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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:
From April 25th to May 20th, 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
July 31st, 1992
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
February 24th, 1987
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Controls:
yes, concurrent no treatment
Amount / concentration applied:
100 mg into one eye
Duration of treatment / exposure:
No rinsing
Observation period (in vivo):
1, 24, 48 and 72 hours as well as 7, 14, 21 days after administration
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.5
Max. score:
1
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: no observation at 24 h
Irritation parameter:
conjunctivae score
Basis:
animal: #2, #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible within: 7 d
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72 h
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Reversibility of any observed effect: changes fully reversible within 7 days. No corrosion was observed at any of the measuring intervals.
Other effects:
COLORATION: conjunctival staining was reversible in two of three animals after 21 days, whereas scleral staining persisted until the end of the observation period.
MORTALITY/CLINICAL SIGNS: no mortality and no clinical signs were observed.

Applicant's summary and conclusion

Conclusions:
Blue staining of the sclera and conjunctivae by the test article was observed in all animals. Conjunctival staining was reversible in two of three animals after 21 days, whereas scleral staining persisted until the end of the observation period.
No corrosion was observed at any of the measuring intervals.