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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:
other: GLP 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
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): Fixapret CP konz., PBG = 10073662, after Concentration
- Analytical purity: 93.4 %
- Lot/batch No.: 000335MCA0

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: 3.92-4.01 kg
- Housing: single housing
- Diet (e.g. ad libitum): Kliba Labordiät (Kaninchen & Meerschweichenhaltung "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 felt 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 (if done): 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:
other: 24h - 48h - 72h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24h - 48h - 72h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24h - 48h - 72h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24h - 48h - 72h
Score:
0.2
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

Chemosid

Discharge

 

1h

01

0

0

0

2

2

3

49

02

0

0

0

2

2

1

49

03

0

0

0

2

2

3

49

 

24 h

01

0

0

0

1

0

1

48

02

0

0

0

2

1

0

48

03

0

0

0

1

1

1

48

 

48 h

01

0

0

0

0

0

0

 

02

0

0

0

1

0

0

48

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

1.0

0.3

 

 

03

0.0

 

0.0

0.7

0.3

 

 

Mean

 

0.0

 

0.0

0.7

0.2

 

 

48 = scleral vessels injected, circumscribed area

49 =scleral vessels injected, circular

Applicant's summary and conclusion

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