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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1995-05-30
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Repeated-dose toxicity studies performed with the only identified and quantified 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 data on the registered substance these studies serve as a good surrogate studies: a) it represents the effects of the only identified and quantified constituent of the substance, since the constituents 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 effect levels of 2-ethylhexanol when administered via oral cavage.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Principles of method if other than guideline:
- Similar to that of OECD 408, but with 11 day sub-acute study was performed to adjust the proper doses for the actual 90-day study. Number of animals per treatment group per sex was 10.
- GLP compliance:
- yes
- Remarks:
- U.S EPA Good laboratory practice was adopted
- Limit test:
- 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
- Smiles notation (if other than submission substance): OCC(CC)CCCC
- Substance type: 2-Ethylhexanol (2-EH), or isooctanol, is a fatty alcohol, an organic compound
- Physical state: colorless liquid
- Analytical purity: 99,8%
- Purity test date: 99, 8%
- Stability under test conditions: concentration and homogeneity was checked by gas chromatography analysis of samples from each dose level at the start of 11-day studies and periodically in 13-week studies.
- Storage condition of test material: no data
Constituent 1
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:
- polyoxyethylene glycerol triricinoleate, Cremophor EL, BASF Aktien Gesellshaft, Ludwigshafen, Germany
- Details on oral 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:
Subacute: 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. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Gas chromatographic analysis of homogeneity and concentrations, start of the study (11-days study) and peridiocally (90-days study).
- Duration of treatment / exposure:
- 11 days sub-acute study
90-days sub-chronic study - Frequency of treatment:
- 5-times a week, consecutively.
- No. of animals per sex per dose:
- 11-day study: 10 females and 10 males, rats and mice
90-day study: 10 females and 10 males, rats and mice - Positive control:
- not needed
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily treatment days, once non-treatment days.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: 11-day study: days -3, 0, 4, 10. 90-day study: day -1 and weekly thereafter
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food and water consumption were measured on 11-day study on days 4 and 10. In 90-day study average food consumption was determined weekly.
HAEMATOLOGY: Yes
- Time schedule for collection of blood: 11-day study: retro-orbital bleeding prior to termination or after decapitation. In 90-days study: from fasted animals on the morning of days 29 and 84.
- Anaesthetic used for blood collection: No data
- Animals fasted: Yes
- How many animals: no data
- Parameters checked in table [No.?] were examined: leucocytes, eryhtrocytes, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelets and differential leucocytes, and reticulocytes (only 90-day study).
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: 11-day study: retro-orbital bleeding prior to termination or after decapitation. In 90-days study: from fasted animals on the morning of days 29 and 84.
- Anaesthetic used for blood collection: No data
- Animals fasted: Yes
- How many animals: no data
- Parameters checked in table [No.?] were examined.: alanine , aspartate aminotransferase, creatine kinase, gamma-glutamyltransferase, glucose, urea, total protein, albumin/globulin, Natrium, Potassium, Calcium, Chlorine, creatinine, cholesterol, triglycerides, total bilirubin.
URINALYSIS: Yes / No / No data
- Time schedule for collection of urine:
- Metabolism cages used for collection of urine: Yes / No / No data
- Animals fasted: Yes / No / No data
- Parameters checked in table [No.?] were examined. - Sacrifice and pathology:
- Moribund animals were euthanized; dead and euthanized animals were immediately necropsied and assessed grossly. Gross and microscopic examinations were made as follows:
11-day study adrenals, brain, kidneys, livers, lungs, spleen, stomach, and testes were weighed and together with any gross lesions and thymuses were processed, fixed in 4% formalin, stained with hematoxylin.eosin and examined microscopically.
In 90-days study: drenals, brain, kidneys, livers, lungs, spleen, stomach, and ovaries from all animals were weighed with other tissues listed in U.S. EPA Health Effect guidelines (1978b) fixed in 4% formalin. Livers were also stained with oil red for lipid content and examined microscopically. Animals in 90-day ancillary studies were used only to determine hepatic peroxisome proliferation. Livers were removed at termination and weighed and cyano-insensitive pCoA activities and protein concentrations were determined.
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Statistics:
- Means and standard deviations were calculated for body weights, food and water consumption, clinical pathology results, and organ weights. Values for test groups were compared with controls in the main study by ANOVA followed by Dunnett's test and in ancillary studies by ANOVA followed by Student't t-test.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- reduced body weight
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- higher dose levels groups had reduced food intake 10-20%
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- increased liver, kidney, stomach and testes weights.
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 125 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: overall effects, clinical signs: reduced body weight and increased relative liver, kidney, stomach and testes weight.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- These studies were peformed in order to derive suitable dose levels for oncogenicity testing (U.S EPA, 1987c) according to U.S EPA requirements. These studies were performed as an oral cavage since irritative effects of oesophagus and mucosa of the GI tract was wanted to be excluded as it is the primary effect on first contact with external surfaces of the body.
A no-effect level for target organ (liver) was established as 125 mg/kg day bodyweight for both rat and mouse.
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