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EC number: 263-009-0 | CAS number: 61788-81-6
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4900 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-ethylhexanoic acid
- EC Number:
- 205-743-6
- EC Name:
- 2-ethylhexanoic acid
- Cas Number:
- 149-57-5
- Molecular formula:
- C8H16O2
- IUPAC Name:
- 2-ethylhexanoic acid
- Details on test material:
- TEST SUBSTANCE: 2-ethylhexanoic acid (Sigma E4134)
Purity: no data available
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Age at arrival: males: 70 days; females: 63 days
- Weight at study initiation: males: 175-200 g; females: 130-150 g
- Housing: stainless steel wire mesh cages
- Diet (e.g. ad libitum): Prolab Certified Ground Rodent Chow, RMH-3200; ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 69-72
- Humidity (%): 45-65
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The test chemical was diluted in certified corn oil (Mazola, Best Foods, Inc., CPC International) and mixed by inversion prior to the onset of the study. GC analysis indicated that the test material was stable for at least 21 days when stored at room temperature and uniformly distributed in corn oil. A dose volume of 2 ml/kg bodyweight (concentration in vehicle: 0 - 250 mg/ml) was administered by gavage, based on the body weight of each animal on gestation day 6. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Actual concentrations of test material in corn oil were determined by GC analysis and were 50.4, 132.0 and 246.0 mg/ml for the 100, 250 and 500 mg/kg/day doses, respectively. Analysis values ranged from 92.5 to 109.7% of the nominal dosing concentrations.
- Details on mating procedure:
- - Impregnation procedure: cohoused
- M/F ratio per cage: 1:1
- Each male was used only once
- Proof of pregnancy: vaginal plug referred to as day 0 of pregnancy (GD 0)
- Successfully mated females weighing 147-174 g were housed singly and were randomly assigned (stratified by body weight) to each experimental group. - Duration of treatment / exposure:
- Gestation day 6 through 15
- Frequency of treatment:
- Daily
- Duration of test:
- Up to gestation day 21
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Dose / conc.:
- 250 mg/kg bw/day (nominal)
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 25 (females only)
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: based on dose range finding study
Examinations
- Maternal examinations:
- CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: on GD 0, 6 (prior to dosing), 12, 15, 18 and 21.
FOOD CONSUMPTION: Yes
- Food consumption (g food/animal/day) was measured for the intervals GD 0-3, 3-6, 6-9, 9-12, 12-15, 15-18 and 18-21.
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 21 (CO2)
- Gross examination: gravid uterus, ovaries (including corpora lutea), cervix, vagina and abdominal and thoracic cavities.
- Organ weights: liver, uterus
- The liver was fixed for possible future examination - Ovaries and uterine content:
- The uterus was externally examined for signs of hemorrhage, removed from the abdominal cavity and dissected longitudinally to expose the contents. All live and dead fetuses and resorption sites were noted and recorded. Uteri from females that appeared nongravid were placed in ammonium sulfide for detection of early resorptions.
- Fetal examinations:
- All live fetuses were weighed and sexed. All fetuses were examined for external malformations including cleft palate and variations. One half of the fetuses in each litter were examined for thoracic and abdominal visceral abnormalities. These fetuses were decapitated and their heads were fixed for examination of craniofacial structures. Remaining fetuses were eviscerated, fixed and examined for skeletal malformations and variations. Decapitated fetuses were also processed for staining but were not examined.
- Statistics:
- The unit of comparison was the pregnant female or the litter. Results of the quantitative continuous variables were intercompared for the dose groups by the Levene's test for equal variances, ANOVA, and t-tests with Bonferroni probabilities for pairwise comparisons. When Levene's test indicated homogeneous variances and the ANOVA was significant, the pooled t-test was used. When Levene's test indicated heterogeneous variances, all groups were compared by ANOVA for unequal variances followed, when necessary, by the separate variance t-test. Nonparametric data obtained following laparohysterectomy were treated using the Kruskal-Wallis test followed by the Mann-Whitney U test when appropriate. Incidence data were compared using Fisher's Exact Test.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Details on maternal toxic effects:
Clinical signs were observed at the high-dose level only and included hypoactivity, ataxia, audible respiration, ocular discharge and periocular encrustations. No effects on body weight and mortality were observed. Liver weight (absolute and relative) was increased in the high-dose group.
Effect levels (maternal animals)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Details on embryotoxic / teratogenic effects:
Fetal body weights per litter were reduced in the high-dose group, but these findings may be confounded by the slightly larger mean litter size in this group. Reduced skeletal ossification was observed in the mid- and high-dose group. Dilation of the lateral ventricles of the brain with no tissue compression and extra (14th) thoracic centrum and arches were observed in all groups but were significantly increased at the high dose only.
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Developmental toxicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL for maternal toxicity was decided to be 250 mg/kg bw/day wheras the NOAEL for developmental toxicty was decided to be 100 mg/kg bw/day.
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