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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Principles of method if other than guideline:
Internal BASF method was used. The substance is applied in the eye of the rabbit undiluted. Observations are recorded 1 hour, 24 hours, 48 hours, 72 hours after application.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: solid

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: male 2.84 kg, female 3.34 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: other eye of animals treated with Talcum
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 mg
Duration of treatment / exposure:
one application
Observation period (in vivo):
1, 3, 24, 48, 72 h, 4 d, 7 d, 8 d
Number of animals or in vitro replicates:
2
Details on study design:
SCORING SYSTEM:
The original BASF grading was converted into the numerical grading according to the OECD Draize system.

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

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

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

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

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

(C) Discharge
0 = No discharge
1 = Any amount different from normal (does not include small amounts observed in inner canthus of normal animals
2 = Discharge with moistening of the lids and hairs just adjacent to lids
3 = Discharge with moistening of the lids and hairs, and considerable area around the eye

TOOL USED TO ASSESS SCORE: fluorescein at day 8

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
other: no irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.5
Max. score:
3
Reversibility:
other: no irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not irritant

Any other information on results incl. tables

Animal 1: female, 3.34 kg

Animal 2: male, 2.84 kg

Results:

Readings Animal Cornea Iris Conjunctival Symptoms
Erythema  Chemosis
1h 1 0 0 1 0 0
  2 0 0 1 0 0
3 h 1 0 0 1 0 0
  2 0 0 1 0 0
24 h 1 0 0 1 0 0
  2 0 0 2 0 0
48 h 1 0 0 0 0 0
  2 0 0 0 0 0
72 h 1 0 0 0 0 0
  2 0 0 0 0 0
4 d 1 0 0 0 0 0
  2 0 0 0 0 0
7 d 1 0 0 0 0 0
  2 0 0 0 0 0
8 d 1 0 0 0 0 0
  2 0 0 0 0 0
mean 24 - 72 h 1 0.0 0.0 0.3 0.0  
  2 0.0 0.0 0.7 0.0  
mean 1 0.0 0.0 0.5 0.0  

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met