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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
see attachment "Endpoint-specific read-across justification for the iron oxide category" in section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1981-05-12
Deviations:
no
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Triiron tetraoxide
EC Number:
215-277-5
EC Name:
Triiron tetraoxide
Cas Number:
1317-61-9
Molecular formula:
Fe3O4
IUPAC Name:
Iron oxide
Details on test material:
Bayferrox-schwarz 350: Fe3O4

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
3 female rabbits were kept under standard conditions in single cases. The temperature was between 19 and 25°C, the relative humidity was between 40 and 60%. The organisms were fed with a standard diet and were allowed to drink tap water ad libitum.

Test system

Vehicle:
other: 0.2% Na-Polyacrylate, 0.1% Preventol D2 and water (remainder)
Controls:
no
Amount / concentration applied:
100 µl was applied
Duration of treatment / exposure:
24 hrs. After 24 hrs the eye was rinsed with a sodium chloride solution.
Observation period (in vivo):
one,, 24, 48, 72 hours and 7 days
Number of animals or in vitro replicates:
3 females
Details on study design:
All three female New Zealand white rabbits were applied 100 µl of the sample in the conjunctival sack of one eye. After application the eye was kept close for about one second. The other eye served as a control. The treated eye was rinsed with physiological salt (NaCl) solution after 24 hrs.
After 1, 24, 48, 72 and 168 hrs the condition of the eye was checked according to OECD guideline 405. Apart from this the eye was checked for swellings, flow of tears and other observable abnormalities.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
no
Other effects:
no

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Bayferrox-Black 350 liquid was not irritating.
According to the EC-Regulation 1272/2008 and subsequent adaptations, the substance does not require classification as eye irritant.
Executive summary:

Three female New Zealand white rabbits were applied 100 µl of undiluted Bayferrox-Schwarz 350 flüssig in the conjunctival sack of one eye. After application the eye was kept close for about one second. The other eye served as a control. The treated eye was rinsed with physiological salt (NaCl) solution after 24 hrs. The condition of the eye was observed 1, 24, 48, 72 and 168 hrs after the application. The condition of the eye was checked according to OECD guideline 405 for cornea, iris, conjunctivea, swelling and excessive tear effects. No sign of any physiological effect of the test material could be observed on the eyes of the treated rabbits at any point in time.