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Diss Factsheets
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EC number: 700-831-5 | 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP, non-guideline study, published in peer reviewed literature, minor restrictions in design and/or reporting but otherwise adequate for assessment.
Data source
Reference
- Reference Type:
- publication
- Title:
- The Developmental Toxicity of 2-Ethylhexanoic Acid in Wistar Rats
- Author:
- Pennanen S, Tuovinen K, Huuskonen H, Komulainen H
- Year:
- 1 992
- Bibliographic source:
- Fundamental and Applied Toxicology 19, 505-511 (1992)
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- not specified
- Limit test:
- no
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:
- Purity: 99.5%
Supplier: Merck (Darmstadt, FRD)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- Virgin female Han:Wistar rats (National Laboratory Animal Center, University of Kuopio, Finland) weighing 200-220 g (12 to 14-weeks old) and male rats of the same strain 360-380 g (16-weeks old) were used for this study. Rats were housed in stainless steel wire mesh cages and kept under a photoperiodic cycle of 12 hr light/12 hr dark in an air-conditioned animal room. Temperature and relative humidity of the room were maintained ay 21 ± 1°C and 55-65% respectively. Animals were housed three per cage before mating and individually during gestation. The animals received commercial rat chow (R3-EWOS, Sodertalje, Sweden) and tap water ad libitum except 2-EHA solution during the experiment.
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- other: 2-EHA was administered as a sodium salt by mixing 2-EHA and NaOH equimolarly in drinking water.
- Details on exposure:
- Mated females were exposed to 2-EHA on Days 6-19 of gestation via drinking water at doses of 100, 300 and 600 mg/kg bw/day. Control animals received deionised water. Water consumption was recorded for the whole exposure period and the doses were corrected individually according to the most recent body weight taken on days 0, 6, 13 and 20.
- Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- Female rats were paired overnight with males and the vaginal smears were checked the next morning for the presence of sperm.
- Duration of treatment / exposure:
- 14-days (days 6-19 of gestation).
- Frequency of treatment:
- Daily
- Duration of test:
- 20 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 300 and 600 mg/kg bw/day
Basis:
nominal in water
- No. of animals per sex per dose:
- 20-21 dams per treatment group
Control: 21 dams
100 mg/kg/day: 21 dams
300 mg/kg/day: 20 dams
600 mg/kg/day: 20 dams - Control animals:
- yes, concurrent no treatment
Examinations
- Maternal examinations:
- - The animals were observed daily for clinical signs.
- Water consumption was recorded for the whole exposure period and the doses were corrected individually according to the most recent bodyweight taken on days 0, 6, 13 and 20
- Food consumption was recorded in the same gestational stage during days 13 to 16 of pregnancy. - Ovaries and uterine content:
- The uterine contents and ovaries were examined for the number of corpora lutea, weight of uterus with its contents, number of implantation sites, sex and number of live and dead fetuses, number of early and late resorptions, external abnormalities, and placental weights.
- Fetal examinations:
- Individual fetal weights, skeletal anomalies and visceral anomalies.
- Statistics:
- Maternal, fetal, and placental weights, implantations, and living fetuses per litter were analysed by one-way analysis of variance (ANOVA). Comparisons of significant group effects were conducted using the Fisher PLSD test. The fetal bodyweight data were also evaluated using covariate analysis with litter size and sex ratio as covariates. Dose-response relationships for maternal and fetal body weights and affected fetuses and fetuses with skeletal or visceral malformations (group mean of litter percentages) were analysed by the Pearson correlation test. Pre- and postimplantation losses and group mean values of litter percentages of skeletal and visceral anomalies were analysed by the Mann-Whitney U nonparametric test. Other data were analysed by the X2 test.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Reduced maternal weight gain at 600 mg/kg/day
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 300 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
Lower fetal weight at 300 and 600 mg/kg/day
Increased incidences of clubfoot at 300 and 600 mg/hg/day
Increased wavy ribs at all doses, and of extra thoracic ribs at 600 mg/kg/day
Reduced ossification at 600 mg/kg/day
Increased incidences of fetuses with dialation of the lateral ventricles at 600 mg/kg/day.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The maternal NOAEL was 300 mg/kg bw/day and the NOAEL for teratogenicity was 100 mg/kg bw/day. Maternal effects included slightly lower pregnancy rate and reduced body weights. Teratogenic effects included reduced fetal weights and skeletal variations.
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