Registration Dossier

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:
1992
Report Date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes
Remarks:
Department of Toxicology, BASF AG

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): beta-Ionone
- Substanz-Nr . : 91/24 5
- Physical state: liquid, yellow
- Analytical purity: 96.9%
- Lot/batch No.: continous production; 8 May 1991
- Storage condition of test material: room temperature, kept under nitrogen
- Stability under test conditions: stable under conditions used in this study, as verified by analysis from April 7th 2003, (GLP)

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler; D-6050 Offenbach/Main, Germany
- animal identification: ear tattoo
- Weight at study initiation: males 3.41 and 3.13 kg (mean weight 3.27 kg); female 2.79 kg
- Housing: cage made of stainless steel with wire mesh walk floors; floor area: 40x51 cm; no bedding in cages, saw dust in waste trays
- Diet (e.g. ad libitum): Kliba 341, 4 mm; Firma Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland (about 130 g/animal/day)
- Water (e.g. ad libitum): tap water, about 250 ml/animal/day
- Acclimation period: > 8 days before begin of study


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

OTHER: Feed analysis
- diet: the food in this study was assayed for contaminants. In view of the aim and duration of the study the contaminants occuring in commercail feed ought not to influence the results.
- water: drinking water was regulary assayed for contaminants by the municipal authorities of Frankenthal and the technical service of BASF AG. In view of the aim and duration of the study there were no special requirements exceeding the specifications of the drinking water.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 100%
Duration of treatment / exposure:
72 hour(s)
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3
Details on study design:
APPLICATION
- to the conjunctival sac of the right eye
- substance was not washed out

SCORING SYSTEM:
Scale for scoring ocular lesions:

Chemosis (Sw) and cornea (OP; opacity-degree of density):
0 = none
1 = slight
2 = well-defined
3 = severe
4 = very severe

Area of cornea involved (AR):
1 = > 0; < 0.25
2 = >= 0.25; < 0.5
3 = >= 0.5; < 0.75
4 = >= 0.75

Conjunctival redness (RED):
0 = normal
1 = slight
2 = well-defined
3 = severe

Discharge (DI):
0 = normal
1 = slightly increased
2 = clearly increased
3 = distinctly increased

Iris:
0 = normal
1 = circum-corneal injection
2 = iritis

Calculation of the mean acc. to 83/467/EEC criteria of july 29th, 1983 (for calculation of the means of opacity, iris, redness and swelling only readings of 24, 48 and 72 hours were used)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.2
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 72 h

Any other information on results incl. tables

The treatment lead to the following effects at the different observation  times (individual and mean scores).
For calculation of the means of opacity, iris, redness and chemosis only  the readings of 24, 48 and 72 hrs were used.

Readings Animal cornea Iris conjunctiva Symptons
opacity area redness swelling discharge
1h 1 0 0 0 2 0 2  
2 0 0 0 2 1 2  
3 0 0 0 2 0 2  
24 h 1 0 0 0 1 0 0  
2 1 2 1 2 1 1
3 0 0 1 2 0 1 RE
48 h 1 0 0 0 0 0 0  
2 0 0 0 2 0 1  
3 0 0 0 2 0 1 RE
72 h 1 0 0 0 0 0 0  
2 0 0 0 0 0 0  
3 0 0 0 0 0 0 RE
Mean 24 - 72 h 1 0 0 0 0.3 0 0  
2 0.3 0.7 0.3 1.3 0.3 0.7  
3 0 0 0.3 1.3 0 0.7  
Mean   0.1 0.2 0.2 1 0.1 0.5  


RE: Small retractions in the eyelid

Applicant's summary and conclusion