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EC number: 203-322-1 | CAS number: 105-68-0
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Data is from publication.
Data source
Reference
- Reference Type:
- publication
- Title:
- PRIMARY MUTAGENICITY SCREENING OF FOOD ADDITIVES CURRENTLY USED IN JAPAN
- Author:
- M. ISHIDATE, JR, T. SOFUNI, K. YOSHIKAWA, M. HAYASHI, T. NOHMI, M. SAWADA and A . MATSUOKA
- Year:
- 1 984
- Bibliographic source:
- Fd Chem. Toxic. Vol. 22- No. 8, pp. 623-636, 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as per mentioned below
- Principles of method if other than guideline:
- Reverse mutation assays using S. typhimurium strains TA92, TA1535, TA100, TA1537, TA94 and TA98 were carried out according to the method of Ames, McCann & Yamasaki.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Isopentyl propionate
- EC Number:
- 203-322-1
- EC Name:
- Isopentyl propionate
- Cas Number:
- 105-68-0
- Molecular formula:
- C8H16O2
- IUPAC Name:
- 3-methylbutyl propanoate
- Details on test material:
- Name of test material (as cited in study report): Isoamyl Propionate
Substance type: Organic
Physical state: Liquid
Supplied from Japan Food Additives Association, Tokyo, at the request of the Ministry of Health and Welfare of Japan.
Constituent 1
- Specific details on test material used for the study:
- Name of test material (as cited in study report): Isoamyl Propionate
Substance type: Organic
Physical state: Liquid
Supplied from Japan Food Additives Association, Tokyo, at the request of the Ministry of Health and Welfare of Japan.
Method
- Target gene:
- Histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: Salmonella Typhirium TA92, TA1535, TA100, TA1537, TA94 and TA98
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 was prepared from the liver of Fischer rats ( pretreated 5 days before with polychlorinated biphenyls (500 mg/kg body weight of Kanechlor KC-400 in olive oil, ip).
- Test concentrations with justification for top dose:
- 0.1 – 10 mg/plate
- Vehicle / solvent:
- Solvent used: DMSO
Justification for choice of solvent/vehicle: Since the chemical was insoluble in water
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- not specified
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation; in suspension; as impregnation on paper disk
: pre incubation
DURATION
Preincubation period: Cells cultured overnight were pre-incubated with both the test sample and the S-9 mix for 20 min at 37°C before plating. The number of revertant (his +) colonies was scored after incubation at 37°C for 2 days
Exposure duration: 2 days
NUMBER OF REPLICATIONS: Duplicate plates were used for each of six different concentrations of the sample. - Rationale for test conditions:
- Not specified
- Evaluation criteria:
- The test result was considered to be negative.if there were no significant increases in the numbers of revertant colonies detected in any S. typhimurium strains at the maximum dose.
- Statistics:
- Yes
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: Salmonella Typhimurium TA92, TA1535, TA100, TA1537, TA94 and TA98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- The liver microsome fraction (S-9) was prepared from the liver of Fischer rats (Charles River Japan Co.) pretreated 5 days before with polychlorinated biphenyls (500 mg/kg body weight of Kanechlor KC-400 in olive oil, ip). The reaction mixture (S-9 mix) contained 5 mM-glucose 6-phosphate, 4mM-NADPH, 4mM-NADH, 33mM-KC1, 8 mM-MgCI 2, 100 mM-phosphate buffer (pH 7.4) and 3.75 ml S-9 (129 mg protein) in a total volume of 12.5 ml.
- Remarks on result:
- other: No mutagenic effect were observed.
Applicant's summary and conclusion
- Conclusions:
- Isoamyl Propionate (105-68-0) was evaluated for its mutagenic potential.A negative result indicates that no significant increases in the number of revertant colonies were detected in any S. typhimurium strains at the maximum dose.The test chemical was tested by the AMES test using 6 strains of S.typhimurium.At the maximum dose of 10mg/plate, the test chemical was non mutagenic
- Executive summary:
This report presents data from primary screening by the Ames test on 200 food additives used in Japan for Isoamyl Propionate (105-68-0).The samples were supplied from the Japan Food Additives Association, Tokyo, at the request of the Ministry of Health and Welfare of Japan, where the purity and quality of each sample were checked.
Reverse mutation assays usingS. typhimuriumstrains TA92, TA1535, TA100, TA1537, TA94 and TA98 were carried out at the concentraton of 0.1 – 10 mg/plate in the presence and absence of S9 .Acetone was used as a solvent since test compound is insoluble in water.All samples were kept in a refrigerator before use.Reverse mutation assays usingS. typhimuriumstrains TA92, TA1535, TA100, TA1537, TA94 and TA98 were carried out according to the method of Ames, McCann & Yamasaki.All these test strains were originally provided by Dr B. N. Ames, University of California, Berkeley, USA. The liver microsome fraction (S-9) was prepared from the liver of Fischer rats (Charles River Japan Co.) pretreated 5 days before with polychlorinated biphenyls (500 mg/kg body weight of Kanechlor KC-400 in olive oil, ip). The reaction mixture (S-9 mix) contained 5 mM-glucose 6-phosphate, 4mM-NADPH, 4mM-NADH, 33mM-KCl, 8 mM-MgCI2, 100 mM-phosphate buffer (pH 7.4) and 3.75 ml S-9 (129 mg protein) in a total volume of 12.5 ml. Cells cultured overnight were pre-incubated with both the test sample and the S-9 mix for 20 min at 37°C before plating. Duplicate plates were used for each of six different concentrations of the sample.The number of revertant (his +) colonies was scored after incubation at 37°C for 2 days. The result was considered positive if the number of colonies found was twice the number in the control (exposed to the appropriate solvent or untreated). A negative result indicates that no significant increases in the number of revertant colonies were detected in anyS. typhimuriumstrains at the maximum dose.At the maximum dose of 10mg/plate, the test chemical was non mutagenic. Therefore Isoamyl Propionate was considered to be non mutagenic in AMES test..Hence the test chemical cannot be classified as gene mutant in vitro.
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