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EC number: 605-546-9 | CAS number: 169280-10-8
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- Start of study: March 08; End of evaluation March 31, 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed according to international guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4-(Cyclopropylcarbonyl)-α,α-dimethyl-ethyl ester benzeneacetic acid
- EC Number:
- 605-546-9
- Cas Number:
- 169280-10-8
- Molecular formula:
- C16 H20 O3
- IUPAC Name:
- 4-(Cyclopropylcarbonyl)-α,α-dimethyl-ethyl ester benzeneacetic acid
- Test material form:
- solid - liquid: suspension
- Details on test material:
- - Physical state: white, crystalline powder
- Content: 100%
- Lot/batch No.: H 0080 dated January 24, 2000
- Expiration date of the lot/batch: September 30, 2000
- Solubility: solution in DMSO
- Stability under test conditions: confirmed over 4h in DMSO
- Storage condition of test material: darkness at approximately 5°C in a refrigerator
- Concentration of stock solution: 50 mg/ml
Constituent 1
Method
- Target gene:
- Histidine
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):
- Bacterial strains were checked half-yearly with regard to their respective biotin, histidine and/or tryptophan requirements, membrane permeability, ampicillin resistance, crystal violet sensitivity, UV resistance and response to diagnostic mutagens.
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- Plate incorporation test:
- without metabolic activation: 50, 160, 500, 1600 and 5000 µg/plate
- with metabolic activation: 50, 160, 500, 1600 and 5000 µg/plate
Repeat plate incorporation test: without metabolic activation: 1.6, 5, 16, 50, 160 and 500 µg/plate (TA 100, TA 1535, TA 1537, TA 98)
Preincubation test:
- without metabolic activation: 1.6, 5, 16, 50, 160 and 500 µg/plate (TA 100, TA 1535, TA 1537, TA 98)
16, 50, 160, 500, 1600 and 5000 µg/plate (WP2uvrA)
- with metabolic activation: 16, 50, 160, 500, 1600 and 5000 µg/plate - Vehicle / solvent:
- DMSO
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- untreated controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Remarks:
- Without metabolic activation for strain TA 100 and TA 1535
- Positive control substance:
- sodium azide
- Remarks:
- 99% (w/w), batch n° 04786, 1.0 µg/plate
- Untreated negative controls:
- yes
- Remarks:
- untreated controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Remarks:
- Without metabolic activation for strain TA 1537
- Positive control substance:
- 9-aminoacridine
- Remarks:
- 98% (w/w), batch n° 55731, 50.0 µg/plate
- Untreated negative controls:
- yes
- Remarks:
- untreated controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Remarks:
- Without metabolic activation for strain TA 98
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- 98% (w/w), batch n° 70202, 2.5 µg/plate
- Untreated negative controls:
- yes
- Remarks:
- untreated controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Remarks:
- Without metabolic activation for strain WP2uvrA
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- 99.9 % (w/w), batch n° 037H0792, 2.0 µg/plate (plate incorp.), 0.5 µg/plate (preincub.)
- Untreated negative controls:
- yes
- Remarks:
- untreated controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Remarks:
- With metabolic activation for all strains
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- 96% (w/w), batch n°70056, 0.5 µg/plate (TA 98 and TA 100), 1.0 µg/plate (TA 1535 and TA 1537), 10.0 µg/plate (WP2uvrA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
- Preincubation period: 20 min at ca. 30°C
- Exposure duration: 48h at ca. 37°C
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY: Thinning of the bacterial lawn - Evaluation criteria:
- Acceptance criteria
The assay was considered valid if the following criteria were met:
1. the negative control counts fell within the normal ranges for the spontaneous mutant frequency
2. the positive control chemicals induced clear increases in revertant numbers and within the laboratory's normal range
Evaluation criteria
For valid data, the test article was considered to be mutagenic if:
1. it produces at least a 2-fold increase in the mean number of revertants/plate of at least one of the tester strains over the mean number of revertants/plate of the appropriate vehicle control at complete background lawn.
2. it induces a dose-related increase in the mean number of revertants/plate of at least one of the tester strains over the mean number of revertants/plate of the appropriate vehicle control in at least 2 to 3 concentrations of the test compound at complete bacterial background lawn.
The test article was considered as positive in this assay if all of the above criteria were met.
The test article was considered as negative in this assay if none of the above criteria were met.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 1600 and 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 1600 and 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 1600 and 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 160 and 500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Only in the preincubation test visible precipitation of the test compound on the plates was observed at 5000 µg/plate with metabolic activation with all tester strains and without metabolic activation with the strain E.coli WP2uvrA. Test toxicity was observed without metabolic activation at 160 µg/plate and above with all S.thyphimurium strains. In the presence of metabolic activation, the test compound proved to be toxic to the S.thyphimurium strains in a dose range of 500 to 5000 µg/plate.
- Remarks on result:
- other: other: First plate incorporation test
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The substance is not mutagenic with and without metabolic activation.
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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