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
Study period:
The study was conducted in 1979.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Single or repeated instillations of 0.1 mL of the test material were made in one or more test concentrations in one eye of three rabbits per concentration group. The untreated eye served as control. Observations of the eyes were made immediately and at 1, 24, 48 and 72 hours, and 7 and 14 days.
GLP compliance:
no
Remarks:
Study pre-dates GLP.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Liquid
Details on test material:
- Name of test material: LRG 1188

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
No data

Test system

Vehicle:
not specified
Controls:
not required
Amount / concentration applied:
10, 30 and 100 % (0.1 mL)
Duration of treatment / exposure:
No data
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
Three animals per group
Details on study design:
Single or repeated instillations of 0.1 mL of the test material were made in one or more test concentrations in one eye of three rabbits per concentration group. The untreated eye served as control. Observations of the eyes were made immediately and at 1, 24, 48 and 72 hours, and 7 and 14 days.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
Animal 1
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No effects seen
Remarks on result:
other: Concentration tested: 100 %
Irritation parameter:
cornea opacity score
Remarks:
Animal 2
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No effects seen
Remarks on result:
other: Concentration tested: 100 %
Irritation parameter:
cornea opacity score
Remarks:
Animal 3
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No effects seen
Remarks on result:
other: Concentration tested: 100 %
Irritation parameter:
iris score
Remarks:
Animal 1
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: No effects seen
Remarks on result:
other: Concentration tested: 100 %
Irritation parameter:
iris score
Remarks:
Animal 2
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: No effects seen
Remarks on result:
other: Concentration tested: 100 %
Irritation parameter:
iris score
Remarks:
Animal 3
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: No effects seen
Remarks on result:
other: Concentration tested: 100 %
Irritation parameter:
chemosis score
Remarks:
Animal 1
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No effects seen
Remarks on result:
other: Concentration tested: 100 %
Irritation parameter:
chemosis score
Remarks:
Animal 2
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No effects seen
Remarks on result:
other: Concentration tested: 100 %
Irritation parameter:
chemosis score
Remarks:
Animal 3
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No effects seen
Remarks on result:
other: Concentration tested: 100 %
Irritation parameter:
other: Conjunctival redness Animal 1
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Concentration tested: 100 %
Irritation parameter:
other: Conjunctival redness Animal 2
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Concentration tested: 100 %
Irritation parameter:
other: Conjunctival redness Animal 3
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Concentration tested: 100 %
Irritant / corrosive response data:
Up to a concentration of 30 %, the test substance caused weak and short-lasting conjunctival irritation. No alteration of the cornea was noted. Application of undiluted test substance caused moderate conjunctival irritation disappearing after one week. No alteration of the cornea was noted.

Applicant's summary and conclusion

Interpretation of results:
Category II
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Up to a concentration of 30 %, the test substance caused weak and short-lasting conjunctival irritation. No alteration of the cornea was noted. Application of undiluted test substance caused moderate conjunctival irritation disappearing after one week. No alteration of the cornea was noted.
Executive summary:

Single or repeated instillations of 0.1 mL of the test material were made in one or more test concentrations in one eye of three rabbits per concentration group. The untreated eye served as control. Observations of the eyes were made immediately and at 1, 24, 48 and 72 hours, and 7 and 14 days.

Up to a concentration of 30 %, the test substance caused weak and short-lasting conjunctival irritation. No alteration of the cornea was noted. Application of undiluted test substance caused moderate conjunctival irritation disappearing after one week. No alteration of the cornea was noted.