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EC number: 203-837-1 | CAS number: 111-13-7
- 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: dermal
Administrative data
- Endpoint:
- chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviewed publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Neurophysiological Studies on Rats
- Author:
- J. Misumi
- Year:
- 1 984
- Bibliographic source:
- British Journal of Industrial Medicine
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- The repeated dose dermal toxicity test was conducted on Donryu rats exposed for 21 weeks subcutaneously with dose concentration of 400 mg/kg/day of test substance.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Octan-2-one
- EC Number:
- 203-837-1
- EC Name:
- Octan-2-one
- Cas Number:
- 111-13-7
- Molecular formula:
- C8H16O
- IUPAC Name:
- octan-2-one
- Details on test material:
- - Name of test material: 2-octanone
- IUPAC name: octan-2-one
- Molecular formula: C8H16O
- Molecular weight: 128.2134 g/mol
- Substance type: Organic
- Physical state: Liquid
- Impurities (identity and concentrations): No data available
- Purity: > 97% v/v
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Donryu
- Details on species / strain selection:
- No data
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data available
- Age at study initiation: No data available
- Weight at study initiation: 200-300 gm
- Fasting period before study: No data available
- Housing: No data available
- Diet (e.g. ad libitum): Standard pellet diet (Nihon Nosan, MR-3-A) ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: : No data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): : No data available
- Humidity (%):: No data available
- Air changes (per hr): : No data available
- Photoperiod (hrs dark / hrs light): : No data available
Administration / exposure
- Type of coverage:
- other: Subcutaneous injections
- Vehicle:
- not specified
- Details on exposure:
- No data available
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- 21 weeks
- Frequency of treatment:
- 5 days per week for 21 weeks
Doses / concentrations
- Remarks:
- 0 or 400 mg/kg/day
- No. of animals per sex per dose:
- Total: 37
0 mg/Kg/day: 30
400 mg/Kg/day: 7 male rats - Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data available
- Positive control:
- No data available
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Every third day
- Cage side observations checked in table [No.?] were included. No data
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Every third day
DERMAL IRRITATION (if dermal study): No data
- Time schedule for examinations: No data
BODY WEIGHT: Yes
- Time schedule for examinations: Every third day
FOOD CONSUMPTION: Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
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
WATER CONSUMPTION: No data
- Time schedule for examinations: No data
OPHTHALMOSCOPIC EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
HAEMATOLOGY: No data
- Time schedule for collection of blood: No data
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. No data
CLINICAL CHEMISTRY: No data
- Time schedule for collection of blood: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. No data
URINALYSIS: No data
- Time schedule for collection of urine: No data
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters checked in table [No.?] were examined. No data
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: No data
- Dose groups that were examined: 400 mg/kg
- Battery of functions tested: sensory activity / grip strength / motor activity / other: Neurological signs and maximum conductioin velocities of motor and sensory fibres (MCV and SCV)
OTHER: The skin temperature of the tail inguinal regions was measured at the beginning of each measurement - Sacrifice and pathology:
- No data
- Other examinations:
- No data available
- Statistics:
- Statistical significance of difference between mean values for the treated and control group was tested by student’s t test
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Dermal irritation:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Details on results:
- Clinical signs and mortality :
Clinical signs: No appreciable clinical evidence in parameters like effect on growth, Dullness in movement, Difficulty in walking, paralysis in hind limbs were noted. No salivation was observed in test group.
Mortality: No data available
Dermal Irritation: No data available
Body weight and weight gain: No data available
Food consumption and compound intake: No data available
Food efficiency: No data available
Water consumption and compound intake: No data available
Opthalmoscopic examination: No data available
Haematology: No data available
Clinical chemistry: No data available
Urinanalysis No data available
Neurobehaviour: No effect of chemical on nerve conduction velocity and motor distal latency was observed as compared to control
Organ weights: No data available
Gross pathology: No data available
Histopathology: No data available
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 400 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: No signs of clinical or neurophysiological evidence of neuropathy was noted
- Remarks on result:
- other: No toxic effects were observed
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table: Neurobehavioral changes noted
|
Motor conduction velocity |
Sensory conduction velocity |
Distal latency |
|||
|
|
Whole |
proximal |
Distal |
|
|
Control |
100 |
100 |
100 |
100 |
100 |
|
2-octanone |
100 |
102 |
101 |
103 |
92 |
Applicant's summary and conclusion
- Conclusions:
- The No observed adverse effect level (NOAEL) is 400 mg/kg in chronic dermal toxicity study when rats were exposed to test substance for 21 weeks.
- Executive summary:
Repeated dose chronic toxicity study was performed to determine the dermal toxic nature of test substance . The test substance in, 200 -300 g weighing male Donryu rats were injected subcutaneously with 0 or 400 mg/Kg/day 2 -octanone 5 days/weeks for 21 weeks. The treated animals were observed for clinical signs, body weight and food intake changes and neurological signs and maximum conduction velocities of motor and sensory fibres (MCV and SCV). Treated animals failed to show any appreciable changes in clinical signs like effect on growth, dullness in movement, difficulty in walking, paralysis in hind limbs. No salivation was observed in test group, and neurophysiological evidence of neuropathy was not observed. Hence, the No observed adverse effect level (NOAEL) is 400 mg/kg in chronic dermal toxicity study when rat were exposed to test substance for 21 weeks.
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