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EC number: 835-183-3 | CAS number: 83420-16-0
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05/12/2019-12/05/2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N4,N4'-hexane-1,6-diylbis[N-butyl-6-chloro-N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)-1,3,5-triazine-2,4-diamine]
- EC Number:
- 835-183-3
- Cas Number:
- 83420-16-0
- Molecular formula:
- C56 H102 Cl2 N14
- IUPAC Name:
- N4,N4'-hexane-1,6-diylbis[N-butyl-6-chloro-N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)-1,3,5-triazine-2,4-diamine]
- Test material form:
- solid: particulate/powder
- Details on test material:
- light yellow powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: SUQIAN UNITECH CORP., LTD; 190701
- Expiration date of the lot/batch:24 July 2021
- Purity: 91%
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing : The test item was dissolved in ethanol, processed by ultrasound for 3 min at 37 °C and diluted prior to treatment. The solvent was compatible with the survival of the bacteria and the S9 activity.
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Remarks:
- [E. coli WP2 uvrA (pKM 101)]
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9 :Trinova Biochem GmbH, Gießen, Germany. Male Sprague Dawley rats were induced with phenobarbital/β-naphthoflavone.
- method of preparation of S9 mix : 100 mM of ice-cold sodium-ortho-phosphate-buffer, pH 7.4, was added to the following pre-weighed sterilised reagents to give final concentrations in the S9 mix of: 8 mM MgCl2/33 mM KCl/5 mM glucose-6-phosphate/4 mM NADP. This solution was mixed with the liver 9000 x g supernatant fluid in the following proportion:co-factor solution 9.5 parts/liver preparation 0.5 parts
During the experiment the S9 mix is stored on ice.
- concentration or volume of S9 mix and S9 in the final culture medium :
The protein concentration in the S9 preparation was 40.5 mg/mL (Lot: 3952, expiry date: 26.04.2020) or 39.2 mg/mL (Lot: 4180, expiry date: 12.12.2021), respectively and was adjusted to 30 mg/mL.
- quality controls of S9 (e.g., enzymatic activity, sterility, metabolic capability)
The following quality control determinations were performed by Trinova Biochem GmbH:
a) Alkoxyresorufin-O-dealkylase activities
b) Test for the presence of adventitious agents
c) Promutagen activation (including biological activity in the Salmonella typhimurium assay using 2-aminoanthracene and benzo[a]pyrene) - Test concentrations with justification for top dose:
- Pre-experiment: 3.16, 10.0, 31.6, 100, 316, 1000, 2500 and 5000 μg/plate. Due to strong toxicity, observed in the pre-experiment, 316 μg/plate was selected as the maximum concentration for the main experiment I.
Experiment I: 0.100, 0.316, 1.00, 3.16, 10.0, 31.6, 100 and 316 μg/plate (TA98, TA100)
0.0316, 0.100, 0.316, 1.00, 3.16, 10.0, 31.6 and 100 μg/plate (TA1535, TA1537, E. coli WP2 uvrA (pKM 101))
Experiment II:
0.0158, 0.050, 0.158, 0.50, 1.58, 5.00, 15.8, 50.0 and 100.0 μg/plate (all strains) - Vehicle / solvent:
- - Solvent(s) used: ethanol
- Justification for choice of solvent: The solvent was compatible with the survival of the bacteria and the S9 activity.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Negative - water; Solvent - ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine: S. typhimurium: TA98, TA1537 - S9; 2-aminoanthracene: all strains +S9
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration : triplicate
- Number of independent experiments : 2
METHOD OF TREATMENT/ EXPOSURE:
- Test substance added in agar (plate incorporation): In case of severe toxicity of the test item or the use of e.g. ethanol, acetone or tetrahydrofuran as the most appropriate solvent, the confirmatory experiment is carried out according to the plate incorporation method with a different spacing between dose levels. So both experiments were via the plate incorporation method.
TREATMENT AND HARVEST SCHEDULE:
- Exposure duration/duration of treatment: incubated at 37 °C for at least 48 h in the dark.
METHODS FOR MEASUREMENT OF CYTOTOXICITY
Cytotoxicity can be detected by a clearing or rather diminution of the background lawn or a reduction in the number of revertants down to a mutation factor of approximately ≤ 0.5 in relation to the solvent control.
- Evaluation criteria:
- The Mutation Factor is calculated by dividing the mean value of the revertant counts by the mean values of the solvent control (the exact and not the rounded values are used for calculation).
A test item is considered as mutagenic if:
- a clear and dose-related increase in the number of revertants occurs and/or
- a biologically relevant positive response for at least one of the dose groups occurs
in at least one tester strain with or without metabolic activation.
A biologically relevant increase is described as follows:
- if in tester strains TA98, TA100 and E. coli WP2 uvrA (pKM 101) the number of reversions is at least twice as high
- if in tester strains TA1535 and TA1537 the number of reversions is at least three times higher
as compared to the reversion rate of the solvent control.
According to the OECD guidelines, the biological relevance of the results is the criterion for the interpretation of results, a statistical evaluation of the results is not regarded as necessary.
A test item producing neither a dose related increase in the number of revertants nor a reproducible biologically relevant positive response at any of the dose groups is considered to be non-mutagenic in this system. - Statistics:
- Mean and SD
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- Remarks:
- Experiment 1
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 10μg/plate - S9; 100μg/plate +S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Remarks:
- Experiment 2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 15.8μg/plate - S9; 100μg/plate +S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Remarks:
- Experiment 1
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 10μg/plate - S9; 100μg/plate +S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Remarks:
- Experiment 2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5μg/plate - S9; 50μg/plate +S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Remarks:
- Experiment 1
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 3.16μg/plate - S9; 31.6μg/plate +S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Remarks:
- Experiment 2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5μg/plate - S9; 50μg/plate +S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Remarks:
- Experiment 1
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 0.316μgμg/plate - S9; 100μg/plate +S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Remarks:
- Experiment 2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 0.158μg/plate - S9; 50μg/plate +S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Remarks:
- Experiment 1
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 31.6μg/plate - S9; 100μg/plate +S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Remarks:
- Experiment 2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 15.8μg/plate - S9; 50μg/plate +S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation and time of the determination: No precipitation of the test item was observed in any tester strain used in experiment I and II (with and without metabolic activation).
RANGE-FINDING/SCREENING STUDIES (if applicable):
The toxicity of the test item was determined with tester strains TA98 and TA100 in a pre-experiment. Eight concentrations were tested for toxicity and induction of mutations with three plates each. The experimental conditions in this pre-experiment were the same as described below for the main experiments (plate incorporation test; Table 1). Due to strong toxicity, observed in the pre-experiment, 316 μg/plate was selected as the maximum concentration for the main experiment I. The concentration range covered two logarithmic decades.
STUDY RESULTS
- Concurrent vehicle negative and positive control data: All criteria of validity were met.
For all test methods and criteria for data analysis and interpretation:
- Concentration-response relationship where possible: None
- Statistical analysis; p-value if any: Not applicable
Ames test:
- Signs of toxicity: Toxic effects of the test item were noted in all tester strains used in experiment I and II:
- In experiment I toxic effects of the test item were observed at concentrations of 0.316 μg/plate and higher (without metabolic activation) and at concentrations of 10.0 μg/plate and higher (with metabolic activation), depending on the particular tester strain.
- In experiment II toxic effects of the test item were noted at concentrations of 0.158 μg/plate and higher (without metabolic activation) and at concentrations of 50.0 μg/plate (with metabolic activation), depending on the particular tester strain.
- Individual plate counts & Mean number of revertant colonies per plate and standard deviation: refer to attached results tables.
HISTORICAL CONTROL DATA (with ranges, means and standard deviation, and 95% control limits for the distribution as well as the number of data)
Historical control data (+/-S9) for positive and negative controls were provided. Data from 2017 – 2019 for all tester strains, except for E. coli WP2 uvrA (pKM 101). For this tester strain the period was December 2019 to February 2020 (Appendix 1).
Applicant's summary and conclusion
- Conclusions:
- N4,N4’-hexane-1,6-diylbis[N-butyl-6-chloro-N,N’-bis(2,2,6,6-tetramethylpiperidin-4-yl)-1,3,5-triazine-2,4-diamine] is considered to be non-mutagenic in this bacterial reverse mutation assay.
- Executive summary:
In a reverse gene mutation assay in bacteria (OECD 471/GLP), strains of S. typhimurium TA 98, TA 100, TA1535, TA1537 and E. coli WP2uvrA (pKM 101) were exposed to N4,N4’-hexane-1,6-diylbis[N-butyl-6-chloro-N,N’-bis(2,2,6,6-tetramethylpiperidin-4-yl)-1,3,5-triazine-2,4-diamine] (91%) in ethanol at concentrations of 0.100, 0.316, 1.00, 3.16, 10.0, 31.6, 100 and 316 μg/plate (TA98, TA100; experiment 1), 0.0316, 0.100, 0.316, 1.00, 3.16, 10.0, 31.6 and 100 μg/plate (TA1535, TA1537, E. coli WP2 uvrA (pKM 101); experiment 1) and 0.0158, 0.050, 0.158, 0.50, 1.58, 5.00, 15.8, 50.0 and 100.0 μg/plate (all strains; experiment 2). Both experiments were carried out via the plate incorporation method and metabolic activation was phenobarbital/β-naphthoflavone-induced rat liver S9.
The positive controls of each strain showed a marked increase in the number of revertant colonies compared to that of the corresponding negative control of each strain.
No precipitation of the test item was observed in any tester strain used in experiment I and II (with and without metabolic activation). In experiment I toxic effects of the test item were observed at concentrations of 0.316 μg/plate and higher (without metabolic activation) and at concentrations of 10.0 μg/plate and higher (with metabolic activation), depending on the particular tester strain. In experiment II toxic effects of the test item were noted at concentrations of 0.158 μg/plate and higher (without metabolic activation) and at concentrations of 50.0 μg/plate (with metabolic activation), depending on the particular tester strain.
No biologically relevant increases in revertant colony numbers of any of the five tester strains were observed following treatment with N4,N4’-hexane-1,6-diylbis[N-butyl-6-chloro-N,N’-bis(2,2,6,6-tetramethylpiperidin-4-yl)-1,3,5-triazine-2,4-diamine] at any concentration level, neither in the presence nor absence of metabolic activation in experiment I and II. Therefore, N4,N4’-hexane-1,6-diylbis[N-butyl-6-chloro-N,N’-bis(2,2,6,6-tetramethylpiperidin-4-yl)-1,3,5-triazine-2,4-diamine] is considered to be non-mutagenic in this bacterial reverse mutation assay.
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