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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
Endpoint summary
Administrative data
Description of key information
Repeated dose oral:
The no observed adverse effect level (NOAEL) for test substance when administered orally by intubation to male rats was 10 mg/kg/day daily in 16 days study period.
The study does not conclude higher dose value. Hence it is acceptable to take such low NOAEL .
Repeated dose inhalation:
The No Observed Adverse effect concentration (NOAEC) was considered to be in a dose range of 80 ppm (80 mg/L) (actual dose 78.6 mg/L or 78600 mg/m3) - 6.6mg/m3 when rodents were treated with test substance.
Repeated dose dermal:
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.
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- 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
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- The repeated dose toxicity test was conducted on rats to determine the toxic nature of test substance by oral route of administration
- GLP compliance:
- not specified
- Limit test:
- no
- Specific details on test material used for the study:
- - 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 - Species:
- rat
- Strain:
- Sprague-Dawley
- Details on species / strain selection:
- No data
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Zivic Miller, Allison Park, Pa.)
- Age at study initiation:No data available
- Weight at study initiation: No data available
- Fasting period before study: No data available
- Housing:
- Diet (e.g. ad libitum): Purina lab chow ad libitum
- Water (e.g. ad libitum): water 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
IN-LIFE DATES: From: To: No data available - Route of administration:
- oral: gavage
- Details on route of administration:
- No data
- Vehicle:
- other: carboxymethylcellulose- H20 (1% CMC) solution
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: 2-octanone was suspended in 1% carboxymethylcellulose- H20 (1% CMC) and homogenized at dose level of 0 or 10 mg/Kg/day
DIET PREPARATION
- Rate of preparation of diet (frequency): No data
- Mixing appropriate amounts with (Type of food): No data
- Storage temperature of food: No data
VEHICLE
- Justification for use and choice of vehicle (if other than water): 1% carboxymethylcellulose- H20 (1% CMC)
- Concentration in vehicle: 10 mg/Kg/day
- Amount of vehicle (if gavage): No data
- Lot/batch no. (if required): No data
- Purity: No data - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- 16 days
- Frequency of treatment:
- Daily at 11:00 am
- Remarks:
- 0 or 10 mg/kg/day
- No. of animals per sex per dose:
- Total: 16
0 mg/Kg day: 8
10 mg/Kg day: 8 - Control animals:
- yes, concurrent vehicle
- Details on study design:
- Controls were given 1%CMC(carboxymethylcellulose-H20)
- Positive control:
- No data available
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Not specified
- Time schedule: Not specified
- Cage side observations checked in table [No.?] were included. Not specified
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Not specified
BODY WEIGHT: Yes
- Time schedule for examinations: Not specified
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Not specified
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Not specified
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Not specified
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: Not specified
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Not specified
- Time schedule for examinations: Not specified
OPHTHALMOSCOPIC EXAMINATION: Not specified
- Time schedule for examinations: Not specified
- Dose groups that were examined: Not specified
HAEMATOLOGY: Not specified
- Time schedule for collection of blood: Not specified
- Anaesthetic used for blood collection: Not specified
- Animals fasted: Not specified
- How many animals: Not specified
- Parameters checked in table [No.?] were examined. Not specified
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: On day 4, 10 and 16 after the last dose (24 hr)
- Animals fasted: Not specified
- How many animals: Not specified
- Parameters checked in table [No.?] were examined. Serum cholesterol level and Hypocholesterolemic Activity was observed
URINALYSIS: Not specified
- Time schedule for collection of urine: Not specified
- Metabolism cages used for collection of urine: Not specified
- Animals fasted: Not specified
- Parameters checked in table [No.?] were examined. Not specified
NEUROBEHAVIOURAL EXAMINATION: Not specified
- Time schedule for examinations: Not specified
- Dose groups that were examined: Not specified
- Battery of functions tested: sensory activity / grip strength / motor activity / other: Not specified
IMMUNOLOGY: Not specified
- Time schedule for examinations: Not specified
- How many animals: Not specified
- Dose groups that were examined: Not specified
- Parameters checked in table [No.?] were examined. Not specified
OTHER: Not specified - Sacrifice and pathology:
- No data available
- Other examinations:
- No data available
- Statistics:
- The number of animals in a group, expressed as N, the mean of the percent of control, and standard deviation, expressed as x± S.D.,are noted. The probable significant level ( p ) was determined by the Student's t test according to the procedure of Snedecor.
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No observable toxic effects were noted
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No significant changes in body weight change was observed.
- 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:
- effects observed, treatment-related
- Description (incidence and severity):
- Test substance as found to reduce serum choleterol to 34% of control
- 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
- Dose descriptor:
- NOAEL
- Effect level:
- 10 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: No significant changes were observed at the mentioned dose level
- Remarks on result:
- other: No toxic effect were observed
- Critical effects observed:
- not specified
- Conclusions:
- The no observed adverse effect level (NOAEL) for test substance when administered orally by intubation to male rats was 10 mg/kg/day daily in 16 days study period.
- Executive summary:
Subacute toxicity study was performed to determine the toxic nature of test substance upon repeated exposure by oral intubation route. The test substance was administered to male Sprague-Dawley rats daily for 16 days using 0.2cc oral intubation needle. The animals were observed for clinical signs if any, changes in body weight, and after the last dose (24 hr), blood was collected by tail vein bleeding and analyzed for serum cholesterol content. Test substance was found to reduce serum choleterol level to 34% of control. No significant changes were were noted in body weight and no observable toxic effects were observed. Hence, the no observed adverse effect level (NOAEL) for test substance when administered orally by intubation to male rats was 10 mg/kg/day daily in 16 days study period.
Reference
Table I. Hypocholesterolemic Activity of 2-ooctanone at 10 mg/kg/day in Sprague-Dawley Rats
|
Serum cholesterol as % of control on day |
% body weight increase |
||
4 |
10 |
16 |
|
|
Control(1% CMC) |
100±7 |
100±12 |
100±8 |
100±4 |
2-octanone (10 mg/Kg/day) |
74±11 |
59±7 |
34±8 |
100±5 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 10 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The data is K2 peer reviwed publication
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEC
- 78 600 mg/m³
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Weight of evidence prepared from various publication
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Link to relevant study records
- 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
- 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
- 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 - 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
- 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
- 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
- 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 - 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
- Critical effects observed:
- not specified
- 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.
Reference
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 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 400 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Data is from K2 peer reviewed publication
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Peer reviewed publication of test substance was reviewed to determine the toxic nature of 2 -octanone (IUPAC name: octan-2-one CAS NO: 111-13-7) upon repeated exposure by oral route. The summary is as mentioned below:
Repeated dose toxicity: Oral
Subacute toxicity study was performed to determine the toxic nature of test substance upon repeated exposure by oral intubation route. The test substance was administered to male Sprague-Dawley rats daily for 16 days using 0.2cc oral intubation needle. The animals were observed for clinical signs if any, changes in body weight, and after the last dose (24 hr), blood was collected by tail vein bleeding and analyzed for serum cholesterol content. Test substance was found to reduce serum choleterol level to 34% of control. No significant changes were were noted in body weight and no observable toxic effects were observed. Hence, the no observed adverse effect level (NOAEL) for test substance when administered orally by intubation to male rats was 10 mg/kg/day daily in 16 days study period.
The study does not conclude higher dose value. Hence it is acceptable to take such low NOAEL .
In a 28 days repeated dose toxicity study, the effect of test chemical was evaluated in male and female Sprague Dawley rats. The test chemical was administered by oral gavage in the concentration of 0, 250, 500 and 1000 mg/kg/ body weight/day. The results showed no effect on mortality, no changes were in food consumption and ophthalmology. Changes were observed in clinical signs like soft stool, nasal discharge, red crust around nostrils, perineum soiled with fecal matter were observed. Significant decreased were observed in water consumption and locomotor activity of female rat in 1000 mg/kg dose group. Bodyweight was increased significantly in male and female rats. Significant increase in MCV, Lymphocyte, Basophils level and significant decrease in WBC, platelet, monocytes, neutrophils and eosinophils were observed in male and female rats. Significant changes were observed in the level of testosterone, sodium, total proteins, total cholesterol, SGOT, SGPT, albumin, Blood urea nitrogen (BUN) and Creatinine when treated with 500 and 1000 mg/kg/day. Significant changes were observed in absolute and relative weight of brain, adrenals, spleen, thymus, epididymides, heart, kidneys, ovaries, uterus and liver in 500 and 1000 mg/kg/day. In addition, minimal to mild gross pathological and histopathological changes were observed in liver, spleen and intestine. However, the biological significance of these findings are not related to test chemical. Therefore, the No Observed Adverse Effect Level (NOAEL) was considered to be 1000 mg/kg/day when Sprague-Dawley rat exposed to test substance orally.
Repeated dose oral toxicity study with reproductive and developmental screening was conducted to investigate the repeated dose toxicity of the test material. The chemical was administered by oral gavage route of exposure to dose groups, each of 13 male and 13 female Crj:CD (SD) strain rats upto forty-three days at dose levels of 0, 100, 300 or 1000 mg/kg/day. A control group of 13 males and 13 females was dosed with vehicle alone (corn oil). As a result, in males, abnormalities in death cases and general conditions were not observed in any treated animal. There was also no change in body weight and food consumption suggesting the effect of test chemical administration. Necropsy, histopathological examination, hematology examination, and blood biochemical examination after repeated administration of 42 times also showed no findings or abnormal values suggesting the effect of test chemical administration. In females, there were no deaths in any test chemical administration group. In addition, no change was observed in general condition, body weight and food intake. Necropsy at 4 days postpartum and histopathological examination also did not show findings suggestive of the effect of test chemical administration. On the reproductive and developmental toxicity, test chemical dose up to 1000 mg / kg did not affect mating rate and conception rate. In addition, changes suggesting the effect of test chemical administration on the pregnancy period, birth rate, labor condition and nursing condition of the mother animals were not observed. No treatment related adverse effects were found in either dose group 0, 100, 300 or 1000 mg/kg/day, though some slight changes were observed in blood biochemistry and histopathology in testes. Thus, on the basis of overall discussion of the study, the 'No Observed Effect Level' (NOEL) for repeated dose toxicity by oral route is to be 1000 mg/kg/day.
Repeated dose inhalation:
In subchronic test, Sprague Dawley male and female rats were exposed to test substance by inhalation in the concentration of 0, 80, 400 and 1000 ppm (0, 80, 400 or 1000 mg/L). Actual exposure concentrations is 0, 78.6, 405.8 or 1022.6 ppm (0, 78.6, 405.8 or 1022.6 mg/L) for 6 hours/day, 7 days/week for 50 days. All adult animals survived to study termination and there were no test substance-related changes in mean terminal body weight. For the 1000 mg/L male group, there was a reduction in food consumption during days 0-7. No effect on survival, body weight and weight gain were observed in treated rats as compared to control. Minimal reductions in activity level were observed in 400 and 1000 mg/L dose group and reduction in food consumption during days 0 -7 in 100 mg/L dose group were observed as compared to control. Mean sperm motility and mean epididymal spermatozoan and testicular spermatid counts were comparable among the groups. No test substance-related gross pathology was observed for adult animals from any group. No exposure-related changes were observed during histological examination of the reproductive organs of any of the test substance-exposed animals. Therefore, the No Observed Adverse effect concentration (NOAEC) was considered to be 80 ppm (80 mg/L) (actual dose 78.6 mg/L or 78600 mg/m3) when Sprague-Dawley male and female rats treated with test substance.
Repeated dose oral toxicity was evaluated for test substance using authoritative database. The study assumed the use of rabbits in a subacute study for 30 days .Opthalmoscopic examinations was observed. Since no significant changes were noted, the No observed adverse effect concentration (NOAEC) for test substance in rabbits is estimated to be 6.6 mg/m3/2H after repeated exposure via inhalation route.
Repeated dose toxicity: Dermal
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.
Repeated dose chronic dermal toxicity study was performed to determine the dermal toxic nature of test substance upon repeated applcatioin by dermal route of exposure. The test chemical was administered subcutaneously in daily dose of 400 mg/kg into the back of seven rats, weighing 290g, 5 days per week for a period of 21 weeks. The animals were observed for clinical signs, changes in body weight and neurophysiological changes. Treated animals failed to exhibit apparent clinical and neurophysiologic evidence except for a slight inhibition of weight gain and narcotic effects after treatment. Hence, the No observed adverse effect level (NOAEL) for test substance in rats exposed for 21 weeks is 400 mg/kg.
Based on the data available from the test chemical, 2 -octanone (IUPAC name: octan-2-one CAS NO: 111-13-7) not likely to exhibit repeated dose oral ,inhalation and dermal toxicity. Hence the test chemical is not likely to classify as per the criteria mentioned in CLP regulation.
Justification for classification or non-classification
Based on the data available from the test chemical, 2 -octanone (IUPAC name: octan-2-one CAS NO: 111-13-7) not likely to exhibit repeated dose oral ,inhalation and dermal toxicity. Hence the test chemical is not likely to classify as per the criteria mentioned in CLP regulation.
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