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EC number: 616-391-1 | CAS number: 76812-02-7
- 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:
- Start of study: 17-09-1997 / End of study: 17-10-1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to international guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
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 OTS 798.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)
- 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-[4-[4-(Hydroxydiphenylmethyl)-1-piperidinyl]-1-oxobutyl]-α,α-dimethyl-ethyl ester benzeneacetic acid
- EC Number:
- 616-391-1
- Cas Number:
- 76812-02-7
- Molecular formula:
- C34 H41 N O4
- IUPAC Name:
- 4-[4-[4-(Hydroxydiphenylmethyl)-1-piperidinyl]-1-oxobutyl]-α,α-dimethyl-ethyl ester benzeneacetic acid
- Reference substance name:
- 4-(4-(4-Hydroxydiphenylmethyl)-1-piperidinyl)-1-oxobutyl- alpha,alphadimethylbenzeneacetic acid ethyl ester
- IUPAC Name:
- 4-(4-(4-Hydroxydiphenylmethyl)-1-piperidinyl)-1-oxobutyl- alpha,alphadimethylbenzeneacetic acid ethyl ester
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Product number/Code ((I.N.N. or U.S.A.N): HOE CG 0529 OY ZD.. 0001
- Name or number of compound: Fexofenadonethylester
- Synonyms: Terfenadonethylester
- Chemical name: 4-[4-[4-hydroxydiphenylmethyl]-1-piperidinyl]-1- oxobutyl]- a.,a.-dimethylbenzeneacetic acid ethyl ester
- Retention Sample: L00446/001
- Batch number: TAM 40-96-13
- Certificate of analysis: dated Augusf 19th, 1997, CR&T Analytisches Laboratorium Dr. D. Andert
- Content: 98.65 % (w/w)
- Appearance: white powder
- Date of production: August 27th, 1996
- Date of receipt: August 28th, 1997
- Date of expiry: August 27th, 1998
- Storage conditions: darkness at approximately 5°C in a refrigerator
- Solubility: solution in DMSO
- Stability in the solvent: confirmed over 4 hours in DMSO
- Concentration of stock solution: 5% (w/v)
Constituent 1
Constituent 2
Method
- Target gene:
- Histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: rfa uvrB for all strains. All 4 Salmonella strains are deficient in the structure of their LPS layer and in DNA excision repair system. TA 98 and TA 100 also possess a modified postreplication DNA repair system.
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- Test groups
First experiment:
a: without metabolic activation: 4, 20, 100, 500, 2500, 5000 µg/plate
b: with metabolic activation: 4, 20, 100, 500, 2500, 5000 µg/plate
Second experiment:
a: without metabolic activation: 0.032, 0.16, 0.8, 4, 20 and 100 µg/plate
b: with metabolic activation: 0.16, 0.8, 4, 20, 100 and 500 µg/plate - Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- untreated control
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without metabolic activation for strains TA 100 and TA 1535
- Untreated negative controls:
- yes
- Remarks:
- untreated control
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without metabolic activation for strains TA 1537
- Untreated negative controls:
- yes
- Remarks:
- untreated control
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- without metabolic activation for strains TA 98
- Untreated negative controls:
- yes
- Remarks:
- untreated control
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with metabolic activation for all strains
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
Incubation period: 48h at approx. 37°C
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY: reduced rate of spontaneously occurring colonies and visible thinning of the bacterial lawns
OTHER: A toxicity test using histidine-enriched agar plates and a dilution of the tester strain TA 100 (designated TA 100 D) was performed in parallel with the second mutation experiment. - Evaluation criteria:
- Criteria for a valid assay
The assay is considered valid if the following criteria are met:
- the solvent control data are within the laboratory's normal control range for the spontaneous mutant frequency
- the positive controls induced increases in the mutation frequency which were both statistically significant and within the laboratory's normal range
Criteria for a positive response
A test compound is classified as mutagenic if it has either of the following effects:
a) it produces at least a 2-fold increase in the mean number of revertants per plate of at least one of the tester strains over the mean number of revertants per plate of the appropriate vehicle control at complete bacterial background lawn
b) it induces a dose-related increase in the mean number of revertants per plate of at least one of the tester strains over the mean number of revertants per plate of the appropriate vehicle control in at least two to three concentrations of the test compound at complete bacterial background lawn.
The test results must be reproducible.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- The test compound proved to be toxic to most of the bacterial strains at concentrations of 100 µg/plate and above in the presence of S9-mix
- 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:
- The test compound proved to be toxic to most of the bacterial strains at concentrations of 20 µg/plate and above in the absence of S9-mix.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The results lead to the conclusion that Fexofenadonethylester is not mutagenic in these bacterial test systems either in the absence or in the presence of an exogenous metabolizing system.
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