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EC number: 695-101-5 | CAS number: 1275611-65-8
- 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:
- 28-Mar-2016 to 28-Apr-2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
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
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-C16-18-alkyl-(evennumbered, C18 unsaturated) trimethylpropane-1,3-diamine
- EC Number:
- 695-101-5
- Cas Number:
- 1275611-65-8
- Molecular formula:
- Not applicable
- IUPAC Name:
- N-C16-18-alkyl-(evennumbered, C18 unsaturated) trimethylpropane-1,3-diamine
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Diamine methylated
- Substance type:Amber liquid
- Physical state:Liquid
- Storage conditions of test material:At room temperature
- Content (certified): 100% (UVCB–Substance)
- Batch/Lot number:211401A Morris
- Expiration date of the lot/batch:24 March 2018
Constituent 1
Method
- Target gene:
- - S. typhimurium: Histidine gene
- E. coli: Tryptophan gene
Species / strainopen allclose all
- 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:
- Rat liver S9-mix induced by Aroclor 1254
- Test concentrations with justification for top dose:
- Experiment 1
Preliminary test (without and with S9) TA100 and WP2uvrA: 1.7, 5.4, 17, 52, 164, 512, 1600 and 5000 µg/plate
Main study: TA1535, TA1537 and TA98:
Without S9-mix: 0.18, 0.52, 1.7, 5.4, 17 and 52 μg/plate.
With S9-mix: 0.52, 1.7, 5.4, 17, 52 and 164 μg/plate.
Experiment 2:
Without S9-mix: 2.6, 4.7, 8.4, 15, 27 and 48 μg/plate.
With S9-mix: 8.4, 15, 27, 48, 86 and 154 μg/plate. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle:
Test compound was soluble in ethanol and ethanol has been accepted and approved by authorities and international guidelines
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- without S9 Migrated to IUCLID6: 650 µg/plate in DMSO for TA100
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- without S Migrated to IUCLID6: 10 µg/plate in DMSO for TA98 and 15 µg/plate for TA1537
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- without S9 Migrated to IUCLID6: 10 µg/plate in DMSO for WP2uvrA
- Positive control substance:
- sodium azide
- Remarks:
- without S9 Migrated to IUCLID6: 5 µg/plate in saline for TA1535
- Positive control substance:
- other: 2-aminoanthracene in DMSO for all tester strains
- Remarks:
- with S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 hour
NUMBER OF REPLICATIONS:
- Doses of the test substance were tested in triplicate in each strain. Two independent experiments were conducted.
NUMBER OF CELLS EVALUATED: 10E8 per plate
DETERMINATION OF CYTOTOXICITY
- Method: The reduction of the bacterial background lawn, the increase in the size of the microcolonies and the reduction of the revertant colonies.
OTHER EXAMINATIONS:
- The presence of precipitation of the test compound on the plates was determined. - Evaluation criteria:
- A test substance is considered negative (not mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 or WP2uvrA is not greater than two (2) times the concurrent control, and the total number of revertants in tester strains TA1535, TA1537 or TA98 is not greater than three (3) times the concurrent control.
b) The negative response should be reproducible in at least one independently repeated experiment.
A test substance is considered positive if:
a) A two-fold (TA100, WP2uvrA) or more or a three-fold (TA1535, TA1537, TA98) or more increase above solvent control in the mean number of revertant colonies is observed in the test substance group.
b) In case a repeat experiment is performed when a positive response is observed in one of the tester strains, the positive response should be reproducible in at least one independently repeated experiment.
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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- 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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation was observed up to and including the top dose of 5000 µg/plate
CYTOTOXICITY RANGE-FINDING/SCREENING STUDIES:
TA1535: without S9: 52 µg/plate and with S9: 164 µg/plate
TA1537: without S9: 52 µg/plate and with S9: 164 µg/plate
TA98: without S9: 52 µg/plate and with S9: 164 µg/plate
TA100: without S9: 52 µg/plate and above and with S9: 164 µg/plate and above
WP2uvrA: without S9: 52 µg/plate and above and with S9: 164 µg/plate and above
COMPARISON WITH HISTORICAL CONTROL DATA:
Acceptable responses were obtained for the negative and strain-specific positive control items indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
TA1535: without S9: 27 µg/plate and above and with S9: 154 µg/plate
TA1537: without S9: 27 µg/plate and above and with S9: 154 µg/plate
TA98: without S9: 27 µg/plate and above and with S9: 154 µg/plate
TA100: without S9: 27 µg/plate and above and with S9: 154 µg/plate
WP2uvrA: without S9: 45 µg/plate and with S9: 154 µg/plate
Applicant's summary and conclusion
- Conclusions:
- It is concluded that Diamine methylated is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay
- Executive summary:
Diamine methylated did not induce a significant dose-related increase in the number of revertant (His+) colonies in each of the four tester strains (TA1535, TA1537, TA98 and TA100) and in the number of revertant (Trp+) colonies in the tester strain WP2uvrA both in the absence and presence of S9-metabolic activation. These results were confirmed in a follow-up experiment.
The negative control values were within the laboratory historical control data ranges.
The strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly, except the response for TA98 in the first experiment (absence of S9-mix).The purpose of the positive control is as a reference for the test system, where a positive response is required to check if the test system functions correctly. Since the value was more than 3 times greater than the concurrent solvent control values, this deviation in the mean plate count of the positive control had no effect on the validity of the study.
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