Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study without 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

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS- Source: Gaukler; D-6050 Offenbach/ Main, Frg.- Age at study initiation: no data.- Average weight at study initiation: 2.97 kg- Housing: Individual caging in stainless steel cages with wire mesh walk floors; floor area = 40 cm x 51 cm.- Diet: Kliba 341, 4 mm; Klingenthalmuehle AG, CH-4303 Kaiseraugst, Switzerland; ad libitum (ca. 130 g/animal/day).- Water: ad libitum (ca. 250 mL tap water/animal/day).- Acclimation period: at least 8 days.ENVIRONMENTAL CONDITIONS- Temperature (°C): 20-24.- Humidity (%): 30-70.- Air changes (per hr): no data- Photoperiod (hrs dark / hrs light): 12/12.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the other eye (untreated).
Amount / concentration applied:
TEST MATERIAL- Amount(s) applied: 0.1 ml (ca. 28 mg of the comminuted test substance).
Duration of treatment / exposure:
After application, eyes were not washed.
Observation period (in vivo):
72 hours- readings were performed 30-60 min after removal of the test patches, as well as 24, 48 and 72 hours after the start of exposure.
Number of animals or in vitro replicates:
3 (males).
Details on study design:
REMOVAL OF TEST SUBSTANCE- Washing: noSCORING SYSTEM: OECD scoring systemTOOL USED TO ASSESS SCORE: no data.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable.
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours.
Score:
0
Max. score:
4
Reversibility:
other: not applicable.
Irritation parameter:
iris score
Basis:
mean
Remarks:
(3 animals)
Time point:
other: 24, 48 and 72 hours.
Score:
0
Max. score:
2
Reversibility:
other: not applicable.
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
1.7
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours.
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours.
Other effects:
- Loss of corneal tissue: seen in animal # 3 (5 hours after start of application), animal # 1 (24 and 48 hours after start of application). This effect was fully reversible 72 hours after start of exposure.- Retractions of the eyelid: seen in animal # 2 (24 and 48 hours after start of application). This effect was fully reversible 72 hours after start of exposure.

Any other information on results incl. tables

Table 1: Table of results (Individual scores and means).

Readings

Animal

Cornea opacity

Iris

Conjunctivae

Symptoms

Redness

Chemosis

1 h

1

0

0

2

2

 

2

0

0

2

2

 

3

1

0

2

2

L

24 h

1

2

0

2

1

L

2

0

0

2

1

R

3

0

0

2

1

 

48 h

1

2

0

2

0

L

2

0

0

2

0

R

3

0

0

1

0

 

72 h

1

0

0

1

0

 

2

0

0

0

0

 

3

0

0

0

0

 

mean

1

1.3

0

1.7

0.3

 

2

0

0

1.3

0.3

 

3

0

0

1.0

0.3

 

 

L = Loss of corneal tissue

R = Small retractions in the eyelids

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information