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EC number: 248-570-1 | CAS number: 27610-92-0
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-03-29 to 2002-05-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-butyloctanoic acid
- EC Number:
- 248-570-1
- EC Name:
- 2-butyloctanoic acid
- Cas Number:
- 27610-92-0
- Molecular formula:
- C12H24O2
- IUPAC Name:
- 2-butyloctanoic acid
- Test material form:
- liquid
- Details on test material:
- - Name of test material: 2-butyl octanoic acid
- Molecular formula: C12H24O2
- Molecular weight: 200.32 g/mole
- Smiles notation: O=C(O)C(CCCCCC)CCCC
Constituent 1
Method
- Details on test system and experimental conditions:
- SYSTEM OF TESTING
- Species/cell type: Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Deficiencies/Proficiencies: histidine auxotroph
- Metabolic activation system: rat liver S9 of Phenobarbital/beta-Naphthoflavone induced male Sprague-Dawley rats
ADMINISTRATION:
- Dosing:
experiment I:
313, 625, 1250, 2500 and 5000 µg/plate (TA 1535, TA 98 and TA 1537 only with metabolic activation)78.1, 156, 313, 625, 1250, 2500 µg/plate (TA 102, TA 100 and TA1537 only without metabolic activation)
experiment II:
156, 313, 625, 1250, 2500 and 5000 µg/plate (TA 1535 and TA 1537 only with metabolic activation)
78.1, 156, 313, 625, 1250, 2500 µg/plate (TA 100 and TA1537 only without metabolic activation)
313, 625, 1250, 2500 and 5000 µg/plate (TA 98)
78.1, 156, 313, 625, 1250 µg/plate (TA 102)
experiment III:
9.77, 19.5, 39.1, 78.1, 156 µg/plate (TA 1535, TA 100 and TA 1537 only with metabolic activation)
4.88, 9.77, 19.5, 39.1, 78.1 µg/plate (Ta 102 and TA 1537 only without metabolic activation)
19.5, 39.1, 78.1, 156, 313 µg/plate (TA 98)
- Number of replicates: 3
- Application:
Experiment I (plate-incorporation method): Bacteria cultures, test item, S9 mix or phosphate buffer were added to the molten overlay agar and vortexed. The mixture was poured onto the surface of a medium agar plate and allowed to solidify prior to incubation. Plates were incubated upside down for approx. 72 hours at 37° C.
Experiment II and III (pre-incubation method): Bacteria cultures, test item, S9 mix or phosphate buffer were mixed and placed at 37° C for 30 minutes. Afterwards overlay agar was added and the mixture was vortexed and poured onto the surface of a medium agar plate and allowed to solidify. Plates were incubated upside down for approx. 72 hours at 37° C.
- Positive control: without metabolic activation: Sodium azide (1 µg/plate with TA 1535 and TA 100), 9-aminoacridine (50 µg/plate with TA 1537), 2-nitrofluorene (2 µl/plate with TA 98), cumene hydroperoxide (100 µg/plate with TA 102); with metabolic activation: with metabolic activation: 2-aminoanthacene (1 µg/plate with TA 1535, Ta 1537, TA 98 and TA 100; 10 µg/plate with TA 102)
- Negative control: solvent control (DMSO) and untreated control
- Pre-incubation time: 30 minutes (only in experiment II and III)
DESCRIPTION OF FOLLOW UP REPEAT STUDY: see above - Evaluation criteria:
- The test item is considered as a mutagen if at least a two-fold increases in mean revertant numbers are observed at two consecutive dose-levels or at the highest practicable dose level only. In addition there must be evidence of a dose-response relationship showing increasing numbers of mutant colonies with increasing dose-levels.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- toxicity was observed at higher dose-levels with all tester strains, both in the absence and presence of S9 metabolic activation
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- toxicity was observed at higher dose-levels with all tester strains, both in the absence and presence of S9 metabolic activation
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- toxicity was observed at higher dose-levels with all tester strains, both in the absence and presence of S9 metabolic activation
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- toxicity was observed at higher dose-levels, both in the absence and presence of S9 metabolic activation
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:
negative
The test item ISOCARB 12 does not induce reverse mutation in Salmonella typhimurium under the reported experimental conditions.
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