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Diss Factsheets
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EC number: 236-691-2 | CAS number: 13465-08-2
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- No data.
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- not specified
- Limit test:
- yes
Test material
- Reference substance name:
- Hydroxylammonium sulphate
- IUPAC Name:
- Hydroxylammonium sulphate
- Test material form:
- not specified
- Details on test material:
- Purity: > 98.4%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- No data.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- at a standard dose volume of 5 ml/kg bw
- Details on exposure:
- No data.
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data.
- Details on mating procedure:
- No data.
- Duration of treatment / exposure:
- Pregnant rats were treated on day 6 through to day 15 post coitum.
- Frequency of treatment:
- Daily
- Duration of test:
- Animals were dosed with the test chemical from day 6 through to day 15 post coitum and sacrificed on day 20.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1, 3, 10, 20 mg/kg bw/day
Basis:
nominal in diet
- No. of animals per sex per dose:
- 22 - 24 pregnant female/dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data.
Examinations
- Maternal examinations:
- Food consumption and body weights of the animals were recorded regularly throughout the study period. Animal health was checked daily.
- Ovaries and uterine content:
- After sacrifice, the number of corpora lutea, the number and distributions of implantation sites were counted.
- Fetal examinations:
- No data.
- Statistics:
- No data.
- Indices:
- No data.
- Historical control data:
- No data.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes. Remark: 10 mg/kg bw/day
Details on maternal toxic effects:
An enlargement of the spleen and a dose related statistically significant increase in absolute and relative spleen weights were observed in dams administered the two highest doses of bis(hydroxylammonium) sulfate.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 10 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects. Remark: at highest dose administered (20 mg/kg bw/day)
Details on embryotoxic / teratogenic effects:
There were no substance-related effects on conception rates, the mean number of corpora lutea, implantation sites, pre and post implantation losses, the number of resorptions and of viable foetuses. Examination of foetuses did not reveal any signs for substance related abnormalities.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- At the highest dose (20 mg/kg bw/day) administered to Wistar rats in this study, hydroxylammonium sulphate was not considered to cause embryo/foetotoxicity.
- Executive summary:
In a developmental toxicity study according to OECD TG414, hydroxylammonium sulphate was administered to Wistar rats (22 -23/pregnant females/dose) via oral gavage at doses of 1, 3, 10 and 20 mg/kg bw/day on days 6 - 15 post coitum. Animals were sacrificed on day 20 and necropsied. At the two highest doses, dams displayed splenomegaly and a significant increase in absolute and relative spleen weights. No embryo/fetotoxicity was observed at the highest dose administered in this study. A maternal NOAEL of 3 mg/kg bw/day based on effects to the spleen and a NOAEL for embryo/fetotoxicity of 20 mg/kg bw/day can be derived. This study is considered to be reliable, therefore hydroxylammonium sulphate is not considered to be developmental toxicant at concentrations of 20 mg/kg bw/day in rats.
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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