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Diss Factsheets
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EC number: 931-740-0 | 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1996-12-31
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The need for further investigations is re-evaluated after registration when more information is expected to be available on the exposure pattern and on the properties of the target substance and potential analogue substances. Oncogenicity studies performed with the main constituent of the registered substance, 2-ethylhexanol. Studies performed with Fischer F344 rats and B6C3F1 mice followed the current U.S. EPA Good Laboratory Practice Guidelines. In the absence of proper toxicokinetic or metabolism study with the registered substance this study serves as a good surrogate studies: a) it represents the effects of the only identified and quantified consituent of the substance, since the consituents of this registered UVCB-substance cannot be recognized and its composition varies to the degree that composition cannot be fixed. b) studies have been performed following U.S. EPA Good Laboratory Practice. c) they provide information on metabolism and metabolites of 2-ethylhexanol and information what also is predicted to happen when this registered UVCB-substance is metabolized.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Prechronic toxicity studies on 2-ethylhexanol in F344 rats and b6C3F1 mice.
- Author:
- Astill B.D., K. Deckardt, Chr. Gembardt, R-Gingell, D.Guest, J.R. Hodgson, W.Mellert, S.R. Murphy and T.R. Tyler
- Year:
- 1 996
- Bibliographic source:
- Fundamental and applied toxicology 29, 31-39 (1996)
- Report date:
- 1996
- Reference Type:
- publication
- Title:
- Oncogenicity testing of 2-ethylhexanol in Fischer 344 rats and B6C3F1 mice
- Author:
- Astill B.D., R. Gingell, D.Guest, J. Hellwig, J.R. Hodgson, K. Kuettler, W.Mellert, S.R. Murphy, R.L. Sielken jr and T.R. Tyler
- Year:
- 1 996
- Bibliographic source:
- Fundamental and applied toxicology 31, 29-41
- Report date:
- 1996
Materials and methods
- Objective of study:
- metabolism
- Principles of method if other than guideline:
- Oncogenicity (76 weeks in mice, 104 weeks in rats) and subchronic studies (13 weeks both in mice and rats) also discussed and studied the metabolites of 2-ethylhexanol.
- GLP compliance:
- no
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
- Details on test material:
- - Name of test material (as cited in study report): 2-ethylhexanol
- Molecular formula (if other than submission substance): C8H18O
- Molecular weight (if other than submission substance): 130.23 g/mol
- Substance type: branched-chain primary alcohol
- Physical state: liquid
- Analytical purity: >99.0% purity (Gas chromatography)
- Stability: gas chromatographic analysis of dose samples indicated that under the conditions of dose formulation preparation and for the duration of the daily dosing period, the aqueous emulsion of 2-ethylhexanol was stable, homogenous, and within +-10% of nominal concentrations at all dose levels.Homogeneity ensured by 1-min high-speed sonication with ultra-turrax sonicator and maintained with magnetic stirring during dosing. Samples were prepared daily in batches of 150ml per study group.
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- 1-14C
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Test animal species: Fischer 344 rats and B6C3F1 mice
TEST ANIMALS
- Source:not disclosed, age: rats 33-35 days upon arrival, mice 43-44 days upon arrival.
- Age at study initiation: 42 days rats, 44 days mice
- Weight at study initiation: rats: males 103g (86-128) and females 81g (64-95), mice: males 23g (21-26) and females 19g (17-23)
- Fasting period before study: 16-20 hours
- Housing: following U.S. EPA GLP: rats housed singly in suspended stainless steel wire mesh cages and mice singly in plastic cages arranged in racks.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%):30-70
- Air changes (per hr): not disclosed
- Photoperiod (hrs dark / hrs light): 12 hours
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- Cremophor EL
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
DIET PREPARATION
- Rate of preparation of diet (frequency): daily
- Mixing appropriate amounts with (Type of food): cavage solution in Cremophor LE
- Justification for vehicle choice: most stable dose formulation and minimized tract irritation and inflammation.
VEHICLE
- Justification for use and choice of vehicle (if other than water): not disclosed
- Concentration in vehicle: 11-day study: 1000 and 1500 mg/kg bw ; 13-week study: 25, 125, 250 and 500 mg/kg bw. Oncogenicity: rats 50, 150, 500 mg/kg bw and mice 0, 50, 200 and 750 mg/kg bw.
- Amount of vehicle (if gavage): 10ml/kg bw or 1ml in mice 3ml in rats (solution of 0,005% Cremophor EL)
- Lot/batch no. (if required):not disclosed
- Purity: not disclosed
HOMOGENEITY AND STABILITY OF TEST MATERIAL: see test material details. - Duration and frequency of treatment / exposure:
- 5 times a week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Prechronic: 11-day study 1000 and 1500 mg/kg bw 13-week study 25, 125, 250 and 500 mg/kg bw. Oncogenicity: rats 50, 150, 500 mg/kg bw and mice 0, 50, 200 and 750 mg/kg bw.
- No. of animals per sex per dose / concentration:
- Prechronic study: 10 males and females, rats and mice.
Oncogenic study: 50 males and females, rats and mice. - Control animals:
- yes, concurrent vehicle
- Positive control reference chemical:
- Not required
Results and discussion
- Preliminary studies:
- The target organs of 2-ethylhexanol in rodents are the liver, the kidney, the central nervous system and the mucosa of respiratory and gastrointestinal tracts, depending on the route of administration.
Main ADME resultsopen allclose all
- Type:
- metabolism
- Results:
- 54% recovered after 24 hours, 76% recovered within 4 days
- Type:
- excretion
- Results:
- Metabolites excreted in urine were mostly glucuronides of oxidative products of 2-ethylhexanol
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Absorption was not studied but clearance in urine was reported to be 54% within 24 hours, absorption and metabolism must be fast.
- Details on excretion:
- Metabolites excreted in urine were mostly glucuronides of oxidative products of 2-ethylhexanol.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- Metabolites excreted in urine were mostly glucuronides of oxidative products of 2-ethylhexanol (% of radiolabel in urine free, % as glucuronide):
2-ethylhexanoic acid (9%, 48%), 5-hydroxy-2-ethylhexanoic acid (4.2%, 2.0%), 6-hydroxy-2-ethylhexanoic acid (1.35%, 12.0%) and 2-ethyladipic acid (7.6%, 15.3%). Only traces of 2-ethylhexanol was found in urine.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): bioaccumulation potential cannot be judged based on study results
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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