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EC number: 204-626-7 | CAS number: 123-42-2
- 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 bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4-hydroxy-4-methylpentan-2-one
- EC Number:
- 204-626-7
- EC Name:
- 4-hydroxy-4-methylpentan-2-one
- Cas Number:
- 123-42-2
- Molecular formula:
- C6H12O2
- IUPAC Name:
- 4-hydroxy-4-methylpentan-2-one
- Details on test material:
- - Name of test material (as cited in study report): Diacetone alcohol
- Physical state: Colorless transparent liquid
- Analytical purity: 99.8%
- Storage conditions: Stored in a cool dark location
Constituent 1
Method
- Target gene:
- Histidine opero
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital and 5,6-benzoflavone-induced rat liver microsomes (S9)
- Test concentrations with justification for top dose:
- 0, 313, 625, 1250, 2500, or 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Japanese Pharmacopeia water for injection
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Japanese Pharmacopeia water for injection
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: - See Table 1
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 minutes at 37°C
- Exposure duration: 48 hours at 37°C
NUMBER OF REPLICATIONS: 3 plates for both the solvent and the positive control groups in the dose range finding tests and 1 for each dose. Additionally, during this study, 3 plates were used for each of the control groups and each dose. Independent repeat performed.
METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation; in suspension; as impregnation on paper disk
DETERMINATION OF CYTOTOXICITY
Dose levels: 0, 50, 150, 500, 1500, or 5000 µg/plate (±S9) - Evaluation criteria:
- Of the five types of assay strains, under the conditions with and without the S9 mix in at least one type of assay strain, if the mean values for the number of mutant colonies on a plate containing the test substance were more than double than those of the solvent control when verifying the reproducibility and dose dependence, the test substance was deemed to be mutagenic (positive) for this study. If only one of these two tests confirmed a dose at which the mean number of colonies was double or more that of the solvent control values, and if the solvent control value was 10 or less, dose dependency could not be confirmed by an increase in the number of mutant colonies, it was deemed to be negative.
- Statistics:
- None required (number of revertant colonies counted).
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- 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 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- 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 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- 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
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results : negative
- Executive summary:
DAA was tested a bacterial reverse mutation assay (according to OECD guideline 471) at doses of 0, 313, 625, 1,250, 2,500, or 5,000 µg/plate in Salmonella typhimurium strains TA 98, TA 100, TA 1535, and TA 1537 and Escherichia coli strain WP2 uvr A both in the absence and presence of exogenous metabolic activation (phenobarbital and 5,6-benzoflavone-induced rat liver S9). Incubations at each concentration were done in triplicate and an independent repeat experiment was performed. Water for injection was used as the vehicle and positive controls were included in all incubations. No cytotoxicity and no increase in the reverse mutation rate were observed at any DAA concentration in any of the tester strains either in the absence or presence of metabolic activation. Incubation with positive control substances either in the absence or presence of metabolic activation resulted in anticipated increases in the reverse mutation rate.
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