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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- On the toxicity of Hydroxylamine
- Author:
- Riemann, H.
- Year:
- 1 950
- Bibliographic source:
- Acta pharmacol. 6:285-292
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 12 females and 6 males received daily for 6 days/week a supplement of the test substance, which was added to milk as a solution over a period of 178 days.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Hydroxylammonium chloride
- EC Number:
- 226-798-2
- EC Name:
- Hydroxylammonium chloride
- Cas Number:
- 5470-11-1
- Molecular formula:
- ClH.H3NO
- IUPAC Name:
- hydroxyammonium chloride
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: About 3 weeks old
- Weight at study initiation: Females: 45 - 59 g; Males: 35 - 59 g
- Housing: The animals were individually housed.
- Diet: Standard diet consisting of casein (20%), dry yeast (15%), starch (55%), salt mixture (5%) and lucerne meal (5%), ad libitum. In addition, the rats were frequently fed raw carrot, lettuce or apple.
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: The test substance was added to milk as a solution (pH 5.2) partly neutralized with sodium hydroxide.
PREPARATION OF THE DOSING SOLUTION
- Rate of preparation of the dosing solution: The solution for the drinking study was prepared daily.
- Mixing appropriate amounts with: The doses of the test substance were adjusted to be proportional to the weight of the rats. The rats with an average body weight of 30 - 70 g received 10 mg of the test substance (corresponding to 333 - 142 mg/kg bw/d and a mean value of 237.5 mg/kg bw/d), those with an average weight of 70 - 110 g received 20 mg of the test substance (corresponding to 285 - 181 mg/kg bw/d and a mean value of 233 mg/kg bw/d), those with an average weight of 110 - 150 g received 30 mg of the test substance (corresponding to 272 - 200 mg/kg bw/d and a mean values of 236 mg/kg bw/d) and the rats with an average weight > 150 g received 40 mg of the test substance (corresponding to 266 mg/kg bw/d). - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 178 days
- Frequency of treatment:
- Daily, 6 days/week
Doses / concentrations
- Remarks:
- range: 233 - 266 mg/kg bw/d
- No. of animals per sex per dose:
- 12 females and 6 males
- Control animals:
- yes
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
BODY WEIGHT: Yes, the body weight was recorded at the beginning and after 5 months. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, after 178 days the rats were killed with chloroform, frozen and kept at -20 °C for up to 30 days, after which they were dissected. The rats were kept wrapped up so that they could not lose water and were dissected after partial thawing. The organs were examined macroscopically, and the following organs were weighed: heart, lungs, liver, spleen, kidneys, adrenals and thyroid.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- The relative spleen weights were distinctly increased in treated females (1.645%) and males (1.56%) when compared with control females (0.469%) and males (0.316%), respectively. The relative thyroid weights were considerably reduced in females (0.038%) and males (0.032%) compared with control females (0.065%) and males (0.055%), respectively.
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- A considerable development of the spleen and a marked reduction of the thyroid were observed in the animals of the treatment group. These findings correlate with the distinct increase of the relative spleen weights and with the strong induction of the relative thyroid weights.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Effect levels
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 233 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- gross pathology
- organ weights and organ / body weight ratios
Target system / organ toxicity
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 233 mg/kg bw/day (nominal)
- System:
- haematopoietic
- Organ:
- spleen
- thyroid gland
- Treatment related:
- yes
Applicant's summary and conclusion
- Conclusions:
- CLP: STOT RE 2, H373 (Annex VI harmonized classification)
The registrant follows the harmonised classification, thus the available data with the test substance meet the classification criteria according to Regulation (EC) 1272/2008.
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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