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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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to accepted scientific standards.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- Name of test material (as cited in study report): Isopropyl acetate
Analytical purity: >99% - GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- - Type and identity of media:
- Culture prepared at 37C overnight with shaking in Oxoid #2 broth or in defined minimal medium supplemented with biotin and histidine. Phenotype analysed at time of use. - Species / strain / cell type:
- S. typhimurium TA 97
- Details on mammalian cell type (if applicable):
- - Type and identity of media:
- Culture prepared at 37C overnight with shaking in Oxoid #2 broth or in defined minimal medium supplemented with biotin and histidine. Phenotype analysed at time of use. - Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced male SD rat and male Syrian hamster liver S9 fraction, each used at two concentrations (10% and 30%)
- Test concentrations with justification for top dose:
- 0 ; 100 ; 333 ; 1000 ; 3333 ; 10000 µg/plate. Doses were prepared using dimethyl sulphoxide as the solvent; a maximum of 0.5 ml solvent was added to each plate. Each dose was tested in triplicate without activation, and with 10% rat and hamster liver S-9.
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2374 used for TA1535 and TA100 without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 28 used for TA97 without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 1342 4-nitro-o-phenylenediamine used for TA98 without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 1342 2-aminoanthracene for all strains with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 mins at 37C
- Expression time (cells in growth medium): 2 days at 37C
NUMBER OF REPLICATIONS: 5 concentrations in triplicate without metabolic activation, and with 10% and 30% liver S-9 from rat and hamster. Replicate tests were performed after the initial trial to confirm these results. - Evaluation criteria:
- A material was considered mutagenic if it produced a reproducible, dose-related increase in revertants over the solvent control, under a single metabolic activation condition, in replicate trials. A material was considered questionable if the positive response was elicited at only one concentration, or if the response could not be reproduced. A chemical was designated as non-mutagenic only after it was tested without metabolic activation, and with 10% and 30% rat and hamster S-9.
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- up to maximum dose tested (10000ug/ml)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- up to maximum dose tested (10000ug/ml)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
Zeiger et al (1992) reported that isopropyl acetate was negative in a Salmonella gene mutation assay (Ames Tester Strains TA97, TA98, TA100, TA1535, and TA1537), with and without exogenous metabolic activation. - Executive summary:
Isopropyl acetate was non-mutagenic when tested to a maximum concentration of 10 mg/plate, using the Salmonella typhimurium pre-incubation protocol. At least five doses were tested in triplicate, without metabolic activation, and with 10% and 30% liver S-9 from rat and hamster. Replicate tests were performed after the initial trial to confirm these results.
Reference
After a negative result was obtained, isopropyl acetate was retested without metabolic activation and with 30% S-9. Repeat experiments were performed at least one week following the initial trial.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for selection of genetic toxicity endpoint
Best available data
Justification for classification or non-classification
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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