Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-412-0 | CAS number: 106-58-1
- 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:
- 1996-01-19 - 1996-02-16
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Only two replicates per group were used, method for measuring toxicity was not specified, no historical control data provided, and the procedure (preincubation or plate incorporation) used for the preliminary reverse mutation test was not provided. However, all other parts of OECD guideline 471 were followed.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- Only two replicates per group were used, method for measuring toxicity was not specified, no historical control data provided, and procedure (preincubation or plate incorporation) used for the preliminary reverse mutation test was not provided.
- GLP compliance:
- yes
- Remarks:
- Japanese Good Laboratory Practice
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,4-dimethylpiperazine
- EC Number:
- 203-412-0
- EC Name:
- 1,4-dimethylpiperazine
- Cas Number:
- 106-58-1
- Molecular formula:
- C6H14N2
- IUPAC Name:
- 1,4-dimethylpiperazine
- Details on test material:
- - Name of test material (as cited in study report): Jeffcat DMP
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): N,N'-dimethylpiperazine (DMP)
- Molecular weight (if other than submission substance): 114.19
- Physical state: colorless liquid
- Analytical purity: 99.0 % or more
- Impurities (identity and concentrations): water, 0.1 %
- Lot/batch No.: U3-1-1294
- Stability under test conditions: stable at room temperature; stability in solvent: stable in distilled water
- Storage condition of test material: at room temperature, shield under from light
Method
- Target gene:
- Histidine locus (Salmonella strains) and tryptophan locus (E. coli strain)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: TA100 and TA1535 are base pair substitution detecting strains and TA98 and TA1537 are frameshift detecting strains
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- other: base pair substitution detecting strain
- Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbital and 5,6-benzoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- 313, 625, 1250, 2500 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: distilled water
- Justification for choice of solvent/vehicle: the test substance was soluble in water at concentrations of 100 g/L or more. From these results, distilled water was used as the solvent for the test substance.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- distilled water
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide-used for strains TA100 and WP2 uvrA at 0.01 ug/plate and TA98 at 0.1 ug/plate
- Remarks:
- without activation
- Untreated negative controls:
- yes
- Remarks:
- distilled water
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without activation used for strain TA1535 at 0.5 ug/plate
- Untreated negative controls:
- yes
- Remarks:
- distilled water
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without activation used for strain TA1537 at 80 ug/ plate
- Untreated negative controls:
- yes
- Remarks:
- distilled water
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene-used for strain TA1535 at 2 ug/plate and WP2 uvrA at 10 ug/plate
- Remarks:
- with activation
- Untreated negative controls:
- yes
- Remarks:
- distilled water
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with activation used for strains TA100, TA98 and TA1537 at 5 ug/plate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: pre-incubation
DURATION
- Preincubation period: 30 minutes
- Exposure duration: 48 hours
- Selection time (if incubation with a selection agent): 48 hours (simultaneous with exposure)
SELECTION AGENT (mutation assays): L-histidine (Salmonella strains), L-tryptophan (E.coli strain)
NUMBER OF REPLICATIONS: 2
DETERMINATION OF CYTOTOXICITY
- Method: cytotoxicity was determined but no information was given on how it was determined.
- Evaluation criteria:
- The number of revertant colonies at each dose was compared with that of the solvent control group for each bacterial strain with and without metabolic activation. The test substance was considered as positive when significant dose-related and more than two-fold increases in the number of revertant colonies were observed with sufficient reproducibility.
- Statistics:
- No statistical analysis was performed for evaluation of the test results.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- 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:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES: A preliminary reverse mutation test was performed in each of the strains listed above with and without metabolic activation to determine the suitable dosage of the test substance to be applied in the reverse mutation test. The maximum dose level for the preliminary test was set at 5000 µg/plate and six dose levels (10, 50, 100, 500, 1000 and 5000 µg/plate) were employed.
Neither toxic effect nor more than two-fold increases in the number of revertant colonies were observed in any test substance treated groups with and without metabolic activation, while the dose related increase in the number of revertant colonies was observed in TA100 with and without metabolic activation. Considering these results, the maximum dose level for the reverse mutation test was set at 5000 µg/plate, and five different amounts of the test substance were prepared by serial dilution with a factor of 2 from the maximum dose.
- Remarks on result:
- other: strain/cell type: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Any other information on results incl. tables
Neither toxic nor more than two-fold increase in the number of revertant colonies were observed in any test substance treated groups with and without metabolic activation, while the dose related increase in the number of revertant colonies was observed in TA100 with and without metabolic activation. On the other hand, all of the positive controls produced more than two-fold increases in the number of the revertant colonies in comparison with that of the solvent control with all bacterial strains with and without metabolic activation. These results indicated that the test had been properly carried out.
Applicant's summary and conclusion
- Conclusions:
- The test substance was evaluated for mutagenic potential in the reverse mutation test in the presence and absence of metabolic activation using S. typhimurium strains TA100, TA98, TA1535, TA1537 and E. coli strain WP2 uvrA. Based on the results of the assay, the test substance was considered to be negative under the test conditions employed up to a dose level of 5000 µg/plate. According to the criteria laid down in the CLP Regulation, the substance is considered not classified as mutagenic.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

EU Privacy Disclaimer
This website uses cookies to ensure you get the best experience on our websites.