Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study but without GLP.

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)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): D-Pantolacton kristallin
- Physical state: solid white crystals
- Analytical purity: >99 %

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach, Germany
- Weight at study initiation: mean weight females 3.50 kg; male 3.59 kg
- Housing: in cages made of stainless steel with wire mesh walk floors; floor area 40 cm x 51 cm
- Diet: Kliba 341, 4 mm (Klingentalmuehle AG, Kaiseraugst, 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: 20-24 °C
- Humidity: 30-70 %
- Air changes (per hr): fully air-conditioned rooms
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye of the same animal served as control
Amount / concentration applied:
0.1 ml bulk volume (about 37 mg of the comminuted test substance)
Duration of treatment / exposure:
the substance was not washed out
Observation period (in vivo):
9 days
Number of animals or in vitro replicates:
3 animals, 2 females and 1 male
Details on study design:
- Application site: single application to the conjunctival sac of the right eyelid
- Reading time points: 1h, 24h, 48h, 72h and 9d after application

SCORING SYSTEM: according to OECD TG 405

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 9 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 9 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 9 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 9 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 9 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 9 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 9 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 9 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 9 days

Any other information on results incl. tables

Table 1: Results acute eye irritation for the individual animals:

Readings

Animal

Cornea

Iris

Conjunctiva redness

Conjunctiva chemosis

Symptoms

1 h

1

0

0

2

1

 

2

0

0

2

2

 

3

0

0

2

2

 

24 h

1

1

1

2

2

pupil contracted

2

1

0

2

2

 

3

1

0

2

2

 

48 h

1

1

1

2

1

 

2

1

0

2

1

 

3

1

0

2

1

 

72 h

1

1

0

2

1

 

2

1

0

2

1

 

3

1

0

2

1

 

9 d

1

0

0

0

0

 

2

0

0

0

0

 

3

0

0

0

0

 

Applicant's summary and conclusion