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EC number: 258-061-6 | CAS number: 52636-67-6
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study with a structur analogous substance. For read-across justification please refer to IUCLID section 13.
Data source
Reference
- Reference Type:
- publication
- Title:
- Toxicological studies of ammonium sulfamate in rat after repeated oral administration
- Author:
- Gupta, B.N., Khanna, R.N., Datta, K.K.
- Year:
- 1 979
- Bibliographic source:
- Toxicology, 13, 45-49
Materials and methods
- Principles of method if other than guideline:
- 90-day oral administration of the test item
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Ammonium sulphamidate
- EC Number:
- 231-871-7
- EC Name:
- Ammonium sulphamidate
- Cas Number:
- 7773-06-0
- Molecular formula:
- H3NO3S.H3N
- IUPAC Name:
- ammonium sulfamate
- Reference substance name:
- Ammonium sulphamate
- EC Number:
- 237-372-0
- EC Name:
- Ammonium sulphamate
- Cas Number:
- 13765-36-1
- Molecular formula:
- H3NO3S.xH3N
- IUPAC Name:
- ammonium sulfamate
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): Ammonium sulfamate
- Molecular formula: H6N2O3S
- Molecular weight: 114.125 g/mol
- Smiles notation: [O-]S(=O)(=O)N.[NH4+]
- InChl: 1S/H3NO3S.H3N/c1-5(2,3)4;/h(H3,1,2,3,4);1H3
- Substance type: salt formed from ammonia and sulfamic acid
- Physical state: chrystalline
- Analytical purity: 99 %
- Impurities: moisture: 0.5 %, iron: 100 ppm
- Solubility: extremely soluble in water and moderatly soluble in glycerol, glycol and formamide
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: ITRC animal house colony
- Weight at study initiation: 170-200 g
- Housing: 2 animals per cage
- Diet: Standard diet ad libitum
- Water: Tap water ad libitum
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Justification for use and choice of vehicle: water
- Concentration in vehicle: 100 mg/mL in distilled water - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- Once a day
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100, 250, 500 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 20
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Post-exposure recovery period in satellite groups: 30, 60 and 90 day post feeding
- Section schedule: 6 rats of each dose group on day 30, 60 and 90 post feeding - Positive control:
- none
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
BODY WEIGHT: Yes
- Time schedule for examinations: twice weekly during the first two month and once a week in the third month
FOOD CONSUMPTION: Yes
- Time schedule for examinations: prior to weighing: twice weekly during the first two month and once a week in the third month
WATER CONSUMPTION: Yes
- Time schedule for examinations: prior to weighing: twice weekly during the first two month and once a week in the third month
HAEMATOLOGY: Yes
- Time schedule for collection of blood: on day of sacrifice
- Anaesthetic used for blood collection: Yes, anaesthetic ether
- Animals fasted: No data
- How many animals: all animals
- Parameters checked: hemoglobine concentration, packe dcell volume, total red cell count, total and differential white cell counts.
CLINICAL CHEMISTRY: No data - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, of heart, liver, stomach, spleen, kidneys, thyroid, adrenal glands, gonads, intestine, lung, lymph nodes
HISTOPATHOLOGY: Yes, of heart, liver, stomach, spleen, kidneys, thyroid, adrenal glands, gonads, intestine, lung, lymph nodes
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- lesser weight gain in group 4 (500 mg/kg bw/day)
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Description (incidence and severity):
- water consumption increased generally in all groups. weanlings in group 4 (500 mg/kg bw/day), both male and female, consumed significantly more than controls
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- non-significant increase in the neutrophils in the adults and male weanling rats in group 4 (500 mg/kg bw/day)
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- liver of 1 rat in group 4 (500 mg/kg bw/day) showed slight fatty degerative changes in the hepatic cytoplasm after 90 days
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- Throughout the test period, the general condition and health of all rats appeared good. However, one rat each from the adult (group 3) and one male weanling (group 4) died on day 64 and day 76 of the experiment, repsectively, due to bronchopneumonia.
No significant difference in mean body weight. Food intake relative to body weight gradually decreased in all groups of rats during the study, with no significant difference in case of adults. Food intake was significantly less (P<0.05) by the weanlings in group 4 (500 mg/kg bw/day). Adult rats of group 4 began to lag behind in weight gain after 45-day period. By end of the study period, the body weight of group 4 was significantly (P<0.05) less than the weight of controls. The weanlings of group 4, both males and females) consumed significantly (P<0.01) more water than the controls. Although there was no difference in food or water intage by group 4, this group showed lesser weight gain compared with all other groups.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: No adverse effects observed.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
The authors note that increase in water intake along with decrease in food intake relative to body weight without any change in the growth rate of the weanlings in group 4 (500 mg/kg bw/day), may be as a result of changes in the acid-base balance in the organisms resulting from the exposure to ammonium sulfamate. The authors anticpate that ammonium sulfamate readily dissociates in the body to form the ammonium and sulfamic acid ions.
Applicant's summary and conclusion
- Conclusions:
- A NOAEL of 500 mg/kg bw/day appears appropriate given the differences observed between groups.
- Executive summary:
A 90-day study on adult female rats and male/female weanlings was conduced with dosing (via water) at 0 (group 1), 100 (group 2), 250 (group 3) and 500 mg/kg (group 4) of ammonium sulfamate 6 days a week. No adverse effect was observed regarding appearance, behaviour or survival of animals. In the case of adult rats (group 4), the body weight was significantly less than the controls after the end of 60 days. No significant change in relative organ weights were observed. Haematological examination conducted revealed non-significant increase in the neutrophils in the adults and male weanling rats (group 4) after 90 days. Histological examination found the liver of 1 rat in adults (group 4) to have slight fatty degenerative changes after 90 days.
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