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EC number: 208-060-1 | CAS number: 506-93-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984-02-29 to 1984-04-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
- Reference Type:
- publication
- Title:
- Acute Oral Toxicity of Guanidine Nitrate
- Author:
- Korte D W et al
- Year:
- 1 993
- Bibliographic source:
- International Journal of Toxicology, Vol. 12, No. 6, p.594-595
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Health effects test guidelines, August 1982, EPA 560/6-82-001
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Guanidinium nitrate
- EC Number:
- 208-060-1
- EC Name:
- Guanidinium nitrate
- Cas Number:
- 506-93-4
- Molecular formula:
- CH6N4O3
- IUPAC Name:
- amino(imino)methanaminium nitrate
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- water
- Reference substance name:
- Ammonium nitrate
- EC Number:
- 229-347-8
- EC Name:
- Ammonium nitrate
- Cas Number:
- 6484-52-2
- Molecular formula:
- H3N.HNO3
- IUPAC Name:
- Ammonium nitrate
- Reference substance name:
- 4,6-diamino-1,3,5-triazin-2(1H)-one
- EC Number:
- 211-455-1
- EC Name:
- 4,6-diamino-1,3,5-triazin-2(1H)-one
- Cas Number:
- 645-92-1
- Molecular formula:
- C3H5N5O
- IUPAC Name:
- 4,6-diamino-1,3,5-triazin-2(1H)-one
- Reference substance name:
- (4,6-Diamino-1,3,5-triazine-2-yl)guanidine
- Cas Number:
- 4405-08-7
- Molecular formula:
- C4H8N8
- IUPAC Name:
- (4,6-Diamino-1,3,5-triazine-2-yl)guanidine
- Reference substance name:
- Melamine
- EC Number:
- 203-615-4
- EC Name:
- Melamine
- Cas Number:
- 108-78-1
- Molecular formula:
- C3H6N6
- IUPAC Name:
- 1,3,5-triazine-2,4,6-triamine
- 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
impurity 1
impurity 2
impurity 3
impurity 4
impurity 5
impurity 6
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Bantin-Kingman Inc., Fremont, CA
- Age at study initiation: Males: 58 days at dosing - Females 33 to 41 days at dosing
- Weight at study initiation: Males 190 to 225 g at dosing - Females 140 to 174 g at dosing
- Fasting period before study: Males: not stated - Females: overnight
- Housing: individually in stainless steel wire mesh cages with automatically flushing dumptanks
- Diet: ad libitum: Certified Purina Rodent Chow No. 5002 (Ralston Purina Company, Checkerboard Square St. Louis, MD)
- Water: ad libitum: automatic lick dispensers
- Acclimation period: quarantine: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): different rooms: (22.8 to 25.0) or (20.6 to 22.8) or (22.2 to 26.7 with a temporary drop to 18.9)
- Humidity (%): different rooms: (44 to 52 with a temporary spike to 64) or (44 to 64 with a temporary spike to 74 or (32 to 44)
- Air changes (per hr): not described
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: Males from 1984-03-14 to 1984-03-28 - Females from: 1984-03-21 to: 1984-04-11
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Remarks:
- Tween® 80 + sterile water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0,2 % methylcellulose, 0,4 % Tween® 80 in sterile water for injection
- Amount of vehicle (if gavage): Males 1.9 to 2.6 ml - Females 1.2 to 1.8 ml for dosed animals
2.0 ml for all vehicle control group animals
- Justification for choice of vehicle: data not available
- Lot/batch no. (if required):
methylcellulose (Sigma, St. Louis, MO, Lot Number 72F-047B)
Tween® 80 (Fisher Scientific, Fairtown, NJ, Lot Number 713137)
sterile water for injection (Cutter Medical, Berkeley, CA, Lot Number 426-27, 13 Mar 84, Lot Number CH7936, 20 Mar 1984)
- Purity: data not available
MAXIMUM DOSE VOLUME APPLIED: 2.6 ml
DOSAGE PREPARATION (if unusual):
Depending upon the dose level, various amounts of Guanidine Nitrate were weighed in a Mettler AK 160 Electronic Balance and were added to 50 ml of the vehicle for males and 25 ml of the vehicle for females to yield the desired dosing concentration. Complete analyses of the dosing
solutions/suspensions was performed for homogeneity and verification of concentrations. - Doses:
- Males: 311 - 826 - 1000 - 1210 - 1470 mg/kg bw
Females: 610 - 718 - 847 - 1000 - 1180 - 1390 mg/kg bw - No. of animals per sex per dose:
- Total animals dosed: 108
Dosing groups: 10 animals per sex
Exception: Females lowest dose group: 8 animals - Control animals:
- yes
- Remarks:
- vehicle: 5 Males + 5 Females
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: weekly
- Necropsy of survivors performed: yes
- Other examinations performed: (1) clinical signs (2) body weight (3) histopathology
Details for clinical signs:
1.1 behaviour ( includes ataxia, disorientation, hyperactivity, jumping, irritableness, inactivity, changes in preening, prostrate condition,
aggressiveness, sonnolence, tremors, twitching)
1.2 gastrointestinal (includes increased salivation, material in mouth, diarrhea, perianal staining)
1.3 respiratory (includes reddish nasal discharge and stains on head, increase in respiratory rate, decrease in respiratory depth)
1.4 ocular (Includes reddish material around eyes (chromodacryorrhea), conjunctivitis)
1.5 rough coat
1.6 hunched posture
1.7 normal throughout - Statistics:
- Statistical analyses were performed on the study results. Selected lethal dose values were derived by probit analysis according to the maximum likelihood method. The program PROBIT, developed for the Data General Computer, Model MV8000, was used to determine the probit curve and lethal dose values.
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 989.6 mg/kg bw
- 95% CL:
- > 793 - < 1 138
- Remarks on result:
- other: LD50 = 989.6 +/- 68.7
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 729.8 mg/kg bw
- 95% CL:
- > 641 - < 799
- Remarks on result:
- other: LD50= 729.8 +/- 34.3
- Mortality:
- Forty-six (74 %) of the deaths occurred between 1 and 8 hours after dosing. An additional 13 (21 %} deaths occurred between 8 and 24 hours after dosing. Three animals were found dead on the morning of the second day (between 36 and 47 hours after dosing). Furthermore, 2 males and 1 female were inappropriately dosed resulting in latrogenic deaths. The remaining rats survived until completion of the study.
- Clinical signs:
- other: Guanidine nitrate produced clinical signs at each dose level. The most frequently observed signs were behavioral (63 of 99 animals dosed with test compound), gastrointestinal (GI) tract symptoms (37 of 99), and respiratory (26 of 99) signs. Most clinical
- Gross pathology:
- Latrogenic deaths due to oesophagal perforatin or tracheal tears and deposition of the test substance in the thorax occured in 2 males and 1 female. Thirteen females had multiple red foci on the thymus. None of the males had this lesion.
- Other findings:
- - Organ weights: not determined
- Histopathology: The presence of multiple red foci in the thymuses of the females was the only gross lesion which was attributable to the test compound. The presence of foci exhibited a dose-response relationship. The remainng lesions were considered incidential findings which are not compound related. No lesions were seen in the vehicle control animals.
Any other information on results incl. tables
Lethal dose values were calculated by probit analysis, and the equation for the probit regression line was:
Y = -19.6 + 8.2 log X for males and Y = -32.5 + 13.1 log X for females, where X is the dose and Y the corresponding probit value.
Misdosed animals were excluded from statistical analysis and eliminated from the study.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The LD50 values for Guanidine Nitrate were determined to be 989.6 +/- 68.7 mg/kg in male and 729.8 +/-34.3 mg/kg in female animals.
Guanidine Nitrate is classified with Hazard Category 4 for acute oral toxicity (harmful if swallowed). - Executive summary:
In an acute oral toxicity study according to the Health effects test guidelines, August 1982, EPA 560/6-82-001, groups of Sprague Dawley rats (10/sex) were given a single oral dose of guanidinte Nitrate (99.99 % a.i.) in methylcellulose, Tween® 80, sterile water at doses of 311, 826, 1000, 1210 and 1470 mg/kg bw (males) and 610, 718, 847, 1000, 1180 and 1390 mg/kg bw (females) and observed for 14 days.
Oral LD50 Males = 989.6 ± 68.7 mg/kg bw (95% C.I. > 793 - < 1138)
Females = 729.8 ± 34.3 mg/kg bw (95% C.I. > 641 - < 799)
65 animals died during the study, most of them during the first 8 hours after dosing. Weight gains of surviving animals were not significantly affected by dosing.
The primary category of clinical signs was behavioral (e.g., inactive, irritable, disoriented, hyperactive, ataxic) which was observed in 63 of 99 animals dosed with Guanidine Nitrate. Other categories of frequently observed clinical signs were gastrointestinal (e.g., material in mouth, perlanal staining, increased salivation, diarrhea) which was observed in 37 of 99 animals, and respiratory (e.g. reddish nasal discharge, increased rate and/or decreased depth of respiration) which was observed in 26 of 99 animals. These findings suggest that guanidine nitrate exhibits a primary effect on the central nervous / neuromuscular system.
The presence of multiple red foci in the thymuses of the females was dose related and the only gross lesion which was attributable to the test compound.
According to CLP, EU GHS (Regulation (EC) No 1272/2008), Guanidine Nitrate is classified with Hazard Category 4 for acute oral toxicity (harmful if swallowed). Findings may suggest that the guanidine ion exhibits a primary effect on the central nervous / neuromuscular system. However, effects were observed in the range of classification Hazard Category 4, therefore on the basis of available data no additional classification for STOT-SE is considered necessary. A sub-chronic repeated dose toxicity study is proposed, which will provide additional more detailed information for evaluation.
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