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Diss Factsheets
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EC number: 600-775-0 | CAS number: 1067676-04-3
- 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: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 days, plus supplementary group for 14 days post dosing
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Justification for type of information:
- Study following OECD guidelines and well documented.
Surrogate polyamine substance used for assessment; considered representative of the registered substance.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes
- Remarks:
- Performed as part of a medical research project; assumed to conform to GLP
- Limit test:
- no
Test material
- Reference substance name:
- 4-azaoctamethylenediamine
- EC Number:
- 204-689-0
- EC Name:
- 4-azaoctamethylenediamine
- Cas Number:
- 124-20-9
- Molecular formula:
- C7H19N3
- IUPAC Name:
- 4-azaoctamethylenediamine
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Balb/c
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Groups of 5 individuals.
Autoclaved nest material and paper houses served as cage enrichment, with access to food and water was provided ad libitum
Administration / exposure
- Route of administration:
- oral: feed
- Details on oral exposure:
- Food supplemented with a polyamine-rich extract to provide a dose level of 0.5 g/kg, 5 g/kg or 50 g/kg animal bodyweight daily
- Duration of treatment / exposure:
- Treatment period 28 days
14 days post treatment animals were included in recovery groups - Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- Dose / conc.:
- 5 000 mg/kg bw/day (nominal)
- Dose / conc.:
- 50 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- Five
- Control animals:
- yes, plain diet
Examinations
- Observations and examinations performed and frequency:
- Weekly for their external appearance
Bodyweight of all animals was recorded weekly - Sacrifice and pathology:
- Whole blood was collected immediately after euthanasia
Animals were thoroughly examined for neo-plasias and visible abnormalities.
Various organs were weighed and samples retained frozen
Results and discussion
Results of examinations
- 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:
- not examined
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Relative kidney weight to bodyweight ratio was significantly increased in female mice treated with 50 g/kg bodyweight.
Relative kidney weight was increased by 12% in this group compared to control animals. - Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Details on results:
- The polyamines used in the study were found in the blood and are clearly absorbed following ingestion.
Effect levels
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Target system / organ toxicity
- Critical effects observed:
- no
Any other information on results incl. tables
Bodyweight of animals of all treatment groups did not differentiate from the control group
Relative kidney weight to bodyweight ratio was significantly increased in female mice treated with 50 g/kg bodyweight. Relative kidney weight was increased by 12% in this group compared to control animals and is considered to likely be an adaptive change.
Applicant's summary and conclusion
- Conclusions:
- No adverse effects following treatment with polyamine at up to 50 g/kg/day, other than an adaptive change in relative kidney weight.
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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