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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