Registration Dossier
Registration Dossier
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EC number: 207-312-8 | CAS number: 461-58-5
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- publication
- Title:
- Dicyanodiamide
- Author:
- DFG, Deutsche Forschungsgemeinschaft
- Year:
- 2 007
- Bibliographic source:
- The MAK-Collection PartI: MAK Value Documentations, Vol. 24
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Not specified in the assessment.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- 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: crystalline
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: 3% gum arabic solution
- Details on oral exposure:
- In the diet in concentrations of 0, 12500, 25000, 50000 and 100000 mg/kg diet corresponding to about 0, 570, 1250, 2600 and 5800 mg/kg body weight per day for males and 0, 700, 1500, 3000 and 6800 mg/kg body weight per day for females based on body weight
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- Daily
- Control animals:
- not specified
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- At 12500 mg/kg diet and above.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- At 12500 mg/kg diet and above.
- Food efficiency:
- effects observed, treatment-related
- Description (incidence and severity):
- At 12500 mg/kg diet and above.
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- At 12500 mg/kg diet and above.
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- At 12500 mg/kg diet and above.
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- At 12500 mg/kg diet and above.
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 570 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
Target system / organ toxicity
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 570 mg/kg bw/day (nominal)
- System:
- haematopoietic
- Organ:
- blood
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The NOAEL for the test substance in a 90-day feeding study in rats was 570 mg/kg bw/day.
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