Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16 April - 18 May 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
April 24, 2002
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
30 May, 2008
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
august 1998
Qualifier:
according to
Guideline:
other: Japan MAFF Testing Guideline of 12 Nousan No8147, Nov 24, 2000
GLP compliance:
yes (incl. certificate)
Remarks:
Bioassay, Labor fuer biologische Analytik GmbH, Heidelberg, Germany

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid
Details on test material:
- Name of test material (as cited in study report): L4-Ligand
- Physical state: white solid
- Analytical purity: 97.0g/100g ± 0.3g/100g
- Lot/batch No.: 0005473663
- Expiration date of the lot/batch: 01 February, 2013
- Storage condition of test material: room temperature, under N2; protected agianst humidity
- Other: homogeneous by visual inspection

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: approximately 3 months
- Weight at study initiation: 2.28 - 2.39 kg
- Housing: single housing in stainless steel wire mesh cages with grating shallow cage floor enriched with wooden gnawing blocks
- Diet: STANRAB (P) SQC, SDS Special Diets Services, Altrip, Germany
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 30 -70%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL bulk volume (about 36 mg)
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
reading time points: 1, 24, 48 and 72 hours
Number of animals or in vitro replicates:
3 (sequential testing)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: 3 to 6 mL of hand warm tap water
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize Scoring System

TOOL USED TO ASSESS SCORE: hand-slit lamp, fluorescein and otoscope lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal#1 - animal#3
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal#1 - animal#3
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 hours
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal#2 + animal#3
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
3
Reversibility:
other: reversibility: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal#1 - animal#3
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
Slight conjunctival redness was noted in all animals at the 1 hours reading time point and persisted in one animal up to 24 hours. Additional findings like injected scleral vessels in a circumscribed area were noted in one animal up to 24 hours after application. All occular reactions were reversible within 48 hours.
Other effects:
No other effects were observed during the study.

Any other information on results incl. tables

Table1: Individual Occular Observations

   animal #1           animal #2           animal #3         
 hours  cornea  Iris  Redness  Chemosis  Cornea  Iris  Redness  Chemosis  Cornea  Iris  Redness  Chemosis
 1  0  0  1  0  0  0  1  0  0  0  1  0
 24  0  0  1  0  0  0  0  0  0  0  0  0
 48  0  0  0  0  0  0  0  0  0  0  0  0
 72  0  0  0  0  0  0  0  0  0  0  0  0

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
DSD: not classified
CLP: not classified