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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Valid studies for skin irritation/corrosion and eye irritation are available for manganese ferrite black spinel.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: short report
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Due to the age of the study, deficiencies in study conduct and reporting.
Principles of method if other than guideline:
500 mg/animal were applied onto the ear, washing of the ear with water and soap/ vegetable oil; post observation period: 7 days
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3 - 4 kg
- Housing: individual
- male and female
Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg/ animal
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
2
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
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 #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 #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:
The test item is not irritating to the skin and does not require classification and labelling.
Executive summary:

500 mg/animal were applied onto the ear, washing of the ear; post observation period 7 days

Result: nor irritating

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: short report
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Due to the age of the study, deficiencies in study conduct and reporting.
Principles of method if other than guideline:
application into conjunctival sac, post observation period: 7 days
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3- 4 kg
- Housing: individual
- male and female
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 mg/ animal
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
2
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:
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 #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:
The test item is not irritating to eye and does not require classification and labelling.
Executive summary:

Application of test substance into conjunctival sac, post observation period: 7 days

Result: not irritating

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 manganese ferrite black spinel was not irritating to the eye and to the skin.

Justification for classification or non-classification

Due to the results of the available studies for manganese ferrite black spinel a classification is not justified