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EC number: 206-992-3 | CAS number: 420-04-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was conducted before the LLNA-method became the standard in vivo-method for evaluation of the skin sensitising potential of a substance. Furthermore, the in vitro methods had not been established as sufficient methods to replace animal testing.
Test material
- Reference substance name:
- Cyanamide
- EC Number:
- 206-992-3
- EC Name:
- Cyanamide
- Cas Number:
- 420-04-2
- Molecular formula:
- CH2N2
- IUPAC Name:
- cyanamide
- Test material form:
- solid: crystalline
- Details on test material:
- - Test substance: SKW Cyanamid F1000
- Appearance: White crystalline
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male
- Details on test animals and environmental conditions:
- - Source: Central Institute for the breeding of Laboratory animals TNO; Netherlands
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- 1% and 2.5% dilution of Cyanamid F1000
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 1% and 2.5% dilution of Cyanamid F1000
- Day(s)/duration:
- 24 and 48 h
- No. of animals per dose:
- 10 Guinea pigs per dose (per test group) and 5 Guinea pigs in each control group
- Details on study design:
- - The dermal sensitisation potential of SKW Cyanamid F1000 (pure active substance) was evaluated in the Guinea Pig Maximisation Test (GPMT) according to the method of Magnusson and Kligman in 15 male albino guinea pigs. Approximately 24 and 48 hours after the challenge phase, the test sites were evaluated for signs of elicited sensitisation. The same procedures were carried out on a contemporaneous control group, where the test articles were replaced by water (vehicle control).
Intradermal induction was performed with 10% (v/v) cyanamide in water. A dermal induction was performed one week after intradermal induction with 5% (w/w) cyanamide in vaseline. Dermal challenge was done two weeks after dermal induction with 1% (w/w) cyanamide in vaseline (left flank) and with 2.5% (w/w) cyanamide in vaseline (right flank). - Challenge controls:
- - 5 challenge control animals were treated (only during the challenge exposure) with 2.5% dilution of the test substance and 5 challenge control animals were treated (only during the challenge exposure) with 1% dilution of the test substance.
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- No positive control
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1% Cyanamid F1000
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1% Cyanamid F1000. No with. + reactions: 8.0. Total no. in groups: 10.0. Clinical observations: none.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1% Cyanamid F1000
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1% Cyanamid F1000 . No with. + reactions: 7.0. Total no. in groups: 10.0. Clinical observations: none.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1% Cyanamid F1000
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Negative control (received only challenge treatment with 1% Cyanamid F1000). Dose level: 1% Cyanamid F1000. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1% Cyanamid F1000
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: Negative control (received only challenge treatment with 1% Cyanamid F1000). Dose level: 1% Cyanamid F1000. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2.5% Cyanamid F1000
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2.5% Cyanamid F1000. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: none.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2.5% Cyanamid F1000
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2.5% Cyanamid F1000. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: none.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 2.5% Cyanamid F1000
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other:
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Negative control (received only challenge treatment with 2.5% Cyanamid F1000). Dose level: 2.5% Cyanamid F1000. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 2.5% Cyanamid F1000
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other:
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: Negative control (received only challenge treatment with 2.5% Cyanamid F1000). Dose level: 2.5% Cyanamid F1000. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
- Group:
- positive control
- Remarks on result:
- other: no positive control
Any other information on results incl. tables
- Induction:
The intradermal injection caused slight erythema and abscesses in all test animals. The dermal applications induced slight erythema in four out of ten test animals.
The challenge treatment of the left flank (1 % dilution) provoked slight to moderate erythema in all test animals. The erythema was visible immediately after removal of the dressing. At the same time one of the control animals reacted slight positive. After 24 and 48 hours most of the test animals still showed slight to moderate erythema. None of the control animals showed a positive reaction at this time. No test substance-related clinical signs of toxicity were observed.
All ten test animals challenged with 2.5 % dilution of the test substance showed well-defined to severe erythema immediately after removing of the dressing. At the same time one of the control animals reacted slight positive. After 24 and 48 hours the test animals still showed clear positive reactions. None of the control animals showed a positive reaction at this time. No test substance-related clinical signs of toxicity were observed.
Table 1: Results in the Buehler test of Cyanamide in males:
Control group animals
| 24 h after patch removal
| 48 h after patch removal
| Test group animal
| 24 h after patch removal
| 48 h after patch removal
|
1 | 0/0 | 0/0 | 1 | 0/0 | 0/0 |
2 | 0/0 | 0/0 | 2 | 0/0 | 0/0 |
3 | 0/0 | 0/0 | 3 | 0/0 | 0/0 |
4 | 0/0 | 0/0 | 4 | 0/0 | 0/0 |
5 | 0/0 | 0/0 | 5 | 0/0 | 0/0 |
6 | 0/0 | 0/0 | 6 | 0/0 | 0/0 |
7 | 0/0 | 0/0 | 7 | 0/0 | 0/0 |
8 | 0/0 | 0/0 | 8 | 0/0 | 0/0 |
9 | 0/0 | 0/0 | 9 | 1/0 | not applicable |
10 | 0/0 | 0/0 | 10 | 1/0 | not applicable |
Score: grade of erythema/oedema
Table 2: Results in the Buehler test of cyanamide in females:
Control group animals
| 24 h after patch removal
| 48 h after patch removal
| Test group animal
| 24 h after patch removal
| 48 h after patch removal
|
1 | 0/0 | 0/0 | 1 | 1/0 | not applicable |
2 | 0/0 | 0/0 | 2 | 0/0 | 0/0 |
3 | 0/0 | 0/0 | 3 | 0/0 | 0/0 |
4 | 0/0 | 0/0 | 4 | 0/0 | 0/0 |
5 | 0/0 | 0/0 | 5 | 0/0 | 0/0 |
6 | 0/0 | 0/0 | 6 | 1/0 | not applicable |
7 | 0/0 | 0/0 | 7 | 0/0 | 0/0 |
8 | 0/0 | 0/0 | 8 | 0/0 | 0/0 |
9 | 0/0 | 0/0 | 9 | 0/0 | 0/0 |
10 | 0/0 | 0/0 | 10 | 0/0 | 0/0 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Based on the results of the Guinea Pig Maximisation Test (GPMT) according to the method of Magnusson and Kligman the active substance Hydrogen cyanamide is a sensitiser.
- Executive summary:
The dermal sensitisation potential of SKW Cyanamid F1000 (pure active substance) was evaluated in the Guinea Pig Maximisation Test (GPMT) according to the method of Magnusson and Kligman in 15 male albino guinea pigs. Approximately 24 and 48 hours after the challenge phase, the test sites were evaluated for signs of elicited sensitisation. The same procedures were carried out on a contemporaneous control group, where the test article was replaced by water (vehicle control).
Induction: The intradermal injection caused slight erythema and abscesses in all test animals. The dermal applications induced slight erythema in four out of ten test animals. The challenge treatment of the left flank (1 % dilution) provoked slight to moderate erythema in all test animals. The erythema was visible immediately after removal of the dressing. At the same time one of the control animals reacted slight positive. After 24 and 48 hours most of the test animals still showed slight to moderate erythema. None of the control animals showed a positive reaction at this time. No test substance-related clinical signs of toxicity were observed.
All ten test animals challenged with 2.5 % dilution of the test substance showed well-defined to severe erythema immediately after removing of the dressing. At the same time one of the control animals reacted slight positive. After 24 and 48 hours the test animals still showed clear positive reactions. None of the control animals showed a positive reaction at this time. No test substance-related clinical signs of toxicity were observed.
Based on the results of the Guinea Pig Maximisation Test (GPMT) according to the method of Magnusson and Kligman the active substance Hydrogen cyanamide is a sensitiser.
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