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 documented guideline study, no GLP.

Data source

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

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Laromer 8748
- Physical state: liquid, slightly yellow
- Analytical purity: ca. 90%
- Lot/batch No.: Batch no. 7/85, 8.7.85
- Expiration date of the lot/batch: not mentioned
- Storage condition of test material: cool, below 25°C, protected from light
- other: test substance number: 85/342




Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler; Offenbach/Main
- Age at study initiation: not mentioned
- Weight at study initiation: male: 3.08 kg (mean of two animals); female: 2.94
- Housing: single housing
- Diet: Kliba 341, 4 mm, Klingentalmuehle AG, Switzerland (about 130 g per animal per day)
- Water: about 250 ml tap water per animal per day
- Acclimation period: at least 8 days before the beginning of the study


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 ml

Duration of treatment / exposure:
No washing performed.
Observation period (in vivo):
72 hrs
Number of animals or in vitro replicates:
3 (two males, one female)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no washing performed

SCORING SYSTEM: according to OECD Guideline 405; Calculation of the mean according to 83/467/EEC Criteria of July 29th, 1983, only the readings of 24, 48 and 72 hrs were used


TOOL USED TO ASSESS SCORE: not mentioned

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
4
Reversibility:
other: no effect
Remarks on result:
other: mean
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
4
Reversibility:
other: no effect
Remarks on result:
other: mean
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
4
Reversibility:
other: no effect
Remarks on result:
other: mean
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
2
Reversibility:
other: no effect
Remarks on result:
other: mean
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
2
Reversibility:
other: no effect
Remarks on result:
other: mean
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
2
Reversibility:
other: no effect
Remarks on result:
other: mean
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
3
Reversibility:
other: no effect
Remarks on result:
other: mean
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, 72 hrs
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hrs
Remarks on result:
other: mean
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
3
Reversibility:
other: no effect
Remarks on result:
other: mean
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
4
Reversibility:
other: no effect
Remarks on result:
other: mean
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
4
Reversibility:
other: no effect
Remarks on result:
other: mean
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
4
Reversibility:
other: no effect
Remarks on result:
other: mean
Irritant / corrosive response data:
After 1 hr conjunctivae redness (animal 1: 2, animal 2: 1, animal 3: 2) and chemosis (animal 1: 2, animal 2: 1, animal 3: 0) could be detected. But the conjunctivae redness was reversible within 24 hrs (animal 1 and animal 3) or 48 hrs (animal 2), and the chemosis was reversible within 24 hrs.
Other effects:
no other effects observed

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information