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EC number: 225-791-1 | CAS number: 5080-22-8
- 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
Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 9-12 January 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was not conducted according to guidelines but was conducted according to GLPs and the report contains sufficient data for interpretation of study results
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The objective of this in vivo assay was to determine the dose range of the test article, NIPHA, to be used in a subsequent acute in vivo bone marrow micronucleus assay. Toxicity and/or mortalities were assessed in ICR mice. The test article was suspended in 0.9% saline and dosed by intraperitoneal injection at 250, 500, 875, 1250, and 1625 mg/kg body weight. Animals were dosed with the test article and the survivors were euthanatized three days later. Six animals (three males and three females) were randomly assigned to each dose group.
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-isopropylhydroxylamine
- EC Number:
- 225-791-1
- EC Name:
- N-isopropylhydroxylamine
- Cas Number:
- 5080-22-8
- Molecular formula:
- C3H9NO
- IUPAC Name:
- N-(propan-2-yl)hydroxylamine
- Details on test material:
- NIPHA, N-isopropylhydroxylamine
(Lot #14422-83-1S)
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- ICR
- Sex:
- male/female
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- physiological saline
- Doses:
- Solubility and Stability
The test article, NIPHA, was supplied in the form of white crystals. The soluhility of the test article was evaluated in deionized water and 0.9% saline. Sterile saline (0.9%, Abbott Lot 115-117-DM-03, Exp. 4/1/90) was selected as the vehicle to be used in the assay. In the solubility test 663.4 mg of NIPHA was added to 2.0 ml of 0.9% saline which resulted in a clear colorless solution with a final volume of --2.4 ml and a final calculated concentration of about 276.4 mg/ml. The stability of the test article under the preparation and dosing conditions of the assay is the responsibility of the sponsor.
Dose Selection
The dose levels used in the assay were 250, 500, 875, 1250, and 1625 mg/kg body weight and were administered by intraperitoneal injection. Initial dose levels of 500, 1625, 2750, 3875, and 5000 mg/kg were selected based upon the lack of any available toxicity data for the test article. These dose levels were reassigned by the study director at the time of dosing when immediate toxicity was observed at the 1625 mg/kg dose level. The route of administration used in this assay was specified by the sponsor.
Dosing Information
The animals used in the assay were dosed on Tuesday, January 9, 1990. The weight range of the animals used in the dose range finding assay was 27.0 - 35.6 grams and 24.5 - 29.7 grams for the males and females, respectively. Dosing solutions were prepared just prior to dosing. A 250 mg/ml stock solution was prepared by adding 17 ml of 0.9% saline to 5.5006 grams of NIPHA for a final calculated concentration of 250 mg/ml. All dose levels were prepared by making dilutions of this stock solution. An outline of the dosing scheme is found in the table below. - No. of animals per sex per dose:
- 3 males/sex/dose level
- Control animals:
- not specified
Results and discussion
Any other information on results incl. tables
All animals were examined after dosing and periodically throughout the duration of the study (three days) for toxic effects and/or mortalities. Five to seven minutes after dosing two animals of each sex in the 1625 mg/kg dose group had died. The surviving female was languid and the surviving male was prostrate with polypnea. All other animals in the other dose groups with the exception of those in the 250 mg/kg group were slightly languid after dosing. Those animals in the 250 mg/kg group appeared normal and healthy after dosing. On the day after dosing all surviving animals had recovered and for the duration of the study, appeared normal and healthy.
Table 1. Summary of Mortalities Within 3 Days in Mice Dosed Acutely with RIPHA
Observations | ||
Treatment | Males | Females |
250 mg/kg | 0/3 | 0/3 |
500 mg/kg | 0/3 | 0/3 |
875 mg/kg | 0/3 | 0/3 |
1250 mg/kg | 0/3 | 0/3 |
1625 mg/kg | 2/3 | 2/3 |
Applicant's summary and conclusion
- Conclusions:
- Based upon the mortality data from this study the LDso was calculated by probit analysis (Finney, 1971), for the males and females combined to be 1605 mg/kg (95% confidence limits could not be calculated). The results of this range finding assay were sufficient to select doses for a mouse bone marrow micronucleus assay.
- Executive summary:
The objective of this in vivo assay was to determine the dose range of the test article, NIPHA, to be used in a subsequent acute in vivo bone marrow micronucleus assay. Toxicity and/or mortalities were assessed in ICR mice. The test article was suspended in 0.9% saline and dosed by intraperitoneal injection at 250, 500, 875, 1250, and 1625 mg/kg body weight. Animals were dosed with the test article and the survivors were euthanatized three days later. Six animals (three males and three females) were randomly assigned to each dose group. Based upon the mortality data from this study the LD50 was calculated for the males and females combined to be 1605 mg/kg (95% confidence limits could not be calculated).
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