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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:
03.10. - 19.11.1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guideline study, GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical properties: liquid
- Storage conditions: room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GMBH, Chemisch-pharmazeutische Fabrik, D-7950 Biberach/Riss
- Weight at study initiation: between 2660 to 2760 g
- Housing: individually in metal cages
- Diet: ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: October 29, 1991 To: November 12, 1991

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye remained untreated and served as a control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL


Duration of treatment / exposure:
single instillation
Observation period (in vivo):
Examination of the eyes after 1 hour and 1, 2, 3, 7 days after instillation of the test substance.
Number of animals or in vitro replicates:
3 male NZW rabbits
Details on study design:
SCORING SYSTEM:
According to the grading system given in the OECD guideline 405

TOOL USED TO ASSESS SCORE:
hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: mean (24+48+72h)
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: mean (24+48+72h)
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: mean (24+48+72h)
Score:
0.89
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: mean (24+48+72h)
Score:
0.11
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
See table 1 below.
Other effects:
None.

Any other information on results incl. tables

Table 1: Eye irritation scores of the test substance

 

time

animal 1

animal 2

animal 3

corneal opacity

24 h

0

0

0

48 h

0

0

0

72 h

0

0

0

iris

24 h

0

0

1

48 h

0

0

0

72 h

0

0

0

conjunctivae

24 h

1

1

1

48 h

1

1

1

72 h

0

1

1

chemosis

24 h

0

0

1

48 h

0

0

0

72 h

0

0

0

All ocular reactions were reversible within 7 days.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Under the experimental conditions employed the test article, when instilled into the conjunctival sac of albino rabbits' eyes, induced irritation of the conjunctiva below the threshold of significance and does therefore not require classification for eye irritation.
Executive summary:

In an acute eye irritation/corrosion study according to OECD guideline 405 and in compliance with GLP, 0.1 ml of the undiluted test item was instilled into one eye of each of three male New Zealand White rabbits. Observations were made 1, 24, 48, 72 hours and 7 days after instillation. Irritation of the conjunctivae was seen as redness and chemosis, reversible within 7 days. The average scores (24 -72 hours) for each animal were 0.67, 1 and 1 for redness and 0, 0 and 0.33 for chemosis, respectively. Based on these results and according to the EC criteria for classification and labeling requirements the test substance does not need to be classified.