Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1962
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
Data source
Reference
- Reference Type:
- publication
- Title:
- Evaluation of calcium carbimide in the treatment of alcoholism
- Author:
- Brunner-Orne M.
- Year:
- 1 962
- Bibliographic source:
- Journal of neuropsychiatry, 3, (1962): 163-167
Materials and methods
- Type of study / information:
- Efficacy clinical trial in volunteers
- Endpoint addressed:
- repeated dose toxicity: oral
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- - Principle of test: Efficacy study with 53 alcoholic patients who were administered Temposil (citrated calcium carbimide) orally.
- Short description of test conditions: Exposure of 53 alcoholic patients to Temposil were investigated in an efficacy study. Temposil was administrated orally once a day to the patients for 6 months.
- Parameters analysed / observed: The health status of patients was established via clinic-chemical examinations (e.g. blood pressure, Protein-Bound Iodine (PBI) tests and thyroid function examinations). - GLP compliance:
- no
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
- Specific details on test material used for the study:
- - Name in the study report: Temposil (calcium carbimide)
Method
- Ethical approval:
- confirmed, but no further information available
- Details on study design:
- - 53 alcoholic patients were selected to test Temposil efficacy, were investigated in a controlled clinical trial.
- The total duration of exposure was 6 months.
- The authors did not clearly state Temposil dosage. However, they reported that the drug was available for research purposes in 50 mg tablets and average dose is one tablet. Therefore, we assumed that patients were exposed to 50 mg Temposil/day via oral route
- The health status of patients was established via clinic-chemical examinations (e.g. blood pressure, Protein-Bound Iodine (PBI) tests and thyroid function examinations) - Exposure assessment:
- estimated
- Details on exposure:
- TYPE OF EXPOSURE: Oral
TYPE OF EXPOSURE MEASUREMENT: other: Patients took one tablet Temposil a day
EXPOSURE LEVELS: 50 mg/day
EXPOSURE PERIOD: 6 months
POSTEXPOSURE PERIOD: not specified
Results and discussion
- Results:
- The study provided no evidence of adverse health effects or disorders caused by exposure to citrated calcium carbide. There were no significant changes in protein bound iodine (PBI) tests (evaluated using the modified bark method) and no clinical observations of hypothyroidism in the 53 patients who received Temposil (citrated calcium carbide) orally (estimated 50 mg dose taken 1-2 times)
Applicant's summary and conclusion
- Conclusions:
- In this study, no adverse effects on health were observed among 53 alcoholic patients who received Temposil (citrated calcium carbimide) orally (assumed to be a tablet of 50 mg taken every day).
- Executive summary:
In an efficacy study, 53 alcoholics patients were orally exposed to 50 mg Temposil (citrated calcium carbamide) every day for 6 months. The health status of patients was established via clinic-chemical examinations (e.g. blood pressure). Thyroid functions were also examined via Protein-Bound Iodine (PBI) tests.
The study did not provide evidence of adverse effects on health or disorders caused by exposure to citrated calcium carbimide. There were no significant changes in Protein-Bound Iodine (PBI) tests (assessed using the Modified Barker Method) and no clinical observations of hypothyroidism among the 53 patients. The last results were not presented in the publication by the authors.
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.