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EC number: 205-861-8 | CAS number: 156-62-7
- 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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.7600 (Dermal Penetration)
- Deviations:
- yes
- Remarks:
- There was no sampling after dermal application in order to observe serial non-detects in excreta.
- GLP compliance:
- yes
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
- Reference substance name:
- Cyanoguanidine
- EC Number:
- 207-312-8
- EC Name:
- Cyanoguanidine
- Cas Number:
- 461-58-5
- Molecular formula:
- C2H4N4
- IUPAC Name:
- 2-cyanoguanidine
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- Dihydrogen oxide
- Reference substance name:
- Orthophosphoric acid
- EC Number:
- 231-633-2
- EC Name:
- Orthophosphoric acid
- Cas Number:
- 7664-38-2
- Molecular formula:
- H3O4P
- IUPAC Name:
- phosphoric acid
- Test material form:
- liquid - solid: mixture of
Constituent 1
impurity 1
additive 1
additive 2
- Radiolabelling:
- yes
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- The rats were obtained from Charles River Laboratories (Massachusetts U.S.A)
Administration / exposure
- Type of coverage:
- other: Non-occlusive
- Vehicle:
- water
- Duration of exposure:
- Up to 24 hours
- Doses:
- 0.1, 1 and 10 mg of Hydrogen cyanamide for a rat in a volume of 100 µl.
- No. of animals per group:
- 24 animals per group
- Control animals:
- yes
- Details on study design:
- - The dosing solutions were prepared by mixing appropriate amounts of [14C] Hydrogen cyanamide stock solution in deionized water (adjusted to pH 4.5 with phosphoric acid). Three dosing solutions were prepared to deliver 0.1, 1 and 10 mg of Hydrogen cyanamide in a volume of 100 µl on an area of 12.5 cm2.
- Approximately 24 hours before dosing, the back and shoulders of each rat were shaved and the shaved area was washed with acetone. At 0 hour, the test material solution was applied evenly to the test site. The application site was then covered with a non-occlusive cover to prevent disturbance of the application site and mechanical loss of the test material.
- A single cumulative faeces sample was collected from each rat from the time of dosing to the time of sacrifice. After all urine and faeces samples had been collected, each cage was rinsed and the cage wash was collected. Four rats from each group were sacrificed at each of the six times (0.5; 1; 2; 4; 10 and 24 hours) after application of the test substance. Blood was collected via cardiac puncture. The skin at the application site (with cover in place) and carcass were collected for analysis. All samples were assayed by liquid scintillation counting (LSC).
- A single cumulative urine sample was collected from each rat from the time of dosing to the time of sacrifice. Any residual urine present at sacrifice was collected and added to the appropriate urine sample.
Results and discussion
- Signs and symptoms of toxicity:
- not specified
- Dermal irritation:
- not specified
- Absorption in different matrices:
- Blood:
For the animals in the lowest dose group (0.1 mg dose) mean blood radioactivity concentrations ranged from non-detectable at 2 and 4 hours to 0.002 µg equivalents/g at 24 hours. Higher concentrations were observed for the animals in the mid (1 mg dose) and the high (10 mg dose) dose with mean values for each group generally increasing with time of exposure up to 10 hours. For the mid dose group the mean blood radioactivity concentration ranged from 0.006 µg equivalents/g at 0.5 hours to 0.37 µg equivalents at 10 hours. For the high dose group the mean concentrations ranged from 0.029 µg equivalents/g at 0.5 hours to 1.04 µg equivalents/g at 10 hours.
Urine and faeces:
The amount of radioactivity found in urine ranged between n.d. and 0.22 % during the period from 0.5 to 4 h when considering all dose levels. After 10 h exposure the recoveries of radioactivity in urine were 0.7, 1.45 and 4.38 % for the low, mid and high dose, respectively. In faeces of the low dose animals, no radioactivity was found up to and including 10 h exposure. The recoveries after 24 application were 0.05, 0.02, < 0.01 and 0.07 % for the individual test animals. In faeces of the mid dose animals, no radioactivity was found up to and including 4 h exposure. The recovery after 10 h application was 0.07 %. After 24 h application, < 0.01, 0.04, 0.06 and 0.08 % of radioactivity was recovered in the faeces of individual test animals. In faeces of the high dose animals, no radioactivity was found up to and including 4 h exposure. The recoveries after 10 h application was < 0.01, < 0.01 and 0.23 %. After 24 h application, 0.28, 0.12, 0.19 and 0.22 % of radioactivity was recovered in the individual animals.
Carcass:
Radioactivity was detectable in the carcass of animals from all three dose levels with highest amounts of mean radioactivity at 10 and 24 hours. The result are also consistent with the blood data.
The result indicate some systemic absorption of the test material at all dose levels. The amounts of absorbed dose increased with exposure time and reached maximum values at 24 hours.
Amount of dose remaining in or on the skin after washing:
The amount of radioactivity found in the skin of all test groups after wash is constant between 0.5 h and 10 h. The amount in the skin ranged between 4.4 and 8.7 % for the low and mid dose in the time period 0.5 to 10 h. The variation over time observed for the high dose animals was larger. However, the mean recovery over time (0.5 – 10 h) is comparable to the low and mid dose.
Amount of unabsorbed dose:
For all three dose groups the amount of radioactivity recovered was inversely related to the amount of absorbed dose and skin radioactivity observed at the later time points. At 0.5 hours the mean radioactivity recovered in the skin rinses as approximately 97 % for the low and mid dose group and approximately 90 % for the high dose group. The values decreased to 69 %, 68 % and 53 % for the low, mid and high dose group respectively at 24 hours.
The average material balance indicate that there was no appreciable loss of radioactivity due to formation of volatile products either on the skin or from absorbed dose. The mean material balance was between 93.34 % and 98.61 %.
Percutaneous absorptionopen allclose all
- Dose:
- 0.1 mg/rat
- Parameter:
- percentage
- Absorption:
- 1.2 %
- Remarks on result:
- other: After 10 hours exposure
- Remarks:
- The total means systemically absorbed dose including the amount located in the skin is 8.23%.
- Dose:
- 1 mg/rat
- Parameter:
- percentage
- Absorption:
- 2.6 %
- Remarks on result:
- other: After 10 hours
- Remarks:
- The total means systemically absorbed dose including the amount located in the skin is 9.45%.
- Dose:
- 10 mg/rat
- Parameter:
- percentage
- Absorption:
- 7.5 %
- Remarks on result:
- other: After 10 hours exposure
- Remarks:
- The total means systemically absorbed dose including the amount located in the skin is 14.34%.
- Conversion factor human vs. animal skin:
- Conversion factor C (rat ->human) is not indicated in the study report.
Based on the following calculation C can be received as follows:
C (rat, in vito ->human, in vitro) = % absorbance in an in-vitro rat study / % absorbance in-vitro human
Based on the resulting C the % absorbance in-vivo human can be calculated by:
% absorbance in-vivo human = % absorbance in an in-vivo rat study (present study) / C
Any other information on results incl. tables
Mean percent dose in urine, faeces and carcass at specified time postdose:
Sacrifice time (hours) |
Mean percent dose in urine |
Mean percent dose in faeces |
Mean percent dose in carcass |
||||||
0.1* |
1.0* |
10.0* |
0.1* |
1.0* |
10.0* |
0.1* |
1.0* |
10.0* |
|
0.5a) |
nd** |
nd** |
< 0.01 |
nd** |
nd** |
nd** |
0.07 |
0.16 |
0.12 |
1a) |
0.02 |
nd** |
nd** |
nd** |
nd** |
nd** |
0.17 |
0.29 |
0.65 |
2a) |
0.05 |
< 0.01 |
nd** |
nd** |
nd** |
- |
0.08 |
0.65 |
0.91 |
4a) |
0.17 |
nd** |
0.22 |
- |
- |
nd** |
0.10 |
0.53 |
1.63 |
10 |
0.7 |
1.45 |
4.38 |
nd** |
0.02 |
0.06 |
0.5 |
1.07 |
2.35 |
24 |
0.93 |
1.69 |
7.65 |
0.04 |
0.05 |
0.2 |
0.65 |
0.89 |
2.05 |
*mg/animal in a volume of 100 µL on an area of 12.5 cm2 **not detectable
Amount of [14C] Hydrogen cyanamide systemically absorbed as indicated by the total radioactivity found in carcass, excreta, cage wash and cage wipe:
Sacrifice time (hours) |
Total radioactivity found in carcass, excreta, cage wash and cage wipe |
||
0.1 (mg/animal) |
1.0 (mg/animal) |
10.0 (mg/animal) |
|
0.5 |
0.07 % |
0.16 % |
0.12 % |
1 |
0.19 % |
0.29 % |
0.66 % |
2 |
0.13 % |
0.69 % |
0.91 % |
4 |
0.27 % |
0.53 % |
1.85 % |
10 |
1.2 % |
2.64 % |
7.53 % |
24 |
1.79 % |
2.84 % |
11.1 % |
Amount of [14C]-Hydrogen cyanamide in skin:
Sacrifice time (hours) |
Mean percent dose in skin at specified times postdose |
||
0.1 (mg/animal) |
1.0 (mg/animal) |
10.0 (mg/animal) |
|
0.5 |
6.57 % |
4.41 % |
7.47 % |
1 |
6.80 % |
4.03 % |
11.7 % |
2 |
7.48 % |
8.67 % |
9.46 % |
4 |
6.48 % |
5.99 % |
5.33 % |
10 |
7.03 % |
6.81 % |
6.81 % |
24 |
17.0 % |
13.5 % |
11.1 % |
Total amount of [14C]-Hydrogen cyanamide absorbed as calculated by including the amount located in the rat skin:
Dose levels |
% absorbed of dose applied after 10 h exposure |
|
|
systemically |
total* |
10 mg/rat |
7.53 |
14.34 |
1 mg/rat |
2.64 |
9.45 |
0.1 mg/rat |
1.20 |
8.23 |
* total means systemically absorbed dose including the amount located in the skin
Applicant's summary and conclusion
- Conclusions:
- Hydrogen cyanamide is absorbed through rat skin (Total amount of systemically absorbed dose at 10 h:1.2% (low dose) to 7.53% (high dose). At 10 h: 1.2% (low dose) to 11.1% (high dose)).
- Executive summary:
The study was performed using male Crl:CD(SD)BR rats. Each dose group consisted of 24 animals. The dosing solutions were prepared by mixing appropriate amounts of [14C] hydrogen cyanamide stock solution in deionized water (adjusted to pH 4.5 with phosphoric acid). Three dosing solutions were prepared to deliver 0.1, 1 and 10 mg of hydrogen cyanamide in a volume of 100 µl on an area of 12.5 cm2. A single cumulative faeces sample was collected from each rat from the time of dosing to the time of sacrifice. After all urine and faeces samples had been collected, each cage was rinsed and the cage wash was collected. Four rats from each group were sacrificed at each of the six times (0.5; 1; 2; 4; 10 and 24 hours) after application of the test substance. Blood was collected via cardiac puncture. The skin at the application site (with cover in place) and carcass were collected for analysis. All samples were assayed by liquid scintillation counting (LSC). At 0 hour, the test material solution was applied evenly to the test site. The application site was then covered with a non-occlusive cover to prevent disturbance of the application site and mechanical loss of the test material. The control animals were treated in the same way as the treated animal, but dosed with the vehicle.
The amount of systemically absorbed [14C] hydrogen cyanamide increased with the dose level and with time of exposure. Maximum blood concentration of radioactivity were observed at 24 hours for the low and mid dose and at 10 hours for the high dose. Urinary excretion of radioactivity increased with time and amount of the test material applied. The amount of radioactivity associated with the washed skin was relatively constant (average 5 % to 10 % of the applied dose). The majority of the applied dose was recovered in the skin wash. The amount of radioactivity in the skin wash generally decreased with time through 24 hours and did not appear to be related to the applied dose. The total amount of systemically absorbed dose averaged 1.2 %, 2.64 % and 7.53 % of the dose at 10 hours and 1.79 %, 2.84 % and 11.1 % of the dose at 24 hours for low, mid and high dose, respectively.
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