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EC number: 304-059-6 | CAS number: 94233-27-9
- 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 in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- publication
- Title:
- Metabolism of 2-ethylhexanol administered orally and dermally to the female Fischer 344 rat.
- Author:
- P. J. Deisinger, R. J. Boatman & D. Guest
- Year:
- 1 994
- Bibliographic source:
- Xenobiotica. 1994 May;24(5):429-40
Materials and methods
- Objective of study:
- other: ADME and kinetics
Test material
- Reference substance name:
- 2-ethylhexan-1-ol
- EC Number:
- 203-234-3
- EC Name:
- 2-ethylhexan-1-ol
- Cas Number:
- 104-76-7
- Molecular formula:
- C8H18O
- IUPAC Name:
- 2-ethylhexan-1-ol
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Duration and frequency of treatment / exposure:
- 1) single dose exposure
2) repeated dose exposure, 14 days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 50 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 500 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose / concentration:
- 4
- Control animals:
- no
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- 2-EH was rapidly absorbed after oral administration of 50 and 500 mg/kg bw; evidenced by the rapid excretion (approx. 50% of the dose within
8 hrs). 95-97% of the dose were excreted within 96 hrs. - Details on distribution in tissues:
- Distribution into tissues is of minor relevance, due to rapid excretion, mainly as polar conjugates in urine. Bioaccumulation is unlikely to occur, as excretion was virtually complete (>95%) within 96 hrs.
- Details on excretion:
- 2-EH was rapidly absorbed after oral administration of 50 and 500 mg/kg bw; evidenced by the rapid excretion (approx. 50% of the dose within 8 hrs). 95-97% of the dose were excreted within 96 hrs, mainly as polar conjugates in urine. Bioaccumulation is unlikely to occur, as excretion was virtually complete within 96 hrs.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- The majority of the oral and dermal doses were eliminated as glucuronides of oxidized metabolites of 2-ethylhexanol (2-EH). Major metabolites:
glucuronides of 2-ethyladipic acid, 2-ethylhexanoic acid, 5-hydroxy-2-ethylhexanoic acid, and 6-hydroxy-2-ethylhexanoic acid. Only trace amounts of the unchanged 2-ethylhexanol were detected in urine.
Applicant's summary and conclusion
- Conclusions:
- No bioaccumulation potential based on study results.
1. Excretion balance studies were conducted with 2-ethylhexanol (2-EH) in female Fischer 344 rats following single high (500 mg/kg) and low (50 mg/kg) oral doses of 14C labeled 2-EH, following repeated oral dosing with unlabelled 2-EH at the low level, following dermal exposure for 6h with a 1 g/kg applied dose of [14C]2-EH, and following a 1 mg/kg i.v. dose of [14C]2-EH.
2. The high, low and repeated low oral dose studies with 2-EH showed similar excretion balance profiles of [14C], with some evidence of metabolic saturation at the high dose.
3. No evidence of metabolic induction was seen following the repeated low oral dosing.
4. All of the oral doses were eliminated rapidly, predominantly in the urine during the first 24 h following dosing.
5. T h e dermal dosing resulted in only about 5% absorption of the 1 g/kg dose, with the major portion of the dose recovered unabsorbed from the dermal exposure cell at 6 h.
6 . Urinary metabolites eliminated following the oral and dermal doses were predominately glucuronides of oxidized metabolites of 2-EH, including glucuronides of 2-ethyladipic acid, 2-ethylhexanoic acid, 5-hydroxy-2-ethylhexanoicacid and 6-hydroxy-2-ethylhexanoic acid. - Executive summary:
As the target substance hydrolyses rapidly (half-life < 30 minutes) the intrinsic properties are related to hydrolysis products of the target substance. This information is used as a supporting evidence on the toxicity of the target substance in CSA.
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