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EC number: 603-894-6 | CAS number: 135108-88-2
- 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 mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (GLP)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- 2,4-bis[(4-aminocyclohexyl)methyl]aniline; 2,4-bis[(4-aminocyclohexyl)methyl]cyclohexan-1-amine; 2-[(1-aminocyclohexyl)methyl]aniline; 4-[(4-aminocyclohexyl)methyl]cyclohexan-1-amine; 4-{[4-({4-[(4-aminocyclohexyl)methyl]cyclohexyl}amino)cyclohexyl]methyl}cyclohexan-1-amine
- EC Number:
- 603-894-6
- Cas Number:
- 135108-88-2
- Molecular formula:
- Exact identification is not feasible
- IUPAC Name:
- 2,4-bis[(4-aminocyclohexyl)methyl]aniline; 2,4-bis[(4-aminocyclohexyl)methyl]cyclohexan-1-amine; 2-[(1-aminocyclohexyl)methyl]aniline; 4-[(4-aminocyclohexyl)methyl]cyclohexan-1-amine; 4-{[4-({4-[(4-aminocyclohexyl)methyl]cyclohexyl}amino)cyclohexyl]methyl}cyclohexan-1-amine
- Test material form:
- liquid: viscous
- Details on test material:
- Formaldehyde, polymer with benzenamine, hydrogenated of Evonik Degussa Antwerpen N.V., batch no. 180-120417, Molecular weight: Mn approx. 305, Mw approx. 315 g/mol
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- The indicator cell used for this study was the L5178Y mouse lymphoma cell line that is heterozygous at the TK locus (+/-). The particular clone (3.7.2C) used in this assay is isolated by ATCC (American Type Culture Collection), 0801 University Blvd., Manassas, VA 20110-2209, USA.
Stock cultures were obtained from ATCC, and master stocks were maintained in liquid nitrogen. Laboratory cultures were periodically checked for karyotype stability and the absence of mycoplasma contamination by culturing methods. To reduce the background mutant frequency (spontaneous frequency) of TK-/- mutants to a level as low as possible, cell cultures were exposed to conditions that select against the TK-/- phenotype (exposure to aminopterin or methotrexate). Cell cultures were maintained in cleansing medium for one day, placed in recovery medium for one day and then returned to normal growth medium for three to eight days before use. - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- In the first experiment without metabolic activation and both experiments with metabolic activation (3-hour exposure):
15.63, 31.25, 62.5, 125 and 250 µg/mL medium
In the second experiment without metabolic activation (24-hour exposure):
7.81, 15.63, 31.25, 62.5 and 125 µg/mL medium. - Vehicle / solvent:
- The test item was completely dissolved in dimethylsulfoxide (DMSO).
As recommended by the guidelines at least 10 exp5 cells were suspended in treatment medium and diluted to 5 x 10 exp5 cells/mL.
Fresh preparations of the test and reference item solutions were prepared on each day of biological testing.
Controls
- Untreated negative controls:
- no
- Remarks:
- The vehicle dimethylsulfoxide (DMSO) served as the negative control.
- Negative solvent / vehicle controls:
- yes
- Remarks:
- The vehicle dimethylsulfoxide (DMSO) served as the negative control.
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 3-methylcholanthrene
- methylmethanesulfonate
- Remarks:
- The vehicle dimethylsulfoxide (DMSO) served as the negative control.
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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- 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
Under the present test conditions, Copolymer of aniline and formaldehyde, hydrogenated, tested up to cytotoxic concentrations, in the absence and presence of metabolic activation in two independent experiments was negative with respect to the mutant frequency in the L5178Y TK +/- mammalian cell mutagenicity test. Under these conditions the positive controls exerted potent mutagenic effects and demonstrated the sensitivity of the test system and conditions.
In addition, no change was noted in the ratio of small to large mutant colonies. Therefore, Copolymer of aniline and formaldehyde, hydrogenated also did not exhibit clastogenic potential at the concentration-range investigated.
According to the evaluation criteria for this assay, these findings indicate that Copolymer of aniline and formaldehyde, hydrogenated, tested up to cytotoxic concentrations in the absence and presence of metabolic activation, did neither induce mutations nor have any chromosomal aberration potential. - Executive summary:
Copolymer of aniline and formaldehyde, hydrogenatedwas assayed in a gene mutation assay in cultured mammalian cells (L5178Y TK +/-) both in the presence and absence of metabolic activation by a liver post-mitochondrial fraction (S9 mix) from Aroclor 1254-induced rats. The test was carried out employing two exposure times without S9 mix: 3 and 24 hours, and one exposure time with S9 mix: 3 hours; the experiment with S9 mix was carried out in two independent assays.
Copolymer of aniline and formaldehyde, hydrogenated was completely dissolved indimethylsulfoxide (DMSO).The vehicle DMSO served as the negative control.
In the preliminary experiment without and with metabolic activation (24-hour or 3-h exposure)cytotoxicity (decreased survival) was noted starting at a concentrations of 100 or 250 µg/mL, respectively.
Hence, in the main studythe concentration-range of 15.63 to 250 µg/mL was usedin theexperiments without and with metabolic activation with a 3-hour exposure time and a concentration-range of 7.81 to 125 µg/mL was used in the second experiment without metabolic activation (24-hour exposure).
Methylmethanesulfonate (at 10 or 15 µL/mL) was employed as a positive control in the absence of exogenous metabolic activation and 3 -Methylcholanthrene (at 2.5 or 4.0 µg/mL) in the presence of exogenous metabolic activation.
In the main study,cytotoxicity(decreased survival) was noted in the presence and absence of metabolic activation (3-hour exposure) at the top concentration of 250 µg/mL and in the second experiment without metabolic activation (24-hour exposure) at the top concentration of 125 µg/mL.
The values of mutation frequencies of the negative controls ranged from 57.54 to 74.74 per 106 clonable cells in the experiments without metabolic activation and from 55.50 to 69.29 per 106 clonable cells in the experiments with metabolic activationand, hence, were well within the historical data-range.
The mutation frequencies of the cultures treated with Copolymer of aniline and formaldehyde, hydrogenated ranged from 67.37to 127.28 per 106 clonable cells (3 hours exposure) and from 49.44 to 60.19 per 106clonable cells (24 hours exposure) in the experiments without metabolic activation and from 63.68 to 95.20 per 106clonable cells (3 hours exposure, first assay) and from 66.66 to 96.51 per 106 clonable cells (3 hours exposure, second assay) in the experiments with metabolic activation. These results were within the range of the negative control values and the normal range of 50 to 170 mutants per 106 viable cells and, hence, no mutagenicity was observed according to the criteria for assay evaluation.
In addition, no change was observed in the ratio of small to large mutant colonies, ranging from 0.43 to 1.50 for Copolymer of aniline and formaldehyde, hydrogenated treated cells and from 0.67 to 0.95 for the negative controls.
The plating efficiency (PE step 1 and step 2) of the negative control was ≥ 50%, the mean cloning efficiencies (CE) within the range of 65% to 120% two days after treatment, and the mean suspension growth (SG) within the range of 8 to 32 following 3 -hour treatments and between 32 and 180 following 24-hour treatments.
The positive controls Methylmethanesulfonate (MMS) and 3-Methylcholanthrene (3-MC) caused pronounced increases in the mutation frequency ranging from 1157.15 to 2592.61 per 106 clonable cells in the case of MMS and ranging from 917.29 to 1434.11 per 106 clonable cells in the case of 3 -MC.
In addition, the colony size ratio was moderately shifted towards an increase in small colonies, ranging from 1.65 to 2.29 in the case of MMS.
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