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EC number: 201-796-4 | CAS number: 88-09-5
- 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 somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Version / remarks:
- T37-15: Chemical Substances Control Law of Japan
- GLP compliance:
- yes
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- 2-ethylbutyric acid
- EC Number:
- 201-796-4
- EC Name:
- 2-ethylbutyric acid
- Cas Number:
- 88-09-5
- Molecular formula:
- C6H12O2
- IUPAC Name:
- 2-ethylbutyric acid
- Test material form:
- not specified
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: T23-48:BDF1 (C57BL/6 x DBA/2)
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle/solvent used: Corn oil.
- Duration of treatment / exposure:
- 48-hour experimental period
- Frequency of treatment:
- Twice at 0 and 24 hours (24-hour interval)
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Remarks:
- Control
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Dose / conc.:
- 2 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- Five male animals per dose
- Control animals:
- yes, concurrent no treatment
- yes, historical
- Positive control(s):
- Positive control based on historical data for mitomycin C (2 mg/kg i.p. single administration).
Examinations
- Tissues and cell types examined:
- Mouse bone marrow cells
Results and discussion
Test results
- Key result
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- See additional information.
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- At 1000 and 2000 mg/kg bw/day, the ratio of polychromatic erythrocytes (PCE) to total erythrocytes (%) observed in mice significantly decreased. One animal died at 2000 mg/kg bw/day.
Applicant's summary and conclusion
- Conclusions:
- 2-Ethylbutyric acid at ≤2000 mg/kg bw/day was determined not to be mutagenic as part of an in vivo mammalian erythrocyte micronucleus assay using mouse bone marrow cells.
- Executive summary:
An in vivo mammalian erythrocyte micronucleus assay for 2-ethylbutyric acid was undertaken in line with Good Laboratory Practise (GLP), OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test), and T37-15: Guideline for Screening Mutagenicity Testing of Chemicals (Chemical Substances Control Law of Japan). The purpose of the experiment was to determine the mutagenic potential of the registered substance in male mice (strain: T23-48:BDF1 (C57BL/6 x DBA/2)) following administration of 0 (untreated control), 500, 1000, and 2000 mg/kg bw/day in a corn oil vehicle via oral gavage twice with a 24-hour interval. The experiment ran for a 48-hour period. A dose-finding study was conducted initially to obtain the concentrations for the main test. Historical positive (mitomycin C 2 mg/kg i.p. single administration) and negative control data from 1986 - 2002 were referred to.
The study was reported to have satisfied validity criteria. That one animal died at 2000 mg/kg bw/day, and that a significant decrease in the ratio of polychromatic erythrocytes (PCEs) to normochromatic erythrocytes (NCEs) (%) was observed at 1000 and 2000 mg/kg bw/day, is suggestive of bone marrow toxicity induced by the substance. However, 2-ethylbutyric acid was ultimately concluded not to be mutagenic to mammalian cells in vivo given that there was no significant increase in the frequency of micronucleated polychromatic erythrocytes (MNPCE) in all treatment groups.
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