Registration Dossier
Registration Dossier
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EC number: 205-861-8 | CAS number: 156-62-7
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Disposition and Pharmacokinetics of Disulfiram and calcium Carbimide (Calcium Cyanamide)
- Author:
- Brien, J. F.; Loomis, C. W.
- Year:
- 1 983
- Bibliographic source:
- Drug Metabolism Reviews, 14(1), 113-126 (1983)
Materials and methods
- Objective of study:
- toxicokinetics
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Different methods used for characterisation of the pharmacokinetic behaviour of calcium cyanamide. No guidelines were indicated.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Calcium cyanamide
- EC Number:
- 205-861-8
- EC Name:
- Calcium cyanamide
- Cas Number:
- 156-62-7
- Molecular formula:
- CN2.Ca
- IUPAC Name:
- calcium cyanoazanediide
- Reference substance name:
- Calcium oxide
- EC Number:
- 215-138-9
- EC Name:
- Calcium oxide
- Cas Number:
- 1305-78-8
- Molecular formula:
- CaO
- IUPAC Name:
- oxocalcium
- Reference substance name:
- Carbon
- EC Number:
- 231-153-3
- EC Name:
- Carbon
- Cas Number:
- 7440-44-0
- Molecular formula:
- C
- IUPAC Name:
- carbon
- Reference substance name:
- Hematite (Fe2O3)
- EC Number:
- 215-275-4
- EC Name:
- Hematite (Fe2O3)
- Cas Number:
- 1317-60-8
- Molecular formula:
- Fe2O3
- IUPAC Name:
- diiron oxide
- Reference substance name:
- Urea
- EC Number:
- 200-315-5
- EC Name:
- Urea
- Cas Number:
- 57-13-6
- Molecular formula:
- CH4N2O
- IUPAC Name:
- urea
- Reference substance name:
- Silicon dioxide
- EC Number:
- 231-545-4
- EC Name:
- Silicon dioxide
- Cas Number:
- 7631-86-9
- Molecular formula:
- O2Si
- IUPAC Name:
- dioxosilane
- Reference substance name:
- Trisilicon tetranitride
- EC Number:
- 234-796-8
- EC Name:
- Trisilicon tetranitride
- Cas Number:
- 12033-89-5
- Molecular formula:
- N4Si3
- IUPAC Name:
- trisilicon tetranitride
- Reference substance name:
- Calcium dihydroxide
- EC Number:
- 215-137-3
- EC Name:
- Calcium dihydroxide
- Cas Number:
- 1305-62-0
- Molecular formula:
- CaH2O2
- IUPAC Name:
- calcium dihydroxide
- Reference substance name:
- Aluminium oxide
- EC Number:
- 215-691-6
- EC Name:
- Aluminium oxide
- Cas Number:
- 1344-28-1
- Molecular formula:
- Al2O3
- IUPAC Name:
- aluminium oxide
- 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:
- Calcium acetylide
- EC Number:
- 200-848-3
- EC Name:
- Calcium acetylide
- Cas Number:
- 75-20-7
- Molecular formula:
- C2Ca
- IUPAC Name:
- calcium ethynediide
- Reference substance name:
- unknown
- IUPAC Name:
- unknown
- Test material form:
- solid: particulate/powder
- Details on test material:
- Kalkstickstoff (calcium cyanamide, technical grade)
Constituent 1
impurity 1
impurity 2
impurity 3
impurity 4
impurity 5
impurity 6
impurity 7
impurity 8
impurity 9
impurity 10
impurity 11
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No details on test animals
Administration / exposure
- Route of administration:
- other: oral and intraperitoneal
- Vehicle:
- water
- Details on exposure:
- Pharmacokinetics of calcium cyanamide were studied after intraperitoneal and oral administration.
- Duration and frequency of treatment / exposure:
- no details given
Doses / concentrations
- Remarks:
- Doses / Concentrations:
In one of the tests 7.0 mg/kg bw was administered orally.
- No. of animals per sex per dose / concentration:
- no details given
- Control animals:
- not specified
- Positive control reference chemical:
- no data
- Details on study design:
- Distribution, metabolism and excretion were studied measuring cyanamide and metabolite concentration in different tissues and in the urine.
The time-course of plasma cyanamide concentration in the rat was determined following oral administration of 7.0 mg/kg calcium cyanamide. - Details on dosing and sampling:
- no details given
- Statistics:
- no details given
Results and discussion
- Preliminary studies:
- It has been demonstrated that calcium cyanamide is quantitatively hydrolysed to cyanamide in one hour under simulated gastric conditions. This hydrolysis is required for absorption, as calcium cyanamide is insoluble in aqueous solutions.
Toxicokinetic / pharmacokinetic studies
- Details on distribution in tissues:
- Intraperitoneal:
The disposition of cyanamide in the rat has been studied after the intraperitoneal administration of 14C-cyanamide. Radioactivity was found only in the liver at the 1-h interval after drug administration. Radioactivity was excreated primarily in the urine and to a small extent in the breath as carbon dioxide.
- Details on excretion:
- Intraperitoneal:
At 6 h following intraperitoneal administration of 14C-cyanamide, 94% and 1.5% of the radioactivity were excreted in the urine and breath respectively.
Oral:
Peak plasma cyanamide concentration was achieved at 80 min after calcium cyanamide administration. The plasma cyanamide concentration decreased monoexponentially, which indicated first-order kinetics of elimination, and the apparent plasma elimination half-life was 92.4 min. Throughout this 6h study, no cyanamide was detected in the liver.
Toxicokinetic parameters
- Key result
- Toxicokinetic parameters:
- half-life 1st: 92.4 min
Metabolite characterisation studies
- Metabolites identified:
- no
- Details on metabolites:
- Intraperitoneal:
The radioactivity in the urine was not associated with cyanamide, its dimer cyanoguanidine, or urea. A metabolite containing a cyano group was isolated from the urine and appeared to be an acid with a pKa of 3.9.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: no bioaccumulation potential based on study results
In the rat, peak plasma cyanamide concentration was achieved 60 minutes after oral administration of calcium cyanamide and plasma elimination half-life was 92.4 minutes. - Executive summary:
In the review of Brien and Loomis (1983), data on the absorption, distribution, biotransformation, excretion and pharmacokinetics of calcium cyanamide in experimental animals and man after oral and i.p. administration are summarised. It has been mentioned that calcium cyanamide is quantitatively hydrolysed to cyanamide in one hour under simulated gastric conditions (see toxicokinetics study entry of Loomis and Brien, 1981). This hydrolysis is required for absorption as calcium cyanamide is insoluble in aqueous solutions.
Also, an in vivo study on the disposition of cyanamide using [14C]-cyanamide revealed that radioactivity was found only in liver and excretion was primarily via urine. The time course of plasma concentration was determined following oral administration of 7 mg calcium cyanamide/kg bw to rats. Peak plasma cyanamide concentration was achieved 60 minutes after administration and plasma elimination half-life was 92.4 minutes. Calcium cyanamide inhibits aldehyde dehydrogenase in vitro and is used as a drug in the treatment of alcoholism. No indication for bioaccumulation or sex-difference in toxicokinetic were found.
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