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EC number: 262-679-1 | CAS number: 61260-55-7
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07.07.2015 to 04.09.2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine
- EC Number:
- 262-679-1
- EC Name:
- N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine
- Cas Number:
- 61260-55-7
- Molecular formula:
- C24H50N4
- IUPAC Name:
- N1,N6-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine
- Test material form:
- solid: flakes
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Details on mammalian cell type (if applicable):
- Periodically checked with regard to membrane permeability (rfa), UV sensitivity (uvrA and uvrB), ampicillin resistance (amp), as well as spontaneous mutation frequencies.
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 5000; 2500; 1000; 316; 100; 31.6 and 10 µg/plate (Range finding test)
5000; 1581; 500; 158.1; 50; 15.81; 5 and 1.581 µg/plate (Main tests) - Vehicle / solvent:
- Based on the results of a solubility test, the test item was formulated in Acetone.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Remarks:
- 4 µg/plate
- Positive control substance:
- other: 4-nitro-1,2-phenylene-diamine (NPD)
- Remarks:
- TA98 without activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Distilled water
- Positive controls:
- yes
- Remarks:
- 2 µg/plate
- Positive control substance:
- sodium azide
- Remarks:
- TA100 and TA1535 without activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Remarks:
- 50 µg/plate
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA1537 without activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Distilled water
- Positive controls:
- yes
- Remarks:
- 2 µL/plate
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- WP2 uvrA without activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Remarks:
- 2 µg/plate
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- all Salmonella strains with activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Remarks:
- 50 µg/strain
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- WP2 uvrA with activation
- Details on test system and experimental conditions:
- Preliminary Concentration Range Finding Test and Initial Mutation Test:
- plate incorporation method
- incubation: 48+/-1 hours at 37°C (plates)
Confirmatory Mutation Test:
- pre-incubation method
- incubation: 20 at 37°C (direct contact between bacteria and test item), 48+/-1 hours at 37°C (plates)
In the main tests, each sample (including the controls) was tested in triplicate. - Evaluation criteria:
- Criteria for Validity:
The study was considered valid if:
- the number of revertant colonies of the negative (vehicle/solvent) and positive controls were in the historical control range in all strains of the main tests;
- at least five analyzable concentrations were presented in all strains of the main tests.
Criteria for a Positive Response:
A test item was considered mutagenic if:
- a dose–related increase in the number of revertants occurred and/or;
- a reproducible biologically relevant positive response for at least one of the dose groups occurred in at least one strain with or without metabolic activation.
An increase was considered biologically relevant if:
- the number of reversions was more than two times higher than the reversion rate of the negative (vehicle/solvent) control in Salmonella typhimurium TA98, TA100 and Escherichia coli WP2 uvrA bacterial strains;
- the number of reversions was more than three times higher than the reversion rate of the negative (vehicle/solvent) control in Salmonella typhimurium TA1535 and TA1537 bacterial strains.
Criteria for a Negative Response:
A test item was considered non-mutagenic if it produced neither a dose-related increase in the number of revertants nor a reproducible biologically relevant positive response at any of the dose groups, with or without metabolic activation.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Cytotoxicity (absent/reduced/slightly reduced background lawn development and pinpoint colonies, in some cases reduced revertant counts):
- Initial Mutation Test in S. typhimurium TA98, TA100 and TA1537 bacterial strains at 5000 μg/plate with and without metabolic activation and in Escherichia coli WP2 uvrA strain at 5000 μg/plate without metabolic activation;
- Confirmatory Mutation Test in all examined bacterial strains at 5000 and 1581 μg/plate with and without metabolic activation; and in S. typhimurium TA 98, TA100 and TA1535 strains at 500 μg/plate without metabolic activation.
Higher numbers of revertant colonies compared to the vehicle control were detected in the main test in some sporadic cases. However, no dose-dependence was observed in those cases and they were below the biologically relevant threshold value.
The numbers of revertant colonies were within the historical control range in each case, so they were considered as reflecting the biological variability of the test.
No precipitate was detected on the plates in the main tests in any examined bacterial strains with and without metabolic activation.
The examined concentration range was considered to be adequate as the highest examined concentration was the highest recommended concentration (5000 μg/plate). At least five analyzable concentrations were presented in all strains with and without metabolic activation. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
In conclusion, the test item Hexamethylene-bis-triacetone diamine (HMBTAD) had no mutagenic activity in the examined bacterial strains with and without metabolic activation under the test conditions of this study.
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