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EC number: 806-688-6 | CAS number: 1180132-17-5
- 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:
- Laboratory phase of the study: 12 to 20 August
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- This assay design was based on OECD Guideline 471 (OECD, 1997) and ICH Guidelines S2(R1) (November 2011).
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 5-[(4-ethylpiperazin-1-yl)methyl]pyridin-2-amine
- EC Number:
- 806-688-6
- Cas Number:
- 1180132-17-5
- Molecular formula:
- C12H20N4
- IUPAC Name:
- 5-[(4-ethylpiperazin-1-yl)methyl]pyridin-2-amine
Constituent 1
- Specific details on test material used for the study:
- - Source and lot/batch No.of test material: RS0-H81051-018- Storage condition of test material: Ambient temperature protected from light- Analytical purity: 99.7%
Method
- Target gene:
- Mutation of the uvrA gene (E. coli) or the uvrB gene (Salmonella)
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Additional strain / cell type characteristics:
- DNA polymerase A deficient
- Metabolic activation:
- with and without
- Metabolic activation system:
- Arochlor 1254-induced rat liver S9 fraction
- Test concentrations with justification for top dose:
- The test material was evaluated in the mutagenicity assay at doses of 1.60, 5.00, 16.0, 50.0, 160, 500, 1600, and 5000 micrograms/plate with and without S9
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Dose formulations of the test material and dimethyl sulfoxide were prepared on the day of use- Justification for choice of solvent/vehicle: The volume of Dimetyl Sulfoxide used has been shown not to effect survival or induce mutations in control cultures
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- Tester Strain TA98 with S9 activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- Tester strains TA100, TA1535, TA1537 and WP2uvrA with S9 activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- Tester strain TA98 without S9 activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Tester strain TA100 and TA1535 without S9 activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: ICR-191
- Remarks:
- Tester strain TA1537 without S9 activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- WP2uvrA without S9 activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: Plate incorporation method - the tester strain, test article, and S9 mix (where appropriate) are combined in molten top agar, which is then overlaid onto a minimal bottom agar plate. Following incubation, revertant colonies are counted.DURATION: Plates are incubated for 48 hours at 37oCSELECTION AGENT (mutation assays): Bacterial reverse mutation assayNUMBER OF REPLICATIONS: All test and control articles were evaluated in triplicate platesDETERMINATION OF CYTOTOXICITY: Cytotoxicty is indicated by the presence of "pinpoint" colonies and the absence of background lawn.
- Rationale for test conditions:
- The bacterial reverse mutation assay has been shown to be a sensitive, rapid, and accurate indicator of the mutagenic activity of many materials including a wide range of chemical classes. By using several different tester strains, both base pair substitution and frameshift mutations can be detected. Salmonella and E. coli strains used in this assay are histidine and tryptophan auxotrophs, respectively, by virtue of conditionally lethal mutations in the appropriate operons. When these histidine (his–) or tryptophan (trp–) dependent cells are exposed to the test article and grown under selective conditions (minimal media with a trace amount of histidine or tryptophan), only those cells which revert to histidine (his+) or tryptophan (trp+) independence are able to form colonies. Trace amounts of histidine or tryptophan added to the media allow all the plated bacteria to undergo a few cell divisions, which is essential for mutagenesis to be fully expressed. his+ or trp+ revertants are readily discernable as colonies against the limited background growth of his– or trp– cells.
- Evaluation criteria:
- VALID STUDY CRITERIAThe vehicle control (Dimethyl Sulphoxide ) must show a normal range of bacterial colonies for each bacterial strain and should be consistent with historical data.The positive controls Benzo{a}pyrene (BP), 2-aminoanthracene (2AA), 2 -nitrofluorene (2NF), sodium azide (SA), ICR-191 and 4-nitroquinoline-N-oxide must show a mutagenic response and should be consistent with historical data.In the absence of toxicity or precipitation, a maximum treatement concentration of 5000 mcg/plate is sufficiently high to support study validity.POSITIVE RESPONSE CRITERIATest substance is judged to have induced a positive response when a concentration -related increase in revertants is observed in which the number of revertants exceeds the control values by at least 2 -fold (strains TA98, TA100, and WP2uvrA) or at least 3 -fold (strains TA1535 or TA1537) for at least two successive test article concentrations.When the above criteria are met for only one concentration, the determination of a positive response will be made on the basis of scientific judgement relative to the quality of the concentration response finding.NEGATIVE RESPONSE CRITERIAA test article is considered to produce a negative response when the criteria for a positive response is not met and the conditions for a valid assay have been satisfied.
- Statistics:
- No statistical analysis was used
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- 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
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- 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
Applicant's summary and conclusion
- Conclusions:
- LSN2812839 was considered positive in the Bacterial Reverse Mutation Assay in TA98, and TA1537 under conditions with S9 metabolic activation. LSN2812839 was negative in all other strains and test conditions when tested up to 5000 micrograms/plate. A positive Bacterial Reverse Mutation Assay by itself is not sufficient for EU CLP classification. Due to inconclusive data the classification criteria for germ cell mutagenicity are not met.
- Executive summary:
The objective of this study was to evaluate LSN2812839, for its ability to induce reverse mutations at the histidine locus in Salmonella typhimurium tester strains TA98, TA100, TA1535, and TA1537, and at the tryptophan locus of Escherichia coli (E. coli) strain WP2uvrA in the presence or absence of an exogenous mammalian metabolic activation system (S9). LSN2812839 was evaluated in the mutagenicity assay in all five tester strains at dose levels of 1.60, 5.00, 16.0, 50.0, 160, 500, 1600, and 5000 micrograms/plate with and without S9. LSN2812839 was prepared in dimethylsulfoxide (DMSO) vehicle and formed a transparent, orange solution.
LSN2812839 remained soluble on plates after treatment as evident by no detectable precipitate on plates at any dose level tested with any strain. Normal background lawn growth was observed on all plates indicating there was appropriate bacterial growth during treatment to express a potential mutagenic event. Dose-dependent increases in the mean number of revertant colonies that exceeded positive criteria were observed with TA98 and TA1537 under conditions with S9. There were no other observed increases in revertants noted in any other strain tested with or without S9.
All positive and vehicle control values were within acceptable ranges, and all criteria for a valid study were met. LSN2812839 was considered positive in the Bacterial Reverse Mutation Assay in TA98, and TA1537 under conditions with S9 metabolic activation. LSN2812839 was negative in all other strains and test conditions when tested up to 5000 micrograms/plate.
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