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EC number: 237-396-1 | CAS number: 13770-89-3
- 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:
- 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
- Reference Type:
- publication
- Title:
- Acute Oral Toxicity of Nickel Compounds
- Author:
- Henderson RG, Durando J, Oller A, Merkel DJ, Marone PA, and Bates HK.
- Year:
- 2 012
- Bibliographic source:
- Regul Toxicol and Pharmacol (doi.org/10.1016/j.yrtph.2012.02.002)
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- not specified
- Remarks:
- regarding limit test
- Principles of method if other than guideline:
- Not Applicable
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
Test material
- Reference substance name:
- Nickel bis(sulphamidate)
- EC Number:
- 237-396-1
- EC Name:
- Nickel bis(sulphamidate)
- Cas Number:
- 13770-89-3
- Molecular formula:
- Ni(NH2SO3)2
- IUPAC Name:
- nickel(2+) disulfamate
- Reference substance name:
- 124594-15-6
- Cas Number:
- 124594-15-6
- IUPAC Name:
- 124594-15-6
- Details on test material:
- - Name of test material (as cited in study report): Nickel sulfamate (nickel sulfamate tetrahydrate), Code #N104-PTL
- Physical state: green crystals
- Analytical purity: nickel sulfamate tetrahydrate 100%
- Storage condition of test material: under nitrogen
- Stability: expected to be stable for the duration of the testing
- Solubility: soluble in water
- Other: EPSL Reference Number 080707-38H
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Received from Ace Animals, Inc, Boyertown, PA
- Age at study initiation: young adult (9-12 weeks)
- Weight at study initiation: 175-231 grams
- Fasting period before study: overnight
- Housing: singly in suspended stainless steel caging with mesh floors; litter paper was placed beneath the cage and changed at least three times/week
- Diet (e.g. ad libitum): Purina Rodent Chow #5012
- Water (e.g. ad libitum): ad libitum, filtered tap supplied by an automatic water dispensing system
- Acclimation period: 10-30 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 56-86 (the humidity was above the targeted upper limit of 70% during the study due to exceptionally high, seasonal humidity; portable dehumidifiers were used to lower the humidity levels during this time)
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 60% w/w mixture in distilled water
- Other: preliminary solubility testing conducted by EPSL indicated that mixtures in excess of 60% were too viscous to be administered properly.
MAXIMUM DOSE VOLUME APPLIED:
- Individual doses were calculated based on the initial body weights, taking into account the specific gravity (determined by EPSL) and concentration of the test mixture.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: the Main Test was conducted using a default starting dose level of 175 mg/kg - Doses:
- A Main Test was conducted using a default starting dose level of 175 mg/kg; remaining doses were determined using the Up and Down procedure (a dose of 550 or 2000 mg/kg was administered to the remaining animals). The decision to proceed with the next animal was based on the survival of the previous animal following dosing.
- No. of animals per sex per dose:
- 175 mg/kg: 1 female
550 mg/kg: 3 females
2000 mg/kg: 3 females
See table for dosing sequence. - Control animals:
- no
- Details on study design:
- DETAILS ON STUDY DESIGN
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: multiple observations within the first several hours post-dosing; at least once daily thereafter. Body weight was recorded prior to test substance administration and again on Days 7 and 14 following dosing or after death.
- Necropsy of survivors performed: yes; gross necropsies were performed on all decedents and euthanized animals, tissues and organs of the thoracic and abdominal cavities were examined
- Other examinations performed: mortality, signs of gross toxicity, behavioral changes, gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behavior pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhea, and coma. - Statistics:
- The Acute Oral Toxicity (Guideline 425) Statistical Program (Weststat, version 1.0, May 2001) was used for all data analyses including: dose progression selections, stopping criteria determinations, and/or LD50 and confidence limit calculations.
Results and discussion
- Preliminary study:
- Not Applicable
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 098 mg/kg bw
- 95% CL:
- ca. 500 - ca. 2 000
- Mortality:
- 175 mg/kg (1 animal): survived
500 mg/kg (3 animals): survived
2000 mg/kg (3 animals): died - Clinical signs:
- other: 175 mg/kg (1 animal): appeared active and healthy during the study 500 mg/kg (3 animals): apart from one female exhibiting reduced fecal volume on Day 1, there were no other signs of gross toxicity, adverse pharmacologic effects, or abnormal behavior 2000
- Gross pathology:
- 175 mg/kg (1 animal): no signs of gross toxicity, adverse pharmacologic effects, or abnormal behavior
500 mg/kg (3 animals): no gross abnormalities were noted for any of the animals when necropsied at the conclusion of the observation period
2000 mg/kg (3 animals): red intestines were observed at necropsy - Other findings:
- Not Applicable
Any other information on results incl. tables
Dosing Sequence | Animal No. | Dose Level (mg/kg) | Short-Term Outcome | Long-Term Outcome |
1 | 3101 | 175 | S | S |
2 | 3102 | 550 | S | S |
3 | 3103 | 2000 | D | D |
4 | 3104 | 550 | S | S |
5 | 3105 | 2000 | D | D |
6 | 3106 | 550 | S | S |
7 | 3107 | 2000 | D | D |
S= Survived
D = Death
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, the acute oral LD50 of nickel sulfamate crystals (nickel sulfamate tetrahydrate) is estimated to be 1,098 mg/kg body weight in female rats with an approximate 95% confidence interval of 550 mg/kg (lower) to 2,000 mg/kg (upper). A NOAEL of 550 mg/kg bw (or 96 mg Ni/kg bw/day) was observed.
- Executive summary:
Eurofins Product Safety Laboratory (EPSL) conducted an acute toxicity up and down procedure in female rats according to OECD Test # 425 guidelines and using GLP standards. This test allows for the estimation of an LD50 with a confidence interval and the results allow a substance to be classified for acute toxicity according to the Globally Harmonized System of classification and labeling of chemicals. Information regarding a limit test was not provided, thus it is not clear if such was conducted; however, the maximum dose in this study was 2000 mg/kg which is the OECD limit and thus the study is within guidelines. For the main test, a young female rat was exposed to a single default starting dose (175 mg/kg) of green nickel sulfamate crystals (nickel sulfamate tetrahydrate) administered via gavage as a 60% w/w mixture in distilled water. Remaining doses were determined using the Up and Down procedure (a dose of 550 or 2000 mg/kg was administered to the remaining animals, 3 animals per dose level). The decision to proceed with the next animal was based on the survival of the previous animal following dosing (a total of 7 animals were exposed in the following dose sequence: 175, 550, 2000, 550, 2000, 550, 2000 mg/kg). All animals were observed for mortality, signs of gross toxicity, and behavioral changes at least once daily; body weight was monitored prior to dosing and again on Days 7 and 14, and all animals were necropsied following death or at study termination (Day 14). Animals exposed to 175 or 550 mg/kg of the test substance survived, gained weight, and generally did not demonstrate any signs of gross toxicity, adverse effects, or abnormal behavior throughout the 14-day observation period. Additionally, no abnormalities were noted when these animals were necropsied. All three animals exposed to 2000 mg/kg died within three hours; these animals exhibited hypoactive and/or hunched posture and piloerection prior to death. Red intestines were noted upon necropsy. The oral LD50 was calculated using the maximum likelihood method and was estimated to be 1098 mg/kg bodyweight in female rats (95% CI of 550 mg/kg to 2000 mg/kg). STUDY RATED BY AN INDEPENDENT REVIEWER
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