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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: dermal
Administrative data
- Endpoint:
- chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: data from publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Neurophysiological Studies on the Relation between the Structural Properties and Neurotoxicity of Aliphatic Hydrocarbon Compounds in Rats
- Author:
- J. Misumi and M. Nagano
- Year:
- 1 984
- Bibliographic source:
- British Journal of Industrial Medicine Vol. 41, No. 4 (Nov., 1984), pp. 526-532
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as per mentioned below
- Principles of method if other than guideline:
- The repeated dose toxicity test was conducted on Donryu rats exposed for 21 weeks subcutaneously with dose concentration of 400 mg/kg/day
- GLP compliance:
- no
Test material
- Reference substance name:
- 111-13-6
- IUPAC Name:
- 111-13-6
- Reference substance name:
- Octan-2-one
- EC Number:
- 203-837-1
- EC Name:
- Octan-2-one
- Cas Number:
- 111-13-7
- IUPAC Name:
- octan-2-one
- Details on test material:
- - Name of test material: Octan-2-one
- Molecular formula: C8H16O
- Molecular weight: 128.21 g/mol
- Substance type: Organic
- Physical state: Liquid
- Impurities (identity and concentrations): 97% v/v
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: Donryu
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- Details on test animal
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 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
- Duration of treatment / exposure:
- 21 weeks
- Frequency of treatment:
- Daily dose ,5 days per week for 21 weeks
Doses / concentrations
- Remarks:
- Doses / Concentrations:
400 mg/kg
Basis:
no data
- No. of animals per sex per dose:
- 7 rats
- Control animals:
- not specified
- Details on study design:
- No data available
- Positive control:
- No data available
Examinations
- Observations and examinations performed and frequency:
- No data available
- Sacrifice and pathology:
- Observations and examinations performed & frequency
CAGE SIDE OBSERVATIONS: no data
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule:Every third day
DERMAL IRRITATION (if dermal study): No data
BODY WEIGHT: Yes
- Time schedule for examinations: Every third day
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
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
OPHTHALMOSCOPIC EXAMINATION: No data
HAEMATOLOGY: No data
.
CLINICAL CHEMISTRY: No data
URINALYSIS: No data
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: No data
- Dose groups that were examined:Test group(4-00 mg/kg/day)
- Battery of functions tested: sensory activity / grip strength / motor activity / other:Maximum conduction velocity ofmotor,sensory fibres,motor distal latency in the tail nerve of the rats was determined - Other examinations:
- No data available
- Statistics:
- 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:
- effects observed, treatment-related
- Description (incidence and severity):
- Clinical signs: No effect on following parameter was observed when tested: Effect on growth,Dullness in movement,Difficulty in walking,paralysis in hind limbs. No salivation was observed in test group.
- Dermal irritation:
- not specified
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- Clinical signs: No effect on following parameter was observed when tested: Effect on growth,Dullness in movement,Difficulty in walking,paralysis in hind limbs. No salivation was observed in test group.
- 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):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- Neurobehaviour
No effect of chemical on nerve conduction velocity and motor distal latency was observed as compared to control
Motor conduction velocity Sensory conduction velocity Distal latency
Whole proximal Distal
Control 100 100 100 100 100
2-octanone 100 102 101 103 92
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 400 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: Clinical signs,Motor conduction velocity,sensory conduction velocity
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The No observed adverse effect level (NOAEL) was found to 400 mg/kg in chronic study when exposed to rat for 21 weeks with dose concentration of 400 mg by subcutaneous route daily for 5 days per week.
- Executive summary:
The chronic toxicity study was conducted on chemical 2-octanone exposed to rat .The test chemical was administered subcutaneously in daily dose of 400 mg/kg .weighing 200-300 g,5 days per week for a period of 21 weeks.Treated animals failed to show any changes in clinical sign and there isno change in nerve conduction velocity and motor distal latency was observed. Hence, The No observed adverse effect level (NOAEL) was found to 400 mg/kg in chronic study when exposed to rat for 21 weeks with dose concentration of 400 mg by subcutaneous route for 5 days per week.
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.