Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June 15, 1992-June 22, 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test procedure according to national standards.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: EEC Directives 83/467 and 84/449
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Conelli - Arona
- Weight at study initiation: 2.5-3.5 kg
- Housing: stainless steel cages
- Diet (e.g. ad libitum): pellet complete diet
- Water (e.g. ad libitum): filtered tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2 degree C
- Humidity (%): 55 +/- 15%
- Air changes (per hr): 25 changes/hr
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark


IN-LIFE DATES: From: June 15, 1992 To: June 22, 1992

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 100%
Duration of treatment / exposure:
7 days
Observation period (in vivo):
1, 24, 48, and 72 hrs, and 7 days after start of exposure
Number of animals or in vitro replicates:
6
Details on study design:
SCORING SYSTEM: Draize


Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48, and 72 hrs
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
No signs of irritation or corrosion were seen in any animal during any of the observations.

Any other information on results incl. tables

Results of Eye Irritation Study  - Mean Scores                  

Observation

Cornea

Iris

Conjunctiva (Redness)

Conjunctiva (Chemosis)

1 hr

0

0

0

0

24 hrs

0

0

0

0

48 hrs

0

0

0

0

72 hrs

0

0

0

0

7 days

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is not an eye irritant according to EU GHS guidelines.
Executive summary:

This study examined the potential of the test substance to cause eye irritation. 0.1 ml of test substance was placed in one eye of 6 rabbits. The untreated eyes served as controls. The eyes were examined at 1, 24, 48, and 72 hrs, and 7 days after start of exposure for signs of irritation. No signs of irritation were seen in any animal at any observation. The test substance is considered no irritating to eyes.