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EC number: 204-640-3 | CAS number: 123-66-0
- 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:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016-08-25 to 2017-02-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- Ethyl hexanoate
- EC Number:
- 204-640-3
- EC Name:
- Ethyl hexanoate
- Cas Number:
- 123-66-0
- Molecular formula:
- C8H16O2
- IUPAC Name:
- ethyl hexanoate
- Test material form:
- liquid
Constituent 1
Results and discussion
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse treatment-related effects of toxicological significance were observed.
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- This study was conducted to evaluate the potential toxicities of the test substance in the general systemic and reproductive/development when administered via oral gavage to Sprague-Dawley rats with dose levels of 0, 100, 300 and 1000 mg/kg. There were no test item-related adverse effects in general effects and reproduction/development up to 1000 mg/kg. Therefore, the No Observed Adverse Effect Levels (NOAELs) for general toxicity effects and reproduction/developmental toxicity are considered to be at least 1000 mg/kg/day.
- Executive summary:
This study was conducted to evaluate the potential toxicities of a test substance, regarding general systemic effects and reproductive/developmental toxicity. The test item was administered by oral gavage to Sprague-Dawley rats (12 animals per sex per group) at dose levels of 0, 100, 300 and 1000 mg/kg with a dose volume of 2 mL/kg. Males and females were dosed for two weeks prior to mating and continued through the day before sacrifice in males (at least 50 days), and continued through the lactation day 13 in females. Additional animals in the recovery groups 0 and 1000 mg/kg (6 animals per sex per group) received the test substance, but were not mated. Afterwards, they were assigned to 2 weeks of recovery period after the completion of the test item administration.
No deaths or moribund animals occurred in any group throughout the study. Test item-related salivation was observed in both sexes at 1000 mg/kg; however, it was not considered to have toxicological relevance since it was considered to be attributed to the palatability of the test item. At 1000 mg/kg, test item-related changes were also observed including increased prothrombin time (up to 1.11-fold of the control) in both sexes and increased kidney weight (1.13-fold of control) in females. However, it was not considered to have toxicological relevance since there was no correlated microscopic findings. In addition, in males in all test item-treated groups, decreased gamma glutamyl transpeptidase (up to 32% of control) was observed. However, it was not considered to have toxicological relevance since there was no correlated microscopic finding.
No test item-related change was observed in oestrus cycle, precoital time, fertility data, reproductive and littering findings, F1 pups clinical signs, body weight, anogenital distance, nipple retention and external examinations. Test item-related increase in T4 was observed in adult males (1.14-fold of control) and pups (1.20-fold of control) at 1000 mg/kg. However, it was not considered to have toxicological relevance since there were no correlated changes in other parameters including microscopic findings of thyroids (with parathyroids).
In conclusion, no test item-related adverse effects for general toxicity effects and reproductive/developmental effects were observed up to 1000 mg/kg. Therefore, the No Observed Adverse Effect Levels (NOAELs) for general toxicity effects and reproduction/developmental toxicity are considered to be at least 1000 mg/kg/day.
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