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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to the OECD Guideline and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
other: EC-Guideline 93/21
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Ro 1525 corresponds to Colipa A 155
Ro1525
Batch No.: Ro-Rn 6567-083.
SAT 980375

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
water
Controls:
not specified
Amount / concentration applied:
undiluted , moistened
Amount applied: 0.1 ml
Duration of treatment / exposure:
24 hour(s)
Observation period (in vivo):
72 hour(s)
Number of animals or in vitro replicates:
3
Details on study design:
Comment: not rinsed

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable, no irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable, no irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable, no irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable, no irritation
Irritation parameter:
other: conjunctivae, redness
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
other: conjunctivae, redness
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
other: conjunctivae, redness
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
2.67
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
other: conjunctivae, chemosis
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
2.33
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
other: conjunctivae, chemosis
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
4
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
other: conjunctivae, chemosis
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
2.67
Max. score:
4
Reversibility:
fully reversible

Any other information on results incl. tables

Mean Scores for redness and chemosis of the conjunctivae exceed the thresholds for classifying

a test substance as "irritating" as set by the EC Guideline 9312 1. Criteria for corrosion are not

fulfilled.

Therefore the test substance "Ro1525" is an irritant according to the EC-guideline 93/21.

Applicant's summary and conclusion

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

The following mean scores were calculated for each animal from the individual examinations
performed 24 h, 48 h and 72 h p.a.:
Cornea: 0, 1, 0
Iris: 0, 0.33, 0
Conjunctivae, redness: 2, 3, 2.67
Conjunctivae, chemosis: 2.33, 4, 2.67
Ocular lesions were reversible in all animals. A noteworthy high interindividual variation in the
response to the test substance was present.
Mean scores for redness and chemosis of the conjunctivae exceed the thresholds for classifying
a test substance as "irritating" as set by the EC Guideline 93/21. Criteria for corrosion are not
fulfilled.
Therefore the test substance "Ro1525" is an irritant according to the EC-guideline 93/21.
Executive summary:

Aim of the study

The aim of this study was to investigate possible irritating or corrosive effects of the undiluted

test substance following a single administration into a conjunctival sac of rabbits.

Methods

Methods and investigations were performed in conformance with the following guidelines:

OECD Guideline 405, 1987.

EC Guideline 92/69, method B.5.

EC Guideline 9312 1 (classification).

ECETOC Document No. 37, 1997.

Administration of the test substance

The equivalent of 0.1 ml "Ro1525" was instilled into the conjunctival sac of one eye of each of

3 rabbits. The eyes were rinsed with warm water after 24 h.

Investigations

Body weight: at the Start and at the conclusion of the test.

General signs: once daily.

Eye examination: 1, 24,48, 72 h and 6,8, 10, 13, 15, 17,21, 26 d after the administration

(p.a.) of the test substance (ending individually, when the animal was free of alterations).

Results

General signs

No other than ocular lesions were noted.

Eye examination

Cornea: 2 animals were normal at any time. In one animal diffuse opacity of the cornea was

present from 48 h to 21 d p.a., this cornea was normal again 26 d p.a.

Iris: 2 animals were normal at any time. In one animal mild lesions were observed from 72 h

to 17 d p.a.

Conjunctivae, redness: Pronounced redness was observed in all animals already 1 h p.a.

Redness decreased slowly, and had vanished in the last animal21 d p.a.

Conjunctivae, chemosis: An obvious to a severe swelling was Seen in all animals already

1 h p.a. The severity of the swelling diminished with time and 15 d p.a. chemosis had

returned to normal in the last animal.