Registration Dossier

Toxicological information

Eye irritation

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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)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions performed on analogue substance 1

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Code of Federal Regulations, Title 16, Section 1500.42
Principles of method if other than guideline:
The test was carried out by applying 100 µl bulk volume of the crystalline substance to the conjunctival sac of the lower right eyelid of rabbits that had been previously examined and had a mean weight of 2.3 kg. The lids were then gently held together for 1 sec. The eye was not washed after the application. The second, left eye of the rabbits always remained untreated as the control. The assessment was made with the aid of an ophthalmoscope.Cornea findings were verified after 8 days using the fluorescein test (instillation of 1 drop of fluorescein solution in an ophthalmological formulation directly onto the cornea. After washing with physiological saline solution corneal lesions appear yellow-green, UV light or cobalt blue-filter).Findings were obtained 24, 48 and 72 h and 8 days after the beginning of the study.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
semi-solid (amorphous): gel
Remarks:
migrated information: paste

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS- Source: Versuchstierzuchten W. Ostrop, Meerbusch, FRG- Weight at study initiation: 2.3 kg- Housing: animais were housed in single cages- Diet: "muemmel z" feed (ssniff, Soest, FRG) ad libitum.- Water: ad libitum- Acclimation period: 4-6 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 16-18 °C- Humidity (%): 40%

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated eye served as control.
Amount / concentration applied:
TEST MATERIAL- Amount applied: 100 µl
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
6
Details on study design:
TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.3
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.3
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1.7
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal:
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
conjunctivae score
Basis:
animal:
Time point:
24/48/72 h
Remarks on result:
not measured/tested

Any other information on results incl. tables

   24h                 48h                 72h                 8 days               
 Animal No.  1  2  3  4  5  6  1  2  3  4  6  1  4  6  1  2  3

Cornea

                                               
 A) Opacity  3  3  2  1  1  1  3  2  2  1  2  1  1  2  2  2  1  2  1  2  1  1  1
 B)Area  4  4  4  1  1  3  3  2  2  1  3  2  3  1  1  1  1  1  4  1  1  1  1  1
 a=A*B*5  60  60  40  5  5  15  45  20  20  5  30  10  15  10 10   10  10  5            
                                                 

 Iris

 2  2  1  1  2
 b=A*5  10  10  10  5  5  10  10  10  10  5  5  10  10  10  10  5  5 10             
                                                 

 Conjunctivae

                                               
 A) Redness  3  3  3  3  3  3  3  3  3  3  3  3  3  3  2  3  3  3  3 1  2  1  1  3
 B) Swelling  4  4  4  4  4  4  4  2  2  2  4  4  3  2  3  3  2  1  2  1  2
 C) Discharge  3  2  3  3  3  3  2  2  2  3  3  2  2  2  2  2  3  2  0  1  1  2
 c=(A+B+C)*2  20 20  18  20 20  20  20  14  14  14  20  20  16  14  14  14  16  16             
                                                 
total= a+b+c(max. 110) 90   90  68  30  30  45  75  44  44  24  55  40  41  34  34  29  31  31            

Applicant's summary and conclusion

Interpretation of results:
other: classified under Regulation 1272/2008 H318, Eye Damage 1
Conclusions:
The analogue substance 1 was tested for eye irritation following Code of Federal Regulations, Title 16, Section 1500.42 . Under the experimental conditions and following critieria set by Regulation 1272/2008 the substance is classified as Eye Damage 1, H318: Causes serious eye damage (iris score > 1.5 for 4 animals out of 6).
Executive summary:

The analogue substance 1 was tested for eye irritation following Code of Federal Regulations, Title 16, Section 1500.42 . Based on the iris average indexes at 24, 48 and 72h, under the experimental conditions and following critieria set by Regulation 1272/2008 the substance is classified as Eye Damage 1, H318: Causes serious eye damage.