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:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 625-Triketone
- Substance No.: 95/225-1
- Physical state: Powder, beige
- Analytical purity: 99.4 %
- Lot/batch No.: LJ 27881/1
- Date of manufacturing: 18-27 Jul 1995
- Stability under test conditions: guaranteed by the sponsor and verified by reanalysis
- Storage condition of test material: refrigerator

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, FRG
- Strain/Quality: WHITE NEW ZEALAND (SPF)
- Age at study initiation: young adult animals
- Weight at study initiation: animals of comparable weight; 3.99-4.0 kg
- Fasting period before study: none
- Housing: single housing
- Diet: KLIBA-Labordiaet 341, Klingenthalmuehle AG Kaiseraugst, Switzerland, about 130 g per day
- Water: tap water about 250 ml per day
- Acclimation period: at least 1 week


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

Analysis of drinking water
The drinking water is regularly assayed for chemical contaminants by the municipal authorities of Frankenthal and the technical services of the BASF AG as well as for the presence of germs by a contract laboratory.

Analysis of feed:
The feed used in the study was assayed for chemical and microbial contaminates.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml bulk volume (about 20 mg of the comminuted test substance)


Duration of treatment / exposure:
24 hours
Observation period (in vivo):
8 days (since all ocular lesions induced by the treatment returned to normal on day 8 the study was terminated. Therefore, the reduced observation period does not represent a deviation from the protocol recommended by the guidance documents.)
Number of animals or in vitro replicates:
3 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Tap water
- Time after start of exposure: 24 hours

SCORING SYSTEM: The OECD Draize scoring system was used (OECD guideline no. 405 (adopted February 24, 1987))

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean 24, 48, 72 hrs
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
animal: #2; #3
Time point:
other: mean 24, 48, 72 hrs
Score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean 24, 48, 72 hrs
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal: #2, #3
Time point:
other: mean 24, 48, 72 hrs
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean 24, 48, 72 hrs
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean 24, 48, 72 hrs
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean 24, 48, 72 hrs
Score:
0.6
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean 24, 48, 72 hrs
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean 24, 48, 72 hrs
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean 24, 48, 72 hrs
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Other effects:
In animal #2, loss of corneal tissue was observed 24 h post application.

Any other information on results incl. tables

 

Readings Animal Cornea Iris Conjunctiva Additional findings
red ch
24 h 1 1 1 3 2 LC
2 0 0 2 0  
3 0 0 2 1  
48 h 1 0 0 2 1  
2 0 0 1 0  
3 0 0 0 0  
72 h 1 0 0 1 0  
2 0 0 0 0  
3 0 0 0 0  
8 d 1 0 0 0 0  
2 0 0 0 0  
3 0 0 0 0  
 

Symbols:

LC: Loss of corneal tissue

.

Applicant's summary and conclusion