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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: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Strain: HC:NZW
- Source: Interfauna UK Ltd.
- Age at study initiation: adult animals
- Weight at study initiation: 2.9, 3.1, and 3.1 kg
- Housing: singly in wire mesh cages (Typ III) on low dust wood granulate bedding
- Diet and water: ad libitum
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2
- Humidity (%): 45-65
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The contralateral untreated eye was used as negative control
Amount / concentration applied:
100 µL
Duration of treatment / exposure:
The eyelids were gently held together for approx. one second before releasing.
Observation period (in vivo):
Examinations were terminated after 7 days, since all changes had completely subsided then.
Number of animals or in vitro replicates:
3
Details on study design:
100 µL of the test substance were instilled into the conjunctival sac of the eye and the lids were gently held together for approx. one second before releasing. 24 hours after the treatment the eye was rinsed with saline solution.
Readings were after 1, 24, 48, and 72 hours and after 7, 14, and 21 days.

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: fluorescein and UV-light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
>= 0 - <= 2
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: mean score: 0.7
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2

Applicant's summary and conclusion

Executive summary:

The potential of damage to the eye was investigated according to OECD TG 405 in three rabbits. In this study 100 µL of the test substance was instilled into the conjunctival sac of one eye, and the eye-lid was gently held together for approx. one second before releasing. The contralateral untreated eye of the animal served as negative control. Readings were according to Draize after 1, 24, 48, and 72 hours and after 7 days. Since all changes were subsided by then, the study was terminated.

The substance led to no findings for iris, cornea, chemosis and to a slight effect after 24 hours solely in one rabbit (mean score iris, cornea, chemosis 0; mean score conjunctiva redness 0.2). Complete reversibility was shown after 48 hours.