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EC number: 233-118-8 | CAS number: 10039-54-0
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: Screening for reproductive toxicity (fertility)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Results on reproductive organs are part of a 3 month repeated dose study (Guideline study: OECD 414)
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
- Principles of method if other than guideline:
- Examination of male and female reproductive organs was part of a 3 month repeated dose study.
- 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
- Details on test material:
- - Name of test material (as cited in study report): Hydroxylammoniumsulfat (HAS)
- Analytical purity: >= 99 %
- Lot/batch No.: 84/389
- Stability under test conditions: was ensured during the study period
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach a.d. Riss, Germany
- Age at study initiation: 42 days
- Average weight at study initiation: males ca. 117 g; females ca. 136 g
- Housing: individually in V2A wire mesh cages, type DK III (Becker & Co. Castrop-Rauxel, Germany)
- Diet: Kliba-Haltungsdiaet Ratte/Maus/Hamster 343 Mehl (Klingentalmuehle AG, Kaiseraugst, Switzerland), ad libitum
- Water: Milli-Q-Reinstwasser, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24 °C
- Humidity: 30 - 70 %
- Air changes: fully air-conditioned rooms
- Photoperiod: 12 hrs dark / 12 hrs light
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- other: Mili-Q extra pure water
- Details on exposure:
- Wistar rats (10 animals/sex/dose group) had been exposed to BHAS (purity > 99%) via drinking water for over 3 months at concentrations of 10, 50, and 250 ppm according to dose levels of about 0.9, 4, and 21 mg/kg bw/d.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- For homogeneity and concentration control analyses, each samples of all concentrations were drawn at the start of the study, after 6 weeks and towards at the end of the administration period after 12 weeks of the study. The analysis of the amount of the test material in the drinking water was determined by photometry.
- Duration of treatment / exposure:
- Exposure period: 90 d
- Frequency of treatment:
- ad libitum
Doses / concentrations
- Remarks:
- Doses / Concentrations:
10, 50, 250 mg/l [ca. 0.9, 4, and 21 mg/kg bw/d]
Basis:
nominal in water
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: pretests
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: weekly - Sperm parameters (parental animals):
- Parameters examined in male parental generations: testis weight
Results and discussion
Results: P0 (first parental generation)
Details on results (P0)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Remarks:
- reproductive organs
- Effect level:
- >= 21 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- other: No interference of the test material with reproductive organ weights and morphological integrity
Results: F1 generation
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Remarks on result:
- not measured/tested
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Within the scope of a 90 days study, absolute and relative weights of testes were examined. In treated animals, they were not different from the control, while there was a distinct morphologic response in the spleen, indicating that critical doses were exceeded. There were no treatment-related macroscopic changes in the testes. Ovaries were not considered.
Applicant's summary and conclusion
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