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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
13 Sep - 22 Oct 1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: US Federal Register
Version / remarks:
1973
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
4',4'''-azobis[N-(9,10-dihydro-9,10-dioxo-1-anthryl)[1,1'-biphenyl]-4-carboxamide]
EC Number:
235-436-2
EC Name:
4',4'''-azobis[N-(9,10-dihydro-9,10-dioxo-1-anthryl)[1,1'-biphenyl]-4-carboxamide]
Cas Number:
12227-50-8
Molecular formula:
C54H32N4O6
IUPAC Name:
4',4'''-azobis[N-(9,10-dihydro-9,10-dioxo-1-anthryl)[1,1'-biphenyl]-4-carboxamide]
Test material form:
solid

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Remarks:
SPF-Albino
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight: 1.5 - 2.0 kg
- Housing: single cages
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): 24 h after treatment with physiological saline

SCORING SYSTEM: Draize scoring

TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks:
end of observation period
Remarks on result:
probability of weak irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.83
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks:
end of observation period
Remarks on result:
probability of weak irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks:
end of observation period
Remarks on result:
probability of weak irritation
Irritant / corrosive response data:
The substance caused weak signs of irritation in rabbit eyes (cornea opacity, conjunctivae redness, chemosis). The reversibility could not be assessed appropriately since the observation period ended at 72 h.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance caused weak signs of irritation in rabbit eyes (cornea opacity, conjunctivae redness, chemosis). The reversibility could not be assessed appropriately since the observation period ended at 72 h. However, the scores are too low for a classification according to CLP criteria. Therefore, the substance is not classifiable according to CLP criteria for eye irritation.