Calcium cyanamide

Health surveillance data

Administrative data

Endpoint:

health surveillance data

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Arbeitsmedizinische Untersuchungen an Kollektiven von Beschäftigten einer Kalkstickstofffabrik

Author:

Mertschenk B. et al.

Year:

1991

Bibliographic source:

Zentralbl Arbeitsmed Arbeitsschutz 41: 107– 119

Materials and methods

Study type:

health record from industry

Endpoint addressed:

skin sensitisation

respiratory sensitisation

repeated dose toxicity: inhalation

repeated dose toxicity: dermal

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

- Principle of test: Exposure of humans in calcium cyanamide production plant.
- Short description of test conditions: Two groups (I and II) of approximately 30 workers employed in the calcium cyanamide production units and associated area of SKW Trotsberg AG were investigated in an occupational health study. Hands of each test workers were tested for hand contamination after working for 6 hours. Also, urinary acetylcyanamide (main urinary metabolite of cyanimide) was examined in test workers from group II. These persons also participated in medical and clinical examinations.
- Parameters analysed / observed: The health status of the workers via extensive medical and clinical examinations, urinary excretion of acetylcyanamide, hand contamination

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)

Method

Type of population:

occupational

Ethical approval:

not specified

Details on study design:

- Two groups (I and II) of approximately 30 workers employed in the calcium cyanamide production units and associated area of SKW Trostberg AG were selected for an occupational health study:
Group I: 32 persons (males) took part in the examinations, 22 calcium cyanamide production workers (exposed) and 10 workers who were not assigned to the calcium cyanamide production unit.
Group II: 30 workers from SKW Trostberg AG took part in the study.
- The total duration of employment in the plant in Group I was between 1.5 and 35 years, workers were between 19 – 52 years old.
In Group II the total duration of employment in the plant was not specified but age of workers ranged from 22 and 57 years old
- In Group I workplace concentrations of calcium cyanamide were estimated through hand contamination examinations. After an average work period of 6 hours, the workers washed their hands in one litre of a 0.1% Tween 20 solution. The washing water was collected and used for the analytical detection of cyanamide by means of HPLC following derivation with 1,2 naphthoquinone-4 sulphonate. Dermal cyanamide exposure measured for each worker range from 0.2 to 139.7 mg/m³ per pair of hands)
In Group II to gain an impression of the cyanamide volumes absorbed at different workplaces urinary acetyl cyanamide which is the main metabolite of cyanamide in human was examined before and after an 8-hour working period
- In Group I the cohort was divided into 2 groups for the examinations: workers exposed to calcium cyanamide (n=22) and workers no exposed to calcium cyanamide (n=10).
In Group II the cohort was not divided into different groups
- In group I health status of the workers were examined via allergological examinations (e.g. hypersensitiy tests to cyanamide) and clinical examinations (e.g. ECG, blood pressure measurement, liver size and consistency measurements and urine examinations)
In group II health status of the workers were examined via biochemical and clinical examinations (e.g. blood pressure measurement, urine examinations)

Results and discussion

Results:

- Group I:
The study did not provide evidence of adverse effects on health or disorders caused by calcium cyanamide in relation to exposure (workplace concentration between 0.2 to 139.7 mg/m³ per pair of exposed worker hands).
Furthermore, a toxic reaction (temporary redness of the skin in cases of existing neuro dermatitis) to patch test was observed in two cases, although there no changes to the skin in the area where plasters were applied which would have indicated an allergic reaction (antigen-antibody reaction). Thyroid function parameters (T3, T4, TSH) were reported for each worker although no summary measures were reported. The authors stated that the clinical and biochemical findings were found to be “in line with the findings for the general population.”
- Group II
The study did not provide evidence of adverse effects on health or disorders caused by calcium cyanamide in relation to exposure. All clinical and biochemical values were in the line with findings for the general population.´

Any other information on results incl. tables

This study had some limitations. The authors did not report information regarding when thyroid function was measured (for example before or after the work shift). No clinical measures were available from the time when employment began to see if changes in thyroid function parameters had occurred since exposure began. The authors did not provide reference values for the thyroid function parameters, and such values would be useful to interpret whether any individual worker had values that were outside the range of normal laboratory reference range values. Although there were no obvious links between thyroid function and measurements of cyanamide based on dermal exposure; however, statistical testing for differences was not conducted. Among the 10 workers with indirect exposure, dermal exposure ranged from 0.6 to 139.7 mg cyanamide per pair of hands (median 4.5 mg), there were no obvious differences in thyroid function from what would be reported in the general population (assuming the laboratory reference ranges from the separate study of workers at the facility were applicable).

Applicant's summary and conclusion

Conclusions:

In this study, the examinations of both groups did not give any indication of an increasing number of certain diseases. Adverse effects on health were not observed among workers in the calcium cyanamide production units and associated area of SKW Trostberg AG. Furthermore, no case of confirmed or suspected allergy to cyanamide was found.

Executive summary:

Two groups (I and II) of approximately 30 workers employed in the calcium cyanamide production units and associated area of SKW Trostberg AG were investigated in an occupational health study:

In the first group health status of 32 persons who took part in the examinations, 22 calcium cyanamide production workers (exposed) and 10 workers who were not assigned to the calcium cyanamide production unit was determined. Group I workers were between 19 – 52 years old and had been working in the plant between 5 and 35 years. The plant workers revealed more or less pronounced contamination of their hands (0.2 to 139.7 mg/m³ per pair of hands). From this, absorption of cyanamide can be concluded. The group did not report evidence of adverse effects on health or disorders by calcium cyanamide in relation to exposure. Furthermore, a toxic reaction l (temporary redness of the skin in cases of existing neuro dermatitis) to patch test was observed in two cases, although there no changes to the skin in the area where plasters were applied which would have indicated an allergic reaction (antigen-antibody reaction). Thyroid function parameters (T3, T4, TSH) were reported for each worker although no summary measures were reported. The authors stated that the clinical and biochemical findings were found to be “in line with the findings for the general population.” This study had some limitations. The authors did not report information regarding when thyroid function was measured (for example before or after the work shift). No clinical measures were available from the time when employment began to see if changes in thyroid function parameters had occurred since exposure began. The authors did not provide reference values for the thyroid function parameters, and such values would be useful to interpret whether any individual worker had values that were outside the range of normal laboratory reference range values. Although there were no obvious links between thyroid function and measurements of cyanamide based on dermal exposure; however, statistical testing for differences was not conducted. Among the 10 workers with indirect exposure, dermal exposure ranged from 0.6 to 139.7 mg cyanamide per pair of hands (median 4.5 mg), there were no obvious differences in thyroid function from what would be reported in the general population (assuming the laboratory reference ranges from the separate study of workers at the facility were applicable.

In the second group, to gain an impression of the cyanamide volumes absorbed at different workplaces, health status and urinary acetyl cyanamide (main metabolite of cyanamide in human) was examined in 30 workers from SKW Trostberg AG before and after an 8-hour working period. Group II workers were between 22 and 57 years old, the authors did not specify workers total duration of employment in the plant. In the second group workers did not show evidence of adverse effects on health or disorders caused by exposure to calcium cyanamide. All clinical and biochemical values were in the line with findings for the general population.

To summarize the examinations of both groups did not give any indication of an increasing number of certain diseases. This results also includes observations dealing with the question of potential sensitising properties of cyanamide. No case of confirmed or suspected allergy to cyanamide was found.