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EC number: 616-210-6 | CAS number: 75302-98-6
- 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:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline GLP study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
- Principles of method if other than guideline:
- The point-mutagenic effects were investigated in doses up to 12500 µg/plate on four histidine-auxotropic Salmonella typhimurium LT2 strains, for each substance, dose level and strain 4 plates were used. After an incubation period of 48 h the number of revertant colonies per plate were counted.
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-(tert-butoxy)-2-oxoethyl 2-[1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indol-3-yl]acetate
- EC Number:
- 616-210-6
- Cas Number:
- 75302-98-6
- Molecular formula:
- C25 H26 Cl N O6
- IUPAC Name:
- 2-(tert-butoxy)-2-oxoethyl 2-[1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indol-3-yl]acetate
- Details on test material:
- Acemetacin-tert.-butylester, white powder, content 99.3%
Constituent 1
Method
- Target gene:
- histidin gene locus
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 100, TA 1537, TA 98
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver homogenate (S-9 mix)
- Test concentrations with justification for top dose:
- Acemetacin-tert.-butylester: 20-12500 µg/plate in the first trial and 375-12000 µg/plate in the second trial
Sodium azide: 10 µg/plate (TA 1535)
Nitrofurantoin: 0.2 µg/plate (TA 100)
4-Nitro-o-phenylendiamin: 10 µg/plate (TA 1537) and 0.5 µg/plate (TA 98)
2-Aminoanthracene: 3 µg/plate
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- Remarks:
- No solvent control was used since sufficient evidence was available in the literature and from testing laboratory experience, indicating that the solvents used had no influence on the spontaneous mutant counts of the used strains.
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Sodium azide (TA 1535, without S9-mix), Nitrofurantoin (TA 100, without S9-mix), 4-Nitro-o-phenylendiamin (TA 1537 and 98, without S9-mix), 2-Aminoanthracene (with S9-mix)
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA 1535, TA 100, TA 1537, TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- at 2500 µg/plate and above substance precipitation could be observed; therefore, evaluation of 12500 µg/plate was only possible to a limit extent
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Executive summary:
Acemetacin-tert.-butylester was tested in the Salmonella/microsome test for point-mutagenic effects in doses up to 12500 µg/plate on the four histidine-auxotrophic Salmonella typhimurium LT2 strains TA 1535, TA 100, TA 1537 and TA 98.
No bacteriotoxic effects was seen, but at 2500 µg/plate and above substance precipitation could be observed. Therefore, the evaluation of 12500 µg/plate was only possible to a limit extent.
No evidence for a mutagenic activity of Acemetacin-tert.-butylester was found.
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