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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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
Two non-standardised developmental toxicity tests observed foetotoxic effects after subcutaneous and intracoloemic injection in to the embryo with hydroxylammonium nitrate. These effects were thought to be in part a response of severe methaemoglobinaemia in the dams.
Link to relevant study records
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: One generation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1995
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Study was not conducted to a standardised guideline or reproduction test. Insufficient controls.
- Principles of method if other than guideline:
- Male and female Sprague Dawley rats were exposed to a liquid propellant containing hydroxylammonium nitrate and triethanolammonium nitrate at doses of 20, 100 or 200 mg/100 ml in their drinking water. After 14 days, the animals were mated and treatment continued for a total of 90 days. Half of the male rats were sacrificed after mating, remaining animals were sacrificed at the end of the study period.
- GLP compliance:
- not specified
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data.
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on exposure:
- No data.
- Details on mating procedure:
- No data.
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data.
- Duration of treatment / exposure:
- Animals were administered hydroxylammonium nitrate for 14 days prior to mating and maintained on the treatment for 90 days in total.
- Frequency of treatment:
- Ad libitum.
- Details on study schedule:
- No data.
- Remarks:
- Doses / Concentrations:
20, 100, 200 mg LP/100 ml
Basis:
nominal in water
Specific concentration of hydroxylammonium nitrate not determined. - No. of animals per sex per dose:
- No data.
- Control animals:
- not specified
- Details on study design:
- No data.
- Positive control:
- No data.
- Parental animals: Observations and examinations:
- No data.
- Oestrous cyclicity (parental animals):
- No data
- Sperm parameters (parental animals):
- No data.
- Litter observations:
- No data.
- Postmortem examinations (parental animals):
- No data.
- Postmortem examinations (offspring):
- No data.
- Statistics:
- No data.
- Reproductive indices:
- No data.
- Offspring viability indices:
- No data.
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Male animals showed a treatment related decreases in RBC, HGB, MCV and MCH.
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Other effects:
- effects observed, treatment-related
- Description (incidence and severity):
- Test substance intake: A treatment related decrease in water consumption was noted at the onset of the study and continued through to study termination.
- Reproductive function: sperm measures:
- effects observed, treatment-related
- Description (incidence and severity):
- A decrease in the concentration of motile sperm was observed in the high dose rats at sacrifice.
- Reproductive performance:
- no effects observed
- Dose descriptor:
- NOAEL
- Remarks:
- Specific dose of hydroxylammonium nitrate not determined
- Effect level:
- 200 mg/L drinking water
- Sex:
- male/female
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Reproductive effects observed:
- not specified
- Conclusions:
- A liquid propellant containing hydroxylammonium nitrate and triethanolammonium nitrate caused splenomegaly in male rats after 14 days treatment. These animals also displayed treatment related decreases in RBC, HGB, MCV and MCH. At the highest dose, male rats showed a decrease in the concentration of motile sperm. There were no maternal or pup effects. A reproductive NOAEL of 20 mg LP/l can be derived based on male fertility. However as the specific concentration of of hydroxyammonium nitrate in the liquid propellant was not reported an specific NOAEL for the chemical can not be derived.
- Executive summary:
Male and female Sprague Dawley rats were exposed to a liquid propellant containing hydroxylammonium nitrate and triethanolammonium nitrate at doses of 20, 100 or 200 mg/100 ml in their drinking water (specific concentration of hydroxylammonium nitrate in the liquid propellant was not stated). After 14 days, the animals were mated and treatment continued for a total of 90 days. Half of the male rats were sacrificed after mating, remaining animals were sacrificed at the end of the study period. There was a treatment related decrease in drinking water consumption over the study period, although there were no effects in either the dams or pups. Male rats sacrificed after mating displayed splenomegaly and alterations in blood parameters. At the highest dose, male rats showed lower concentrations of motile sperm. By this study design hydroxylammonium nitrate is considered to be a reproductive toxicant although the reliability of this study is considered to be not reliable.
Reference
Male rats sacrificed after mating showed a treatment related splenomegaly and decreases in RBC, HGB, MCV and MCH. At the highest dose male rats had a decrease in the concentration of motile sperm.
There were no differences between the treated animals and control animals in gestation index, the length of gestation or male to female pup ratio.
Effect on fertility: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 95 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Only one study was located which was considered unreliable as the test chemical was administered in combination with another chemical, the exact concentration of the test chemical was not specified. Furthermore, sufficient control animals were not used to eliminate that possible effects on the test animals were not from the other chemical co-administered.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Male fertility was affected by the administration of hydroxylammonium nitrate. However the study was considered to be unreliable as only limited data was reported, furthermore the exact concentration of hydroxylammonium nitrate in the liquid propellant was not reported.
Short description of key information:
The fertility of female rats were not effected after the administration of a liquid propellant containing hydroxylammonium nitrate, however male animals displayed a decrease in the concentration of motile sperm at doses of 200 mg/L of a liquid propellant containing hydroxylammonium nitrate in drinking water.
Justification for selection of Effect on fertility via oral route:
Only one study was located, however it was considered unreliable. A NOAEL of 95 mg liquid propellant/kg bw/day can be identified, however the exact concentration of hydroxylammonium nitrate in the liquid propellant was not stated and therefore the exact dose can not be identified, the NOAEL is therefore likely to be conservative.
Effects on developmental toxicity
Description of key information
In a standardised OECD TG 414, hydroxylammonium sulphate did not cause developmental effects at the maximum concentration dosed to pregnant Wistar rats (20 mg/kg bw/day), maternal effects were observed at lower doses (maternal NOAEL: 10 mg/kg bw/day). A further study with hydroxylammonium nitrate did not cause developmental effects at doses of 640 mg/kg bw/day, this same study also derived a maternal NOAEL of 325 mg/kg bw/day.
Link to relevant study records
- 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)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- not specified
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- No data.
- 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.
- 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.
- 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.
- 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. - Dose descriptor:
- NOAEL
- Effect level:
- >= 10 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- 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. - Abnormalities:
- not specified
- Developmental effects observed:
- not specified
- 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.
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 20 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Only two studies were located that addressed the reproductive and developmental toxicity of hydroxylammonium nitrate and assoicated analogues, only one of these studies folowed standardised guidelines for reporoductive toxicity testing.
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Hydroxylammonium nitrate is thought to cause indirect foetotoxic effects as a result of severe methaemoglobinaemia in the dams. All effects observed in foetuses were associated with direct toxicity in the dams and foetoxic effects were observed at higher doses than maternal effects.
Justification for selection of Effect on developmental toxicity: via oral route:
The study was conducted to standardised guidelines.
Toxicity to reproduction: other studies
Additional information
Hydroxylammonium nitrate is thought to cause indirect foetotoxic effects as a result of severe methaemoglobinaemia in the dams. All effects observed in foetuses were associated with direct toxicity in the dams and foetoxic effects were observed at higher doses than maternal effects.
Justification for classification or non-classification
Hydroxylammonium nitrate is not classifiable as to its reproductive toxicity.
Additional information
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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