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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:
1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The study was well documented and meets generally accepted scientific principles, and conducted in compliance with GLP, but the purity of the samples is not known. Consequently, the reliability of the data is with restriction.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report): Solfit
- Physical state: colorless liquid
- Lot/batch No.: 024141
- batch recieved on (date): 23 November 1990
- Storage condition of test material: in the dark under ambient conditions

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Interfauna UK Limited, Abbots Ripton Road, Wyton, Huntingdon
- Age at study initiation: adult, young
- Diet (e.g. ad libitum): Standard Rabbit Diet (Special Diets Services, 1 Stepfield, Witham, Essex, CM8 3AD
- Water (e.g. ad libitum): ad libitum (tap water)
- Acclimation period: 32 days before test commencement

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 18 °C
- Humidity (%): 46% rel.
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
One eye of each animal was dosed with 0.1 ml test material, while the other eye served as an untreated control.
Amount applied: 0.1 ml
Duration of treatment / exposure:
Rinsed Group:
The test material was instilled in one rabbits eye and 30 to 60 second after instillation the treated eye was rinsed with ca. 100 ml of distilled water. The rabbit was observed up to 24 h after instillation for signs of severe irritation. As none were noted, the remaining 2 rabbits were then treated in the same manner.
Non-rinsed group:
One rabbit was treated first and observed up to 24 h after instillation for signs of severe instillation. As none were noted, the remaining 5 rabbits were then treated.
Observation period (in vivo):
All treated and control eyes were graded and scored at approx. 1, 24, 48 and 72 h after instillation. Further assessment was carried out at 7, 9 and 10 days (non-rinsed group) and 4, 7 and 11 days (rinsed group) until reversibility was established.
Number of animals or in vitro replicates:
9 (male animals)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0.83
Max. score:
4
Reversibility:
fully reversible within: 11 days
Remarks on result:
other: rinsed group
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.58
Max. score:
1
Reversibility:
fully reversible within: 11 days
Remarks on result:
other: rinsed group
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1.8
Max. score:
2
Reversibility:
fully reversible within: 11 days
Remarks on result:
other: rinsed group
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 11 days
Remarks on result:
other: rinsed group
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0.48
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: non-rinsed group
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.88
Max. score:
1
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: non-rinsed group
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1.88
Max. score:
3
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: non-rinsed group
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
1.75
Max. score:
2
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: non-rinsed group

Any other information on results incl. tables

Rinsed Group

    animal number           Region of the eye     one hour                 day after instillation
 1  2  3  4  7  11
              19       Cornea  degree/opacity  2  1  0  2  2  0  0
 area/opacity  4  4  0  2  2  0  0
 Iris    0  0  1  1  1  0  0
       Conjunctivae  redness  2  2  2  2  2  1  0
 chemosis  3  2  2  2  2  1  0
 discharge  1  1  1  1  1  *  
20                     Cornea  degree/opacity  0  0  0  0  0  0  
 area/opacity  0  0  0  0  0  0  
 Iris    1  1  1  0  0  0  
       Conjunctivae  redness  2  2  2  1  1  0  
 chemosis  2  2  2  2  1  0  
 discharge  1  1  1  *  *  *  
                21 Cornea      degree/opacity  0  1  0(D)  0  0  0  
 area/opacity  0  4  0  0  0  0  
 Iris    0  1  0  1  0  0  
       Conjunctivae  redness  2  2  1  1  0  
chemosis   3  2  1  1  1  0  
 discharge  1  2  *  *  *  *  

*=no discharge; D=dullness

non-rinsed Group

    animal number           Region of the eye     one hour                 day after instillation
 1  2  3  7  9  10
           13      Cornea      degree/opacity  0  1  0(D)  0(D)  0    0
 area/opacity  0  4  0  0  0    0
 Iris    0  1  1  1  0    0
       Conjunctivae  redness  2  2  2  2  1    0
 chemosis  2  1  1  0    0
 discharge  1  1  1  Tw  *    *
14                 Cornea      degree/opacity  0  1  1  1  0    
 area/opacity  0  4  4  4  0    
 Iris    1  1 1  1  0    
Conjunctivae         redness  2  3  2  2  0    
 chemosis  3  1  2  2  0    
 discharge  2  *  1  1  *    
15                     Cornea  degree/opacity  0  0(D)  0(D)  0(D)  0    
 area/opacity  0  0  0  0  0    
 Iris    1  1  1  1  0    
Conjunctivae         redness  2  2  1  2  0    
 chemosis  3  1  2  1  0    
discharge   2  1  Tw  2  *    
16                     Cornea  degree/opacity  0  0(D)  0(D)  0(D)  0  0  
 area/opacity  0  0  0  0  0  0  
 Iris    1  1  1  1  0  0  
       Conjunctivae  redness  3  2  1  2  1  0  
 chemosis  4  1  1  2  0  0  
 discharge  3  1  1  *  *  
          17           Cornea  degree/opacity  0  1  0  0  0    
 area/opacity  0  2  0  0  0    
 Iris    1  1  1  1  0    
       Conjunctivae  redness  2  2  1  1  0    
 chemosis  3  2  1  1  0    
 discharge  2  1  1  *  *    
               18      Cornea  degree/opacity  0(D)  0(D)  0  0    
 area/opacity  0  0  0  0  0    
 Iris    1  1  0  0  0    
       Conjunctivae  redness  2  2  1  2  0    
 chemosis  4  2  1  1  0    
 discharge  2  2  1  *  *    


*=no discharge; Tw = thick white discharge; D = Dullness

Rinsed group:
The 3 rinsed eyes showed slight to moderste corneal opacity,
moderate conjunctival redness and
chemosis, slight iritis and slight discharge. By 7 days 2 of
the 3 rinsed eyes returned to normal and the remain showed
complete recovery by 11 days post-instillation.

Non-rinsed group:
The 6 non-rinsed eyes showed slight corneal opacity, slight 
iritis, moderate to severe conjunctival responses and slight
to severe discharge. By 7 days 4 of the 6 treated eyes
returned to normal and the remaining 2 eyes showed complete
recovery by 9-10 days post-instillation.

Applicant's summary and conclusion

Interpretation of results:
Category II
Conclusions:
Under the experimental conditions described in this study report the substance was considered as moderately irritant when administered by ocular route in rabbits.
Executive summary:

This study was conducted according test guideline EPA OPP 81 -4. MMB was applied to one eye of 3 New Zealand White rabbits and to one eye of 6 New Zealand White rabbits. Reading of the eye scores were made on the day of treatment after 1 hour, and after 24 hrs, 48 hrs and 72 hrs after instillation and on 7, 9 and 10 day until reversibility. Mean scores of 24, 48 and 72 h readings for the rinsed group animal 1/animal 2/animal 3 were for corneal opacity 1/0/0.33, iritis 0.66/0.66/0.66, conjunctiva redness 2/1.66/1.66 and conjunctiva chemosis 2/2/1.33; for the non-rinsed group readings for animal 1/animal 2/animal 3/animal 4/animal 5/animal 6 were for corneal opacity 0.33/1/0/0/0.33/0, iritis 1/1/1/1/1/0.33, conjunctiva redness 2/2.33/1.66/1.66/1.33/1.66 and conjunctiva chemosis 1.33/1.33/1.33/1.33/1.33/1.33. Corneal opacity, iritis, conjunctiva redness and conjunctiva chemosis were fully reversible by 11 days for the rinsed-group and 10 days for the non-rinsed group.