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: Guideline study (GLP, QAU)

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:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: liquid, clear, achromatic
- Analytical purity: 99,4%
- Lot/batch No.: P. 66 A/89
- Stability under test conditions: on completion of all tests, the stability of the substance was verified by a repeated analysis
- Storage condition of test material: at room temperature
- Other: the sample appeared to be homogeneous

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: White Vienna animals from Gaukler; D-6050 Offenbach/Main, FRG
- Age at study initiation: young adult animals
- Weight at study initiation: mean bw of 3.26 kg for males (2) and 3.69 kg for female (1)
- Housing: one animal per cage in cages made of stainless steel with wire mesh walk floors (floor area : 40 cm x 51 cm)
- Diet (e.g. ad libitum): Kliba 341, 4 MM; from Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water (e.g. ad libitum): about 250 ml tap water per animal per day
- Acclimation period: at least 8 days before the beginning of the study

ENVIRONMENTAL CONDITIONS
The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a temperature range and a relative humidity. There were no deviations from these ranges which influenced the results of the study.
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

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
Single application of test substance into the conjunctival sac of the right eye.
Duration of treatment / exposure:
72 hour(s)
Observation period (in vivo):
up to 3 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not rinsed

SCORING SYSTEM: OECD scoring system
Readings after 1, 24, 48 and 72 hours.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
mean
Remarks:
of all animals tested
Time point:
other: 24-48-72-hour
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
of all tested animals
Time point:
other: 24-48-72-hour
Score:
1.1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of all tested animals
Time point:
other: 24-48-72-hour
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
of all tested animals
Time point:
other: 24-48-72-hour
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritant / corrosive response data:
All irritation reactions (only conjunctivae redness) were minimal (see Table 1) and reversible within 72 hours.
Other effects:
None observed

Any other information on results incl. tables

Table 1: Results acute eye irritation (OECD scoring system) 

period

Animal

Corneal opacity

Iris

Conjunctivae

Redness

Swelling (chemosis)

1 Hour after treatment

1

0

0

2

0

2

0

0

2

0

3

0

0

2

0

Mean 1 hour (3 animals)

 

0.0

0.0

2

0.0

24 Hour after treatment

1

0

0

2

0

2

0

0

2

0

3

0

0

2

0

Mean 24 hour (3 animals)

 

0.0

0.0

2

0.0

48 Hour after treatment

1

0

0

2

0

2

0

0

1

0

3

0

0

1

0

Mean 48 hour (3 animals)

 

0.0

0.0

1.3

0.0

72 Hour after treatment

1

0

0

0

0

2

0

0

0

0

3

0

0

0

0

Mean 72 hour (3 animals)

 

0.0

0.0

0.0

0.0

Mean 24-48-72-Hour

1

0.0

0.0

1.3

0.0

2

0.0

0.0

1.0

0.0

3

0.0

0.0

1.0

0.0

Mean 1 hour (3 animals)

 

0.0

0.0

1.1

0.0

 

 

 

 

 

 

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EU GHS