Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 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
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:
- key study
- Study period:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Peer-reviewed, non-GLP study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- not specified
- 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
- Test material form:
- solid: crystalline
- Details on test material:
- The ammonium sulfamate used was a white crystalline, hygroscopic, solid having the following characteristics: purity, 99%;moisture, 0.5%; iron, 100 ppm (maximum); m.p., 130°C; solubility, extremely soluble in water and moderately soluble in glycerol, glycol and formamide.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: ITRC derived albino
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- Continual (drinking water) 6 days/week
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
100 mg/kg/day
Basis:
nominal in water
- Remarks:
- Doses / Concentrations:
250 mg/kg/day
Basis:
nominal in water
- Remarks:
- Doses / Concentrations:
500 mg/kg/day
Basis:
nominal in water
- No. of animals per sex per dose:
- 20
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- Throughout the period of observation, the general condition and health of all rats remained apparently good.
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- One rat each from the adult (group 3) and male weanling (group 4) died on day 64 and day 76 of the experiment respectively due to bronchopneumonia.
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There was no significant difference in the mean body weight of control or treated animals during or at the end of observation period. However, adult rats of group 4 started to lag behind in weight gain after 45-day period. By the end of 90 days the body weight of this group was significantly (P < 0.05) less than the weight of the controls
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- In general the food intake relative to body weight gradually decreased in all groups of rats as the ex'periment progressed. While there was no noticeable difference in case of adults, the food intake was significantly (P < 0.05) less by the weanlings (group 4), both males and females, as compared to the controls (Table II).
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Description (incidence and severity):
- Water intake increased generally in all groups of rats. The weanlings (group 4), males as well as females, drank significantly (P< 0.01) more water than the controls
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- Haematological examination conducted at 30, 60 and 90 days revealed no significant changes.
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- There was no significant difference in the relative organ weights of all groups of animals as compared to controls.
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- In the histological examination, organs in all groups of animals appeared normal.
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- food consumption and compound intake
Target system / organ toxicity
- Key result
- Critical effects observed:
- not specified
- Lowest effective dose / conc.:
- 500 mg/kg bw/day (nominal)
- System:
- other:
- Organ:
- not specified
Any other information on results incl. tables
Mean values of body weights of rats given daily oral doses of 100-500 mg/kg of ammonium sulfamate for 90 days
|
||||||
Body weights are means of 20 rats on 1st, 15th and 30th day, 14 rats on 45th and 60thday and 8 rats on 90th day.
|
||||||
Dose level (mg/kg) |
Body weight (g) at day |
|||||
0a |
15 |
30 |
45 |
60 |
90 |
|
Adult females |
||||||
0 |
188 |
190 |
199 |
212 |
214 |
222 |
100 |
179 |
198 |
201 |
206 |
215 |
218 |
250 |
184 |
189 |
193 |
203 |
210 |
215b |
500 |
180 |
188 |
196 |
210 |
195c |
186c |
Weanling males |
||||||
0 |
47 |
94 |
141 |
168 |
178 |
212 |
100 |
37 |
89 |
135 |
159 |
177 |
206 |
250 |
40 |
87 |
140 |
165 |
169 |
209a |
500 |
38 |
92 |
133 |
155 |
180 |
216b |
Weanling females |
||||||
0 |
48 |
91 |
118 |
138 |
147 |
152 |
100 |
42 |
86 |
115 |
127 |
144 |
148 |
250 |
46 |
89 |
107 |
132 |
150 |
156 |
500 |
42 |
85 |
111 |
129 |
140 |
155 |
a First day of feeding. b Means of 7 rats. c Differ significantly from those of controls, P < 0.05. |
Mean values of food consumption of rats given daily oral doses of 100 -500mg/kg of ammonium sulfamate for 90 days |
||||||||
Food consumptions are means of 20 rats on1st, 15th and 30th day, 14 rats on 45th and 60th day and 8 rats on 90 th day. Food consumption was measured over the 24 -h period preceding the day shown.
|
||||||||
Dose level (mg/kg) |
Food consumption (g/rat/day) at day |
Mean food consumption (g/rat/day) |
||||||
0a |
15 |
30 |
45 |
60 |
75 |
90 |
||
Adult females |
||||||||
0 |
12.5 |
12.2 |
12 |
11.8 |
11.5 |
11 |
10.7 |
11.5 |
100 |
12 |
11.8 |
11.8 |
11.4 |
11 |
10.7 |
10.5 |
11.2 |
250 |
12.8 |
12.4 |
12 |
11.7 |
11.4 |
11 |
10.7 b |
11.5 |
500 |
12.6 |
12 |
11.7 |
11.5 |
11.5 |
11.1 |
10.8 |
11.4 |
Weanling males |
||||||||
0 |
14.2 |
14 |
13.8 |
13.5 |
13.5 |
13.1 |
13 |
13.5 |
100 |
14.5 |
14.2 |
13.9 |
13.6 |
13.1 |
12.8 |
12.8 |
13.4 |
250 |
14.8 |
14.5 |
14.2 |
13.9 |
13.5 |
13 |
12.6 |
13.6 |
500 |
14.6 |
14 |
12.5 |
10.2 |
8.5 |
6.3 |
5.4b |
9.5c |
Weanling females |
||||||||
0 |
13.5 |
13.1 |
12.8 |
12.6 |
12.2 |
12.2 |
11.9 |
12.5 |
100 |
13 |
13.4 |
13 |
12.6 |
12.3 |
11.8 |
11.5 |
12.4 |
250 |
13.6 |
13 |
12.7 |
12.5 |
12.2 |
12 |
12 |
12.4 |
500 |
13.2 |
12.8 |
11.5 |
10.1 |
9 |
8.6 |
6.8 |
9.8c |
aFirstday offeeding. b Meansof7rats. c Differsignificantlyfromthoseofcontrols,p<0.05.
|
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, the No Observed Adverse Effect Level (NOAEL) in rats exposed to the ammonium salt of sulphamidic acid orally for 90 days is 500 mg/kg bw/day.
- Executive summary:
A 90-day study involving administration of 0 (group 1), 100 (group 2), 250 (group 3) and 500 mg/kg (group 4) of ammonium sulfamate to rats 6 days a week was carried out. No adverse effect was observed in respect of appearance, behaviour or survival of animals. No significant difference in the body weights of rats was observed except in case of adult rats (group 4) where the body weight was significantly less than the controls after the end of 60 days. In all the groups, food intake gradually reduced whereas water intake increased as the experiment proceeded. No significant change in relative organ weights were noticed in all groups of rats. Haematological examination conducted at 30, 60 and 90 days revealed non-significant increase in the neutrophils in the adults and male weanling rats (group 4) after 90 days. In the histological examination, organs in all the groups of animals appeared normal except that the liver of 1 rat in adults (group 4) showed slight fatty degenerative changes after 90 days. The No Observed Adverse Effect Level (NOAEL) was 500 mg/kg bw/day.
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.