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EC number: 209-669-5 | CAS number: 590-01-2
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study methodology followed was equivalent or similar to OECD TG 471 and the study was conducted in accordance with the Principles of Good Laboratory Practice (GLP)
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Butyl propionate
- EC Number:
- 209-669-5
- EC Name:
- Butyl propionate
- Cas Number:
- 590-01-2
- Molecular formula:
- C7H14O2
- IUPAC Name:
- butyl propanoate
- Details on test material:
- - Name of test material (as cited in study report): n-butyl propionate
- Physical state: colourless, clear liquid
- Analytical purity: 99.825%
- Lot/batch No.: Ref. PRP/139/88
- Stability under test conditions: to be stable < 7.5 hours
- Storage condition of test material: stored in the dark at room temperature
Constituent 1
Method
- Target gene:
- The bacterial reverse mutation test uses amino-acid requiring strains of Salmonella typhimurium and Escherichia coli to detect point mutations, which involve substitution, addition or deletion of one or a few DNA base pairs. The principle of this bacterial reverse mutation test is that it detects mutations which revert mutations present in the test strains and restore the functional capability of the bacteria to synthesize an essential amino acid. The revertant bacteria are detected by their ability to grow in the absence of the amino acid required by the parent test strain.
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Details on mammalian cell type (if applicable):
- - Type and identity of media: For detecting revertants of both the Salmonella and Escherichia tester strains, ready poured petri plates containing 25 ml of minimal agar medium were obtained form Gibco Europe Ltd., Paisley, Scotland.
- Properly maintained: yes - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- 31.25, 62.5, 125, 250, 500, 1000, 2000 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
- Justification for choice of solvent/vehicle: recommended vehicle by various regulatory agencies
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: Potassium dichromate, Benzo(a)pyrene, Sodium azide, 2-Aminoanthracene, 9-Aminoacridine, Neutral red and 2-Nitrofluorene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) - 20 µl volumes of solutions of n-butyl propionate in acetone (1.56, 3.125, 6.25, 12.5, 25, 50, 100 or 250 mg/ml) were added to top agar mix to give final amounts of 31.25, 62.5, 125, 250, 500, 1000, 2000 or 5000 µg per plate both in the presence and in the absence of rat liver S9 fraction. The cultures were incubated at 37°C for 48-72 h before the revertant colonies were counted
- Evaluation criteria:
- There are several criteria for determining a positive result, such as a concentration-related increase over the range tested and/or a reproducible increase at one or more concentrations in the number of revertant colonies per plate in at least one strain with or without metabolic activation system. Biological relevance of the results should be considered first.
- Statistics:
- Standard statistical methods were employed
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The test compound formed oily smears on the surface of the top agar at 5000 µg per plate showing that it was not miscible in the aqueous test system at this amount.The addition of 2500 µg per ml n-butyl propionate (equivalent to approx. 5000 µg per plate) caused the pH of the medium to change from 7.30 to 7.29.
Microscopical evaluation of the background lawn showed no evidence of cytotoxicity at amounts up to 5000 µg n-butyl propionate per plate either in the presence or in the absence of rat liver S9 fraction. The addition of n-butyl propionate to agar layer cultures of Salmonella tvphimurium TA 1535, TA 1537, TA 1538, TA 98 or TA 100 or Escherichia coli WP2 uvrA pKM101 did not increase the reverse mutation frequency in any of the strains either in the presence or in the absence of rat liver S9 fraction. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the conditions of the study, it was concluded that n-butyl propionate did not induce reverse gene mutation in the selected bacterial tester strains and hence based on the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures, n-butyl propionate will not be classified for genotoxicity. - Executive summary:
The mutagenic activity of n-butyl propionate was investigated in agar layer cultures of selected bacterial tester strains of Salmonella typhimurium and Escherichia coli. Assays were performed both in the presence and in the absence of an S9 microsomal fraction obtained from a liver homogenate from rats pre-treated with Aroclor 1254.
Under the conditions of the study, it was concluded that n-butyl propionate did not induce reverse gene mutation in the selected bacterial tester strains and hence based on the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures, n-butyl propionate will not be classified for genotoxicity.
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