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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1973

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Patch-test technique according Draize (J. Pharmacol. (1944) 82; 377).
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: adult


Test system

Type of coverage:
occlusive
Preparation of test site:
other: abraded and intact skin
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
12
Details on study design:
Primary irritation to the skin is measured by a patch-test technique on the abraded and the intact skin of albino rabbits.
Twelve healthy adult New Zealand White albino rabbits were used for the test substance. 24 hours prior to applying the materials, the hair is removed from the backs of the animals with an electric clipper in such a way as to avoid abrasions.
An amount of 0.5 g of Dicyandiamide was brought into contact of the intact and the abraded skin under a surgical patch measuring 1 inch x 1 inch. The patches are fixed to the application site by means of adhesive tape and the entire trunk of the rabbits is wrapped with an impervious material to maintain the test patches in position and to retard evaporation of volatile substances.
Six rabbits are treated on the intact skin, the other six on the abraded skin. The abrasions are minor incisions through the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding.
After an exposure period of 24 hours the patches and the material applied are removed and the resulting skin reactions are evaluated by the method of Draize (J. Pharmacol. 82 (1944) 377-). A second reading is made 48 hours later (72 hours after application).
In the case of surface active test substances the skin reactions after 72 hours usually consist of scaliness and/or necrosis. Since the Draize grading system does not comprise these abnormalities the second reading is carried out on the basis of the CIVO-grading system.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: n.a
Remarks on result:
no indication of irritation
Remarks:
intact skin
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: n.a
Remarks on result:
no indication of irritation
Remarks:
intact skin
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: n.a
Remarks on result:
no indication of irritation
Remarks:
intact skin
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: n.a
Remarks on result:
no indication of irritation
Remarks:
intact skin
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: n.a
Remarks on result:
no indication of irritation
Remarks:
intact skin
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
no indication of irritation
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: n.a
Remarks on result:
no indication of irritation
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: n.a
Remarks on result:
no indication of irritation
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: n.a
Remarks on result:
no indication of irritation
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: n.a
Remarks on result:
no indication of irritation
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: n.a
Remarks on result:
no indication of irritation
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: n.a
Remarks on result:
no indication of irritation
Remarks:
intact skin
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: n.a
Remarks on result:
no indication of irritation
Remarks:
intact skin
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: n.a
Remarks on result:
no indication of irritation
Remarks:
intact skin
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: n.a
Remarks on result:
no indication of irritation
Remarks:
intact skin
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: n.a
Remarks on result:
no indication of irritation
Remarks:
intact skin
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: n.a
Remarks on result:
no indication of irritation
Remarks:
intact skin
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: very slight scaliness
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: n.a
Remarks on result:
no indication of irritation
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: n.a
Remarks on result:
no indication of irritation
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
animal #4
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: n.a
Remarks on result:
no indication of irritation
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
animal #5
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: n.a
Remarks on result:
no indication of irritation
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
animal #6
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Remarks:
intact skin
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Reversibility:
other: n.a
Remarks on result:
not measured/tested
Remarks:
intact skin
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Reversibility:
other: n.a
Remarks on result:
not measured/tested
Remarks:
intact skin
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Reversibility:
other: n.a
Remarks on result:
not measured/tested
Remarks:
intact skin
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
48 h
Reversibility:
other: n.a
Remarks on result:
not measured/tested
Remarks:
intact skin
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
48 h
Reversibility:
other: n.a
Remarks on result:
not measured/tested
Remarks:
intact skin
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
48 h
Reversibility:
other: n.a
Remarks on result:
not measured/tested
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Reversibility:
other: n.a
Remarks on result:
not measured/tested
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Reversibility:
other: n.a
Remarks on result:
not measured/tested
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
animal #3
Time point:
48 h
Reversibility:
other: n.a
Remarks on result:
not measured/tested
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
animal #4
Time point:
48 h
Reversibility:
other: n.a
Remarks on result:
not measured/tested
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
animal #5
Time point:
48 h
Reversibility:
other: n.a
Remarks on result:
not measured/tested
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
animal #6
Time point:
48 h
Reversibility:
other: n.a
Remarks on result:
not measured/tested
Remarks:
intact skin
Other effects:
No other effects

Any other information on results incl. tables

Table 2: Individual and average skin irritation scores of the product dicyandiamide

Rabbit no.

Intact skin

Rabbit no.

Abraded skin

24 hours

72 hours

24 hours

72 hours

A

B

 

A

B

 

1

0

0

0

7

0

0

1

2

0

0

0

8

1

0

0

3

0

0

0

9

0

0

0

4

0

0

0

10

0

0

0

5

0

0

0

11

1

0

0

6

1

0

0

12

0

0

1

A = erythema

B = edema

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material dicyandiamide is practically non-irritating to the skin of rabbits.
Executive summary:

Primary irritation to the skin was measured by a patch-test technique on the abraded and the intact skin of albino rabbits.

Twelve healthy adult New Zealand White albino rabbits were used for 0.5 g of the test substance Dicyandiamide which was brought into contact of the intact and the abraded skin.

After an exposure period of 24 hours the patches and the material applied were removed and the resulting skin reactions were evaluated by the method of Draize. A second reading was made 48 hours later (72 hours after application).

The test material caused very slight erythema in one out of six rabbits treated on the intact skin and in two out of six rabbits treated on the abraded skin.

After 72 hours no dermal effects were observed in rabbits that had been on the intact skin, whereas slight scaliness was observed in two rabbits that had been treated on the abraded skin.

It may be concluded that the test material dicyandiamide is practically non-irritating to the skin of rabbits.