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EC number: 226-798-2 | CAS number: 5470-11-1
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Feb 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- adopted Jul 2016
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Bis(hydroxylammonium) sulphate
- EC Number:
- 233-118-8
- EC Name:
- Bis(hydroxylammonium) sulphate
- Cas Number:
- 10039-54-0
- Molecular formula:
- H3NO.1/2H2O4S
- IUPAC Name:
- bis(hydroxyammonium) sulfate
- Test material form:
- solid
- Details on test material:
- Name as mentioned in the report: Hydroxylammonium-Sulfat
Date of manufacturing: 04 Apr 1991
Test substance no.: 91/118
Appearance: white crystals
Purity: 98.6%
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River GmbH, Sulzfeld, Germany
- Weight at study initiation: About 27 g (mean)
- Assigned to test groups randomly: Yes, according to a randomization plan prepared with an appropriate computer program.
- Housing: Animals were individually housed in Makrolon cages type M I.
- Diet: Standardized pelleted feed (Kliba Haltungsdiät, Klingentalmühle AG, Kaiseraugst, Switzerland), ad libitum
- Water: Drinking water, ad libitum
- Acclimation period: About one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): Fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: aqua dest.
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Dosing solutions were prepared immediately before administration by dissolving appropriate amounts of the test material in aqua dest. yielding a concentration of 12 g/100 mL, 6 g/100 mL and 3 g/100 mL, respectively. The volume of administration was 10 mL/kg bw.
ANALYSIS
For the determination of the test substance concentration in the solvent 3 samples per dose were taken from the test substance preparation using a stomach tube and transferred to test tubes. The samples were kept at room temperature until the treatment of the last animal (approximately 1 hour) and then deep-frozen until they were determined analytically. The determination of the concentration in the solvent was carried out .
The stability of the test substance in the solvent aqua dest. was determined analytically. - Duration of treatment / exposure:
- not applicable
- Frequency of treatment:
- single treatment
- Post exposure period:
- 300 mg/kg bw: 24 h after last treatment
600 mg/kg bw: 24 h after last treatment
1200 mg/kg bw: 16, 24 and 48 h after last treatment, respectively
Doses / concentrationsopen allclose all
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- Dose / conc.:
- 600 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 200 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 5 (negative control and test group), 2 males and 3 females (cyclophosphamide), 3 males and 2 females (vincristine)
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide
- Route of administration: oral
- Doses / concentrations: 20 mg/kg bw
- Solvent: aqua dest.
vincristine
- Route of administration: intraperitoneal
- Doses / concentrations: 0.15 mg/kg bw
- Solvent: aqua dest.
Examinations
- Tissues and cell types examined:
- Tissue: bone marrow
Cell type: erythrocytes - Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: The maximum tolerated dose was selected based on results determined in a pre-test for the determination of acute oral toxicity.
TREATMENT AND SAMPLING TIMES (in addition to information in specific fields): Sampling was performed 16, 24 and 48 h after administration for the high-dose group and 24 h after administration for the mid- and low-dose group and the control groups.
DETAILS OF SLIDE PREPARATION: Smears were air-dried and first stained with in eosin and methylene blue solution for 5 min and thereafter in Giemsa-solution for 12 min.
METHOD OF ANALYSIS: 1000 polychromatic erythrocytes from each animal of every dose group were evaluated and investigated for micronuclei. In addition normochromatic erythrocytes were scored and investigated for micronuclei. - Statistics:
- A statistical evaluation was not necessary to perform. The number of polychromatic micronucleated erythrocytes after test substance treatment was nearly in the range of the actual control value and within the historical values.
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- The highest dose level revealed evident signs of toxicity, such as irregular respiration, piloerection, apathy, abdominal position, closed eyelids and blueish skin within 30 minutes after test substance administration.
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: In a pre-test for the determination of acute oral toxicity doses of 1250 and 1400 mg/kg bw were tested.
- Clinical signs of toxicity in test animals: Death occured at 1400 mg/kg bw. At 1250 mg/kg bw evident signs of toxicity were observed. Based on this pre-test the highest dose of 1200 mg/kg bw was selected in the main study for the determination of micronucleus.
Any other information on results incl. tables
Table 1: Summary of results
Treatment group | Dose [mg/kg bw] |
Sampling time [h] | Polychromatic erythrocytes investigated | Normochromatic erythrocytes/total amount polychromatic erythrocytes | Cells with micronuclei (‰) in polychromatic erythrocytes |
Cells with micronuclei (‰) in normochromatic erythrocytes |
Vehicle control | 0 | 24 | 10000 | 4271 | 1.6 | 1.17 |
Test substance | 1200 | 16 | 10000 | 6428 | 1.2 | 0.16 |
1200 | 24 | 10000 | 6561 | 1.0 | 0.46 | |
1200 | 48 | 10000 | 4560 | 2.7 | 0.22 | |
600 | 24 | 10000 | 4223 | 1.8 | 0.47 | |
300 | 24 | 10000 | 4906 | 1.3 | 1.02 | |
Positive control (Cyclophosphamide) | 20 | 24 | 5000 | 2997 | 8.8 | 1.33 |
Positive control (Vincristine) | 0.15 | 72 | 5000 | 5789 | 103.8 | 2.07 |
Applicant's summary and conclusion
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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