Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 200-002-3 | CAS number: 50-01-1
- 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:
- 1984-01-19 to 1984-02-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: EPA TS-792 Acute exposure, oral toxicity. Health effects test guidelines, EPA, August 1982; EPA 560/6-82-001
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
Constituent 1
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, Fremont, CA
- Weight at study initiation: 150 – 255 g
- Fasting period before study: yes, over night
- Housing: individually
- Diet (e.g. ad libitum): Certified Purina Rodent Chow Diet 5062, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 11 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23.2°C to 25°C
- Humidity (%): 40 to 53%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: no data
- Amount of vehicle (if gavage): 0.74-1.02 mL/animal in males, 0.59-0.74 mL/animal in females
- Justification for choice of vehicle: test substance is soluble in water - Doses:
- 0, 278, 360, 464, 600, 775 mg/kg bw (expressed as active ingredient Guanidine), corresponding to 0, 453.14, 756.32, 978, 1263.25 mg/kg bw Guanidine hydrochloride
- No. of animals per sex per dose:
- 9 in treated groups; 5 in vehicle control and cage control
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical signs, mortality: after 2 and 4 h, daily thereafter
Body weight: twice weekly
- Necropsy of survivors performed: yes; completet gross necropsy
- Other examinations performed: histopathology of CNS for animals with neurological symptoms - Statistics:
- Probit analysis
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 556.5 mg/kg bw
- Based on:
- other: Guanidine
- 95% CL:
- 492.3 - 630.9
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 474.6 mg/kg bw
- Based on:
- other: Guanidine
- 95% CL:
- 402 - 562.7
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 907.1 mg/kg bw
- Based on:
- test mat.
- Remarks:
- Guanidine hydrochloride
- 95% CL:
- 802.45 - 1 028.4
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 773.6 mg/kg bw
- Based on:
- test mat.
- Remarks:
- Guanidine hydrochloride
- 95% CL:
- 655.3 - 917.2
- Mortality:
- - vehicle control: 0/5 males, 0/5 females died
- cage control: 0/5 males, 0/5 females died
- 278 mg/kg bw: 0/9 males, 0/8 females died
- 360 mg/kg bw: 0/9 males, 2/8 females died
- 464 mg/kg bw: 2/9 males, 5/9 females died
- 600 mg/kg bw: 5/9 males, 4/7 females died
- 775 mg/kg bw: 9/9 males, 9/9 females died
(reduced total numbers are due to misdosing; those animals were removed from the study) - Clinical signs:
- other: most frequent clinical signs: - central nervous system-neuromuscular disturbances at all dose groups( 80 of 86 animals) - increased startle reflex, hyperactivity, and disorientation up to 464 mg/kg bw, recovery within one week - in the two higher dose gr
- Gross pathology:
- - no test compound-related lesions in the CNS (gross and light microscopic examination)
- the only test compound-related findings were in the gastrointestinal tract (black/serosanguinous material in the stomach, focal depression in the glandular mucosa of the stomach, black and diffuse red areas in the glandular mucosa of the stomach, black and tarry material in the intestine, black and tarry feces)
- in surviving animals no test compound-related gross lesions were reported; 2 male and 1 female rats had a unilateral dilated renal pelvis, which is considered incidential - Other findings:
- - Histopathology:
Several rats exhibited central nervous system (CNS) signs. Some rats that exhibited CNS signs died and some others survived. The cerebrum, brainstem and cerebellum of 4 animals died were examined by light microscopy and no lesions were observed.
Any other information on results incl. tables
Sex Endpoint Effect level 95% CL
male LD10 441.8 mg/kg bw (Guanidine base) 326.3 — 497.9
female LD10 321.4 mg/kg bw (Guanidine base) 209.1 — 383.9
male LD90 701.1 mg/kg bw (Guanidine base) 621.1 — 956
female LD90 700.8 mg/kg bw (Guanidine base) 584.8 — 1089.9
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The oral LD50 for Guanidine hydrochloride in rats was 907.1 mg/kg bw (95% c.i. 802.45 - 1028.4) in males and 773.6 mg/kg bw (95% c.i 655.3 - 917.2) in females. Thus, Guanidine hydrochloride has to be classified for Acute oral toxicity, Category 4.
- Executive summary:
In an acute oral toxicity study similar to OECD guideline 401, groups of fasted Sprague-Dawley rats (9/sex) were given a single oral dose of Guanidine hydrochloride (>98% purity, 61.8% base equivalent Guanidine) in water at doses of 0, 278, 360, 464, 600 and 775 mg/kg bw (expressed as Guanidine base), corresponding to 0, 453.14, 756.32, 978, 1263.25 mg/kg bw Guanidine hydrochloride and observed for 14 days.
No mortality occurred in the lowest dose group. 0/9 males, 2/8 females in the 360 mg/kg bw dose group died; 2/9 males, 5/9 females in the 464 mg/kg bw dose group; 5/9 males, 4/7 females in the 600 mg/kg bw dose group and 9/9 males, 9/9 females in the 775 mg/kg bw dose group. Reduced total numbers are due to misdosing; those animals were removed from the study.
Clinical signs were observed in the CNS (increased startle reflex, hyperactivity, and disorientation) and in the gastro-intestinal tract (hunched posture, increased salivation with some staining of the muzzle, and diarrhea) in all dose groups. However, there were no microscopic findings in cerebrum, brainstem and cerebellum of animals with CNS symptoms.
Gross pathology revealed black/serosanguinous material in the stomach, focal depression in the glandular mucosa of the stomach, black and diffuse red areas in the glandular mucosa of the stomach, black and tarry material in the intestine, black and tarry feces.
In the surviving animals no test compound-related gross lesions were reported.
Several rats exhibited central nervous system (CNS) signs. Some rats that exhibited CNS signs died and some others survived. The cerebrum, brainstem and cerebellum of 4 animals died were examined by light microscopy and no lesions were observed.
Oral LD50 Males = 556.5 mg Guanidine/kg bw (95% C.I. 492.3 - 630.9 mg/kg bw)
Oral LD50 Females = 474.6 mg Guanidine/kg bw (95% C.I. 402 - 562.7 mg/kg bw)
corresponding to:
Oral LD50 males = 907.1 mg/kg bw (95% c.i. 802.45 - 1028.4) Guanidine hydrochloride
Oral LD50 females = 773.6 mg/kg bw (95% c.i 655.3 - 917.2) Guanidine hydrochloride
Thus, Based on these data, Guanidine hydrochloride has to be classified for Acute toxicity, Category 4.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
This website uses cookies to ensure you get the best experience on our websites.
Find out more on how we use cookies.