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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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was not conducted to GLP and did not follow a standardised guideline, however it is a well documented study and includes a well reported results section
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
- Deviations:
- yes
- Remarks:
- less animals used than recommended by guideline,
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Hydroxylammonium nitrate
- EC Number:
- 236-691-2
- EC Name:
- Hydroxylammonium nitrate
- Cas Number:
- 13465-08-2
- Molecular formula:
- H3NO.HNO3
- IUPAC Name:
- hydroxylammonium nitrate
- Details on test material:
- The test material was recieved from Ballistics Research Laboraoty, Aberdeen Proving Ground, MD, with lot identification from the Naval Ordinance Station, Indian Head, MF of NOSIH Batch R149/151.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Male New Zealand White Rabbits ranged in weight from 2.2 -2.7 kg and were housed individually in stainless steel cages with food and water available ad libitum
Administration / exposure
- Type of coverage:
- other: none-occlusive
- Vehicle:
- not specified
- Details on exposure:
- The test solution was aplied with a microsyringe onto the clipped mid-lumbar region of the rabbit. Control animals were treated with water. Following each application, the area was covered by a non-occlusive patch to prevent the animal from licking the area. On the weekly shaving day, the compound was applied 4 hours after shaving.
- Details on analytical verification of doses or concentrations:
- No data.
- Duration of treatment / exposure:
- The test solution was applied 5 days a week for 3 weeks.
- Frequency of treatment:
- The test solution was applied 5 days a week for 3 weeks.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.7, 1.5, 2.9, 5.9, 11.7 mg/kg bw/day
Basis:
nominal per unit body weight
- No. of animals per sex per dose:
- 5/male/dose
- Control animals:
- yes
- Details on study design:
- The doses applied were fractions of the acute dermal occluded LD50 (70 mg/kg).
The applied doses were: 0 (control), 0.7, 1.5, 2.9, 5.9 and 11.7 mg/kg.
Animals were weighed weekly and doses for that week were calculated from this weight. - Positive control:
- No data
Examinations
- Observations and examinations performed and frequency:
- Animals were inspected daily prior to treatment. Animals were weighed weekly to to determine the following weeks dose.
- Sacrifice and pathology:
- All animals were sacrificed at the end of the study period and necropsied.
- Other examinations:
- No data.
- Statistics:
- Results from each test group were compared with the control group. Results were compared statistically with a Mann-Whitney U-test. Results were considered stastically significant at 0.05.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Dermal irritation:
- effects observed, treatment-related
- Description (incidence and severity):
- Dermal irritation was oberved at doses of 0.7 mg/kg and greater
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- There was a decrease in bodyweight in animals dosed with 11.7 mg/kg
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Changes in blood parameters were observed at doses of 2.9 mg/kg and higher
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- At concentrations greater than 2.9 mg/kg, spleen weights were higher than control animals
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Splenic haematopoiesis was observed at doses of 2.9 mg/kg and higher
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Extramedullary haematopoiesis observed at doses of 2.9 mg/kg and higher
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- Histopathology:
At the end of the study period, animals in all treatment groups (not controls) displayed a high incidence of dermatitis. The incidence and severity of ulcerative dermatitis was dose-dependent. Ulcerative dermatitis was characterised by marked necrosis and a loss of epidermis with acute and chronic inflammatory infiltrates extending from the base of the epithelia necrosis into the dermis. In some instances superficial crusting composed of necrotic cellular debis and kerating was observed.
Chronic dermatitis did not show a definite dose-response among treatment groups. Chronic dermatitis was characterised by acanthosis, hyperkeratisis and dermal infiltrates of predominantly mono-nuclear cells. Infiltrates were varied (focal to diffuse) and extended from the epidermis to underlying musculature.
Clinical chemistry and haematology:
After the first dose of hydroxylammonium nitrate, blood samples taken 24 hours after application from animals receiving the highest dose contained Heinz bodies. One week after the initiation of dosing, blood samples from animals receiving the top three doses of the chemical were observed to contain Heinz bodies. Anemia was observed in all treatment groups except the lowest and control animals. RBC count, haemoglobin concentration, haemtocrit were lower in these animals and the MCV higher.
No changes in clinical chemistry parameters were detected.
Organ weights and gross pathology:
At necropsy, the relative spleen weight was higher in animals administered the three highest doses (2.9 - 11.7 mg/kg ) compared to controls, these animals also displayed splenic haematopoiesis. The colour of spleens ranged from dark red to black corresponging with increasing dose.
Extramedullary haematopoiesis was also observed in the liver of animals administered the two highest doses of the test chemical. Animals administered the highest dose also displayed higher relative heart weights.
Effect levels
open allclose all
- Dose descriptor:
- LOAEL
- Effect level:
- 0.7 mg/kg bw/day (nominal)
- Basis for effect level:
- other: Local effects
- Dose descriptor:
- NOAEL
- Effect level:
- 0.7 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: systemic effects
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Dermal aplication of hydroxylammonium nitrate to rabbits caused dose dependent dermatitis with increasing severity related to higher doses. At the three highest doses, animals displayed heamolytic anemia and the formation of Heinz bodies in red blood cells. A LOAEL of 0.7 mg/kg bw/day, based on dermatitis can be derived from this study.
- Executive summary:
In an acute dermal toxicity study similar to OECD Guideline 410, New Zealand White rabbits, 0.7, 1.5, 2.9, 5.9 and 11.7 mg/hydroxylammonium nitrate/kg was applied dermally on the mid-lumbar region for 5 days/week for 3 weeks. Animals displayed dose dependent dermatitis with increasing severity related to higher doses. At the three highest doses, animals displayed haemolytic anemia and the formation of Heinz bodies in red blood cells. Animals from these dose groups also displayed extramedullary haematopoiesis. A LOAEL of 0.7 mg/kg based on dermatitis can be derived from this study for local effects and a NOAEL of 0.7 mg/kg bw/day for systemic effects. This study is considered to be reliable and therefore hydroxylammonium nitrate is considered to cause dermatitis, haemolytic anemia and extramedullary haematopoiesis after dermal application in rabbits.
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