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EC number: 203-250-0 | CAS number: 104-90-5
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 1986
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- NOTOX C.V.
- Type of assay:
- bacterial reverse mutation assay
Test material
- Test material form:
- gas under pressure: refrigerated liquefied gas
- Details on test material:
- - Name of test material: 5-ethyl-2-methyl-pyridine
Constituent 1
Method
- Target gene:
- The purpose of the study was to evaluate the test substance for its ability to induce reverse mutations in a gene of histidine-requiring Salmonella typhimurium bacterial strains to produce histidine-independent strains of these microorganisms.
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535
- Details on mammalian cell type (if applicable):
- - Type and identity of media:
Bacterial cultures: Samples of frozen stock cultures of bacteria are transferred into enriched nutrient broth (Oxoid No. 2) and incubated in a shaking water bath (37 °C,
150 spm) until the cultures reach an O.D. of 0.4 at 700 nm (109 cells/ml). Freshly grown cultures of each strain are used for a test.
Selective agar plates: Selective plates containing 25 ml of glucose agar medium. Glucose agar medium contains per liter: 18 g purified agar (Oxoid, code L28) in
Vogel-Bonner Medium E (reference 5), 10 g glucose, 0.5 mg biotin and 0.6 mg histidine.
Top agar: Vogel-Bonner Medium E containing 0.6 % (W/V) purified agar is heated to dissolve the agar. 5amples of 3 ml of top agar are transferred into 10 ml glass tubes with metal caps. Top agar tubes are autoclaved for 20 min at 120°C. - Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 1537
- Details on mammalian cell type (if applicable):
- see above.
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 1538
- Details on mammalian cell type (if applicable):
- see above.
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 98
- Details on mammalian cell type (if applicable):
- see above.
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 100
- Details on mammalian cell type (if applicable):
- see above.
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat Arochlor 1254 induced microsomal fraction (S9-mix)
- Test concentrations with justification for top dose:
- Up to 5000 ug/plate.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
Controlsopen allclose all
- Untreated negative controls:
- no
- Remarks:
- Concurrent solvent control only
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Remarks:
- Concurrent solvent control only
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Migrated to IUCLID6: TA 1535, 1 ug in water/plate without metabolic activation
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- Migrated to IUCLID6: TA 100, 0.5 ul in DMSO/plate without metabolic activation
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- Migrated to IUCLID6: TA 98; TA 1538, 10 ug in DMSO/plate without metabolic activation
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Migrated to IUCLID6: TA 1537, 60 in water/plate without metabolic activation
- Positive control substance:
- other: 2-aminoanthracene(2AA) - all strains, 0.5 ug in DMSO/plate with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: None.
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: Two.
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- ACCEPTABILITY OF ASSAY AND CRITERIA FOR RESPONSE
An Ames test is considered acceptable if it meets the following criteria:
a) The negative control data (number of spontaneous revertants per plate) should reasonably fall within the laboratory background historical range for each tester strain.
b) The positive control chemicals should produce responses in all tester strains which also reasonably fall within the laboratory historical range documented for each positive control substance.
c) The selected dose range should include a clearly toxic concentration as demonstrated by a preliminary toxicity range-finding test with strain TA 100.
A test substance is considered negative (not mutagenic) in the Ames test if:
a) The total number of revertants in any tester strain at any concentration is not greater than two times the solvent control value, with or without metabolic activation.
b) The negative response should be reproducible in at least one independently repeated experiment.
A test substance is considered positive (mutagenic) in the Ames test if:
a) It induces at least a 2-fold and statistically significant (student's t-test, p.lO.05) increase in the number of revertants with respect to the number induced by the solvent control in any of the tester strains, either with or without metabolic activation. Moreover, the positive response should be dose-related. If the test substance shows in the first test only a positive response at one or two concentrations, the assay is repeated with doses just below and exceeding those showing positive effects in the first test.
b) The positive response should be reproducible in at least one independently repeated experiment. - Statistics:
- Student's t-test (p < 0.05)
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- COMPARISON WITH HISTORICAL CONTROL DATA:
- The negative and strain-specific positive control values fell within our laboratory background historical ranges, indicating that the test conditions were optimal and that the metabolic activation system functioned properly.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test substance was tested in the Ames Salmonella/microsome test up to 5000 ug/plate. The test substance induced no statistically significant dose-related increase in the numbers of revertant (His+) colonies in each of the five tester strains (TA 1535; TA 1537; TA 1538; TA 98 and TA 100). These results were confirmed in an independently repeated experiment. The negative and strain-specific positive control values fell within our laboratory background historical ranges, indicating that the test conditions were optimal and that the metabolic activation system functioned properly. Based on these results, the test substance can be considered as non-mutagenic in this Ames Salmonella/microsome assay. - Executive summary:
A study according to OECD Guideline 471 (Bacterial Reverse Mutation Assay) similar or equivalent to EU Method B.13/14 (Mutagenicity – Reverse Mutation Test Using Bacteria) was carried out. Tested up to 5000 ug/plate without and with metabolic activation the test substance induced no statistically significant dose-related increase in the numbers of revertant (His+) colonies in each of the five tester strains (TA 1535; TA 1537; TA l538; TA 98 and TA 100). These results were confirmed in an independently repeated experiment. The negative and strain-specific positive control values fell within our laboratory background historical ranges, indicating that the test conditions were optimal and that the metabolic activation system functioned properly. Based on these results, the test substance can be considered as non-mutagenic in this Ames Salmonella/microsome assay.
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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