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EC number: 209-813-7 | CAS number: 593-85-1
- 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

Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.31 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 82.9 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- 8 h exposure time, extrapolation from 50 % bioavailability oral to 100 % bioavailability inhalation, no inhalation study available
- AF for dose response relationship:
- 1
- Justification:
- not required, starting point is NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- extrapolation from sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- allometric scaling is already applied in route-to-route extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- default factor for worker
- AF for the quality of the whole database:
- 1
- Justification:
- not required
- AF for remaining uncertainties:
- 1
- Justification:
- not required
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 9.93 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 8.33
- DNEL extrapolated from long term DNEL
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 82.9 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- 15 min. exposure time, extrapolation from DNEL systemic long term based on Haber's law.
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.88 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 188 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- extrapolation from 50 % bioavailability oral to 25 % bioavailability dermal, no dermal study available
- AF for dose response relationship:
- 1
- Justification:
- starting point is NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Extrapolation from subchornic to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric scaling factor rat-human
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- default for worker
- AF for the quality of the whole database:
- 1
- Justification:
- not required
- AF for remaining uncertainties:
- 1
- Justification:
- not required
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - workers
As Guanidine is the major component for systemic toxicity, the fractions of carbonate and chloride are not taken into account. Based on the molecular weight, following conversion factor is derived to extrapolate NOAELs from Guanidine chloride to Guanidine carbonate:
- Fraction of Guanidine in Guanidine carbonate = (2 x59.0715)/180.167 = 0.66.
- Fraction of Guanidine in Guanidine chloride =59.0715/95.5324= 0.62
- Conversion factor from Guanidine chloride to Guanidine carbonate = 0.62/0.66 =0.94.
For the subchronic oral NOAEL, following corrections are therefore applied:
- NOAEL systemic: 100 mg/kg x 0.94 = 94 mg/kg
For the modification of systemic long term NOAELs, following absorption rates are applied :
- Inhalation: 100 % (worst case assumption)
- Oral: 50% (this can be considered as a conservative value, based on the comparison between the LD50subcutaneous versus oral in rats for Guanidine, which is at least 3 times lower); currently in the dossier 50% absorption after oral application was described.
- Dermal: 25% (this can be considered as a conservative value, based on the comparison between the LD50oral versus dermal in rats for Guanidine carbonate and Guanidine chloride, which is at least 2 times lower).
For theroute-to-route extrapolation, following modifications are therefore proposed based on the above differences in absorption:
- For inhalation long term DNELS: oral NOAEL :2
- For dermal long term DNELS: oral NOAEL x2
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.82 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 40.9 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- 8 h exposure time, extrapolation from 50 % bioavailability oral to 100 % bioavailability inhalation, no inhalation study available
- AF for dose response relationship:
- 1
- Justification:
- not required, starting point is NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- extrapolation from subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- allometric scaling is already applied in route-to-route extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor for remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- default factor for the general population
- AF for the quality of the whole database:
- 1
- Justification:
- not required
- AF for remaining uncertainties:
- 1
- Justification:
- not required
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.46 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 16.7
- DNEL extrapolated from long term DNEL
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 40.9 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- 15 min. exposure time, extrapolation from DNEL systemic long term based on Haber's law.
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.94 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 188 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- extrapolation from 50 % bioavailability oral to 25 % bioavailability dermal, no dermal study available
- AF for dose response relationship:
- 1
- Justification:
- not required, starting point is NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Extrapolation from subchronic to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default factor rat-human
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor for remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- default factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- not required
- AF for remaining uncertainties:
- 1
- Justification:
- not required
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.47 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 94 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- no route to route extrapolation required
- AF for dose response relationship:
- 1
- Justification:
- not required
- AF for differences in duration of exposure:
- 2
- Justification:
- Extrapolation from subchronic to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default factor rat-human
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor for remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- default factor general population
- AF for the quality of the whole database:
- 1
- Justification:
- not required
- AF for remaining uncertainties:
- 1
- Justification:
- not required
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.41 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 66.7
- DNEL extrapolated from long term DNEL
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 94 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- extrapolation from DNEL systemic long term based on Haber's law.
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - General Population
As Guanidine is the major component for systemic toxicity, the fractions of carbonate and chloride are not taken into account. Based on the molecular weight, following conversion factor is derived to extrapolate NOAELs from Guanidine chloride to Guanidine carbonate:
- Fraction of Guanidine in Guanidine carbonate = (2 x59.0715)/180.167 = 0.66.
- Fraction of Guanidine in Guanidine chloride =59.0715/95.5324= 0.62
- Conversion factor from Guanidine chloride to Guanidine carbonate = 0.62/0.66 =0.94.
For the subchronic oral NOAEL, following corrections are therefore applied:
- NOAEL systemic: 100 mg/kg x 0.94 = 94 mg/kg
For the modification of systemic long term NOAELs, following absorption rates are applied :
- Inhalation: 100 % (worst case assumption)
- Oral: 50% (this can be considered as a conservative value, based on the comparison between the LD50subcutaneous versus oral in rats for Guanidine, which is at least 3 times lower); currently in the dossier 50% absorption after oral application was described.
- Dermal: 25% (this can be considered as a conservative value, based on the comparison between the LD50oral versus dermal in rats for Guanidine carbonate and Guanidine chloride, which is at least 2 times lower).
For theroute-to-route extrapolation, following modifications are therefore proposed based on the above differences in absorption:
- For inhalation long term DNELS: oral NOAEL :2
- For dermal long term DNELS: oral NOAEL x2
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.
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