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EC number: 204-820-1 | CAS number: 127-06-0
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vivo
Description of key information
Link to relevant study records
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to generally vaiid procedures and according to GLP guidelines. All parameters described are closely related or comparable to guidline methods.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.5385 (In Vivo Mammalian Cytogenetics Tests: Bone Marrow Chromosomal Analysis)
- GLP compliance:
- yes
- Type of assay:
- chromosome aberration assay
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Sprague-Dawley, Inc., Frederick, MD
- Age at study initiation: 6-8 weeks
- Weight at study initiation: Males, 175-200 g; Females, 138-161 g
- Assigned to test groups randomly: yes
- Housing: Housed one per cage during study in plastic autoclavable cage
- Diet (e.g. ad libitum): Certified laboratory rodent chow, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.2-27.7
- Humidity (%): 50 +/- 20% relative humidity
- Photoperiod (hrs dark / hrs light): 12/12
- Route of administration:
- oral: gavage
- Vehicle:
- Distilled water
- Amount of vehicle (if gavage or dermal): dose volumes were 0.326, 0.652 and 1.304 mL/kg bw. - Duration of treatment / exposure:
- Single oral dose by gavage
- Frequency of treatment:
- Once
- Post exposure period:
- 6, 24 and 48 hours
- Remarks:
- Doses / Concentrations:
300, 600 and 1200 mg/kg bw
Basis:
nominal in water - No. of animals per sex per dose:
- 5/dose
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- A single oral dose of cyclophoshamide at 25 mg/kg body weight; a dose volume of 1.2 mL/kg body weight was used.
- Tissues and cell types examined:
- Bone marrow cells, arrested in metaphase and collected at 6, 24 and 48 hours after administration were examined microscopically for structural chromosome aberrations.
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- No statistically significant increases in percentage of aberrant cells were observed in the test article treated groups, regardless of treatment or bone marrow collection time.
Clinical signs of toxicity were noted within 4 hours of dosing at each dose level tested. - Conclusions:
- Interpretation of results (migrated information): negative
Methyl ethyl ketoxime did not induce chromosomal aberrations in bone marrow cells of male or female rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
The substance was negative ie non mutagenic in two reliable and one unreliable in vitro bacterial gene mutation assays. It was also negative in a reliable in vitro gene mutation assay, though no metabolic activation was used. It was also negative in four reliable in vitro unscheduled DNA repair assays conducted in V79 cells, hepatocytes and seminal vesicle cells. There is a positive result from an in vivo SMART assay however this study is considered unreliable. There are also two unreliable, non-standard studies which examined effects on nucleoside modification.
These results are broadly consistent with those found for the read-across candidate butanone oxime (CAS 96-29-7), which gave negative results in two reliable in vitro bacterial gene mutation assays and a reliable in vitro unscheduled DNA repair assay in hepatocytes. It gave a positive result in an in vitro mammalian gene mutation assay however this was in the presence of high levels of cytotoxicity. Butanone oxime also gave negative results in a reliable in vivo cytogenetics assay.
Overall, in genotoxicity studies for a variety of endpoints, both acetone oxime and butanone oxime gave a similar negative pattern of results.
Justification for selection of genetic toxicity endpoint
This is the only reliable in vivo study.
Justification for classification or non-classification
The substance gives negative results in a number of in vitro gentoxicity assays. This is also supported by a negative result from a reliable in vivo study on a read-across substance. Therefore there is no requirement for classification.
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.
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