Registration Dossier

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: Guideline study with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
other: Kleinrusse
Details on test animals or tissues and environmental conditions:
According to Guideline.

Test system

Vehicle:
not specified
Controls:
not required
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
n.a.
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24+48+72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24+48+72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24+48+72 h
Score:
2.6
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24+48+72 h
Score:
1.1
Max. score:
4
Reversibility:
fully reversible within: 14 days

Any other information on results incl. tables

Cornea

           time (hrs)                           time (days)
           1      6       24      48     72     7     10     14     17      21
mean A     0.75   0.75    1       1      1      1     0.75   0.75   0.75    0.75
mean B     1.5    1.25    4       3.25   3.25   2.75  2.25   2.25   2.25    1.75

A = cloudiness grade
B = cloudiness surface


Cornea (0.5 % aqueous fluorescein): mean 100 or 40 after 24 hrs or 21  days p.a.


Conjunctivae

           time (hrs)                           time (days)
           1      6       24      48     72     7     10     14     17      21
mean A     1      2       2.25    2.75   2.75   2.25  1.5    1.25   1.25    1.25
mean B     1.25   1       1.25    1      1      0.5   0.25   0      0       0
mean C     3      3       3       3      3      1     2.25   1.75   1.75    0.75

A = erythema
B = chemosis
C = exsudation

Reversibility: no

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information R41 Criteria used for interpretation of results: EU