Registration Dossier

Administrative data

Description of key information

In a study in Albino-rabbits according to OECD Guideline 404, the test substance was tested as not irritating to the skin (Schreiber, 1982).
In an acute eye irritation/corrosion experiment according to OECD Guideline 405 in rabbits the test substance DPK was not irritating (Schreiber, 1982).
These data are supported in additional studies discussed by MAK 2003 and BG Chemie 2000, indicating that the test substance proved not to be irritating to the intact skin or eye in the majority of studies, whereas in older studies mild irritations were observed. Overall the test substance is not found to be irritating to the intact skin or eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin 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
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
500 µl DPK
Duration of treatment / exposure:
4h
Observation period:
1, 24, 48, 72 h; 8d
Number of animals:
3 animals
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Erythema and edema score = 0 at 1h, 24, 48, 72 h and 8 days.
 Time after patch removal  Skin irritation/ Animal No:      
     1  2  3
 Erythema  1h  0  0  0
   24h  0  0  0
   48h  0  0  0
   72h  0  0  0
   8d  0  0  0
 Edema  1h  0  0  0
   24h  0  0  0
   48h  0  0  0
   72h  0  0  0
   8d  0  0  0
Interpretation of results:
GHS criteria not met
Conclusions:
Erythema and edema score = 0 at 1h, 24, 48, 72 h and 8 days.
Executive summary:

In a study in Albino-rabbits according to OECD Guideline 404, DPK was tested as not irritating to the skin.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
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
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.

 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

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).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

In a skin irritation/corrosion test according to OECD 404 and an eye irritation test according to OECD 405 the test substance was not irritating. These data are supported in additional studies.

According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.