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EC number: 203-561-1 | CAS number: 108-21-4
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
- Objective of study:
- excretion
- metabolism
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Isopropyl acetate is believed to be rapidly hydrolysed in vivo to the parent alcohol isopropanol. This study uses two single iv doses of non-radiolabelled isopropyl acetate and the rise and decay of the parent ester and the hydrolysis product isopropanol followed by taking blood samples for up to 4 hours post dosing.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Isopropyl acetate
- EC Number:
- 203-561-1
- EC Name:
- Isopropyl acetate
- Cas Number:
- 108-21-4
- Molecular formula:
- C5H10O2
- IUPAC Name:
- isopropyl acetate
- Reference substance name:
- isopropyl acetate
- IUPAC Name:
- isopropyl acetate
- Details on test material:
- Material re-purified in laboratory before use to a molar purity of 99.99% (molar percent)
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- Source: INEOS nv, Antwerp, Belgium
Purity: to be confirmed - Radiolabelling:
- no
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
Administration / exposure
- Route of administration:
- intravenous
- Vehicle:
- physiological saline
- Duration and frequency of treatment / exposure:
- Single dose. Volume given 10mL.kgbw.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 5 mg/kg bw (total dose)
- Dose / conc.:
- 50 mg/kg bw (total dose)
- No. of animals per sex per dose / concentration:
- 4
- Control animals:
- no
- Positive control reference chemical:
- no
- Details on dosing and sampling:
- - Tissues and body fluids sampled: blood
- Time and frequency of sampling: Collection periods 1, 2, 3, 5, 10, 15, 20, 30, 60, 120, 240 minutes. Number of samples limited to 11 for ethical reasons.
- From how many animals: (samples pooled or not): measurements of individual animals
- Method type(s) for identification: See 'any other information for details of method"
- Limits of detection and quantification: To be confirmed in final report but all key metabolites well above LOD/LOQ. - Statistics:
- Mean and standard deviation calculated
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on excretion:
- Recovery of dose material exceeded 95% at all dose levels leading to conclusion that almost all the substance is excreted by this route.
Toxicokinetic parametersopen allclose all
- Test no.:
- #1
- Toxicokinetic parameters:
- half-life 1st: 2.9 mins
- Remarks:
- Standard deviation 0.87min. Average of the results from the 3 animals tested at a dose of 5mg/kgbw. Mean residence time 4.1 mins.
- Test no.:
- #2
- Toxicokinetic parameters:
- half-life 1st: 2.4 mins
- Remarks:
- Standard deviation 0.4min. Average of the results from the 4 animals tested at a dose of 5mg/kgbw. Mean residence time 3.5 mins.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Remarks:
- isopropanol
Any other information on results incl. tables
All data points from animal #1 in the low dose group indicated a half life of 82 mins. However, the data points were rather scattered, particularly the last two. A plotted line through all the data points was not statistically significant (R=0.42). Discarding the last two data points did produce a statistically significant result indicating a half life of 6-7 mins (still significantly above the other results). This result was discarded as an outlier. Further information on a possible cause for this erroneous result may be available in the full study report.
Applicant's summary and conclusion
- Conclusions:
- The half life for in vivo hydrolysis of isopropyl acetate to isopropanol is 2-3 minutes and is independent of dose over the tested range of 5-50mg/kgbw.
- Executive summary:
An in vivo hydrolysis study was carried out in rats to determine the rate of hydrolysis of isopropyl acetate to isopropanol. Groups of four male rats were dosed iv with isopropyl acetate in physiological saline in two dose groups of 5 and 50mg/kgbw. Blood was sampled from the tail over a period of 60 minutes for analysis of isopropyl acetate, with sampling biased towards the initial part of the study period. The half life was determined to be in the range 2 -3 minutes with no difference between the two dose groups.
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