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EC number: 258-132-1 | CAS number: 52722-86-8
- 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:
- August 18, 1992 - September 10, 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented study report which meets basic scientific principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4-hydroxy-2,2,6,6-tetramethylpiperidine-1-ethanol
- EC Number:
- 258-132-1
- EC Name:
- 4-hydroxy-2,2,6,6-tetramethylpiperidine-1-ethanol
- Cas Number:
- 52722-86-8
- Molecular formula:
- C11H23NO2
- IUPAC Name:
- 1-(2-hydroxyethyl)-2,2,6,6-tetramethylpiperidin-4-ol
- Details on test material:
- - Physical state: solid; white
- Storage condition of test material: room temperature
Constituent 1
Method
- Target gene:
- his, trp
Species / strain
- Species / strain / cell type:
- other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S9-mix
- Test concentrations with justification for top dose:
- Range in the cytotoxicity test: 20.6 - 5000 µg/plate
Range in the mutagenicity test: 185.2 - 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: see below
- Remarks:
- with and without metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 hours
- Expression time (cells in growth medium): 48 hours
NUMBER OF REPLICATIONS: two plates per test substance concentration
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth
POSITIVE CONTROLS
WITHOUT S9:
TA 100, TA 1535: sodium azide in bidist.water, 5.0 µg/plate
WP2 uvrA: 4-nitroquinoline-N-oxide in DMSO, 2.0 µg/plate
TA 98: 2-nitrofluorene in DMSO, 20.0 µg/plate
TA 1537: 9(5)-aminoacridine in DMSO, 150.0 µg/plate
WITH S9
TA 100, TA 98, TA 1537: 2-aminoanthracene in DMSO, 2.5 µg/plate
TA 1535: cyclophosphamide in bidist.water, 400.0 µg/plate
WP2 uvrA: 2-aminoanthracene in DMSO, 50.0 µg/plate - Evaluation criteria:
- The test substance is considered to be mutagenic in this test system if:
- A positive effect is observed in one strain and the effect can be reproduced in a confirmatory experiment.
- A positive effect is observed in two or more strains.
A positive effect is defined as an increase of the mean number of revertants per plate for any concentration above that of the negative control by at least a factor of 2.0 with strains TA 98, TA 1535, TA 1537 and WP2 uvrA, or by a factor of at least 1.5 with strain TA 100. Generally a concentration-related effect should be demonstrable. If equivocal results are obtained, the final decision has to be based on scientific judgement.
Results and discussion
Test results
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
Six concentrations ranging from 20.6 to 5000 µg/plate were tested with strains S. typhimurium TA 100 and E.coli WP2 uvrA to determine the highest concentration to be used in the mutagenicity assay. The experiments were performed with and without metabolic activation. Normal background growth was observed with both strains. The numbers of revertant colonies were not reduced. From the results obtained, the highest concentration suitable for the mutagenicity test was selected to be 5000 µg/plate without and with metabolic activation.
COMPARISON WITH HISTORICAL CONTROL DATA:
Negative Controls were within the historical control range and positive controls produced the expected reactions.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
In the mutagenicity test normal background growth was observed with all strains at all concentrations. The numbers of revertant colonies were not reduced. The test substance exerted no toxic effect on the growth of the bacteria. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Experiment with metabolic activation:
Treatment/Strain | TA100 | TA1535 | WP2 uvrA | TA98 | TA1537 |
Negative control | 100.0 | 10.0 | 15.5 | 41.5 | 7.0 |
185.2 µg/plate | 117.5 | 17.0 | 20.5 | 40.5 | 7.0 |
555.6 µg/plate | 115.0 | 9.5 | 15.5 | 41.5 | 5.5 |
1666.7 µg/plate | 118.0 | 11.0 | 14.0 | 37.0 | 4.5 |
5000.0 µg/plate | 89.0 | 12.0 | 16.5 | 44.0 | 7.0 |
2-aminoanthracene | 841.5 | 573.5 | 1086.0 | 139.5 | |
cyclophosphamide | 431.5 |
Experiment without metabolic activation:
Treatment/Strain | TA100 | TA1535 | WP2 uvrA | TA98 | TA1537 |
Negative control | 85.5 | 13.0 | 14.0 | 17.0 | 6.0 |
185.2 µg/plate | 72.0 | 16.0 | 17.0 | 18.0 | 5.0 |
555.6 µg/plate | 84.0 | 12.0 | 17.5 | 19.5 | 3.5 |
1666.7 µg/plate | 84.0 | 16.5 | 14.5 | 12.5 | 3.5 |
5000.0 µg/plate | 67.5 | 17.5 | 13.5 | 12.5 | 4.5 |
sodium azide | 1066.0 | 790.0 | |||
4-NQO | 789.0 | ||||
2-nitrofluorene | 1230.5 | ||||
9-aminoacridine | 1549.5 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Based on the results of these experiments and on standard evaluation criteria, it is concluded that the test item and its metabolites did not induce gene mutations in the strains of S. typhimurium and E. coli used.
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