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Diss Factsheets
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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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.5395 (In Vivo Mammalian Cytogenics Tests: Erythrocyte Micronucleus Assay)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
- Species:
- mouse
- Strain:
- ICR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Sprague-Dawley Inc
- Age at study initiation: 8 to 11 weeks
- Assigned to test groups randomly: yes
- Diet: ad libitum):
- Water: ad libitum):
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 72+/- 6 F
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12:12 - Route of administration:
- intraperitoneal
- Vehicle:
- 0.9% sodium chloride aqueous solution
- Details on exposure:
- The doses were set following a rangefinder study to determine the MTD.
- Duration of treatment / exposure:
- Single dose with euthanasia at 24, 48 or 72 hr post injection
- Frequency of treatment:
- Once
- Post exposure period:
- 24, 48 or 72 hours
- Dose / conc.:
- 350 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 173 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 2 500 mg/kg bw/day (actual dose received)
- Remarks:
- Dosing originally started at 3500mg/kg but was reduced to 2500mg/kg due to excessive mortality and a second trial initiated.
- No. of animals per sex per dose:
- 45; 15 per time interval for sacrifice.
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide
- Justification for choice of positive control(s): Known positive activity in this test.
- Route of administration: i.p.
- Doses / concentrations: 80 mg/kg - Tissues and cell types examined:
- Bone marrow cells
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: 35/40 mice at the scheduled top dose of 3500 mg/kg IPA died within 24 hr of injection and the top dose was decreased to 2500 mg/kg
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): Bone marrow harvest performed by removal of soft tissue and epiphyses, then flushing with FBS.
DETAILS OF SLIDE PREPARATION: Air dried, fixed in methanol ,stained in May-Grunwald solution followed by Giemsa.
METHOD OF ANALYSIS: scored for micronucleii and PCE/NCE ratio. 1000 PCEs/animal were scored.
OTHER: Normal background frequency of micronucleii in this strain of mouse: 0.4% - Evaluation criteria:
- Frequency of micronuclei and ratio of polychromatic to normochromatic erythrocytes (PCE:NCE)
- Statistics:
- Following square root-arcsine transformation, Tukey's studentized range test was applied to analysis of variance results.
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Conclusions:
- Interpretation of results (migrated information): negative
Isopropanol was not genotoxic to mouse bone marrow cells following single i.p. injection at sub-toxic doses up to 2500 mg/kg. - Executive summary:
An in vivo GLP cytogenicity study was performed using isopropanol according to the EPA OTS 798.5395 guideline (“in vivo mammalian cytogenetics tests: erythrocyte micronucleus assay”). Male and female ICR mice were administered single doses of 350, 1173 and 2500mg/kgbw isopropanol i.p. in saline solution. Groups of 15 animals per sex were sacrificed at 24, 48 and 72 hours post injection. Both negative (solvent) and positive (cyclophosphamide, 80mg/kg) were used. Isopropanol did not increase the frequency of micronuclei or the ration of polychromatic to normochromatic (PCE:NCE) erythrocytes and was therefore considered negative in the assay.
Data source
Materials and methods
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
- Details on test material:
- - Name of test material (as cited in study report): isopropyl acetate
Constituent 1
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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