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: Study performed according to FDA Register 38. No. 187, Para. 1500.41, S27029

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Principles of method if other than guideline:
Study performed according to FDA Register 38. No. 187, Para. 1500.41, S27029
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name as cited in document: Lilial
- Analytical purity: 99%
- Batch No.: not reported
- Physical state: liquid

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
- Source: Gaukler
- Diet: Ssniff (Internast)
- Mean weight at study initiation: 2.8 kg (male), 2.7 kg (female)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 ml
- Concentration: undiluted
Duration of treatment / exposure:
eye were not washed after application
Observation period (in vivo):
24h, 48h, 72h
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24h; 48h; 72h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24h;48h;72h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24h;48h;72h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 3 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24h;48h;72h
Score:
0
Max. score:
4

Any other information on results incl. tables

Summary of results

Cornea

Iris

Conjunctiva

Readings

Animal

Opacity

Area involved

Redness

Swelling

Discharge

Further findings

24h

1

0

0

0

1

0

0

2

0

0

0

1

0

0

3

0

0

0

1

0

1

48h

1

0

0

0

0

0

0

2

0

0

0

0

0

0

3

0

0

0

1

0

0

72d

1

0

0

0

0

0

0

2

0

0

0

0

0

0

3

0

0

0

0

0

0

Mean (24h-72h)

1

0

0

0

0.5

0

0

2

0

0

0

0.5

0

0

3

0

0

0

1

0

0.5

Mean (24h-72h)

all animals

0

0

0.7

0

0.2

Slight redness occured in all animals 24 hours after application of substance. 48 hour after instillation, slight redness was present in only 1/3 animals. By the 72nd hour, redness was totally reversible in all animals.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Classification: not irritating