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EC number: 259-393-4 | CAS number: 54914-37-3
- 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:
- 2011-06-24 to 2011-08-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study; GLP study without deviations
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Version / remarks:
- 2005
- Qualifier:
- according to guideline
- Guideline:
- other: ICH Guideline S2A:'Genotoxicity: Specific Aspects of Regulatory gentoxocoty tests for Pharmaceuticals (CPMP/ICH/141/95)'
- Qualifier:
- according to guideline
- Guideline:
- other: ICH Giudeline S2B: 'A Standard Battery for Genotoxicity Testing of Pharmaceuticals (CPMP/ICH/174/95)'
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,3,3-trimethyl-N-(2-methylpropylidene)-5-[(2-methylpropylidene)amino]cyclohexanemethylamine
- EC Number:
- 259-393-4
- EC Name:
- 1,3,3-trimethyl-N-(2-methylpropylidene)-5-[(2-methylpropylidene)amino]cyclohexanemethylamine
- Cas Number:
- 54914-37-3
- Molecular formula:
- C18H34N2
- IUPAC Name:
- 1,3,3-Trimethyl-N-(2-methylpropylidene)-5-[(2-methylpropylidene)amino]cyclohexanemethanamine
- Test material form:
- other: liquid
- Details on test material:
- Dialdimine 98.30%
Isophorondiamine 0.42%
Monoaldimine 0.47%
Isobutyraldehyde 0.11%
Unidentified 0.70%
Constituent 1
Method
- Target gene:
- mutated gene loci resposible for histidine auxotropy
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- other: histidine auxotroph
- Metabolic activation:
- with and without
- Metabolic activation system:
- Arochlor 1254 induced rat liver S9; male rats
- Test concentrations with justification for top dose:
- Experiment I and II:
10.0, 31.6, 100, 316, 1000 and 3160 µg per plate - Vehicle / solvent:
- dimethyl sulfoxide (DMSO) , a factor of 1.017 was used to correct for impurities
Controls
- Untreated negative controls:
- no
- Remarks:
- solvent test will be used as negative reference item
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- for details see below
- Positive control substance:
- other: without metabolic activation: sodium azide in aqua ad iniectabilia for TA 1535 and TA 100, 2-nitroflurene in DMSO for TA 98, 9-amino-acridine in ethanol abs. for TA 1537, Cumene hydroperoxide in DMSO for TA 102
- Remarks:
- with metabolic activation: 2-aminoanthracene in DMSO for TA 98, TA 102, TA 1537, cyclophosphamide in aqua ad iniectabilia for TA 100, TA 1535
- Details on test system and experimental conditions:
- Bacterial Reverse Mutation Test
SYSTEM OF TESTING
- Pre-Experiment: plate incorporation cytotoxicity test (+/- metabolic activation) with strain TA 100,
10 concentrations ranging from 0.316 to 5000 µg/plate were tested, pronounced cytotoxicity (scarce background lawn and reduction of the
number of revertants by more than 50%) was noted at concentrations of 3160 and 5000 µg/plate (see tables 1 and 2). Hence, 3160 µg
test item/plate was chosen as top concentration for the main study in the plate incorporation test and in the preincubation test, respectively.
- Main test: 1st - Standard plate incorporation method, 2nd - Preincubation method
- Metabolic activation assay: Arochlor 1254 induced rat liver S9 fraction, collected from 20 - 30 rats, the protein content of the S9 fraction was 34.5 mg/mL S9, cytochrome P-450: 0.43 nmol/mg protein.
ADMINISTRATION
- Dosing: 10.0, 31.6, 100, 316, 1000 and 3160 µg per plate
- Data : 2 independent experiments with and without metabolic activation
- Number of replicates: 3 per concentration and experiment
- Positive and negative control groups and treatment:
- without metabolic activation:
10 µg/plate sodium azide in aqua ad iniectabilia for TA 1535 and TA 100
10 µg/plate 2-nitroflurene in DMSO for TA 98
100 µg/plate 9-amino-acridine in ethanol abs. for TA 1537
10 µg/plate cumene hydroperoxide in DMSO for TA 102
- with metabolic acivation
2 µg/plate 2-aminoanthracene in DMSO for TA 98, TA 102, TA 1537
1500 µg/plate cyclophosphamide in aqua ad iniectabilia for TA 100, TA 1535
- negative control: solvent control: DMSO
- Incubation time: 48 h to 72 h at 37 °C in the dark
- Pre-incubation time: 20 min at 37 °C;
- Evaluation criteria:
- The test item is considered to show a positive response if:
- the number of revertants is significantly increased (p ≤ 0 .05, U-test according to MANN and WHITNEY) compared to the solvent control to at least
2-fold of the solvent control for TA 98, TA 100 and TA 102 and 3-fold of the solvent control for TA 1535 and TA 1537 in both independent
experiments.
- additionally, a significant (p ≤ 0.05) concentration (log value)-related effect (Spearman's rank correlation coefficient) is observed.
- positive results have to be reproducible and the histidine independence of the revertants has to be confirmed by streaking random samples on
histidine-free agar plates. - Statistics:
- According to the OECD Guideline 471, a statistical analysis of the data is not mandatory
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- cytotoxicity was noted at concentrations of 3160 and 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- GENTOXIC EFFECTS:
- With metabolic activation: negativ
- Without metabolic activation: negativ
CYTOTOXICITY EFFECTS:
- Cytotoxicity was noted at concentrations of 3160 and 5000 µg/plate - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
The following chemicals served as positive control items:
a) without metabolic activation |
|
sodium azide[1]inaqua ad iniectabilia[2] (10 µg/plate) |
TA 1535, TA 100 |
2-nitro-fluorene[3]in DMSO[4] (10 µg/plate) |
TA 98 |
9-amino-acridine3in ethanol, abs.[5] (100 µg/plate) |
TA 1537 |
Cumene hydroperoxide[6] in DMSO6(10 µg/plate) |
TA 102 |
b) with metabolic activation |
|
2-amino-anthracene3in DMSO6 (2 µg/plate) |
TA 98, TA 102, TA 1537 |
cyclophosphamide3inaqua ad iniectabilia4 (1500 µg/plate) |
TA 100, TA 1535 |
[1] SIGMA-ALDRICH Chemie GmbH, 82024 Taufkirchen, Germany
[2] DeltaSelect GmbH, 63303 Dreieich, Germany
[3] Riedel de Haën AG, 30926 Seelze, Germany
[4] DMSO, spectrometric grade; E. MERCK, 64293,
[5] Ethanol spectrometric grade; E. MERCK, 64293,
[6] E. MERCK, 64293,
Applicant's summary and conclusion
- Conclusions:
- In conclusion, under the present test conditions 1,3,3-trimethyl-N-(2-methylpropylidene)-5-[(2-methylpropylidene)amino]cyclohexane-
methylamine tested up to a cytotoxic concentration of 3160 µg/plate, caused no mutagenic effect in the Salmonella typhimurium strains TA 98,
TA 100, TA 102, TA 1535 and TA 1537 neither in the plate incorporation test nor in the preincubation test each carried out without and with
metabolic activation. - Executive summary:
The purpose of this study was to evaluate 1,3,3 -Trimethyl-N-(2-methylpropylidene)-5-[(2-methylpropylidene)amino]cyclohexane-
methylamine for mutagenic activity (gene mutation) in bacteria without and with the addition of a mammalian metabolic activation system as originally described by AMES et al. (1973, 1975) and revised by MARON and (1983).
The test item was examined in the 5 Salmonella typhimuriumstrains TA 98, TA 100, TA 102, TA 1535 and TA 1537 in two independent experiments, each carried out without and with metabolic activation (a microsomal preparation derived from Aroclor 1254-induced rat liver). The first experiment was carried out as a plate incorporation test and the second as a preincubation test.
The test item was completely dissolved indimethyl sulfoxide (DMSO). A factor of 1.017 was used to correct for impurities.
Preliminary test
The test item was examined in two preliminary cytotoxicity tests (plate incorporation test without and with metabolic activation) in test strain TA 100. Ten concentrations ranging from 0.316 to 5000 µg/plate were tested. Pronounced cytotoxicity
(scarce background lawn and reduction of the number of revertants by more than 50%) was noted at concentrations of 3160 and 5000 µg/plate.Hence, 3160 µg test item/plate was chosen as top concentration for the main study in the plate incorporation test and in the preincubation test, respectively.
Main study
Six concentrations ranging from 10.0 to 3160 µg test item/plate were employed in two independent experiments each carried out without and with metabolic activation.
Cytotoxicity
In the plate incorporation test and in the preincubation test, each carried out without and with metabolic activation cytotoxicity (scarce background lawn and reduction of the number of revertants) was noted at the top concentration of 3160 µg/plate in all test strains.
Mutagenicity
No mutagenic effect (no increase in revertant colony numbers as compared with control counts) was observed for the test item, tested up to a cytotoxic concentrationof 3160 µg/plate,in any of the 5 test strains in two independent experiments without and with metabolic activation, respectively (plate incorporation and preincubation test).
In conclusion, under the present test conditions the test item tested up to a cytotoxic concentration of 3160 µg/plate, caused no mutagenic effect in the Salmonella typhimurium strains TA 98, TA 100, TA 102, TA 1535 and TA 1537 neither in the plate incorporation test nor in the preincubation test each carried out without and with metabolic activation.
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