Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 204-514-8 | CAS number: 122-00-9
- 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 cytogenicity / micronucleus study
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 2012-08-16 to 2013-04-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted under GLP and according to OECD TG 473
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:
- other: OECD 487 "In vitro Mammalian Cell Micronucleus Test"
- Deviations:
- yes
- Remarks:
- The expression phase and harvest time were slightly modified compared to the OECD TG 487
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian cell micronucleus test
Test material
- Reference substance name:
- 4-methylacetophenone
- IUPAC Name:
- 4-methylacetophenone
- Reference substance name:
- 4'-methylacetophenone
- EC Number:
- 204-514-8
- EC Name:
- 4'-methylacetophenone
- Cas Number:
- 122-00-9
- Molecular formula:
- C9H10O
- IUPAC Name:
- 1-(4-methylphenyl)ethanone
- Test material form:
- other: clear liquid, colourless to yellowish
- Details on test material:
- - Name of test material (as cited in study report): Methyl Acetophenone - Para
- Physical state: clear liquid, colourless to yellowish
- Storage condition of test material: at room temperature
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- lymphocytes: human
- Details on mammalian cell type (if applicable):
- - Type and identity of media: DMEM:F12 (Dulbecco's modified eagle medium/Ham's F12 medium, mixture 1:1) supplemented with 200 mM GlutaMax
- Properly maintained: yes - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Mammalian Microsomal Fraction S9 mix
- Test concentrations with justification for top dose:
- Experiment I:
40 h / 4 h: 9.1-1400.0 (±S9 mix)
Experiment IIA:
40 h / 20 h: 9.1-1400.0 (-S9 mix)
40 h / 4 h: 85.3-1400.0 (+S9 mix)
Experiment IIB:
40 h / 20 h: 100.0-1000.0 (-S9 mix) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO; final concentration of DMSO in the culture medium was 0.5 % (v/v)
- Justification for choice of solvent/vehicle: the solvent was chosen due to its solubility properties and its relative non-toxicity to the cell cultures
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- without metabolic activation
- Positive control substance:
- mitomycin C
- other: demecolcin
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- with metabolic activation
- Positive control substance:
- cyclophosphamide
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: 48 h
- Exposure duration: 4 h with and without S9 mix (experiment I), 4 h with and 20 h without S9 mix (experiment IIA) and 20 h without S9 mix (experiment IIB)
- Expression time (cells in growth medium): cells exposed for 4 h have 16 h recovery period before fixation, no recovery period for 20 h exposure cells
- Selection time (if incubation with a selection agent): 20 h with Cytochalasin B (4 µg/mL)
- Cells were prepared 40 hrs after start of the exposure
SELECTION AGENT (mutation assays): Cytochalasin B (4 µg/mL)
STAIN (for cytogenetic assays): Giemsa
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED:
cytotoxic effect the CBPI: ca 500 cells per culture and cytotoxicity is expressed as % cytostasis
micronuclei effects: at least 1000 binucleate cells per culture. The frequency of micronucleated cells was reported as % micronucleated cells
DETERMINATION OF CYTOTOXICITY
- percentages of reduction in the CBPI (cytokinesis-block proliferating index) in comparison with the controls (% cytostasis) by counting 500 cells per culture in duplicate - Evaluation criteria:
- cytotoxic effect: percentages of reduction in the CBPI (cytokinesis-block proliferating index) in comparison with the controls (% cytostasis)
micronuclei effects: 1000 binucleate cells per culture. The frequency of micronucleated cells was reported as % micronucleated cells
criteria for the evaluation of micronuclei:
The micronuclei were counted in cells showing a clearly visible cytoplasm area. The micronuclei have to be stained in the same way as the main nucleus. The area of the micronucleus should not extend the third part of the area of the main nucleus. At least 1000 binucleate cells per culture were scored for cytogenetic damage on coded slides. The frequency of micronucleated cells was reported as % micronucleated cells. To describe a cytotoxic effect the CBPI was determined in approximately 500 cells per culture and cytotoxicity is expressed as % cytostasis. A CBPI of 1 (all cells are mononucleate) is equivalent to 100 % cytostasis.
A test item can be classified as non-mutagenic if:
- the number of micronucleated cells in all evaluated dose groups is in the range of the laboratory historical control data and/or
- no statistically significant or concentration-related increase in the number of micronucleated cells is observed.
A test item can be classified as mutagenic if:
- the number of micronucleated cells is not in the range of the historical laboratory control data and
- either a concentration-related increase of micronucleated cells in three test groups or a statistically significant increase of the number of micronucleated cells is observed. - Statistics:
- Statistical significance was confirmed by means of the Chi square test.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- lymphocytes: human
- 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
- Species / strain:
- lymphocytes: human
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- lymphocytes: human
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Remarks:
- at and above 800.0 µg/mL
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- lymphocytes: human
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 1000.0 µg/mL
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no effects
- Effects of osmolality: no effects
- Evaporation from medium: no data
- Water solubility: no data
- Precipitation: precipitation of the test item in the culture medium was observed microscopically in Experiment IIA in the absence of S9 mix at 1400.0 µg/mL.
RANGE-FINDING/SCREENING STUDIES: yes
COMPARISON WITH HISTORICAL CONTROL DATA: yes - Remarks on result:
- other: other: Experiment I
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the experimental conditions, the test item Methyl Acetophenone - Para did not induce micronuclei in human lymphocytes in vitro, when tested up to cytotoxic, the highest evaluable or required concentrations. - Executive summary:
The test item Methyl Acetophenone - Para, dissolved in DMSO, was assessed for its potential to induce micronuclei in human lymphocytes in vitro in three independent experiments. The following study design was performed:
Without S9-Mix
With S9-Mix
Exp. I
Exp. IIA & IIB
Exp. I and IIA
Exposure period
4 hrs
20 hrs
4 hrs
Recovery
16 hrs
-
16 hrs
Cytochalasin B exposure
20 hrs
20 hrs
20 hrs
Preparation interval
40 hrs
40 hrs
40 hrs
Total culture period
88 hrs
88 hrs
88 hrs
In each experimental group two parallel cultures were analysed. 1000 binucleate cells per culture were evaluated for cytogenetic damage. The highest applied concentration in the pre-test on toxicity (1400.0 µg/mL of the test item, approx. 10 mM) was chosen with regard to the molecular weight and the purity (96.8 %) of the test item and with respect to the current OECD Guideline 487.
Dose selection of the cytogenetic experiment was performed considering the toxicity data in accordance with OECD Guideline 487. The chosen treatment concentrations were 9.1-1400.0 µg/mL (±S9 mix) for Experiment I, and (-S9 mix) for Experiment IIA, 85.3 -1400.0 µg/mL (+S9 mix) for Experiment IIA and 100.0-1000.0 µg/mL (-S9 mix) for Experiment IIB.
In Experiment I in the absence and presence of S9 mix and in Experiment IIA in the presence of S9 mix no clear cytotoxicity was observed up to the highest applied concentration. In Experiment IIA in the absence of S9 mix concentrations showing clear cytotoxicity were not evaluable for cytogenetic damage and therefore had to be repeated in an independent experiment (Experiment IIB). In Experiment IIB in the absence of S9 mix cytotoxicity was observed at the highest evaluated concentration.
In the absence and presence of S9 mix, no increase in the number of micronucleated cells was observed after treatment with the test item. However, one statistically significant increase was observed in Experiment IIA in the presence of S9 mix after treatment with 1400.0 µg/mL (0.75 % micronucleated cells) which was clearly within the range of the historical control data (0.0 – 1.70 %) and therefore not biologically relevant.
Appropriate mutagens were used as positive controls. They induced statistically significant increases in cells with micronuclei. It can be stated that under the experimental conditions reported, the test item did not induce micronuclei as determined by the in vitro micronucleus test in human lymphocytes. Therefore, Methyl Acetophenone - Para is considered to be non-clastogenic and non-aneugenic in this in vitro micronucleus test, when tested up to cytotoxic, the highest evaluable or required concentrations.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.