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Diss Factsheets
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EC number: 447-920-2 | CAS number: 897393-42-9
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- The qualitative judgement is based on physico-chemical characteristics. Some of these are determined under conditions which are not biologically relevant (like the octanol/water partition coefficient at pH 11). Furthermore, the submission substance is a multi constituent substance while physico-chemical characteristics in general refer to pure substances. This limits the reliability of the assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
- Objective of study:
- toxicokinetics
- Principles of method if other than guideline:
- Qualitative judgement on the toxicokinetic behaviour based on physico-chemical characteristics.
- GLP compliance:
- no
Test material
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- No further data
- Radiolabelling:
- no
Results and discussion
Any other information on results incl. tables
The acute oral toxicity test with the test substance showed
the LD50 being between 200 and 2000 mg/kg body weight. The
subacute toxicity test for 28-days revealed a NOAEL of 50
mg/kg/day. Therefore, an extensive toxicokinetic assessment
is considered of limited value. Below, a summary of the
anticipated toxicokinetic behaviour of the test substance is given.
The water solubility of the test substance is high. Since in
general a compound needs to be dissolved before it can be
taken up from the gastro-intestinal tract, it is likely that
the test substance will show a high systemic exposure after
oral administration. It is to be expected that the oral
bioavailability of the test substance will be relatively
high. The highest absorption is expected to be from the duodenum.
In the gastro-intestinal tract, hardly any degradation of
the substance is to be expected. In the case absorption of the
test substance occurs, the aliphatic carbons as well as the
primary nitrogens will undergo extensive hydroxylation,
followed by rapid sulfation or glucuronidation. Direct
conjugation at the nitrogens in the parent compound is
expected. Also extensive cleavage of the ether bonds is
anticipated. The resulting metabolites will be extensively
excreted via bile and/or urine.
The submission substance will show a low volume of distribution,
because of the relatively low lipophilicity of the compound.
The volume of distribution is expected to equal total body
water (about 700 ml/kg). Accumulation in fatty tissues is
therefore not anticipated. The plasma protein binding is
expected to be low.
Uptake via inhalation may take place based on the vapour pressure.
Since it is generally accepted that substances with log Po/w
ranging from 0.1 to 6 penetrate the skin easily, it is
to be expected that the test substance may penetrate the
skin rapidly. The fact that the test substance is corrosive
to the skin may even increase the dermal absorption.
Based on the expected kinetic behaviour in the body, as
described above, the test substance will show a relatively
high absorption after oral administration, mainly because of
its high water solubility. If absorption occurs, the test
substance will be extensively metabolised in the liver and
rapidly excreted via bile and/or urine. Therefore,
accumulation in the body during prolonged exposure will be very low.
Applicant's summary and conclusion
- Conclusions:
- Following a qualitative judgement based on physico-chemical characteristsc of the submission substance, the substance will show a relatively high absorption after oral administration, mainly because of its high water solubility. If absorption occurs, the test substance will be extensively metabolised in the liver and rapidly excreted via bile and/or urine. Therefore, accumulation in the body during prolonged exposure will be very low. Dermal absoprtion is also expected to be significant, following the logPow and skin corrosive properties of the submission substance.
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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