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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January - November 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
no information on body weight changes, no raw data reported
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Cyanoguanidine
EC Number:
207-312-8
EC Name:
Cyanoguanidine
Cas Number:
461-58-5
Molecular formula:
C2H4N4
IUPAC Name:
1-cyanoguanidine
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS

- Age at study initiation: 8 weeks
- Weight at study initiation: males ca. 195 g, females ca. 131 g
- Diet (e.g. ad libitum): stock diet
- Water (e.g. ad libitum): tap water
- Housing: wire screen cages
- observation period: 14 days

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure chamber volume: 1.5 m³
- Method of holding animals in test chamber: animals were housed in wire screen cages
- Source and rate of air: filtered air, flow rate: 1m³/h
- System of generating particulates/aerosols: the powder was continuously dispersed in air by means of a "Wright" Dust Feed Mechanism at a rate of 6g/m³


TEST ATMOSPHERE
- Brief description of analytical method used: particle size determinations and counts were carried out in samples taken from the atmosphere in the chamber with a cascade impactor
- Particle size distribution: 99 % particke size range of 0.6 - 2.4 µm
- Concentration in air: 259 mg/m³ (maximum attainable concentration)
- Determination of concentration: gravimetrically by passing measured amounts of chamber air through glass fibre filters

Analytical verification of test atmosphere concentrations:
yes
Remarks:
Determination of concentration: gravimetrically by passing measured amounts of chamber air through glass fibre filters
Duration of exposure:
4 h
Concentrations:
259 mg/m³ (maximum attainable concentration)
No. of animals per sex per dose:
Five
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no data
- Other examinations performed: mortality, signs of intoxication
Statistics:
No data.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LC0
Effect level:
> 259 mg/m³ air
Exp. duration:
4 h
Mortality:
Mortality did not ocur either during exposure or during the subsequent 14-day observation period.
Clinical signs:
other: Signs of intoxication did not ocur either during exposure or during the subsequent 14-day observation period.
Body weight:
No data.
Gross pathology:
No data.
Other findings:
Other observations:
During the first quarter of an hour of the exposure period the rats showed slight restlessness; during the remaining part of the exposure period they were asleep.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
As a four-hour exposure of rats to a dispersion of Dicyandiamid at a maximum attainable concentration of 259 mg/m³ of air did not cause mortality or any noticeable deleterious effects, it can be concluded that the powder has a very low acute inhalation toxicity. It is not likely, therefore, that the substance at concentrations up to 259 mg/m³ will present acute inhalation hazard to man.
Executive summary:

The aim of this study was to determine the 4 -hour LC50 value of Dicyandiamid. Each five male and female rats were exposed to the test atmosphere generated by dispersing the powder continuously in air by means of a "Wright" Dust Feed Mechanism at a rate of 6 g/m³ for four hours (whole-body exposure) at an actual concentration of 259 mg/m³ (maximum attainable concentration).

The animals were observed for mortality and signs of intixication during exposure and daily thereafter for 14 days. Particle determination and counts in air samples revealed a 99 % particle size range of 0.6 - 2.4 µm.

The four-hour exposure of the rats to a dispersion of Dicyandiamid at a maximum attainable concentration of 259 mg/m³ of air did not cause mortality or any noticeable deleterious effects, it can be concluded that the powder has a very low acute inhalation toxicity. It is not likely, therefore, that the substance at concentrations up to 259 mg/m³ will present acute inhalation hazard to man.

The acute inhalation (4 hour) LC50 for Dicyandiamid in the rat is higher than 259 mg/m³.