Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
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:
2005
Report Date:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(2002)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: Solid; ground / dark yellow
- Analytical purity: 92 %
- Stability under test conditions: The stability under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
- Storage condition of test material: Room temperature

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., 01540 Vonnas, France
- Age at study initiation: about 6 months
- Weight at study initiation: 3.60 kg - 3.95 kg
- Housing: single
- Diet (e.g. ad libitum): Kliba-Labordiaet (Kaninchen & Meerschweinchenhaltung "GLP"), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland (about 130 g per animal per day)
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 5 days

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

Check for dead or moribund animals: Twice each workday (beginning and end) and once on Saturdays, Sundays and on public holidays.

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 bulk volume (about 26 mg of the comminuted test substance)
- Concentration (if solution): undiluted

Duration of treatment / exposure:
1 hour
Observation period (in vivo):
1, 24, 48, 72 h and 7 days after application
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
The treated eye of the animal(s) was rinsed with 3 to 6 mL of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe.
- Time after start of exposure:
About 1 hour after application of the solid test substance

SCORING SYSTEM: Draize test

TOOL USED TO ASSESS SCORE:
Daylight tubes "Lumilux" (L 58W/860 PLUS EGO 25X1, Osram, Germany)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
1.22
Max. score:
3
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: see table for details
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0.22
Max. score:
3
Reversibility:
fully reversible within: 24/48 h
Remarks on result:
other: fully reversible in 1/3 animals within 24 h, in 2/3 animals within 48 h
Other effects:
Discharge: mean 24 - 72 h: 0.22/max.score 3; reversible in 1/3 animals within 24 h; in 2/3 animals within 48 h.

Any other information on results incl. tables

Animal

Reading

Cornea

Iris

Conjunctiva

Additional findings

 

 

Opacity

Cornea area

 

Redness

Chemosis

Discharge

 

1

1 h

0

0

0

2

1

1

Scleral vessels injected, circular

2

1 h

0

0

0

2

1

2

Scleral vessels injected, circular

3

1 h

0

0

0

2

1

2

Scleral vessels injected, circumscribed area

1

24 h

0

0

0

2

0

0

Scleral vessels injected, circumscribed area

2

24 h

0

0

0

2

1

1

Scleral vessels injected, circumscribed area

3

24 h

0

0

0

2

1

1

Scleral vessels injected, circumscribed area

1

48 h

0

0

0

1

0

0

Scleral vessels injected, circumscribed area

2

48 h

0

0

0

1

0

0

Scleral vessels injected, circumscribed area

3

48 h

0

0

0

2

0

0

Scleral vessels injected, circumscribed area

1

72 h

0

0

0

1

0

0

Scleral vessels injected, circumscribed area

2

72 h

0

0

0

0

0

0

Study discontinued because the animal was free of findings

3

72 h

0

0

0

0

0

0

Study discontinued because the animal was free of findings

1

7 d

0

0

0

0

0

0

 

 mean  animal 1

24 - 72 h

0.00

 

0.00

 

1.33

 

0.00

   
 mean animal 2 

24 - 72 h

  

0.00

    

0.00

  

1.00

  

0.33

   
 mean animal 3 

24 - 72 h

  

0.00

    

0.00

  

1.33

  

0.33

   
 mean   total

24 - 72 h

  

0.00

    

0.00

  

1.22

 

 0.22

   

Applicant's summary and conclusion

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