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EC number: 251-974-0 | CAS number: 34375-28-5
- 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 DNA damage and/or repair study
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from USEPA HPVreport
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Genetic Toxicity in vitro study for Ethanol, 2-(hydroxymethylamino) _ (CAS# 34375-28-5)
- Author:
- US EPA HPV Chemical Challenge Program- Troy Corporation
- Year:
- 2 005
- Bibliographic source:
- U.S Environmental Protection Agency/ High Production Volume Information System (HPVIS) 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EPA Guideline 84-2(b)
- Principles of method if other than guideline:
- Genetic toxicity study in vitro was conducted to assess the ability of the Ethanol, 2-(hydroxymethylamino) to induce unscheduled DNA synthesis in primary cultures of adult rat hepatocytes.
- GLP compliance:
- no
- Type of assay:
- other: unscheduled DNA Synthesis
Test material
- Reference substance name:
- 2-(hydroxymethylamino)ethanol
- EC Number:
- 251-974-0
- EC Name:
- 2-(hydroxymethylamino)ethanol
- Cas Number:
- 34375-28-5
- Molecular formula:
- C3H9NO2
- IUPAC Name:
- 2-[hydroxy(methyl)amino]ethanol
- Details on test material:
- Details on test material
- Name of test material (as cited in study report): Ethanol, 2-(hydroxymethylamino)
- Molecular formula (if other than submission substance): C3-H9-N-O2
- Molecular weight (if other than submission substance): 91.1091 g/mole
- Substance type: Organic
- Physical state: Liquid
Purity: 100 % (estimated by calculation)
- Impurities (identity and concentrations): No data available
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: Troysan 174, (2[(Hydroxymethyl)amino] ethanol)
- IUPAC name: 2-[hydroxy(methyl)amino]ethanol
- Molecular formula: C3H9NO2
- Molecular weight: 91.1091 g/mol
- Substance type: Organic
- Physical state: No data
- Purity: 100 %
- Impurities (identity and concentrations): No data
Method
- Target gene:
- No data
Species / strain
- Species / strain / cell type:
- hepatocytes: Rat/ Fischer 344/ adult hepatocytes -
- Details on mammalian cell type (if applicable):
- No data
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- No data
- Metabolic activation:
- not specified
- Metabolic activation system:
- No data
- Test concentrations with justification for top dose:
- 0.78125, 1.5625, 3.125, 6.25, 12.5, 25.0, 50.0 and 100.0 ug/ml
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The chemical was soluble in DMSO
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- other: Michler's ketone (direct acting) at 2.0 and 8.0 ug/ml
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
- Cell density at seeding (if applicable): No data
DURATION
- Preincubation period: No data
- Exposure duration: No data
- Expression time (cells in growth medium): No data
- Selection time (if incubation with a selection agent): No data
- Fixation time (start of exposure up to fixation or harvest of cells): No data
SELECTION AGENT (mutation assays): No data
SPINDLE INHIBITOR (cytogenetic assays): No data
STAIN (for cytogenetic assays): No data
NUMBER OF REPLICATIONS: Duplicate
METHODS OF SLIDE PREPARATION AND STAINING TECHNIQUE USED:
NUMBER OF CELLS EVALUATED: No data
NUMBER OF METAPHASE SPREADS ANALYSED PER DOSE (if in vitro cytogenicity study in mammalian cells): No data
CRITERIA FOR MICRONUCLEUS IDENTIFICATION: No data
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data
- Any supplementary information relevant to cytotoxicity: No data
OTHER EXAMINATIONS:
- Determination of polyploidy: No data
- Determination of endoreplication: No data
- Methods, such as kinetochore antibody binding, to characterize whether micronuclei contain whole or fragmented chromosomes (if applicable): No data
- OTHER: This study was conducted to assess the ability of the test compound to induce
unscheduled DNA synthesis in primary cultures of adult rat hepatocytes, as measured by silver grain counts in photographic emulsion formed by radiation from [6 3H]-thymidine taken up by the cells. The cells were examined microscopically at approximately 1000x magnification under oil immersion using a Leitz Dialux 20L microscope. - Rationale for test conditions:
- No data
- Evaluation criteria:
- Unscheduled DNA Synthesis was measured by counting nuclear grains and subtracting the average number of cytoplasmic grains in 3 nuclear sized areas
adjacent to each nucleus (background count). This value was referred to as the net nuclear grain count. The cell cultures were scored, and the results assessed according to the criteria of Butterworth et al, in conjunction with historical data generated in-house - Statistics:
- No data available
Results and discussion
Test results
- Species / strain:
- hepatocytes: Rat/ Fischer 344/ adult hepatocytes -
- Metabolic activation:
- not specified
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 50 – 100 ug/ml
- Vehicle controls validity:
- valid
- Remarks:
- Vehicle controls were considered valid, having met the requirements as specified by the acceptance criteria
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Remarks:
- Both direct and indirect acting positive controls demonstrated the sensitivity of the assays.
- Additional information on results:
- No data
Applicant's summary and conclusion
- Conclusions:
- Unscheduled DNA Synthesis was not demonstrated by 2-[(Hydroxymethyl) amino] ethanol when tested in dimethylsulphoxide at concentrations extending into the toxic range. Therefore, the substance 2-[(Hydroxymethyl) amino] ethanol is non genotoxic to adult rat hepatocytes.
- Executive summary:
Genetic toxicity study in vitro was conducted to assess the ability of the Ethanol, 2-(hydroxymethylamino) to induce unscheduled DNA synthesis in primary cultures of adult rat hepatocytes. Cultures were established with cells derived from the collagenase-perfused liver of a young adult male Fischer 344 rat. The culture was exposed to Ethanol, 2-(hydroxymethylamino) at concentrations of 0.78125, 1.5625, 3.125, 6.25, 12.5, 25.0, 50.0 and 100.0 ug/ml in 2 independent experiments. Positive control was used Michler's ketone (direct acting) and 2-Acetylamino fluorine (2-AAF) (indirect acting). The cells were examined microscopically at approximately 1000x magnification under oil immersion using a Leitz Dialux 20L microscope. Unscheduled DNA Synthesis was measured by counting nuclear grains and subtracting the average number of cytoplasmic grains in 3 nuclear sized areas adjacent to each nucleus (background count). This value was referred to as the net nuclear grain count. In the first assay, there were no evidence of of unscheduled DNA synthesis up to 25 μg/ml. In the second assay, results were obtained up to 25 µg /ml with no evidence of unscheduled DNA synthesis at concentrations of 12.5 µg /ml and lower. Cell toxicity was observed at concentrations of 50 and 100 µg /ml. At the concentration of 25.5 µg/ml there was, however, a slight increase in the mean net grains per nucleus, accompanied by an increase in the percentage of cells adjudged to be in repair. The increase obtained did not meet the criteria required for a positive response, was not similarly observed in the first experiment and was not associated with a dose-related trend at lower concentrations. Unscheduled DNA Synthesis was not demonstrated by 2-[(Hydroxymethyl) amino] ethanol when tested in dimethylsulphoxide at concentrations extending into the toxic range. Therefore, the substance 2-[(Hydroxymethyl) amino] ethanol is non genotoxic to adult rat hepatocytes.
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