Registration Dossier

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No GLP study defined

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The 3 tested animals served also as control (one eye treated, the other one untreated)
Amount / concentration applied:
100 µl DPK
Duration of treatment / exposure:
no flushing of irritated eye
Observation period (in vivo):
1, 24, 48, 72h; 8d
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
5
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Cornea score, iris score, conjunctiva score and chemosis score = 0 at 1 h, 24 h, 48 h, 72 h and 8 days.

Any other information on results incl. tables

 Time after applikation        1h        24h  48h        72h            8d  
 Animal No:  2 3  1  3  1  3 2
1. CorneaA) opacity   0  0  0  0  0  0  0  0  0  0  0  0
B)Surface   0  0  0
a= AxBx5 (Max.80)  0  0  0  0  0  0
 2. Iris  0  0  0  0
 b= Ax5 (Max 10)  0  0  0  0
3. ConjuncrtivaA) redness  0  0  0  0  0  0
B) Turgor  0  0  0  0  0
 C) defluxion 1 * 1*  0  0  0  0  0  0
c= (A+B+C)x2 (Max.20)         0  0  0  0  0    
 Total= a+b+c (Max 110)        0  0  0  0  0      

* all kind of defluxion over standard amount

classification: 0 -10 not irritating

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Cornea score, iris score, conjunctiva score and chemosis score = 0 at 1 h, 24 h, 48 h, 72 h and 8 days.
Executive summary:

In an acute eye irritation/corrosion experiment according to OECD Guideline 405 in rabbits the test substance DPK was not irritating (Cornea score, iris score, conjunctiva score and chemosis score = 0 at 1 h, 24 h, 48 h, 72 h and 8 days).