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EC number: 203-079-1 | CAS number: 103-09-3
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian germ cell study: cytogenicity / chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: comparable to guideline study conducted in compliance with GLP regulations
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1980
Materials and methods
- Principles of method if other than guideline:
- Following exposure of male rodents to varying concentrations of the test article by a route reflecting the mode of human environmental exposure,
bone marrow cells arrested in C-metaphase are examined microscopically for chromosome aberrations, numerical and structural. The types of damage expected duo to the action of mutagenic compounds are chromatid or chromosomal breaks and structural rearrangements, although in some
advanced cases, clones of aberrant cells may indicate a change from the normal diploid number. - GLP compliance:
- yes
- Type of assay:
- chromosome aberration assay
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
- Details on test material:
- - Name of test material (as cited in study report): R-1213/T1640
- Physical state: liquid
- Analytical purity: 99.7%
- Storage condition of test material: room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Farms
- Age at study initiation: 4-6 weeks old
- Weight at study initiation: 115-150 g
- Assigned to test groups randomly: [yes, under following basis: random, not further specified ]
- Housing: 3-4 per cage during acclimation period, individually thereafter
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 10-14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +-3 °C
- Humidity (%): 50 +- 20 %
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: [corn oil]
- Justification for choice of solvent/vehicle: none given
- Concentration of test material in vehicle: 0.02, 0.07 and 0.21 ml/kg of the test material (amount of vehicle not stated)
- Amount of vehicle (if gavage or dermal): 5 ml/kg - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The test article-carrier mixture was formulated such that each animal received 5 ml/kg body weight/day . The rats were weighed and dosed by gavage for five consecutive days with the appropriate concentration of the test article or vehicle (carrier) control. - Duration of treatment / exposure:
- 5 days
- Frequency of treatment:
- once daily
- Post exposure period:
- none
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.02, 0.07, and 0.21 ml/kg bw/day (corresponding to approximately 16.6, 58.1, and 174.3 mg/kg bw/day)
Basis:
nominal conc.
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- triethylenemelamine
- Justification for choice of positive control(s): none given
- Route of administration: single intraperitoneal injection
- Doses / concentrations: 0.5 mg/kg
Examinations
- Tissues and cell types examined:
- A minimum of 50 metaphase spreads from each animal was examined and scored for chromatid and chromosomal gaps and
breaks, fragmentation, structural rearrangements, and ploidy. - Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
The doses were selected on the basis of the result of the determination of the LD50 in rats.
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields):
The test article-carrier mixture was formulated such that each animal received 5 ml/kg body weight/day . The rats were weighed and dosed by gavage for five consecutive days with the appropriate concentration of the test article or vehicle (carrier) control. The positive control, TEM, was injected
intraperitoneally (IP) as a single-treatment one day prior to sacrifice at a dose level of 0.5 mg/kg.
DETAILS OF SLIDE PREPARATION:
All rats were given colchicina at 4 mg/kg IP 2 hours prior to sacrifice. The rats were sacrificed by carbon dioxide asphyxiation, the femurs were
removed and the marrow was flushed into HBSS. After centrifugation at 800-1000 rpm for 8-10 minutes, the cells were treated with 0.075 M KCl for
20-30 min at 37+-2 °C. The cells were again centrifuged and washed twice with 5 ml Carnoy's fixative. The cells were resuspended in 5 ml Carnoy's
fixative and treated overnight (16-20 hr) at 4 +- 2°C . The cells were centrifuged at 800-1000 rpm for 8-10 min and the cell pellet was resuspended
to opalescence in fresh Carñoy's fixative. Two to five slides were prepared from each animal. Slides were stained with Giemsa and permanently
mounted.
METHOD OF ANALYSIS:
A minimum of 50 metaphase spreads from each animal was examined and scored for chromatid and chromosomal gaps and breaks, fragmentation,
structural rearrangements, and ploidy. The mitotic index was recorded for each rat as the number of cells in mitosis/100 cells observed.
- Evaluation criteria:
- The percentage of cells in the negative control group demonstrating chromosome and chromatid break's and gaps must be less than or equal to 4% of the total cells analyzed. The percentage of cells demonstrating aberrations of any type must not exceed 10% in the negative control group. The
difference between the percentage of calls with aberrations in the positive control group and the negative control group must be at least 15%. The
number of cells with aberrations in the positive control group must also be statistically increased (p<=0.05) relative to the negative control using t-test statistics.
. - Statistics:
- Chi-square analysis using a 2x2 contingency table was used to ascertain significant relationships between the number of cells with aberrations in the
treatment group relative to the negative control. The t-test was used to compare pairwise the number of aberrations per cell of the treatment group with that of the negative control.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
There was no change in ploidy in the treatment groups relative to the negative controls. 2 -Ethylhexan-1 -ol was not a mitotic inhibitor when compared to the negative controls. The percentage-of cells with aberrations for all treatment groups was not statistically (p>0.05) increased relative to the negative control group using Chi-square statistics. The total aberrations per cell for all treatment groups were not significantly p>0.05) increased relative to the negative control group using t-test statistics. Percentage of cells with aberrations:
-------------------------------------
Treatment Gaps Breaks Rearrangements SDC Total
-----------------------------------------------------------
negative c. 0.8 0 0 0 0
positive c. 8.8 7.2 2.0 17.2 26.4
TS 0.21 3.6 0.4 0 0 0.4
TS 0.07 2.8 0.4 0 0 0.4
TS 0.02 4.8 0 0 0 0
-----------------------------------------------------------
Treatment dose (TS): ml/kg/day
SDC: severly damaged cells, i.e. cells having more than 10 aberrations
Severity of damage as aberrations per cell:
-------------------------------------------
Treatment Total Total Total Total Aberrations
Gaps Breaks Rearrange- SDC per cell
ments
-----------------------------------------------------------
negative c. 2 0 0 0 0
positive c. 71 54 19 430 2.01
TS 0.21 13 1 0 0 <0.01
TS 0.07 13 1 0 0 <0.01
TS 0.02 15 0 0 0 0
-----------------------------------------------------------
Treatment dose (TS): ml/kg/day
Total SDC: cells having more than 10 aberrations were counted as 10
Applicant's summary and conclusion
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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