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EC number: 205-593-1 | CAS number: 143-23-7
- 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:
- From 3 FEB 1999 to 5 APR 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- version of 1997
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 7-azatridecane-1,13-diamine
- EC Number:
- 205-593-1
- EC Name:
- 7-azatridecane-1,13-diamine
- Cas Number:
- 143-23-7
- Molecular formula:
- C12H29N3
- IUPAC Name:
- bis(6-aminohexyl)amine
- Test material form:
- solid
- Details on test material:
- white to slight yellow
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL: the substance appeared to be stable under the conditions of the study, no evidence of instability was observed.
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium, other: TA 97a, TA 98, TA 100, and TA 1535
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Metabolic activation system:
- aroclor 1254 induced male rat liver S9-mix
- Test concentrations with justification for top dose:
- 0, 10, 50, 100, 500, 1000, 2500, and 5000 µg/plate (highest concentration is maximum concentration requiered according to guideline)
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used:sterile water
- Justification for choice of solvent/vehicle: no evidence for instability was observed
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- 9,10-dimethylbenzanthracene
- 2-nitrofluorene
- sodium azide
- N-ethyl-N-nitro-N-nitrosoguanidine
- other: ICR-191 dihydrochloride (CASRN: 17070-45-0)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation)
DURATION
- Preincubation period: no
- Exposure duration:incubation at 37°C for 48 hours
NUMBER OF REPLICATIONS: 3 plates per concentration
DETERMINATION OF CYTOTOXICITY
- yes - Rationale for test conditions:
- AN individual trial must have included a negative and a positive control and at least 5 concentration levels of the test substance for each tester strain and condition.
A data point, concnetration level or trial was excluded from analysis when acceptability criteria were not met - these are as follows:
- all tester strains must have had their strain characteristic specifics and exhibit a characteristic number of revertants per plate in the absence of the test substance
- mean positive control values must exhibit at least a three-fold increase of revertants compared to solvent control
- a minimum of three non-toxic concentrations were requiered (non toxic, i.e. < 50% reduction in mean number of revertants per plate relative to the mean of the concurrent negative control) - Evaluation criteria:
- POSITIVE, if the mean number of revertant colonies per plate in at least one strain with or without metabolic activation system was at least two times greater than the mean of concurrent vehicle control and there was a concentration-related increase over the range tested
NEGATIVE, if no two-foldincrease in number of revertant colonies or no concentration-related increase over the range tested
Results not meeting the criteria for positive or negavtive were evaluated using scientific judgment and may have been reported as EQUIVOCAL. - Statistics:
- mean number of three plates/concentration level and condition as well as standard deviation was calculated
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- starting at 2500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- starting at 500 µg/plate
- 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
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- starting at 2500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium, other: TA 97a, TA 100, and TA 1535
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- starting at 1000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- not examined
- Key result
- Species / strain:
- S. typhimurium, other: TA 97a, TA 98, TA 100, and TA 1535
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- starting at 500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study the test item showed no mutagenic activity in bacterial tester strains.
- Executive summary:
In a guideline study according to OECD TG 471 under GLP conditions, mutagenic activity of the test item was investigated in a plate incorporation assay. Salmonella typhimurium strains TA 97a, TA1535, TA98 and TA100 as well as Escherichia coli strain WP2uvrA were exposed to concentrations of 0, 10, 50, 100, 500, 1000, 2500 or 5000 µg test item per plate either with or without metabolic activation system (aroclor induced male rat liver S9 -mix). Three plates at each concentration level were used. No precepitation of the test substance occurred. Cytotoxicity was observed as low as 500 µg/plate in strains tested without metabolic activation system, or as low as 1000 µg/plate in some strains tested with metabolic activation system. All positive controls induced marked increases in frequency of revertant colonies. All negative controls were found to be in an acceptable range. The test item showed no mutagenic activity.
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