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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:
1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity: 95.2%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Controls:
yes
Duration of treatment / exposure:
3 male and female rabbits (New Zealand Albino breed) were more than 2.5 kg. No signs of diseases were observed at clinical check-in.
The test sample (0.1 g) was placed into the conjunctival sac of left eye of animal after gently pulling the lower lid away from the ball. After application the lids were gently held together for a few seconds. The right untreated eye served as a control. Three animals were used in test.
Observation period (in vivo):
The eyes were examined at 1, 24, 48 and 72 hours after application. In 1 hour after test sample application, the eye reaction was examined without rinse of water. In 24 hours, reaction of eye gently rinsed with water was performed. Examination of damage of cornea was performed using 2% solution of fluorescein. Examination of eye reaction in 48 hours was performed without fluorescein. Examination in 72 hours was performed using 2% fluorescein.
Number of animals or in vitro replicates:
3 male and female rabbits (New Zealand Albino breed)

Results and discussion

Results of in vivo studyopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal: 38
Time point:
other: overall at 24, 48 and 72 hr
Score:
0
Max. score:
0
Remarks on result:
other: Mean of all observation
Irritation parameter:
cornea opacity score
Remarks:
corena area
Basis:
animal: 38
Time point:
other: overall 24, 48 and 72 hr
Score:
0
Max. score:
0
Remarks on result:
other: Mean of all observation
Irritation parameter:
iris score
Basis:
animal: 38
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Remarks on result:
other: mean of all observation
Irritation parameter:
conjunctivae score
Remarks:
congestion
Basis:
animal: 38
Time point:
other: overall at 24, 48 and 72 h
Score:
0.66
Max. score:
1
Reversibility:
fully reversible within: 72hr
Remarks on result:
other: mean of all observation
Irritation parameter:
chemosis score
Basis:
animal: 38
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Remarks on result:
other: mean of all observation
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
animal: 38
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Remarks on result:
other: mean of all observation
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal: 39
Time point:
other: overall 24, 48 and 72 hr
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hr
Remarks on result:
other: mean of all observation
Irritation parameter:
cornea opacity score
Remarks:
area
Basis:
animal: 39
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hr
Remarks on result:
other: mean of all observation
Irritation parameter:
iris score
Basis:
animal: 39
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Remarks on result:
other: mean of all observation
Irritation parameter:
conjunctivae score
Remarks:
congestion
Basis:
animal: 39
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72 hr
Remarks on result:
other: mean of all observation
Irritation parameter:
chemosis score
Basis:
animal: 39
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Remarks on result:
other: mean of all observation
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
animal: 39
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hr
Remarks on result:
other: mean of all observation
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal: 40
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hr
Remarks on result:
other: mean of all observation
Irritation parameter:
cornea opacity score
Remarks:
area
Basis:
animal: 40
Time point:
other: overall at 24, 48 and 72 h
Score:
0.66
Max. score:
2
Reversibility:
fully reversible within: 48 hr
Remarks on result:
other: mean of all observation
Irritation parameter:
iris score
Basis:
animal: 40
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Remarks on result:
other: mean of all observation
Irritation parameter:
conjunctivae score
Remarks:
congestion
Basis:
animal: 40
Time point:
other: overall at 24, 48 and 72 h
Score:
1.66
Max. score:
2
Reversibility:
fully reversible within: 72 hr
Remarks on result:
other: mean of all observation
Irritation parameter:
chemosis score
Basis:
animal: 40
Time point:
other: overall at 24, 48 and 72 h
Score:
0.66
Max. score:
2
Reversibility:
fully reversible within: 48 hr
Remarks on result:
other: mean of all observation
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
animal: 40
Time point:
other: overall at 24, 48 and 72 h
Score:
1.66
Max. score:
2
Reversibility:
fully reversible within: 72 hr
Remarks on result:
other: mean of all observation

Any other information on results incl. tables

The following clinical signs were observed 1 hour after application: in one animal – congested conjunctiva (middle), strong serosal discharge colored by the test sample, in two animals: oedema of lids, strong serosal discharge; congestion of conjunctiva was not evaluated by the reason of coloring by the test sample.

The following clinical signs were observed 24 hours after application: in one animal – smoke opacity of cornea, congested conjunctiva (middle) and serosal discharge, oedema of lids (middle), serosal discharge (middle), in one animal slightly congested conjunctiva were recorded.

Examination in 48 hours after application showed very slight congestion of conjunctiva and in one animal slight congestion of conjunctiva.

Examination in 72 hours after application showed very slight congestion of conjunctiva and very slight discharge in one animal; in two animals no finding were recorded.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test sample, Direct black 112, is not irritating to eyes, according to CLP regulation 1272/2008.
Executive summary:

The sample, Direct black 112, was tested for the eye irritation. 3 New Zealand Albino males and females rabbits were applied with 0.1 g Direct black 112 on the conjunctival sac of left eye of animals. Most of the effects were observed at conjunctiva within 48 hrs. Almost no effect was observed 72 hours after treatment, only slight congestion of conjunctiva and very slight discharge in one animal.

The test sample, Direct black 112, is not irritating to eyes, according to CLP regulation 1272/2008.