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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
Study period:
1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

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:
not specified
Details on test material:
None

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Chemisch-pharmazeutische Fabrik D-7950 Biberach/Riss
- Weight at study initiation: 2280 to 2370 g.
- Housing: housed individually in metal cages, identified by ear tattoo
- Diet: ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water: ad libitum fresh water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 30-70 %
- Photoperiod: 12 hours light cycle day

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye of each rabbit remained untreated and served as a control.
Amount / concentration applied:
0.1 ml (62 mg) of FAT 36038/F was placed into the conjunctival sac of the left eye of each animal.
Duration of treatment / exposure:
One single application
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 females rabbits
Details on study design:
0.1 ml (62 mg) of FAT 36038/F was placed into the conjunctival sac of the left eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test article.
The right eye remained untreated and served as a control.
The animals were checked daily for systemic symptoms and mortality (only findings reported).
The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation of FAT 36038/F according to the OECD scoring system.
In order to determine the reversibility of the eye reactions additional evaluations of the ocular reactions were needed in this study. A slit-lamp was used to facilitate the evaluation.

Scores for ocular lesions according to the OECD guideline 405:
*CORNEA
- Opacity: degree of density (area most dense taken for reading).
- No ulceration or opacity: 0
- Scattered or diffuse areas of opacity (other than slight dulling of normal luster), details of iris clearly visible: 1
- Easily discernible translucent area, details of iris slightly obscured: 2
- Nacreous area, no details of iris visible, size of pupil barely discernible: 3
- Opaque cornea, iris not discernible through the opacity: 4

*IRIS
- Normal 0
- Markedly depended rugae , congestion , swelling, moderate circumcorneal hyperaemia, or injection , any of these or combination of any thereof, iris still reaction to light (sluggish reaction is positive): 1
- No reaction to light, haemmorrhage, gross destruction (any or all of these): 2

*CONJUNCTIVAE
Redness: (refers to palpebral and bulbar conjunctivae, cornea and iris)
- Blood vessels normal: 0
- Some blood vessels definitely hyperaemic (injected): 1
- Diffuse, crimson colour, individual vessels not easily discernible: 2
- Diffusy beefy red: 3

*Chemosis - lids and/or nictating membranes.
- No swelling: 0
- Any swelling above normal (includes nictating membranes): 1
- Obvious swelling with partial eversion of lids: 2
- Swelling with lids about half closed. 3
- Swelling with lids more than, half closed: 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
3 male rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24h
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
3 male rabbits
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 male rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 male rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24h
Irritant / corrosive response data:
Reactions were observed within 48 hours after instillation of the test article, the observation period was extended to 7 days to determine the reversibility of the eye reactions.
Other effects:
None

Any other information on results incl. tables

Individual eye scores.

 Animal N° 662/F     Cornea     Iris           Conjunctiva
   ce  te  ce  te     Redness ce te     Chemosisce te
 After 1 hr.  0  0  0  1  0  1  0  1
 After 24 hrs  0  0  0  0  0  1  0  0
 After 48 hrs  0  0  0  0  0  1  0  0
 After 72 hrs  0  0  0  0  0  0  0  0
 Mean 24 -72 hours  0  0  0  0  0  0.67  0  0
 After 7 days  0  0  0  0  0  0  0  0

 Animal N° 016/F     Cornea     Iris           Conjunctiva
   ce  te  ce  te     Redness ce te     Chemosisce te
 After 1 hr.  0  0  0  0  0  1  0  1
 After 24 hrs  0  0  0  0  0  1  0  0
 After 48 hrs  0  0  0  0  0  1  0  0
 After 72 hrs  0  0  0  0  0  0  0  0
 Mean 24 -72 hours  0  0  0  0  0  0.67  0  0
 After 7 days  0  0  0  0  0  0  0  0

 Animal N° 980/F     Cornea     Iris           Conjunctiva
   ce  te  ce  te     Redness ce te     Chemosisce te
 After 1 hr.  0  0  0  0  0  1  0  1
 After 24 hrs  0  0  0  0  0  1  0  0
 After 48 hrs  0  0  0  0  0  1  0  0
 After 72 hrs  0  0  0  0  0  0  0  0
 Mean 24 -72 hours  0  0  0  0  0  0.67  0  0
 After 7 days  0  0  0  0  0  0  0  0

ce = control eye

te = test eye

F = Female

Bodyweight (g):

 Animal N°  662/F 016/F  980/F 
 At start of test  2320 2370  2280 
 After 3 days  2400 2440  2400 
 After 7 days (end)  2510 2580  2590 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 36038/F can be classified as non-irritant to rabbits eyes.
Executive summary:

The Acute Eye Irritation/Corrosion study in albino rabbits was performed to determine the irritant or corrosive potency of FAT 36038/F in the albino rabbit eye and the associated mucous membranes. This test was based on the OECD Guideline No. 405, adopted February 24, 1987, by the OECD council, and on Annex V, part B of Council Directive 79/831/EEC (Commission Directive 92/69/EEC of July 31, 1992).

The lids were held together for about one second in order to prevent loss of the test article. The right eye remained untreated and served as a control. The animals were checked daily for systemic symptoms and mortality. The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation of FAT 36038/F according to the OECD scoring system. A slit-lamp was used to facilitate the evaluation.

No corneal opacity was observed with any of the exposed animals. Slight irritation reactions with iris and chemosis was seen at 1 hour after the exposure, however these reactions were reversed by 24 hours. Slight conjunctival redness was seen in all three exposed animals, which was found to have reversed by 72 hours. Hence, based on the findings of the study, FAT 36038/F induced reactions of the iris and conjunctiva when instilled, into the conjunctival sac of albino rabbits' eyes. Because the mean values of the readings 24 to 72 hours after instillation are below the threshold of significance, FAT 36038/F can be classified as non-irritant.