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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: (EPA) S 163.81-4 "Primary eye irritation study". Federal Register, Vol. 43, No. 163
Principles of method if other than guideline:
An excess (0.1 mL) of undiluted substance was instilled into the conjunctival sac of 6 rabbit left eyes.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Soybean oil, epoxidized
EC Number:
232-391-0
EC Name:
Soybean oil, epoxidized
Cas Number:
8013-07-8
IUPAC Name:
8013-07-8
Details on test material:
- Lot/batch No.: prod.Oct.80

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: 2-3 kg
- Housing: individually in metal cages
- Diet (e.g. ad libitum): ad libitum access to standard rabbit food - NAFAG, No. 814, Gossau SG - and water
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2
- Humidity (%): 55±10

Test system

Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Observation period (in vivo):
The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4, 7, 10 and 14
Number of animals or in vitro replicates:
5

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 day
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 2 day
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 day
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 2 day
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1day
Max. score:
4.7
Reversibility:
fully reversible within: 10 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 2 day
Max. score:
3.3
Reversibility:
fully reversible within: 10 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 3 day
Max. score:
2
Reversibility:
fully reversible within: 10 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 4 days
Max. score:
1.3
Reversibility:
fully reversible within: 10 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 7 day
Max. score:
1
Reversibility:
fully reversible within: 10 days

Any other information on results incl. tables

Score for eye irritation in rabbits 
CORNEA
A Opacity and degree of density (most dense area scored)  
  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 0
  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 Maximum possible score = 80
IRIS
A Normal 0
  Folds above normal, congestion, swelling, circumcornea 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 Maximum possible score =10
CONJUNCTIVAE
A Redness (refers to palpebral and bulbar conjunctiva 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 adjacent to lids 2
  Discharge with moistening of the lids and hairs, and considerable area around the eye 3
(A + B + C) x 2 Maximum possible score = 20

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In rabbit eyes no irritation of cornea and iris was observed at any reading. Irritation was seen only in the conjunctiva with a maximum mean score of 4.7 after 24 hours. After 10 days all irritation had disappeared. No symptoms of systemic intoxication were observed throughout the whole test period.