Registration Dossier

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: well performed GLP and OECD guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

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

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, company breeding colony
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 3.3 - 4.0 kg
- Housing: single cages in completely air conditioned rooms
- Diet: Altromin 2123 ad libitum an 15 gr hay per day
- Water: deionized and chlorinated water from automatic dispensores. ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+-3
- Humidity (%): 50+-20
- Photoperiod: 12 hrs dark / 12 hrs ligh:

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated right eye served as control
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: physiol. saline (37°C)
- Time after start of exposure: 24 hours

SCORING SYSTEM:
cornea: 0 - 4
iris: 0 - 2
conjunctivae redness: 0 - 3
chemosis: 0 - 4

TOOL USED TO ASSESS SCORE: UV lamp /luorescein

Results and discussion

In vivo

Results
Irritation parameter:
cornea opacity score
Basis:
animal: # 1, 2, 3 each
Time point:
other: mean of 24 , 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: Reversibility: No signs of irritation (cornea) at any time
Irritant / corrosive response data:
No initial pain reaction
Other effects:
No other effects reported

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the result of this study the substance was not considered to cause serious eye irritation or damage.
Executive summary:

The substance was tested for eye irritation according to OECD guideline 405. 3 New Zealand albino rabbits were treated with 100 mg of the test substance placed into in the left conjunctival sac of the left eye. The untreated right eyes served as control. The observation period lasted 72h. From one to 24 hours after application moderate conjunctival redness and chemosis were observed. All symptoms were fully reversible within 2 days.