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EC number: 217-168-8 | CAS number: 1761-71-3
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- other: Literature review
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Assessment of the toxicokinetic behaviour of the substance to the extent that can be derived from the relevant available information.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
- Objective of study:
- toxicokinetics
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Review of physico-chemical and other relevant information leading to an understanding of toxicokinetics
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 4,4'-methylenebis(cyclohexylamine)
- EC Number:
- 217-168-8
- EC Name:
- 4,4'-methylenebis(cyclohexylamine)
- Cas Number:
- 1761-71-3
- Molecular formula:
- C13H26N2
- IUPAC Name:
- 4,4'-methylenedicyclohexanamine
- Details on test material:
- no test material needed
Constituent 1
Administration / exposure
- Statistics:
- not applicable
Results and discussion
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- The relatively small molecular weight (210.4) and the moderately water solubility (12.3 g/L) are favorable for absorption. In addition, the moderate log Pow value (2.03) are favorable for absorption by passive diffusion.
- Type:
- distribution
- Results:
- The small molecular weight and moderate water solubility are favorable for distribution throughout the body.
- Type:
- metabolism
- Results:
- The results of repeated dose studies indicate that the substance or its metabolites are distributed to various organs. Genotoxicity studies with and without metabolic activation do not provide further indications on the metabolic pattern of AMICURE PACM.
- Type:
- excretion
- Results:
- Low molecular weight and moderate water solubility are favorable for excretion of AMICURE PACM in urine.
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- The relatively small molecular weight (210.4) and the moderately water solubility (12.3 g/L) are favorable for absorption. In addition, the moderate log Pow value (2.03) are favorable for absorption by passive diffusion, although the potentially ionisable groups of 4,4'-methylenebis(cyclohexylamine), might limit diffusion across biological membranes.
For risk assessment purposes oral absorption of 4,4'-methylenebis(cyclohexylamine) is set at 100%. The results of the acute oral toxicity study and the combined repeated dose reproduction study do not provide reasons to deviate from this proposed oral absorption factor; the LD50 and the NOAEL from these studies indicate that the substance becomes systemically available.
expected that 4,4'-methylenebis(cyclohexylamine) will reach the nasopharyncheal region or subsequently the tracheobranchial or pulmonary region. If 4,4'-methylenebis(cyclohexylamine) reaches the tracheobronchial region, absorption through aqueous pores will be limited, taking the molecular weight of > 200 into account. However, 4,4'-methylenebis(cyclohexylamine) would readily dissolve into the mucus lining of the respiratory tract and the log Pow (2.03) of 4,4'-methylenebis(cyclohexylamine) is favorable for absorption directly across the respiratory tract epithelium by passive diffusion. Overall, although 4,4'-methylenebis(cyclohexylamine) will not reach the tracheobranchial region in a large extent, for risk assessment purposes the inhalation absorption of 4,4'-methylenebis(cyclohexylamine) is set at 100%. - Details on distribution in tissues:
- Once absorbed, the small molecular weight and moderate water solubility are favorable for distribution throughout the body. The results of the combined 28-day reproduction study indicate that AMICURE PACM or its metabolites are widely distributed throughout the body, based on the effects seen in various organs (e.g. liver, brain, kidneys and eyes). Possible ionization, low molecular weight and moderate water solubility are favorable for excretion of 4,4'-methylenebis(cyclohexylamine) in urine.
4,4'-methylenebis(cyclohexylamine) being a liquid has the potential to partition from the stratum corneum into the epidermis. In addition, the log Pow of 2.03 is favorable for penetration into the stratum corneum and hence dermal absorption and the moderate water solubility of 4,4'-methylenebis(cyclohexylamine) will not limited dermal absorption.
- Details on excretion:
- Possible ionization, low molecular weight and moderate water solubility are favorable for excretion of 4,4'-methylenebis(cyclohexylamine) in urine.
Metabolite characterisation studies
- Metabolites identified:
- no
- Details on metabolites:
- The results of the combined 28-day reproduction study indicate that 4,4'-methylenebis(cyclohexylamine) or its metabolites are widely distributed throughout the body, based on the effects seen in various organs (e.g. liver, brain, kidneys and eyes). Available data of 4,4'-methylenebis(cyclohexylamine) (e.g. negative results from in vitro genotoxicity studies with and without metabolic activation) do not give further indications on the metabolic pattern of 4,4'-methylenebis(cyclohexylamine).
Any other information on results incl. tables
Based on the present available data, no additional conclusions can be drawn on the distribution, metabolism and excretion of 4,4'-methylenebis(cyclohexylamine) after dermal and inhalatory absorption.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): low bioaccumulation potential based on study results
A review of the toxicokinetic behaviour of 4-4’-methylenedicyclohexanamine was undertaken. The relatively small molecular weight (210.4) and the moderately water solubility (12.3 g/L) are favorable for absorption, distribution and excretion. The moderate log Pow value (2.03) are favorable for absorption by passive diffusion, although the potentially ionisable groups of the substance, might limit diffusion across biological membranes. Based on the present available data, no additional conclusions can be drawn on the distribution, metabolism and excretion of 4,4'-methylenebis(cyclohexylamine) after dermal and inhalatory absorption. There is a low risk of bioaccumulation of this substance.
For risk assessment purposes oral absorption of 4,4'-methylenebis(cyclohexylamine) is set at 100%.
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