Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given, acceptable for assessment
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).
Deviations:
not specified
Principles of method if other than guideline:
None
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
None

Test animals / tissue source

Species:
rabbit
Strain:
other: Russian breed
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Housing: separately in V2A wire cages and fed on NAFAG, Gossau SG.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum


Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:
One application
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6 rabbits (3 males and 3 females)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): 30 seconds after treatment
- Time after start of exposure: after 24 hours

SCORING SYSTEM:
Evaluation of the Eye Reactions

Cornea
A. Opacity-degree of density (area most dense taken for reading) No opacity 0
Scattered or diffuse area, details of iris clearly visible 1
Easily discernible translucent areas, details of iris slightly obscured 2
Opalescent areas, no details of iris visible, size of pupil barely discernible 3
Opaque, iris invisible 4

B. Area of cornea involved
One quarter (or less) but not zero 1
Greater than one quarter, but less than half 2
Greater than half, but less than three quarters 3
Greater than three quarters, up to whole area 4
A x B x 5 Total maximum = 80

Iris
A. Values Normal 0
Folds above normal, congestion, swelling, circumcorneal injection (any or all of
these or combination of any thereof) iris still reacting to light (sluggish reaction
is positive) 1
No reaction to light, hemorrhage, gross destruction (any or all of these) 2
A x 5

Conjunctivae
A. Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
Vessels normal 0
Vessels definitely injected above normal 1
More diffuse, deeper crimson red, individual vessels not easily discernible 2
Diffuse beefy red 3

B. Chemosis
No swelling 0
Any swelling above normal (includes nictitating membrane) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids about half closed to completely closed 4

C. Discharge
No discharge 0
Any amount different from normal (does not include small amounts
observed in inner canthus of normal animals) 1
Discharge with moistening of the lids and hairs just adj acent to lids 2
Discharge with moistening of the lids and hairs, and considerable area around the eye 3
(A + B + C) x 2 Total maximum = 20

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: slit-lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 males and 3 females
Time point:
other: day 1 to 7 after application
Score:
0
Remarks on result:
other: Eye not rinsed
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 males and 3 females
Time point:
other: day 1 to 7 after application
Score:
0
Remarks on result:
other: Eye not rinsed
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
3 males and 3 females
Time point:
other: day 1 to 7 after application
Score:
0.5
Remarks on result:
other: Eye not rinsed
Irritant / corrosive response data:
None
Other effects:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
other: minimal irritant
Remarks:
Criteria used for interpretation of results: OECD GHS
Conclusions:
The total maximum is 80 for the cornea, 10 for the iris and 20 for the conjunctivae. The irritation index was found to be 0 for the cornea, 0 for the iris and 0.5 for the conjunctivae.
Executive summary:

The primary-irritation index, which serves as a measure of the acute irritation provoked by the substance, was found to be 0 for the cornea, 0 for the iris and 0.5 for the conjunctivae.

Therefore FAT 40061/A is to be considered as a minimal irritant to the eye of rabbits.