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: GLP 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)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Basazol Gelb 8511
- Physical state: powder
- Analytical purity: 96%
- Lot/batch No.: 6123, v. 6781

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach
- Weight at study initiation: male: 3.11; female: 2.93
- Housing:Cag made of stainless steel with wire mesh walk floors, floor area, : 40 cmX 51 cm
- Diet (e.g. ad libitum): about 130 g per animal per day
- Water (e.g. ad libitum):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

Controls:
other: untreated eye of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml bulk volume (about 21 mg of the comminuted test substance)


Duration of treatment / exposure:
Treatment was once. The substanced was not washed out.
Observation period (in vivo):
15 d
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM:
OECD Draize Score

SCALE FOR SCORING OCULAR LESIONS:
Chemosis (SW) and Cornea (OP)          
Opacity-degree of density
0 = none                                                                         
1 = slight                                                                       
2 = severe                                                                   
3 = very severe                                                   

Area of Cornea involved (AR):
1 = > 0 < 1/4
2 = ≥ 1/4 < 1/2
3 = ≥  1/2 < 3/4
4 = ≥ 3/4

Conjunctivae redness (RED):              
0 = normal                                                
1= slight                                                    
2 = well-defined                                    
3 = severe                                                 

Discharge (DI)
0 = normal
1= slightly increased
2 = clearly increased
3 = distinctly increased

Iris:
0 = normal
1 = circum-corneal injection
2 = iritis

Calculation of the mean according to 83/467/EEC criteria of July 29th, 1983 (for calculation of the means of opacity, iris, redness, and swelling only the readings of 24, 48 and 72 hours are used).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1.3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
2.3
Max. score:
3
Reversibility:
not fully reversible within: 15 d

Any other information on results incl. tables

Results acute eye irritation:

Animal

Cornea

Iris

Conjunctiva

Symptoms

OP

AR

RED

SW

DI

1 h

1

0

0

--

--

3

3

S00

2

1

3

--

--

3

3

LC/S00

3

1

3

--

--

3

3

LC/S00

24 h

1

1

4

--

--

3

2

PC/S00

2

1

4

--

--

3

2

S00

3

1

4

--

--

3

2

S00

48 h

1

1

4

1*

2

2

2

S/PC

2

1

4

1*

2

2

2

S/PC/S00

3

1

4

 

2

2

3

S/PC/S00

72 h

1

2

4

1

3

2

3

S/PC/RE

2

2

4

1

3

2

2

S/PC

3

2

4

1*

3

2

3

S/PC/RE/S00

8 d

1

2

4

1

2

1

0

PC/RE/LC/MV

2

2

2

1

2

1

1

MV/LC/RE

3

4

2

1*

2

2

2

RE/LC/MV/S03

15 d

1

4

1

0*

1

0

0

MV/RE/LC/PA/S04/S06

2

1

2

0

1

1

0

MV/LC/RE/S06

3

3

1

0

2

1

1

RE/LC/MV/PA/S06

Mean

(24/48/72 h)

1

1.3

 

--

--

2.3

 

 

2

1.3

 

--

--

2.3

 

 

3

1.3

 

--

--

2.3

 

 

Total mean 

(24/48/72 h)

 

1.3

 

--

--

2.3

 

 

 

FINDINGS WHICH COULD NOT BE READ (FOR REASON SEE SYMPTOMS):

*: If in 1 - 2 animals assessments referring to the same characteristic cannot be made at a particular reading, the mean rounded to the nearest whole number of the values that can be read is inserted instead.

--: If in all animals assessments referring to the same characteristic cannot be made at a particular reading, no mean will be calculated.

 

EXPLANATIONS OF SYMPTOMS:

S00 - Irritation index could not be read because of staining due to the color of the test substance.

S03 - Irritation index could not be read because of severe corneal opacity.

S04 - Irritation index could not be read because of marginal vascularization of the cornea.

S06 - Study discontinued after 15 d because of severe irritation in two animals.

LC - Loss of corneal tissue

MV - Marginal vascularization of the cornea

PC - Pupil contracted

PA - Pannus

RE - Small retractions in the eyelids

S - Suppuration

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Classification: risk of serious damage to eyes