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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-298-2 | CAS number: 105-44-2
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989-10-17 to 1989-11-02
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- 1) only four of the five required strains were tested; 2) limited information on the test substance and methodological details were presented.
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4-methylpentan-2-one oxime
- EC Number:
- 203-298-2
- EC Name:
- 4-methylpentan-2-one oxime
- Cas Number:
- 105-44-2
- Molecular formula:
- C6H13NO
- IUPAC Name:
- 4-methylpentan-2-one oxime
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- aSOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Lot # 37905-27-4
- Expiration date of the lot/batch:
- Date received: 1989-06-10
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: no data
- Solubility and stability of the test substance in the solvent/vehicle: no data
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: no data
Method
- Target gene:
- histidine locus
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA98, TA100, TA1535, TA1537 and TA1538
- Details on mammalian cell type (if applicable):
- not applicable
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 homogenate
- Test concentrations with justification for top dose:
- Dose range finding (TA100 with and without S9-mix): 10.0, 33.3, 66.7, 100, 333, 667, 1000, 3330, 6670 and 10000 µg/plate
Maion test (all strains with and without S9-mix): 0, 33.3, 66.7, 100, 333, 667, 1000, 3330, 6670 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The test article formed a solution at 200 mg per ml, which was the most concentrated stock dilution of test article
prepared, and remained a solution at all dose levels tested in the mutagenicity assay, therefore DMSO was chosen as vehicle.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- With S9: 2.5 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- Without S9: 1 µg/plate for TA98
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Without S9: 2 µg/plate for TA100 and TA1535
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: ICR-191
- Remarks:
- Without S9: 2 µg/plate for TA1537
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- Without S9: 1 µg/plate for TA1538
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
The test article was diluted and the S9 mix was prepared immediately before their use in any experimental procedure. When S9 mix was required, 0.5 ml of S9 mix was added to 13 x 100 mm glass culture tubes, pre-heated to 37 + 2°C. To these tubes were added 100 µl of appropriate tester strain and 50.0 µl of vehicle or test article dilution.
When S9 mix was not required, 0.5 ml of 0.1M phosphate buffer was substituted for the S9 mix. After vortexing, the mixture was allowed to incubate for
20 + 2 minutes at 37.2 2°C. Two ml of molten selective top agar was added to each tube and the mixture was vortexed and overlaid onto the surface of 25 ml
of minimal bottom agar contained in a 15x100 mm petri dish. After the overlay had solidified, the plates were inverted and incubated for approximately 48
hours at 37 + 2°C.
DURATION
- Preincubation period: 20 min +- 2
- Exposure duration: 2 days
SELECTION AGENT: histidine
NUMBER OF REPLICATIONS: triplicate
COLONY COUNTING
Revertant colonies for a given tester strain and activation condition were counted either entirely by automated colony counter or entirely by hand. Plates with sufficient test article precipitate to interfere with automated colony counting were counted manually.
DETERMINATION OF CYTOTOXICITY
- Method: detectable as a decrease in the number of revertant colonies per plate and/or a thinning or disappearance of the bacterial background lawn.
The condition of the background bacterial lawn was evaluatedfor evidence of cytotoxicity due to the test article by using a dissecting microscope. The cytotoxicity was scored relative to the vehicle control plate and is noted along with the revertant counts for all plates at that dose level. - Evaluation criteria:
- 1. Tester Strains TA98 and TA100
For a test article to be considered positive, it must cause at least a 2-fold increase in the mean revertants per plate of at least one tester strain over the mean vehicle control value for that tester strain. This increase in the mean number of revertants per plate must be accompanied by a dose response to increasing concentrations of the test article.
2. Tester Strains TA1535. TA1537 and TA1538
For a test article to be considered positive, it must cause at least a 3-fold increase in the mean revertants per plate of at least one tester strain over the mean vehicle control value for that tester strain. This increase in the mean number of revertants per plate must be accompanied by a dose response to increasing concentrations of the test article. - Statistics:
- no data
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA98, TA100, TA1535, TA1537 and TA1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS:
- Evaporation from medium: no data
- Water solubility: no data
- Precipitation: No test substance precipitate was observed on the plates at any of the doses tested in either the presence or absence of S9-mix.
RANGE-FINDING/SCREENING STUDIES:
Dose levels to be tested in the mutagenicity assay were selected based on the results of the dose rangefinding study, Experiment 11068-A1, conducted on the test article using tester strain TA100 in both the presence and absence of S9 (one plate per dose). Ten dose levels of test article, from 10,000 to 10.0 µg were tested.
Cytotoxicity was observed at 3330 µg per plate and above both in the presence and absence of S9 as evidenced by the reduced number of revertants per plate
and the thinning of the bacterial background lawn.
COMPARISON WITH HISTORICAL CONTROL DATA:
The vehicle control plates gave counts of revertant colonies within the normal range. All of the positive control substances induced marked increases in the frequency of revertant colonies, both with and without metabolic activation. Thus, the sensitivity of the assay and the efficacy of the S9 mix were validated.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
The background lawn was moderately to extremely reduced at the highest dose tested in all tester strains
Any other information on results incl. tables
In Experiment 11068-B1, all data were acceptable and no positive increases in the number of histidine revertants per plate were observed with any of the tester strains either in the presence or absence of S9.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:
negative with and without metabolic activation
The test substance was evaluated for mutagenic potential in the Ames test using S. typhimurium strains TA98, TA100, TA1535 , TA1537 and TA1538 in the presence and absence of metabolic activation. The test substance was considered to be non-mutagenic under the conditions of this test.
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.