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Diss Factsheets
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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
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Endpoint summary
Administrative data
Description of key information
Available data is insufficient to conclude the repeated toxicity of hydroxylamine hydrochloride.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: performed to non-standard protocol, but contirbuting to assessment.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- 24 female and 12 male rats, about 3 weeks old, were divided equally into an experimental group and a control group. They were weighed and each animal was then transferred to a separate oage.
free access to the following diet :
The animals were fed as much whole milk as they would drink and
........................... casein 20 %
dry yeast ........................ 16 .
staroh ........................... 66 .
salt mixture ..................... 6 .
lucerne meal.. .................... 5 .
The salt mixture consisted of:
.................. sodium chloride. 16 Yo
magnesium sulphate.. ............. 30 .
prim. sodium phosphate ........... 32 .
tert. calcium phosphate ........... 9 .
calcium lactate ................... 12 .
ferricitrate ....................... 1 .
In addition, the rats were frequently fed raw carrot, lettuce or apple. - Route of administration:
- other: oral: in milk
- Vehicle:
- not specified
- Details on oral exposure:
- The rats in the experimental group received daily for 6 days each week supplement of hydroxylamine hydrochloride, which was added to the milk as a solution (pH 6.2) partly neutralized with sodium hydroxide.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 178 days
- Frequency of treatment:
- once daily
- Remarks:
- Doses / Concentrations:
rats of an average weight of 30-70 g, 70-1 10 g, 110-160 g and above 160 g, received daily 10 mg, 20 mg, 30 mg and 40 mg of hydroxylamine hydrochloride, respectively.(equal to 333 to 380 mg/kg body weight)
Basis:
nominal in diet - No. of animals per sex per dose:
- 24 female and 12 male rats
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- The doses have been calculated according to TARR and CARTER’S experimenta (1942) and are twice as large as the doses of sodium nitrite used by these authors in corresponding experiments. The hydroxylamine was given in these amounts, because the lethal dose of hydroxylamine hydrochloride is about twice that of sodium nitrite.
The feeding experiment with hydroxylamine lasted 178 days. - Observations and examinations performed and frequency:
- The rats were at first weighed twice a week and later once a week, to the nearest gram.
- Sacrifice and pathology:
- After 178 days the rats were killed with chloroform, frozen and kept in a cold room 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. An attempt at histological examination of the organs had to be given up because of the structural changes during freezing.
- 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):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- enlargement of the spleen by 4 to 5 times and atrophy of the thyroid gland by about 50% were observed
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- There were no treatment-related effects on growth or general well-being in rats that were given 333 to 380 mg/kg body weight of the hydrochloride in their milk for 178 days. However, enlargement of the spleen by 4 to 5 times and atrophy of the thyroid gland by about 50% were observed.
The feeding of hydroxylamine did not prevent the rats from gaining weight in an apparently normal way.On the other hand, the feeding of hy-
droxylamine hydrochloride resulted in a considerable development of the spleen and a marked reduction in size of the thyroid of the hydroxylamine fed rats. - Dose descriptor:
- NOAEL
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
- Critical effects observed:
- not specified
- Conclusions:
- Daily feeding of 0.33-0.38 g of hydroxylamine hydrochloride per kg of body weight for 178 days had no influence on the general condition and the growth-rate of the rats. On the other hand, a considerable development of the spleen and an essential reduction of the thyroid were observed.
- Executive summary:
The 24 female and 12 male rats in the experimental group received daily for 6 days each week supplement of hydroxylamine hydrochloride at doses of 330 -380mg/kg/day, which was added to the milk as a solution (pH 6.2) partly neutralized with sodium hydroxide. The feeding experiment with hydroxylamine lasted 178 days. The feeding of hydroxylamine did not prevent the rats from gaining weight in an apparently normal way.On the other hand, the feeding of hy- droxylamine hydrochloride resulted in a considerable development of the spleen and a marked reduction in size of the thyroid of the hydroxylamine fed rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Only one publication was available, where daily feeding of 0.33-0.38 g of hydroxylamine hydrochloride per kg body weight for 178 days had no influence on the general condition and the growth-rate of the rats. On the other hand, a considerable development of the spleen and an essential reduction of the thyroid were observed.
However, existing study is not sufficient to draw a conclusion on the repeated toxicity of hydroxylamine hydrochloride as lacking of detailed information on clinical sign, clinical biochemistry, haematology, and micromacroscopic and microscopic pathological examination.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
only one study is available
Justification for classification or non-classification
Based on the results given in the study, it is inconclusive to make the classification for the repeated dose toxicity of hydroxylamine hydrochloride.
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