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Toxicological information

Eye irritation

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
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

Test material

Constituent 1
Chemical structure
Reference substance name:
Manganese ferrite black spinel
EC Number:
269-056-3
EC Name:
Manganese ferrite black spinel
Cas Number:
68186-94-7
Molecular formula:
(Fe,Mn)3O4
IUPAC Name:
diiron(3+) dimanganese(3+) manganese(2+) λ²-iron(2+) octaoxidandiide
Test material form:
solid: particulate/powder

Test animals / tissue source

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

Test system

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

Results and discussion

In vivo

Resultsopen allclose all
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

Applicant's summary and conclusion

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