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EC number: 203-745-1 | CAS number: 110-19-0
- 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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Methodological deficiencies, limited reporting (LC50 value not statistically determined, no actual concentrations and particle size distribution measured, only 6 rats used, reporting not according to test guideline)
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 962
- Report date:
- 1962
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 957
- Report date:
- 1957
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- yes
- Remarks:
- : no concentrations and particle size distribution measured, only 6 rats used, reporting limited and not according to test guideline
- Principles of method if other than guideline:
- Pre-guideline study, but method is similar to OECD TG 403. A test with graduate doses (standard test) and an inhalation hazard test were performed.
- GLP compliance:
- no
- Remarks:
- pre-GLP study
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Isobutyl acetate
- EC Number:
- 203-745-1
- EC Name:
- Isobutyl acetate
- Cas Number:
- 110-19-0
- Molecular formula:
- C6H12O2
- IUPAC Name:
- isobutyl acetate
- Details on test material:
- - Name of test material (as cited in study report): Acetic acid, isobutyl ester; isobutyl acetate
- no further information on test substance
- Analytical purity: no data, but as iso-butyl acetate is usually available as high quality / purity, it can probably be assumed that test item purity was high
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Albino
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: own breeding facility
- Age at study initiation: 4 to 5 weeks
- Weight at study initiation: 90 to 120 g
- Fasting period before study: no
- Housing: no data
- Diet (e.g. ad libitum): Rockland rat diet, complete, ad libitum
- Water (e.g. ad libitum): ad libitum
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- Test with graduate doses (standard test)
Test atmosphere was generated by injecting definite amounts of test substance into the flowing stream of breathing air using a suitable proportioning pump.
Inhalation hazard test
Test atmosphere was generated by passing a stream of dried air at 2.5 L/min at room temperature through a fritted glass disc immersed to a depth of at least 1 inch in approximately 50 mL of the test substance contained in a gas washing bottle. Six female albino rats were exposed for different exposure times to this atmosphere (flowing stream of air saturated or close to saturation with vapour). - Analytical verification of test atmosphere concentrations:
- no
- Duration of exposure:
- 4 h
- Remarks on duration:
- test with graduate doses
- Concentrations:
- For the standard test, doses were spaced in a logarithmic series with a factor of 2. Doses of 4000, 8000, and 16000 ppm (19.3, 38.6, and 77.3 mg/L) are reported.
For the inhalation hazard test, the test atmosphere was saturated or close to saturation with test substance vapor as indicated by the generation method of test atmosphere (saturated vapor concentration of isobutyl acetate: 95 mg/L at 20°C according to Auer Technikum Edition 12, Auergesellschaft GmbH, Berlin, 1988) - No. of animals per sex per dose:
- six female animals per dose
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no data
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: no data
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LC50
- Effect level:
- 30 mg/L air
- Remarks on result:
- other: deduction based on study data (see under Remarks on results)
- Sex:
- female
- Dose descriptor:
- LC0
- Effect level:
- 19.3 mg/L air (nominal)
- Remarks on result:
- other: Standard test: at the given dose, 0 of 6 animals died. Dose is converted from ppm as reported by the authors (4000 ppm)
- Sex:
- female
- Dose descriptor:
- other: LC67
- Effect level:
- 38.6 mg/L air (nominal)
- Exp. duration:
- 4 h
- Remarks on result:
- other: Standard test: at the given dose, 4 of 6 animals died. Dose is converted from ppm as reported by the authors (8000 ppm)
- Sex:
- not specified
- Dose descriptor:
- discriminating conc.
- Effect level:
- ca. 95 mg/L air (nominal)
- Exp. duration:
- 1 h
- Remarks on result:
- other: Inhalation Hazard Test: as discriminating dose the saturated vapor concentration of test substance is given. Exposure duration is the longest exposurte time resulting in no death
- Mortality:
- Standard test: Dose [mg/L] Mortality
19.3 0 / 6
38.6 4 / 6 (death occured during exposure between 3rd and 4th h)
77.3 6 / 6 (death occured during exposure within 3.4 h)
Hazard Inhalation Test: Maximum exposure time for no death: 1 hour. - Clinical signs:
- other: Anesthesia
- Body weight:
- The surviving rats of the medium dose group (38.6 mg/L) and the rats of the low dose group (19.3 mg/L) gained weight during the 14 d observation period (ca. 30 g).
- Gross pathology:
- Deaths were caused by breakdown of the capillary bed of the lungs.
Any other information on results incl. tables
Reported data (ppm) are converted to mg/L using a conversion factor of 4.83 (Auer Technikum Edition 12, Auergesellschaft GmbH, Berlin, 1988).
A LC50 value was not derived by the authors. Based on mortality data of the standard test, it is evident that the LC50 falls within the range of 19.3 to 38.6 mg/L (mortality 0 and 4 of 6 animals respectively) being closer to 38.6 mg/L. As conservative estimate, the LD50 is determined to be 30 mg/L.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Exposure to isobutyl acetate vapors in air at concentrations of 19.3 and 38,6 mg/L for 4 hours resulted in the death of 0 and of 4 out of 6 animals respectively (observation period 14 days). From this data, a LC50 of 30 mg/L can be estimated.
With a saturated or nearly saturated vapor concentration in air (ca. 95 mg/L), the exposure period was restricted to one hour in order not to cause any mortality. This coincides with the LC50 estimate. - Executive summary:
For this acute inhalation toxicity study, a standard graduate dose test and an inhalation hazard test were performed. The observation period for both tests was 14 days.
Groups of six female albino rats were exposed for 4 hours to graduate doses of isobutyl acetate vapor in the breathing atmosphere of test animals. Doses were spaced in a logarithmic series with a factor of 2 (4000, 8000, and 16000 ppm; 19.3, 38.6, and 77.3 mg/L respectively).
In the inhalation hazard test, test animals were exposed for various time periods starting from one forth hour up to 8 hours (spacing factor of 2) to an atmosphere saturated or close to saturation with vapors of isobutyl acetate. Actual atmosphere concentrations were not measured but can be estimated to be saturated or close to saturation by the method the atmosphere was generated. Saturated vapor concentration of isobutyl acetate at 20°C in air is 95 mg/L (Auer Technikum, Edition 12, Auergesellschaft GmbH, Berlin, 1988).
In the standard test, concentrations of 4000 and 8000 ppm (ca. 19.3 and 38,6 mg/L) caused a mortality of 0 and of 4 out of 6 animals, respectively. From this data a LC50 of 30 mg/L is estimated.
In the inhalation hazard test (saturated vapor), the exposure time was restricted to 1 hour in order to produce no mortality.
The LC50 value for isobutyl acetate can be estimated to be 30 mg/L (Smyth, 1962).
Standards of the OECD test guideline 403 (Acute Inhalation Toxicity) are only met with restrictions by this investigation (only 6 rats used, no concentrations measured, deficiencies in reporting).
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