Cyanamide

Epidemiological data

Administrative data

Endpoint:

epidemiological data

Type of information:

other: review

Adequacy of study:

supporting study

Study period:

April 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

review article or handbook

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Study type:

other: review

Endpoint addressed:

repeated dose toxicity: oral

Test guideline

Qualifier:

no guideline required

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Cyanamide

EC Number:

206-992-3

EC Name:

Cyanamide

Cas Number:

420-04-2

Molecular formula:

CH2N2

IUPAC Name:

cyanamide

Test material form:

other: aqueous solution

Details on test material:

Different substances.
for this record of concern: COLME-Solution
equal to 6% aqueous solution of cyanamide

Method

Type of population:

other: mainly patients suffering from alcohl disease

Ethical approval:

other: Cyanamide is approved as deterrent for alcoholics. All results are taken form case reports in literature.

Results and discussion

Results:

Gloxhuber (2006; Doc. No. 581-011; MIIA 5.9.3/01) summarized and comprehensively evaluated the available literature in order to establish a NOAEL for human. As the evaluated reports on long-term effects were only suitable for a daily uptake of approx. 100 mg cyanamide, a NOAEL of 100 mg cyanamide/day was deduced, which corresponds to 1.4 mg cyanamide/kg bw/day under the prerequisite that the persons do not simultaneously consume alcohol (body weight 70 kg). Gloxhuber concluded that the intake of minor amounts (primarily via inhalation or percutaneous route), which might occur in agricultural or chemical production, can not be considered as harmful, even if the exposure lasts for a longer period of time. This conclusion is based on medical experience, provided that the absorbed quantities are below the limit doses used in the alcohol aversion therapy.

Applicant's summary and conclusion

Conclusions:

Gloxhuber summarized and comprehensively evaluated the available literature and established a NOAEL for human of approx. 100 mg cyanamide, which corresponds to 1.4 mg cyanamide/kg bw/day.

Executive summary:

Gloxhuber (2006; Doc. No. 581-011; MIIA 5.9.3/01) summarized and comprehensively evaluated the available literature in order to establish a NOAEL for human. As the evaluated reports on long-term effects were only suitable for a daily uptake of approx. 100 mg cyanamide, a NOAEL of 100 mg cyanamide/day was deduced, which corresponds to 1.4 mg cyanamide/kg bw/day under the prerequisite that the persons do not simultaneously consume alcohol (body weight 70 kg). Gloxhuber concluded that the intake of minor amounts (primarily via inhalation or percutaneous route), which might occur in agricultural or chemical production, can not be considered as harmful, even if the exposure lasts for a longer period of time. This conclusion is based on medical experience, provided that the absorbed quantities are below the limit doses used in the alcohol aversion therapy.