Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991-09-25 to 1991-09-28
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): T001624
- Physical state: solid
- Appearance: white powder
- CAS: 132961-05-8
- Molecular formula: C23H28F2N4O2
- Molecular weight: 430.5 g/mol
Specific details on test material used for the study:

- Analytical purity: Base titration revealed 99.8% (w/w) and acid titration revealed 101.6% (w/w).
- Lot/batch No.: BEA011
- Storage condition of test material: at room temperature in closed containers
- Other: The test substance was prepared in Janssen Research Foundation laboratories and passed the specifications of the chemical quality control
department.

Test animals / tissue source

Species:
rabbit
Strain:
other: Cunistar-MDL albino rabbits
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: established stock-farm of Buyens, Lichtaart, Belgium
- Age at study initiation: adult
- Weight at study initiation: ranged between 2.350 and 2.630 kg
- Housing: The rabbits were housed in an air-conditioned room in individual metallic cages. The cages consisted of stainless steel walls and a
wire mesh bottom and front door. The cages were suspended in racks above stainless steel drains with scrapers and sink holes for the collection of faeces and urine.
- Diet: The food consisted of Huybrechts pelleted rabbit food, administered in self-raising hoppers and fed ad libitum throughout the study. The diet met all the nutritional requirements of the test system with guaranteed analysis by the manufacturer.
- Water: free and continuous access to fresh tap-water administered via automatic drinking nipples
- Acclimation period: one week


ENVIRONMENTAL CONDITIONS: no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of each animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount applied : 0.1 grams/rabbit administered once in the left conjunctival sac
- Concentration: not applicable


VEHICLE: not applicable
Duration of treatment / exposure:
single application
Observation period (in vivo):
3 days, at timepoints: 1, 24, 48, and 72 hours after exposure
Number of animals or in vitro replicates:
Three females
Details on study design:
REMOVAL OF TEST SUBSTANCE: no data
SCORING SYSTEM: Draize

SCORING SYSTEM:
- Draize


TOOL USED TO ASSESS SCORE:
- see below for measures used in calculating eye irritation

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 animals
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
3 animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
3 animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
It was concluded that T 1624, when given to albino rabbits at a single dose of 0.1 g/rabbit by ocular application, produced no eye irritation. The erythema and chemosis noted 1 hour after conjunctival application was no longer present at 24 hours.

During grading, moderate erythema was noted in all rabbits (Draize grading = 2, max 3) 1 hour after conjunctival application, whereas rabbit No.3 also showed slight chemosis (Draize grading = 1, max 4) 1 hour after application. These observations were no longer present at 24 hours. The grading scores for corneal opacity, opacity area, iris, and conjunctiva discharge were 0 at 1 hour. Individual scores were 0 at 1, 24, 48, and 72 hours in all rabbits for the cornea, iris and conjunctiva. The overall irritation index was calculated to be 0.00 and evaluated as no eye irritation.
Other effects:
Body weight remained normal in the rabbits during the 3-day observation period.

Any other information on results incl. tables

Table 1.

Individual grading of eye irritation in rabbits

 

 

Score after

 

 

1 h

24 h

48 h

72 h

Rabbit No. 1

Cornea

opacity

0

0

0

0

area

0

0

0

0

Iris

0

0

0

0

Conjunctiva

redness

2

0

0

0

chemosis

0

0

0

0

 

discharge

0

0

0

0

Rabbit No. 2

Cornea

opacity

0

0

0

0

area

0

0

0

0

Iris

0

0

0

0

Conjunctiva

redness

2

0

0

0

chemosis

0

0

0

0

 

discharge

0

0

0

0

Rabbit No. 3

Cornea

opacity

0

0

0

0

area

0

0

0

0

Iris

0

0

0

0

Conjunctiva

redness

2

0

0

0

chemosis

1

0

0

0

 

discharge

0

0

0

0

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
It was concluded that T 1624, when given to albino rabbits at a single dose of 0.1 g/rabbit by ocular application, produced no eye irritation. The erythema and chemosis noted 1 hour after conjunctival application was no longer present at 24 hours. The test item is therefore considered not to be classified.