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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
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
No guideline followed but method is comparable to OECD TG 405 in principle.
Deviations:
not applicable
Remarks:
No guideline followed but method is comparable to OECD TG 405 in principle.
Principles of method if other than guideline:
100 mg test item was applied to the eye of a rabbit and animals were imnvestigated after 24, 48 and 72 h. After 24 h fluorescein test was also performed. The cornea, iris, conjunctivae and secretion observations were scored according to Draize
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
3-methyl-6-[(4-methylphenyl)amino]-3H-naphthol[1,2,3-de]quinolone-2,7-dione
Cas Number:
81-39-0
Molecular formula:
C24H18N2O2
IUPAC Name:
3-methyl-6-[(4-methylphenyl)amino]-3H-naphthol[1,2,3-de]quinolone-2,7-dione
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
Macrolexrot 5B

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Body weight between 2.3 and 2.8 kg; 6 rabbits.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent vehicle
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
24 h
Observation period (in vivo):
24, 48 and 72 h
Number of animals or in vitro replicates:
6 rabbits

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
No effects (scores 0) were reported for all time points.
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
No effects (scores 0) were reported for all time points.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
No effects (scores 0) were reported for all time points.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
No effects (scores 0) were reported for all time points.
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
No effects (scores 0) were reported for all time points.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

100 mg test item was applied to the eye of a rabbit and animals were investigated after 24, 48 and 72 h. The cornea, iris, conjunctivae and secretion observations were scored according to Draize. No effects (scores 0) were reported for all endpoints and all time points.