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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 1977
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:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
number of test animals should be 10 (here: 8)
Principles of method if other than guideline:
The Landsteiner/Draize method was used. The test substance was administered by intra-dermal injections.
GLP compliance:
not specified
Remarks:
pre-GLP
Type of study:
Draize test
Justification for non-LLNA method:
A Skin sensitisation study from 1977 is available

Test material

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

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: not specified; albino guinea pigs
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 198 - 282 g

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: 0.85 % saline
Concentration / amount:
2 % solution in 0.85 % saline
Challengeopen allclose all
Route:
intradermal
Vehicle:
other: 0.85 % saline
Concentration / amount:
2 % solution in 0.85 % saline
No. of animals per dose:
- 8 animals per group
- 2 groups: 1 test group, 1 control group
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: test group animals were treated repeatedly (10 injections), the control group animals were only treated once
- Duration: 3 weeks
- Test groups: 1
- Control group: 1
- Site: right flank
- Frequency of applications: 3 times weekly
- Concentrations: 2 % colution of the substance in 0.85 % saline
- details on injections: test animals received a total of 10 injections; as the first injection each animal received 0.05 ml of the 2.0 % suspension; in the 2nd to 10th injection 0.1 ml was applied per animal


B. CHALLENGE EXPOSURE
- Two weeks after 10th injection the challange-dose was given: 0.05 ml per animal
- At this time the control animals were injected with 0.05 ml of the 2.0 % suspension of the test sample


OTHER:
- shaving of treatment site: some days before starting the treatment the right flank of the animals was shaved with electric clippers; shaving was repeated before each injection and reading if necessary
- The reaction sites were examined 24 hours after the injection; diameter, colour, and thickness were used as criteria for the intensity of the reaction
Challenge controls:
Yes: control animals were injected with 0.05 ml of the 2.0 % suspension of the test sample at challenge exposure.
Positive control substance(s):
no

Results and discussion

Positive control results:
Not applicable

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Group:
test group
Dose level:
0.05 ml of 2 % solution of test substance in 0.85 % saline
No. with + reactions:
0
Total no. in group:
8
Clinical observations:
Not reported
Remarks on result:
other: Reading: 1st reading. Group: test group. Dose level: 0.05 ml of 2 % solution of test substance in 0.85 % saline. No with. + reactions: 0.0. Total no. in groups: 8.0. Clinical observations: Not reported.
Reading:
1st reading
Group:
negative control
Dose level:
0.05 ml of 2 % solution of test substance in 0.85 % saline
No. with + reactions:
1
Total no. in group:
8
Clinical observations:
Reaction to injection at the same time as the challenge
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. Group: negative control. Dose level: 0.05 ml of 2 % solution of test substance in 0.85 % saline. No with. + reactions: 1.0. Total no. in groups: 8.0. Clinical observations: Reaction to injection at the same time as the challenge.
Group:
positive control
Remarks on result:
not measured/tested

Any other information on results incl. tables

Table 1: Individual positive reactions (marked with + signs) observed during the induction and challenge period with Dicyandiamid EH

Test animals

Control animals

No.

Individual direct reaction

Challenge

No.

Reaction to injection at the same time as the challenge

1

2

3

4

5

6

7

8

9

10

1575

 

 

 

 

+

 

+

+

+

 

 

1583

 

1576

 

 

 

 

+

 

+

 

+

 

 

1584

 

1577

 

+

+

+

+

+

+

 

+

 

 

1585

 

1578

 

 

 

 

+

 

+

 

 

 

 

1586

 

1579

 

 

 

 

+

+

+

+

+

 

 

1587

+

1580

 

 

 

 

 

+

+

+

 

+

 

1588

 

1581

 

+

 

 

+

 

+

 

 

 

 

1589

 

1582

 

 

 

 

+

 

+

 

 

 

 

1590

 

 

0

2

1

1

7

3

8

3

4

1

0

 

 1

Degree of reaction: + = mild

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Conclusions:
Dicyandiamid EH is not sensitizing to male guinea pigs under the conditions of this test.
Executive summary:

The test substance was administered by intradermal injections following the Landsteiner/Draize method. Sixteen male albino guinea pigs, were divided into 2 groups (test and control). The test animals were treated repeatedly with a 2 % solution of the substance in 0.85 % saline. During the induction period the test animals received a total of 10 injections, 3 times weekly for 3.weeks. Two weeks after the 10th injection the challenge-dose was given in an amount of 0.05 ml per animal. The reaction sites were examined 24 hours after the injection.

Dicyandiamid EH caused positive skin reactions upon repeated intradermal injections in all test animals. The reaction was mild. None of the test animals reacted positively upon the challenge-dose. One out of 8 controls showed a positive mild reaction to injection at the same time as the challenge.

From these results it can be concluded that Dicyandiamid EH was not sensitizing under the conditions of this study.