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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 233-546-5 | CAS number: 10226-30-9
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- publication
- Title:
- Commercial-Grade Methyl Heptyl Ketone (5-Methyl-2-octanone) Neurotoxicity: Contribution-of 5Nonanone’
- Author:
- JOHN L. ‘DONOGHUE,* WALTER J. KRASAVAGE, GEORGE D. DIVINCENZO, AND DONALD A. ZIEGLER
- Year:
- 1 982
- Bibliographic source:
- TOXlCOLOGY AND APPLIED PHARMACOLOGY 62,307-316 (1982)
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Principles of method if other than guideline:
- To evaluate the acute toxicity of Methyl heptyl ketone in COBS, CD (SD) BR male rats.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Nonan-2-one
- EC Number:
- 212-480-0
- EC Name:
- Nonan-2-one
- Cas Number:
- 821-55-6
- IUPAC Name:
- nonan-2-one
- Reference substance name:
- Methyl heptyl ketone
- IUPAC Name:
- Methyl heptyl ketone
- Test material form:
- other: colorless to pale yellow clear oily liquid
- Details on test material:
- - Name of test material (as cited in study report): Methyl heptyl ketone
- Molecular formula (if other than submission substance): C9H18O
- Molecular weight (if other than submission substance): 142.24g/mol
- Substance type: Organic
- Physical state: colorless to pale yellow clear oily liquid (est)
- Impurities (identity and concentrations): 27.7 %
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: COBS, CD(SD)BR
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Lab; Wilmington, Mass
- Age at study initiation: No data available.
- Weight at study initiation: No data available.
- Fasting period before study: No data available.
- Housing: They were singly housed in solid
floor cages covered by Ab-Sorb-Dri bedding to reduce the likelihood of wire mesh-induced pressure neuropathy.
- Diet (e.g. ad libitum): Purina Rodent Laboratory Chow 5001 was available ad libitum.
- Water (e.g. ad libitum): Water was available ad libitum.
- Acclimation period: No data available.
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):
IN-LIFE DATES: From: To: No data available.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 3 Weeks
- Frequency of treatment:
- 5 days per week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 1000, 2000 and 4000 mg/kg
Basis:
- No. of animals per sex per dose:
- Total animals -18 male rats
0mg/kg 9 male rats
1000mg/kg 3 male rats
2000 mg/kg 3 male rats
4000 mg/kg 3 male rats - Control animals:
- yes, concurrent vehicle
- Details on study design:
- It was a range finding study.
- Positive control:
- No data available.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data available.
DETAILED CLINICAL OBSERVATIONS: Yes - Time schedule: Twice daily
BODY WEIGHT: Yes
- Time schedule for examinations: 0, 3,7,14 and 21day of treatment.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes ,
Time schedule: 0, 3,7,14 and 21day of treatment.
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data available.
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data available.
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water studies): No data available.
OPHTHALMOSCOPIC EXAMINATION: No data available.
HAEMATOLOGY: Yes , the rats were anesthetized with carbon dioxide, bled for hematologic determinations
- Parameters checked in table [No.?] were examined.- Blood samples were analyzed for hemoglobin concentration, haematocrits, and total and relative white blood cell counts by standard methods.
CLINICAL CHEMISTRY: Yes, the rats were anesthetized with carbon dioxide, bled for clinical chemistry determinations.
- Parameters checked in table [No.?] were examined.- Serum clinical chemistries
including glutamic-oxaloacetic transaminase (SGOT), glutamic-pyruvic transaminase (SGPT), alkaline
phosphatase (AP), and lactic dehydrogenase (LDH) were determined with a Beckman Enzyme Activity
Analyzer System TR (Beckman Instruments, Inc., Fullerton, Calif.). Urea nitrogen and glucose were determined by a Technicon Auto analyzer.
URINALYSIS: No data available.
NEUROBEHAVIOURAL EXAMINATION: No data available.
OTHER: Liver and kidney weights were recorded prior to fixation. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes , the rats were anesthetized with carbon dioxide, bled for hematologic and clinical chemistry
determinations, and necropsied, HISTOPATHOLOGY: Yes , The following tissues were fixed in 10% buffered formalin
(pH 7.0), embedded in paraffin, sectioned at 5 pm, stained with hematoxylin-eosin, and examined by light microscopy: trachea, lungs, thymus, heart, tongue, salivary glands, esophagus, stomach, small intestine, large intestine, kidneys, urinary bladder, adrenal glands, pituitary, thyroids, parathyroids, pancreas, testes, epididymides, accessory sex glands, spleen, mesenteric lymph nodes, bone marrow, medulla oblongata, pons, cerebellum, cerebral cortex, thalamus, and basal ganglia. Eyes were fixed in a modified Zenker’s (Russell’s) fixative and handled similarly. - Statistics:
- Statistical analyses included Bartlett’s test, one-way analysis of variance (ANOVA), and Duncan’s multiple range test as a significance level of 5%.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Details on results:
- Mortality –Mortality was observed at 4000 mg/kg/day.
At 1000 and 2000mg/kg/day no mortality was observed.
Clinical signs- At 4000 mg/kg/day depression and consequent failure to maintain normal pulmonary ventilation and perfusion was obsrved.
Rats receiving 1000 and 2000 mg/kg/day showed no adverse clinical signs .
Body weight and weight gain Body weight gain over 20 days was 42% for control animals, 34% for the 2000 mg/ kg /day group, and 28% for the 1000 mg/kg/day group. The 4000 mg/kg group lost 18% of their body weight over 3 days.
Food consumption and compound intake: No significant change was observed in 1000 and 2000 mg/kg/day treated group compare to control group.
Food efficiency: No data available.
Water consumption and compound intake: No data available.
Opthalmoscopic examination No data available.
Haematology No significant change was observed in 1000 and 2000 mg/kg/day treated group compare to control group.
Clinical chemistry: No significant change was observed in 1000 and 2000 mg/kg/day treated group compare to control group.
Urinanalysis: No data available.
Neurobehaviour: No data available.
Organ weights Both absolute and relative liver and relative kidney weights were statistically higher than control values for test 1000 and 2000 mg/kg/day groups. Mean absolute kidney weights were also increased, but the difference was not statistically significant.
Gross pathology: No data available.
Histopathology: At 4000 mg/kg/day compound-related pathological findings included vascular congestion and/or hemorrhage in major organ systems. The most striking change was observed in the livers of all three rats. Moderate hepatocyte hypertrophy with minimal focal hepatic necrosis was observed in two rats. One rat showed severe hypertrophy. Enlarged hepatocyte impinged on sinusoidal spaces reducing their volume.
At 2000 mg/kg/day hepatocyte hypertrophy was absent in one rat, minor in a second, and moderate in the third.
No significant change was observed in 1000 mg/kg/day treated group compare to control group.
Details on results: No data available.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: No significant changes were observed in clinical sign, mortality, gross pathology and histopathology.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was found to be1000mg/kg for Methyl heptyl ketone in Charles River CD, COBS male rats for 3weeks study.
- Executive summary:
In repeated dose toxicity study for Methyl heptyl ketone by oral (gavage) at dose concentration of 1000, 2000 and 4000 mg/kg in Charles River CD, COBS male rats for 3weeks.As test compounds produced clinical evidence of depression and prostration; particularly depression and prostration was followed by death at the high dose of 4000 mg/kg. Significant gross or histopathological compound related changes were found at 2000 and 4000 mg/kg dose level. No significant gross or histopathological compound related changes were found at 1000 mg/kg dose level. Therefore NOAEL was found to be 1000 mg/kg for Methyl heptyl ketone by oral (gavage) for subacute study.
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.