effects
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Iron manganese oxide is not irritating to skin and does not require classification and labelling.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: as reported in source record
- Justification for type of information:
- see attachment "Endpoint-specific read-across justification for the iron oxide category" in IUCLID section 13.2.
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 h not determined; after 24 h and 48 h and on days 5, 6, and 7 no effects
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 h not determined; after 24 h and 48 h and on days 5, 6, and 7 no effects
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 h not determined; after 24 h and 48 h and on days 5, 6, and 7 no effects
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 h not determined; after 24 h and 48 h and on days 5, 6, and 7 no effects
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 h not determined; after 24 h and 48 h and on days 5, 6, and 7 no effects
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 h not determined; after 24 h and 48 h and on days 5, 6, and 7 no effects
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 h not determined; after 24 h and 48 h and on days 5, 6, and 7 no effects
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 h not determined; after 24 h and 48 h and on days 5, 6, and 7 no effects
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Iron manganese trioxide is not irritating to eye and does not require classification and labelling.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In the available studies (Fe,Mn)3O4 (CAS 68186-94-7) as a surrogate for (Fe,Mn)2O3 was not irritating to the eye and to the skin.
Justification for selection of skin irritation / corrosion endpoint:
Key study is used
Justification for selection of eye irritation endpoint:
key study is used
Justification for classification or non-classification
Due to the results of the available studies for (Fe,Mn)3O4 (CAS 68186-94-7) as a surrogate for (Fe,Mn)2O3 a classification is not justified.
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