Registration Dossier

Toxicological information

Eye irritation

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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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

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
Test material form:
liquid: viscous
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: 000161MCA0

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Centre Lago S. A.; Vonnas, France
- Age at study initiation: 6 -7 months
- Weight at study initiation: 4.12 kg - 4.37 kg
- Housing: single housing
- Diet (e.g. ad libitum): Klinab-Labordiät (Kaninchen & Meerschweinchenhaltung "GLP")
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated left eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 24 hours


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.6
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Other effects:
In addition injected scleral vessels in a circumscribed area or circular were noted in the animals during the observation period.

Any other information on results incl. tables

Readings

Animal

Cornea

Iris

Conjunctiva

Additional findings

Opacity

Area of cornea involved

Redness

Chemosis

Discharge

 

1 h

01

0

0

0

1

2

2

49

02

0

0

0

1

1

1

48

03

0

0

0

0

2

2

49

 

24 h

01

0

0

0

1

0

0

48

02

0

0

0

1

0

0

 

03

0

0

0

0

0

1

48

 

48 h

01

0

0

0

0

0

0

48

02

0

0

0

0

0

0

 

03

0

0

0

1

0

0

48

 

72 h

01

0

0

0

0

0

0

 

02

0

0

0

0

0

0

 

03

0

0

0

0

0

0

 

Mean

24 – 72 h

01

0.0

 

0.0

0.3

0.0

 

 

02

0.0

 

0.0

0.3

0.0

 

 

03

0.0

 

0.0

1.0

0.0

 

 

Mean

 

0.0

 

0.0

0.6

0.0

 

 

48 = scleral vessels injected, circumscribed area

49 = scleral vessels injected, circular

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Considering the described ocular reactions as well as the average score for irritation, Fixapret CL, PBG = 10003635, after Concentration does not show an eye irritation potential under the test conditions chosen.