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EC number: 695-268-4 | CAS number: 571188-59-5
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 2013
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- This study was performed following the SOP’s for this test. However, the experiments do not comply with GLP regulations, since they were not controlled by GLP-QA
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The objective of the present study was to assess the mutagenic potential of the test item using Salmonella typhimurium in vitro, with and without the addition of a mammalian
metabolizing system.
The Salmonella/liver homogenate assay (Ames test) is the most widely used test system to assess mutagenicity. It has proved to be a highly sensitive and reliable test to detect
mutagenicity and to predict the carcinogenicity of chemicals.
In this test, histidine auxotrophic strains of Salmonella typhimurium are plated on minimal agar together with the test item, both in the presence and absence of a rat-liver S9 mix for metabolic activation. The medium contains traces of histidine, which allow the bacteria to make a few cell divisions. After exhaustion of this histidine, only prototrophic, i.e. mutant, bacteria are able to grow. Thus, only histidine prototrophic bacteria are able to form colonies during an incubation
time of 3 days. The number of colonies on the tester wells is therefore directly proportional to the number of mutant bacteria. A clear increase in the colony numbers on the treated wells above the corresponding negative control values indicates a mutagenic potential of the test article.
Remarks: This study was performed following the SOP’s for this test. However, the experiments do not comply with GLP regulations, since they were not controlled by GLP-QA. - GLP compliance:
- no
- Remarks:
- This study was performed following the SOP’s for this test. However, the experiments do not comply with GLP regulations, since they were not controlled by GLP-QA
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- tert-butyl 4-(6-aminopyridin-3-yl)piperazine-1-carboxylate
- Cas Number:
- 571188-59-5
- Molecular formula:
- C14H22N4O2
- IUPAC Name:
- tert-butyl 4-(6-aminopyridin-3-yl)piperazine-1-carboxylate
- Test material form:
- solid: bulk
Constituent 1
Method
- Target gene:
- In this test, histidine auxotrophic strains of Salmonella typhimurium are plated on minimal agar together with the test item, both in the presence and absence of a rat-liver S9 mix for metabolic activation. The medium contains traces of histidine, which allow the bacteria to make a few cell divisions. After exhaustion of this histidine, only prototrophic, i.e. mutant, bacteria are able to grow. Thus, only histidine prototrophic bacteria are able to form colonies during an incubation time of 3 days. The number of colonies on the tester wells is therefore directly proportional to the number of mutant bacteria. A clear increase in the colony numbers on the treated wells above the corresponding negative control values indicates a mutagenic potential of the test article.
Species / strain
- Species / strain / cell type:
- other: Strains of Salmonella typhimurium
- Details on mammalian cell type (if applicable):
- Strains of Salmonella typhimurium TA1535, TA98, TA100, TA97a and TA102
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver S9 mix from male rats, Aroclor 1254-pretreated. Per plate, 25 μl S9 was added.
- Test concentrations with justification for top dose:
- Concentrations tested:
• 1.6, 8, 40, 200, 1000, 5000 μg/plate (experiment 1 using strains TA98 and TA100)
• 1.6, 8, 40, 200, 1000, 5000 μg/plate (experiment 2 using strains TA1535, TA97a and TA102)
Metabolic activation system: Liver S9 mix from male rats, Aroclor 1254-pretreated. Per plate, 25 μl S9 was added.
Positive controls used:
All positive controls were dissolved in DMSO and used at one concentration level per strain only at 0.1 mL/plate.
2-Aminoanthracene: This is an indirect-acting mutagen. At 3 μg/plate it is mutagenic for strains TA1535, TA98 and TA100. At 10 μg/plate it is mutagenic for strains TA97a and TA102.
Benzo(a)pyrene: This is an indirect-acting frame-shift mutagen. At the concentration level used (3 μg/plate) it is mutagenic for strain TA98.
Sodium azide: This is a direct-acting agent which induces base-pair substitutions. At 3 μg/plate it is mutagenic for strains TA1535 and TA100.
9-Aminoacridine: This is a direct-acting frame-shift mutagen. At the concentration level used (100 μg/plate) it is mutagenic for strain TA97a.
2-Nitrofluorene: This is a direct-acting frame-shift mutagen. At the concentration level used (2 μg/plate) it is mutagenic for the strain TA98.
Mitomycin C: This is a direct acting agent which is mutagenic for strain TA102 at the concentration level used (0.5 μg/plate).
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium, other: TA98, TA100,TA1535, TA97a and TA102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other:
- Remarks:
- The mean mutant numbers of negative control plates lay within the range of acceptable negative control values except for strain TA1535 +S9 in experiment 2 where the values were found to be above our historical control ranges. However, since the deviation was small, this was not considered to influence the results of the present study.
Applicant's summary and conclusion
- Conclusions:
- Under the testing conditions used and applying standard mutagenicity criteria, LEE011-A2 did not show evidence of a mutagenic potential.
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