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Diss Factsheets
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EC number: 434-430-9 | CAS number: -
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- other: an assessment of toxicokinetic behavior has been conducted to the extent that can be derived from the relevant available information.
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Relevant studies were reviewed with a view to fulfilling the requirements of Annex VIII (8.8.1).
Data source
Reference
- Reference Type:
- other: an assessment of toxicokinetic behaviour has been conducted to the extent that can be derived from the relevant available information.
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
- Objective of study:
- toxicokinetics
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- In accordance with REACH Annex VIII (8.8.1) an assessment of toxicokinetic behaviour has been conducted to the extent that can be derived from the relevant available information.
- GLP compliance:
- no
Test material
- Test material form:
- solid: particulate/powder
Constituent 1
Results and discussion
Any other information on results incl. tables
The acute toxicity tests showed that the LD50 of the test
substance was higher than 2000 mg/kg body weight both after
oral administration and after dermal application. The
subacute oral toxicity test for 28-days revealed a NOAEL of
1000 mg/kg/day.
A sub-chronic 90-day study (on a structural analogue substance ) gave a NOAEL of 250 mg/kg bw/day (highest dose tested) and did not show evidence of signifcant absorption of the substance or systemic distribution.
Therefore, an extensive toxicokinetic
assessment is considered of limited value. Below, a summary
of the anticipated toxicokinetic behaviour of the test
substance is given.
Hydrolysis of two amide bounds in the test substance results (based on
main constituent)
in the compounds 1,6-diaminohexane (hexamethylenediamine,
CAS# 124-09-4, log Pow =0.02, water solubility : 800 g/L) and 12-hydroxystearic acid (12-hydroxy-octadecanoic
acid, CAS# 106-14-9, insoluble in water). Hydrolysis of
amide bounds is generally a slow process. Toxicokinetics of
these compounds will also be described below.
ABSORPTION
The water solubility of the test substance is very low,
caused by the apolar carbon-hydroxy chain. In general, a
compound needs to be dissolved before it can be taken up
from the gastro-intestinal tract after oral administration
. Thus, the very low water solubility can be considered
as a rate-limiting factor for the absorption of the
compound. However, the test substance may be absorbed in the
same way as other fatty acids, by diffusion across the
plasma membrane or by active transport. Overall, it is to be
expected that the oral bioavailability, and thus the
systemic exposure, of the test substance will be low to moderate.
Hydrolysis of the amide bounds may occur in the small
intestine. Following hydrolysis, the absorption of 12-
hydroxystearic acid will be high, like other fatty acids.
For 1,6-diaminohexane it is known that after oral
administration to rats, urinary excretion of diaminohexane-related compounds accounted for 47% of the dose. Thus, in
rats at least half of the dose was absorbed via the gastro-intestinal tract.
Uptake of the test substance via inhalation is not expected
to take place, because of the particle size distribution (10% < 12.4 µm).
Since the bioavailability of dermally applied compounds can
assumed to be zero for substances with a log Pow below -1
and over 5 or a relative molecular mass over 700, it is
not to be expected that the test substance will be absorbed
through the skin.
DISTRIBUTION
The test substance and 12-hydroxystearic acid will show high
volumes of distribution, because of the high lipophilicity
of the compounds. They will be distributed into peripheral
tissue, especially fatty tissues. The plasma protein binding
is expected to be high. Distribution of 1,6-diaminohexane
will be limited to total body water, because of the
relatively low log Pow. Therefore, a volume of distribution
of about 0.7 l/kg is expected. The compound will show
intermediate plasma protein binding.
METABOLISM AND EXCRETION
After absorption of the test substance into the systemic
circulation, hydrolysis of the amide-bounds will take place
in the liver. Direct glucuronidation or sulfation takes
place on the NH2-groups of 1,6-diaminohexane and on the 12-
hydroxy-group or the acids group of 12-hydroxystearic acid. Following glucuronidation or sulfatation, metabolites
will be excreted in urine or via bile into faeces.
CONCLUSION
Based on the expected kinetic behavior in the body, as
described above, the test substance will show low to
moderate absorption after oral administration. The test
substance is not expected to be absorbed via dermal
administration or after inhalation. In the gastro-intestinal
tract and in plasma and liver, the test substance will be
hydrolyzed to 1,6-diaminohexane and 12-hydroxystearic acid.
These compounds will undergo direct glucuronidation or
sulfation and excreted in urine or via bile into faeces.
Therefore, accumulation of the test substance itself in the
body during prolonged exposure is highly unlikely. For 12-
hydroxystearic acid, some retention in fatty tissues may
take place. For 1,6-diaminohexane, accumulation in fatty
tissues is not anticipated.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): other: see summary of conclusions
Accumulation of the test substance itself in the body during prolonged exposure is highly unlikely. For 12- hydroxystearic acid, some retention in fatty tissues may take place. For 1,6-diaminohexane, accumulation in fatty tissues is not anticipated.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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