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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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study not conducted to GLP or following a standardised guideline
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 008
Materials and methods
- Principles of method if other than guideline:
- Female rats (10/female/dose) were exposed via a single dermal application for 24 hours to hydroxylammonium sulphate at either 10, 100 or 500 mg/kg. The chemical was moistened with water and held in contact with the skin by wrapping the torso of the rat with a polyethylene bandage. An additional group of animals (10/female) received the test material via an subcutaneous injection (1% aqueous solution) to act as a rough indication of complete dermal absorption.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Hydroxylammonium sulphate
- IUPAC Name:
- Hydroxylammonium sulphate
- Details on test material:
- Purity > 98%.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- No data.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Remarks:
- Test material was moistened with water
- Details on dermal exposure:
- Female rats were exposed for 24 hours to a single application of hydroxylammonium sulphate moistened with water. The test material was held in contact with the skin by wrapping the torso of the rat with a polythene bandage.
- Duration of exposure:
- 24 hours.
- Doses:
- 10, 100 and 500 mg/kg
- No. of animals per sex per dose:
- 10
- Control animals:
- other: positive control
- Details on study design:
- Animals were observed twice each day for gross signs of toxicity. Blood samples were collected on day 2 and analysed for methaemoglobin. on days 4 and 14 blood samples were analysed for erythrocyte, leukocyte, platelet and reticulocyte counts. Total haemoglobin, hematocrit, mean corpuscular haemoglobin concentrations were also determined.
- Statistics:
- No data.
Results and discussion
Effect levels
- Dose descriptor:
- LD50
- Effect level:
- > 500 mg/kg bw
- Mortality:
- No mortality was observed.
- Clinical signs:
- Skin irritation of moderate incidence and to a lesser extent necrosis and sloughing were evident.
After 24 hours, rats (all doses) became paler, this persisted for up to 6 days after application. Cyanosis was not observed. Other signs of toxicity included a brown staining of the nares, mouth and forepaws and yellow staining of the anogenital area. Lacrimation was also observed. - Body weight:
- Not reported.
- Gross pathology:
- Principle findings at necropsy included a high incidence of enlarged and darkened spleens regardless of the dose level of route of exposure.
Gross effects on the liver were minimal or absent. - Other findings:
- Blood methaemoglobin levels were measured after 2 days and were found to be statistically higher than controls. Heinz bodies were not observed in circulating erythocytes.
Applicant's summary and conclusion
- Conclusions:
- Bis(hydroxylammonium)sulfate resulted in skin irritation, necrosis and sloughing. Exposed animals also displayed methaemoglobin and were a paler colour than control animals. At necropsy, animals had enlarged and darkened spleens. A LOAEL of 10 mg/kg bw can be derived based on mutiple effects. An LD50 could not be identified due to lack of mortality at the highest dose.
- Executive summary:
Female rats were administered bis(hydroxylammonium) sulfate via a single occluded dermal application of either 10, 100 or 500 mg/kg bw for 24 hours. All doses resulted in skin irritation, necrosis and skin sloughing as well as methaemoglobin which was evident after 2 days. All animals also displayed splenomegaly, spleens were also much darker. This study is considered reliable (with restriction), therefore a LOAEL of 10 mg/kg bw can be derived based on mutiple effects. Bis(hydroxylammonium) sulfate is therefore considered a dermal irritant and an agent that causes methemoglobin in rats by this study design.
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