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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Source study has reliability 2. The use of a read across approach is considered as acceptable, since target and read across substance differ only in the degree of salification, i.e. monosodium vs. disodium salt.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Similar Substance 01
IUPAC Name:
Similar Substance 01
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3.3 - 3.6 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 25 °C
- Humidity: 40 - 60 %
- Photoperiod: 12 hours light / 12 hours dark

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 ml of finely powdered test substance were applied into the conjunctival sac of an eyelid.
Duration of treatment / exposure:
After application, the eyelids were held together for about 1 second. Treated eye was rinsed after 24 hours with physiological NaCl solution.
Observation period (in vivo):
Ocular reactions were evaluated at 24, 48 and 72 hours after instillation
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM:
Cornea - opacity
0 No opacitiy
1 Scaterred or difussed area, details of iris clearly visible
2 Easily discernible translucent areas, details of iris slightly obscured
3 Opalescent areas, no details of iris visible
4 Opaque, iris invisible

Cornea - area 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
0 Normal
1 Folds above normal, congestion, swelling, circumcorneal injection
2 No reaction to light, hemorrhage, gross destruction

Conjuctivae - redness
0 Vessels normal
1 Vessels definitely injected above normal
2 More diffuse, deeper crimson red, individual vessels not easily discernible
3 Diffuse beefy red

Conjunctivae - chemosis
0 No swelling
1 Any swelling above normal
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


TOOL USED TO ASSESS SCORE: slit-lamp was used to facilitate the evaluation

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal: #2 and #3
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 d

Any other information on results incl. tables

Results according to Draize score

animal obs. 1h 24 h 48 h 72 h 7 d 14 d 21 d
1 cornea x 0 0 0 0 - -
iris x 0 0 0 0 - -
conj. redness x 0 0 0 0 - -
conj. chemosis 1 0 0 0 0 - -
2 cornea x 0 0 0 0 - -
iris x 0 0 0 0 - -
conj. redness x 1 1 1 0 - -
conj. chemosis 1 0 0 0 0 - -
3 cornea x 0 0 0 0 - -
iris x 0 0 0 0 - -
conj. redness x 1 1 1 0 - -
conj. chemosis 1 0 0 0 0 - -

x = not evaluable (test pattern-related coloring)

- = not examined

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC 1272/2008)
Conclusions:
Not irritant to rabbit eye.
Executive summary:

Method

Eye irritation potential was assessed following OECD guideline 405. Test substance was applied to one eye of 3 rabbits; the other eye served as control. The eye was rinsed 24 h after application. Observations were done at 1, 24, 48 and 72 h and 7d after application. Observations for effects on cornea, iris and conjunctivae were done up to day 7 after application.

Results

No effects on cornea, iris and conjunctival chemosis were noted; slight effects of conjunctival redness were noted in 2/3 rabbits. Such effects were fully reversible within 7 days.