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 with acceptable restrictions. Not performed according to GLP. No analytical purity.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Code of Federal Regulations, Title 16, Section 1500.42
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): Solbrol M Na-Salz
- Physical state: solid
- Analytical purity: no data

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Lippische Versuchstierzucht, Extertal, Germany
- Weight at study initiation: average of 2.1 kg
- Housing: Animals were housed individually.
- Diet: mümmel z, ssniff, Soest, Germany, ad libitum
- Water: ad libitum
- Acclimation period: 7 - 14 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 18
- Humidity (%): 40
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Not required, the untreated eye of each animal served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 100 µL (bulk volume)
Duration of treatment / exposure:
single application without washing
Observation period (in vivo):
8 d
reading time points: 24, 48 and 72 h
Number of animals or in vitro replicates:
6 males
Details on study design:
SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0.89
Max. score:
4
Reversibility:
not fully reversible within: 8 d in 2 animals
Remarks on result:
other: fully reversible in 2 animals each within 48 h and 72 h, respectively
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0.83
Max. score:
2
Reversibility:
not fully reversible within: 8 d in 3 animals
Remarks on result:
other: fully reversible within 48 h in 2 animals and within 8 d in 1 animal
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
2.17
Max. score:
3
Reversibility:
not fully reversible within: 8 d in 3 animals
Remarks on result:
other: fully reversible within 8 d in 3 animals
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
1.33
Max. score:
4
Reversibility:
not fully reversible within: 8 d in 2 animals
Remarks on result:
other: fully reversible within 8 d in 4 animals

Any other information on results incl. tables

Table 1. Results of eye irritation study.

Rabbit #

Time

conjunctivae

iris

cornea

redness

swelling

1

24 h

2

1

1

2

48 h

2

1

1

2

72 h

2

1

1

1

8 d

1

0

1

1

average

2,0

1,0

1,0

1,7

2

24 h

2

1

0

1

48 h

2

1

1

0

72 h

2

1

1

0

8 d

0

0

0

0

average

2,0

1,0

0,7

0,3

3

24 h

2

1

1

1

48 h

2

1

1

1

72 h

2

1

1

0

8 d

2

1

1

0

average

2,0

1,0

1,0

0,7

4

24 h

2

1

1

1

48 h

2

1

1

1

72 h

2

1

0

0

8 d

0

0

0

0

average

2,0

1,0

0,7

0,7

5

24 h

2

1

1

1

48 h

2

1

1

0

72 h

2

1

0

0

8 d

0

0

0

0

average

2,0

1,0

0,7

0,3

6

24 h

3

3

1

1

48 h

3

3

1

2

72 h

3

3

1

2

8 d

1

1

1

1

average

3,0

3,0

1,0

1,7

 

 

Time

conjunctivae

iris

cornea

redness

swelling

 

24 h

2,17

1,33

0,83

1,17

48 h

2,17

1,33

1,00

1,00

72 h

2,17

1,33

0,67

0,50

24+48+72

2,17

1,33

0,83

0,89

After the 8 d-observation period, the effects on cornea and the swelling of conjunctivae were not fully reversible in 2 animals and the effects on iris and the redness of the conjunctivae were not fully reversible in 3 animals.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: Eye dam. 1, H318
DSD: Xi, R41