Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 454-210-6 | CAS number: 13106-24-6
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Link to relevant study records
- 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)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline Study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Salmonella: His
E. coli: Trp - Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-Mix
- Test concentrations with justification for top dose:
- First experiment: 0; 20; 100; 500; 2500 and 5000 µg/plate
Second experiment: 0; 20; 100; 500; 2500 and 5000 µg/plate - Vehicle / solvent:
- water
- Untreated negative controls:
- yes
- Remarks:
- sterility control
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-AA, MNNG, NOPD, AAC, ENNG
- Details on test system and experimental conditions:
- 3 test plates per dose or per control were made.
Sterility control: Additional plates are treated with soft agar, S-9 mix, buffer, vehicle or the test substance but without the addition of tester strains.
Vehicle control: The vehicle control with and without S-9 mix only contains the vehicle used for the test substance at the same concentration and volurne for all tester strains.
Positive controls
The following positive controls are used to check the mutability of the bacteria and the activity of the S-9 mix:
With S-9 mix: 2-aminoanthracene (2-AA)
- 2.5 µg/plate, dissolved in DMSO, strains: TA 1535, TA 100, TA 1537, TA 98
- 60 µg/plate, dissolved in DMS0, strain: Escherichia coli WP2 uvrA
Without S-9 mix: N-methyl-N' -nitro-N-nitrosoguanidine (MNNG)
- 5 µg/plate, dissolved in DMS0, strains: TA 1535, TA 100
4-nitro-o-phenylendiamine (NOPD)
- 10 µg/plate, dissolved in DMS0, strain: TA 98
9-aminoacridine (AAC)
- 100 pg/plate, dissolved in DMS0
- strain: TA 1537
N-ethyl-N' -nitro-N-nitrosoguanidine (ENNG)
- 10 µg/plate, dissolved in DMSO, strain: E. coli WP2 uvrA
Standard plate test:
Test tubes containing 2-ml portions of soft agar (overlay agar), which consists of 100 ml agar (0.6% agar + 0.6% NaCl) and 10 ml amino acid solution (minimal amino acid solution for the determination of mutants: 0.5 mM histidine + 0.5 mM biotin) are kept in a water bath at 45°C, and the remaining components are added in the following order:
0.1 ml test solution or vehicle
0.1 ml fresh bacterial culture
0.5 ml S-9 mix (in tests with metabolic activation) or 0.5 ml phosphate buffer (in tests without metabolic activation)
After mixing, the samples are poured onto Vogel-Bonner agar plates (minimal glucose agar plates) within approx. 30 seconds.
After incubation at 37°C for 48 - 72 hours in the dark, the bacterial colonies (his+ revertants) are counted.
Escherichia coli:
Test tubes containing 2-ml portions of soft agar (overlay agar), which consists of 100 ml agar (0.6% agar + 0.6% NaCl) and 10 ml amino acid solution (minimal amino acid solution for the determination of mutants: 0.5 mM tryptophan) are kept in a water bath at 45'C, and the remaining components are added in the following order: 0.1 ml test solution or vehicle
0.1 ml fresh bacterial culture
0.5 ml S-9 mix (in tests with metabolic activation) or 0.5 ml phosphate buffer (in tests without metabolic activation)
After mixing, the samples are poured onto minimal agar plates within approx. 30 seconds.
After incubation at 37°C for 48 - 72 h in the dark, the bacterial colonies (trp+ revertants) are counted.
Preincubation test:
0.1 ml test solutian or vehicle, 0.1 ml bacterial suspension and 0.5 ml S-9 mix are incubated at 37 °C for the duration of about 20 minutes using a shaker. Subsequently, 2 ml of soft agar is added and, after mixing, the samples are poured onto the agar plates within approx. 30 seconds. After incubation at 37°C for 48 - 72 h in the dark, the bacterial colonies are counted. - Evaluation criteria:
- The test chemical is considered positive in this assay if the following criteria are met:
A dose-related and reproducible increase in the number of revertant colonies, i.e. about doubling of the spontaneous mutation rate in at least one
tester strain either without S-9 mix or after adding a metabolizing system.
A test substance is generally considered nonmutagenic in this test if:
The number of revertants for all tester strains were within the historical negative control range under all experimental conditions in two experiments
carried out independently of each other. - 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:
- cytotoxicity
- Remarks:
- starting with 2500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other:
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- see table 1
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Reference
Table1: Schematic presentation of the number of maximum revertants per plate (concentration where revertants were observed) in the solvent control and substance treated strains from Experiment 1 and 2:
Standard plate test:
Control | Testsubstance | |||
Test strain | -S9 | +S9 | -S9 | +S9 |
TA1535 | 20 ± 1 | 20 ± 3 | 20 ± 1 (20 µg) | 19 ± 2 (20 µg) |
TA100 | 128 ± 8 | 128 ± 4 | 135 ± 18 (100 µg) | 128 ± 20 (100 µg) |
TA1537 | 11 ± 2 | 11 ± 2 | 10 ± 1 (20 µg) | 10 ± 1 (20 µg) |
TA98 | 30 ± 2 | 37 ± 2 | 24 ± 4 (20 µg) | 28 ± 1 (20 µg) |
E. coli WP2 uvrA | 31 ± 4 | 38 ± 1 | 28 ± 2 (20 µg) | 33 ± 2 (20 µg) |
Preincubation test:
Control | Testsubstance | |||
Test strain | -S9 | +S9 | -S9 | +S9 |
TA1535 | 20 ± 3 | 20 ± 3 | 16 ± 3 (20 µg) | 19 ± 1 (100 µg) |
TA100 | 128 ± 21 | 124 ± 12 | 125 ± 12 (100 µg) | 147 ± 16 (100 µg) |
TA1537 | 16 ± 3 | 16 ± 3 | 16 ± 4 (100 µg) | 15 ± 3 (20 µg) |
TA98 | 23 ± 2 | 38 ± 3 | 22 ± 4 (100 µg) | 38 ± 2 (2500 µg) |
E. coli WP2 uvrA | 24 ± 1 | 43 ± 2 | 27 ± 4 (500 µg) | 40 ± 1 (20 µg) |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
There is one reliable and relevant study available investigating the genetic toxicity of 1-Butanaminium, N,N-dibutyl-N-methyl-, methyl sulfate.
Point mutation in bacteria
OECD Guideline Study:
The substance 1-Butanaminium, N,N-dibutyl-N-methyl-, methyl sulfate was tested for its mutagenic potential based on the ability to induce point mutations in selected loci of several bacterial strains, i.e. Salmonella typhimurium and Escherichia coli, in a reverse mutation assay according to OECD 471 under GLP. Strains used are TA 1535, TA 100, TA 1537, TA 98 and E. coli WP2 uvrA with doses range up to 5,000 pg/plate (SPT and PIT). Standard plate test (SPT) and preincubation test (PIT) both with and without metabolic activation (Aroclor-induced rat liver S-9 mix) are conducted. No precipitation of the test substance was found and a bacteriotoxic effect (slight decrease) was observed in SPT and PIT. An increase in the number of his* or trp* revertants was not observed in the standard plate test or in the preincubation test either without S-9 mix or after the addition of a metabolizing system. According to the results of the present study, the test substance 1-Butanaminium, N,N-dibutyl- N-methyl-, methyl sulfate is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay under the experimental conditions (BASF, 1998).
As this study is the only avaiable information, but reliable and good documented, this information is integrated as key study. Further according to the integrated testing strategy (ITS) for genetic toxicity no furhter testing in necessary for the applied tonnage band if results from a ames study is negative and no further hints for mutagenicity are observed.
Assessement:
As the available information for 1-Butanaminium, N,N-dibutyl-N-methyl-, methyl sulfate shows no hints for mutagenicity the substance is considered to be not mutagenic (Ames).
Justification for classification or non-classification
Based on the above information and according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, a classification of the substance for mutagenicity is not justified.
Mutagenicity:
-GHS: no classification
-DSD: no classification
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.