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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
Carcinogenicity
Administrative data
Description of key information
There is no evidence of increasing the incidence of cancer that induced by Hydroxylamine hydrochloride.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: abstracted from the summary published in the well-known publication
- Qualifier:
- no guideline followed
- GLP compliance:
- no
- Species:
- mouse
- Strain:
- other: 78 male AKR mice, 60 female C3H mice and 85 male Swiss mice
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 78 male AKR mice, 60 female C3H mice and 85 male Swiss mice
- Route of administration:
- oral: feed
- Vehicle:
- not specified
- Details on exposure:
- given pelleted feed to which 1 or 2% by weight of hydroxylamine hydrochloride
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- entire lifetime
- Remarks:
- Doses / Concentrations:
1 or 2% by weight of hydroxylamine hydrochloride
Basis:
nominal in diet - Control animals:
- yes, plain diet
- Details on study design:
- In a long-term study, a total of 78 male AKR mice, 60 female C3H mice and 85 male Swiss mice were given pelleted feed to which 1 or 2% by weight of hydroxylamine hydrochloride had been added. Treatment continued for their entire lifetime.
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Details on results:
- While tumours developed in most C3H controls (no further details), there was a considerable reduction in the spontaneous tumour incidence in the group treated with 2% of the hydrochloride (0% after 15 months compared with 20% in the controls). In the AKR mice the treatment led to a dose-dependent increase in survival time. A positive influence on the survival time was also established in the C3H mice given 1% by weight. In the male Swiss mice no relevant effects were found in either dose group.
- Relevance of carcinogenic effects / potential:
- No substance-induced tumours were observed in any of the mouse strains.
- Dose descriptor:
- NOAEL
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
- Conclusions:
- No substance-induced tumours were observed in any of the mouse strains during the test period.
- Executive summary:
In a long-term study, a total of 78 male AKR mice, 60 female C3H mice and 85 male Swiss mice were given pelleted feed to which 1 or 2% by weight of hydroxylamine hydrochloride had been added. Treatment continued for their entire lifetime. While tumours developed in most C3H controls (no further details), there was a considerable reduction in the spontaneous tumour incidence in the group treated with 2% of the hydrochloride (0% after 15 months compared with 20% in the controls). In the AKR mice the treatment led to a dose-dependent increase in survival time. A positive influence on the survival time was also established in the C3H mice given 1% by weight. In the male Swiss mice no relevant effects were found in either dose group. No substance-induced tumours were observed in any of the mouse strains
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data, Hydroxylamine hydrochloride cannot cause the increase of cancer incidence. Thus, it cannot be classified according to CLP (EC No. 1272/2008).
Additional information
In vivo study was reported by Springer-verlag, 1994. In this long-term study, no substance-induced tumours were observed in any of the mouse strains during the test period.
In vitro carcinogenesis assays utilizing an attachment indepencence endpoint was conducted by Karl A. Traul and K. Takayama; 1980, which showed that Hydroxylamine hydrochloride clearly gave a positive response.
In generally, data in vivo should be given more weight as it gave high relevance to human exposure and more reliability was presented. Therefore, it is reasonable to conclude that Hydroxylamine hydrochloride has no positive potential of increasing the cancer incidence.
Justification for selection of carcinogenicity via oral route endpoint:
Available data in vivo should be given more weight as its high relevance and reliability.
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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