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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: similiar to OECD guideline (instillation of only 50 mg , not 100 mg), no GLP

Data source

Reference
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: ETAD-Subkomitee für Toxikologie: Empfohlenen Methoden zur toxikologischen Untersuchung von Farbstoffen und Hilfsmitteln
Principles of method if other than guideline:
Method: application of test substance into the conjunctival sac of one eye of each of 2 rabbits, .Observation period was 7 days.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid
Details on test material:
IUCLID4 Test substance::
commercial formulation, purity ca. 99%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
body weight at the start of the study: 3-4 kg
one male and one female rabbit
housing individually
diet ad libitum
water ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the opposite eye served as contol
Amount / concentration applied:
50 mg/animal
Duration of treatment / exposure:
no data
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
2
Details on study design:
Method: application of test substance into the conjunctival sac of one eye of each of 2 rabbits, .Observation period was 7 days., the opposite eye served as control.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
animal:
Time point:
other: up to 7 days
Score:
ca. 0
Max. score:
110
Remarks on result:
other: no irritation was observed
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: score = 0 at any time point
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: score = 0 at any time point
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritant / corrosive response data:
no reactions were observed

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

Application of 50 mg and not 100 mg test substance into the conjunctival sac of one eye of each of 2 rabbits; the untreated other eye served as control Observation period was 7 days. No reaction of the eyes were observed. Therefore, Nigrosin WLF has to be evaluated as non-irritating to the mucous membranes.