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EC number: 206-992-3 | CAS number: 420-04-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Two separate studies in guinea pigs examined the dermal sensitisation potential of cyanamide. In the key study a SKW Cyanamid F1000 (pure active ingredient) was examined according to the Magnusson-Kligman method while the other study examined the dermal sensitisation of an aqueous solution of cyanamide (53 % w/v) according to the method of Buehler. Results of the key study showed distinct skin sensitisation properties whereas the study conducted with the aqueous solution showed an ambiguous result, indicating that cyanamide may have skin sensitization properties.
This result was supported by case reports in which men and women exhibited inflammatory skin conditions after contact with cyanamide in different formulations.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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
- 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.
- 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
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- 1% and 2.5% dilution of Cyanamid F1000
- 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
- Positive control results:
- No positive control
- 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
- 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.
Reference
- 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 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Two available studies investigated the skin sensitising potential of cyanamide. The dermal sensitisation potential of SKW Cyanamid F1000 (pure active ingredient) was evaluated by the Magnusson-Kligman method. All test animals showed a positive response in the challenge test with the 2.5 % dilution after 24 and 48 hours after patch removal. Sensitising properties were also observed in most animals treated with the 1 % concentration. According to the classification by Magnusson and Kligman, cyanamide is considered to have distinct sensitising properties. In another study an aqueous solution of cyanamide (53 % w/v) was used to evaluate the sensitising potential in guinea pigs according to the method of Buehler. Under the conditions described in the study cyanamide induced some positive skin reactions after the challenge application (4/20). However, histological examination revealed in one of these animals severe irritating effect. The study provided a borderline result, thus, according to the study cyanamide may have skin sensitisation properties.
Sensitisation data in humans (case reports) which are documented in IUCLID in section 7.10.4 imply of a sensitisation potential of hydrogen cyanamide in humans who had contact with aqueous solution of cyanamide mostly due to their occupational backgroud (Conde-Salazar et al., 1981; Calnan, 1970; De Corres and Lejarazu, 1982; Bujan et al., 1994). On the other side, examinations of employees from the cyanamide production unit SKW Trostberg AG did not show any case of confirmed or suspected allergy towards hydrogen cyanamide, even though these persons were exposed. Therefore, it can be concluded that the sensitising potential of hydrogen cyanamide is low and under practical conditions it is very unlikely to occur.
Nevertheless, on the basis of the two available animal studies, the test substance, cyanamide, is classified as a category 1 substance for inducing skin sensitisation.
Summary of results:
Species
Method
Number of animals sensitised/total number of animals
Result
Reference
Guinea pig
The study follows to a great extent OECD guideline 406
Guinea Pig Maximisation Test1% 8/10
2.5 % 10/10sensitising
Til et al., 1982
Doc. No. 567-003
Guinea pig
OECD 406 (1981); EEC 92/69- B6
Buehler test4/20
Not sensitising
Mercier, 1988
Doc. No. 567-001
Justification for selection of skin sensitisation endpoint:
GLP and guideline compliant study with the pure substance.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Based on experience in handling and use the substance cyanamide is not regarded as sensitising to the respiratory system (occupational health safety control).
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on sensitisation properties of Cyanamid F1000, the test item was classified and labelled as a skin sensitiser as skin sensitiser Cat. 1 (H317: May cause an allergic skin reaction) according to Regulation (EC) No 1272/2008 (CLP), as amended for the eighteenth time in Regulation (EU) 2022/692.
This classification is in accordance with the conclusion of the 33 RAC-Meeting (1-5 June, 2015), Helsiniki.
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