Calcium cyanamide

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:

1962

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

Test material information

Constituent 1

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

impurity 1

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

impurity 2

Reference substance name:

Carbon

EC Number:

231-153-3

EC Name:

Carbon

Cas Number:

7440-44-0

Molecular formula:

C

IUPAC Name:

carbon

impurity 3

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

impurity 4

Reference substance name:

Urea

EC Number:

200-315-5

EC Name:

Urea

Cas Number:

57-13-6

Molecular formula:

CH4N2O

IUPAC Name:

urea

impurity 5

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

impurity 6

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

impurity 7

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

impurity 8

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

impurity 9

Reference substance name:

Cyanoguanidine

EC Number:

207-312-8

EC Name:

Cyanoguanidine

Cas Number:

461-58-5

Molecular formula:

C2H4N4

IUPAC Name:

2-cyanoguanidine

impurity 10

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

impurity 11

Reference substance name:

unknown

IUPAC Name:

unknown

Test material form:

solid: particulate/powder

Details on test material:

Kalkstickstoff (calcium cyanamide, technical grade)

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.