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Diss Factsheets
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EC number: 226-218-8 | CAS number: 5329-14-6
- 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:
- 70.5 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:
- 1 763.2 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- using bioavailability of 10% for the oral and 10% for the inhalation route and assuming that rat oral and inhalation absorptions are equal to human oral and inhalation absorption, a NOAEC corr of 1000 mg/kg/day / 0.38 m³/kg * 6.7/10 * 10/10 = 1763.2 mg/m³ is used.
- AF for dose response relationship:
- 1
- Justification:
- not required, starting point is NOAEL/NOAEC
- AF for differences in duration of exposure:
- 2
- Justification:
- due to subchronic study data used
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not required due to route-to-route extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- for worker, a default AF of 5 is to be used
- AF for the quality of the whole database:
- 1
- Justification:
- not required, as supporting studies for the oral NOAEL are available
- AF for remaining uncertainties:
- 1
- Justification:
- not required
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10 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:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- using bioavailability of 10% for the oral and 10% for the dermal route and assuming that rat oral and dermal absorptions are equal to human oral and dermal absorption, thus the corrected dermal NOAEL is 1000 mg/kg/day based on the oral NOAEL of 1000 mg/kg bw/d derived from subchronic studies.
- AF for dose response relationship:
- 1
- Justification:
- not required, starting point is NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- due to subchronic study data used
- 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:
- for worker, a default AF of 5 is to be used
- AF for the quality of the whole database:
- 1
- Justification:
- not required, as supporting studies for the oral NOAEL are available
- AF for remaining uncertainties:
- 1
- Justification:
- not required
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
Several subchronic toxicity studies are available, all with oral exposure.
Whereas Donaubauer 1984 reported a NOAEL of 1000 mg/kg bw/d (929 mg/kg bw/d for males and 1004 mg/kg bw/d for females) in a feeding study with 90 days exposure period, Gupta et al. 1979 reported a NOEL of 500 mg/kg bw/d for ammonium sulphamate which was the highest dose tested in this study. Ambrose et al. 1943 investigated sulphamic acid in a feeding study with 105 days of exposure and the NOAEL was set to 600 mg/kg bw/d with effects only on growth rate seen at 1500 mg/kg bw/d. When dosing ammonium sulphamate rather than sulfamic acid, similar effects but to a lesser extent were seen at the same doses (calculated as sulfamic acid).
In a 2-week range finding study with female rats up to 1000 mg/kg bw/d dosed, one animal in the 1000 mg/kg bw/d dose was found dead. This study was gavage dosed and gastro-intestinal lesions were observed as well as hepatic changes (liver partly pale). This may have occurred due to a dosing injury effect by gavage as no other effects were seen and the other two animals of the dose group had shown no such effects. Thus, the NOAEL of 300 mg/kg bw/d in this study should be seen with caution and is disregarded here.
Although in the OECD 414 study slight growth reduction was observed at 600 mg/kg bw/d in parental animals when dosed for 14 days (GD 6-19) such effects were also observed in the subchronic studies at higher doses only.
Considering all studies in a weight of evidence, the subchronic NOAEL of 1000 mg/kg bw/d from the key study (Donaubauer, 1984) appears best suited to derive DNELs for long-term exposure, considering exposure time and reliability of the study and also considering consistency with the remaining supportive studies.
Although sulfamic acid is a very strong acid (negative pKa) it was shown not to be corrosive to skin. When tested in vivo only mild skin and eye irritation was observed. Only when tested to abraded skin stronger irritation response was observed. Thus, the skin barrier seems to be efficient and stable towards sulfamic acid and absorption via skin is low.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 17.4 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:
- 869.6 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- using bioavailability of 10% for the oral and 10% for the inhalation route and assuming that rat oral and inhalation absorptions are equal to human oral and inhalation absorption, a NOAEC corr of 1000 mg/kg/day / 1.15 m³/kg * 10/10 = 869.6 mg/m³ is used.
- AF for dose response relationship:
- 1
- Justification:
- not required, starting point is NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- due to subchronic study data used
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not required due to route-to-route extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor for remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- for consumer, a default AF of 10 is to be used
- AF for the quality of the whole database:
- 1
- Justification:
- not required, as supporting studies for the oral NOAEL are available
- AF for remaining uncertainties:
- 1
- Justification:
- not required
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5 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:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- using bioavailability of 10% for the oral and 10% for the dermal route and assuming that rat oral and dermal absorptions are equal to human oral and dermal absorption, thus the corrected dermal NOAEL is 1000 mg/kg/day based on the oral NOAEL of 1000 mg/kg bw/d derived from subchronic studies.
- AF for dose response relationship:
- 1
- Justification:
- not required as NOAEL is used
- AF for differences in duration of exposure:
- 2
- Justification:
- due to subchronic study data used
- 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:
- 10
- Justification:
- for consumer, a default AF of 10 is to be used
- AF for the quality of the whole database:
- 1
- Justification:
- not required, as supporting studies for the oral NOAEL are available
- AF for remaining uncertainties:
- 1
- Justification:
- not required
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5 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:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No route to route extrapolation applied
- AF for dose response relationship:
- 1
- Justification:
- not required as NOAEL is used
- AF for differences in duration of exposure:
- 2
- Justification:
- due to subchronic study data used
- 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:
- 10
- Justification:
- for consumer, a default AF of 10 is to be used
- AF for the quality of the whole database:
- 1
- Justification:
- not required, as supporting studies for the oral NOAEL are available
- AF for remaining uncertainties:
- 1
- Justification:
- not required
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
Several subchronic toxicity studies are available, all with oral exposure.
Whereas Donaubauer 1984 reported a NOAEL of 1000 mg/kg bw/d (929 mg/kg bw/d for males and 1004 mg/kg bw/d for females) in a feeding study with 90 days exposure period, Gupta et al. 1979 reported a NOEL of 500 mg/kg bw/d for ammonium sulphamate which was the highest dose tested in this study. Ambrose et al. 1943 investigated sulphamic acid in a feeding study with 105 days of exposure and the NOAEL was set to 600 mg/kg bw/d with effects on growth rate seen at 1500 mg/kg bw/d. When dosing ammonium sulphamate rather than sulfamic acid, similar effects but to a lesser extent were seen at the same doses (calculated as sulfamic acid).
In a 2-week range finding study with female rats up to 1000 mg/kg bw/d dosed, one animal in the 1000 mg/kg bw/d dose was found dead. This study was gavage dosed and gastro-intestinal lesions were observed as well as hepatic changes (liver partly pale). This may have occurred due to a dosing injury effect by gavage as no other effects were seen and the other two animals of the dose group had shown no such effects. Thus, the NOAEL of 300 mg/kg bw/d in this study should be seen with caution and is disregarded here.
Although in the OECD 414 study slight growth reduction was observed at 600 mg/kg bw/d in parental animals when dosed for 14 days (GD 6-19) such effects were also observed in the subchronic studies at higher doses only.
Considering all studies in a weight of evidence, the subchronic NOAEL of 1000 mg/kg bw/d from the key study (Donaubauer, 1984) appears best suited to derive DNELs for long-term exposure, considering exposure time and reliability of the study and also considering consistency with the remaining supportive studies.
Although sulfamic acid is a very strong acid (negative pKa) it was shown not to be corrosive to skin. When tested in vivo only mild skin and eye irritation was observed. Only when tested to abraded skin stronger irritation response was observed. Thus, the skin barrier seems to be efficient and stable towards sulfamic acid and absorption via skin is low.
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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