Registration Dossier
Registration Dossier
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EC number: 207-312-8 | CAS number: 461-58-5
Skin irritation / corrosion
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:
- 1 977
- 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 substance name:
- Cyanoguanidine
- EC Number:
- 207-312-8
- EC Name:
- Cyanoguanidine
- Cas Number:
- 461-58-5
- Molecular formula:
- C2H4N4
- IUPAC Name:
- 1-cyanoguanidine
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
