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EC number: 203-939-6 | CAS number: 112-14-1
- 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
Octyl acetate is not a toxicant upon repeated exposure by oral route.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from peer reviewed publication
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- Repeated dose toxicity study was conducted to assess the potential health effect of octyl acetate in Sprague-Dawley rats
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Lakeview, New Jersey
- Age at study initiation: 6 weeks old
- Weight at study initiation: No data
- Fasting period before study: No data
- Housing: housed individually in suspended stainless-steel cages
- Diet (e.g. ad libitum): food (Purina Certified Rodent Chow) ad libitum
- Water (e.g. ad libitum): water ad libitum
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24.4 °C
- Humidity (%): 40-70%
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12-hr light-dark cycle
IN-LIFE DATES: From: To: No data - Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- Distilled water
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: Octyl acetate was dissolved in distilled water to give a dose range of 0, 100, 500 or 1000 mg/Kg
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): Distilled water
- Concentration in vehicle: 0, 100, 500 or 1000 mg/Kg
- Amount of vehicle (if gavage): 0, 0..1, 0.5 or 1.1 mL/Kg repectively
- 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:
- 13 weeks
- Frequency of treatment:
- Once daily, 5 days per week
- Remarks:
- Doses / Concentrations:
0, 100, 500 or 1000 mg/Kg
Basis: - No. of animals per sex per dose:
- Total: 160
0 mg/Kg: 20 males and 20 females
100 mg/Kg: 20 males and 20 females
500 mg/Kg: 20 males and 20 females
1000 mg/Kg: 20 males and 20 females - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: No data
- Rationale for animal assignment (if not random): The animals were selected for study using a computer-generated body weight sorting program
- Rationale for selecting satellite groups: No data
- Post-exposure recovery period in satellite groups: No data
- Section schedule rationale (if not random): No data - Positive control:
- No data
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily
- Cage side observations checked in table [No.?] were included. Overt signs of toxicity
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: prior to the first dosing and weekly thereafter during the test period.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes (measured weekly)
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: 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 AND COMPOUND INTAKE (if drinking water study): No data
- Time schedule for examinations: No data
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: after 13 weeks of dosing
- Dose groups that were examined: all animals were examined
HAEMATOLOGY: Yes
- Time schedule for collection of blood: After 45 days and at 13th week during necropsy
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: 5 animals/ sex at day 45 and all animals at necropsy
- Parameters checked in table [No.?] were examined. Hematology measurements included erythrocyte count, hematocrit, hemoglobin, leukocyte count (total and differential), mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, and platelet count.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: After 45 days and at 13th week during necropsy
- Animals fasted: No data
- How many animals: 5 animals/ sex at day 45 and all animals at necropsy
- Parameters checked in table [No.?] were examined. Serum chemistry measurements included sodium, potassium, chloride, calcium, inorganic phosphorous, blood urea nitrogen, creatinine, total protein, albumin, total bilirubin, triglycerides, cholesterol, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, -y-glutamyl transpeptidase, and serum osmolarity.
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: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
- Battery of functions tested: sensory activity / grip strength / motor activity / other: No data
OTHER: - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, An interim termination was made after 45 days of dosing. Five animals per sex per group were terminated and necropsied. Livers were removed, weighed, and processed for histologies] examination. After 13 weeks of dosing, all animals were terminated, and a complete necropsy was performed. The animals were terminated over a 3-day period. Organ weights were obtained for the kidneys, liver, brain, and testes.
HISTOPATHOLOGY: Yes, The tissues and organs were preserved in 10% neutral buffered formalin. All tissues preserved from the control and 1000 mg/kg groups were sectioned, stained with hematoxylin and eosin, and evaluated microscopically. Selected tissues for histologic evaluation were as
follows: brain (three sections; medulla/pons, cerebellar cortex, and cerebral cortex), spinal cord (three sections: cervical, thoracic, and lumbar), sciatic nerve, eyes with optic nerve, esophagus, stomach duodenum, jejunum, ileum, cecum, colon, rectum, liver, pancreas, kidneys, urinary bladder, lymph nodes, heart, aorta, larynx, trachea, thymus, lungs, thyroid, parathyroid, sternum and femur (with marrow) testes, epididymides, prostate, seminal
vesicles, ovaries, uterus, vagina, mammary gland, and any gross lesions.
In animals from the 100 and 500 mg/Kg dose groups, only the liver, kidneys, lungs, spleen, thymus, and representative lymph nodes were evaluated microscopically. The remaining tissues from the 100 and 500 mg/Kg dose groups were processed only to the paraffin block stage. - Other examinations:
- No data
- Statistics:
- Data from the treated groups were compared statistically to those of the control group using the following tests: Bartlett's test of homogeneity of variance was used to determine if the groups had equivalent variances at the p< 0.01 level. If the variances were not significantly different, the groups were compared using a standard one-way analysis of variance (ANOVA). If significant differences among the means were indicated, Dunnett's test was used to determine which treatment groups differed from controls. If the groups did not have equivalent variances at the p < 0.01 level, then the Kruskall-Wallis test was used to assess differences in group means (Hollander and Wolfe, 1973), and, if the means were different, Dunn's summed rank test was used to determine which treatment group differed significantly from control. For the renal microscopic findings, an analysis of discrete variables was done by the Grizzle, Starmer, and Koch linear model technique
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- 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:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- Clinical signs and mortality O
Mortality: One male rat in the high-dose group died on Day 15 of the study. The histopathology findings indicated that the probable cause of death in this animal was pulmonary hemorrhage. It is likely that this death was due to accidental instillation of test material into the lungs during the oral gavage procedure. There were no other deaths during the study.
Clinical signs: No data
Body weight and weight gain: Mean body weight for the 100 and 500 mg/Kg dose group were comparable to control group. Body weights for the 1000 mg/Kg dose males and females were lower than in the corresponding control groups, although the differences were not statistically significant. This finding suggested a borderline treatment- related effect on body weight in the high-dose group of animals.
Food consumption and compound intake: Mean food consumption values for the high-dose animals of both sexes were slightly lower than those observed in the corresponding control groups and in most cases was not statistically significant.
Food efficiency: No data available
Water consumption and compound intake: No data available
Opthalmoscopic examination
At week 13: Ophthalmological exam did not reveal any ocular effects which were treatment related. The few lesions which were observed were considered to be common in rats of this age.
Haematology:
Interim kill at day 45 and at week 13: No statistically significant differences in mean hematology values were noted between any of the test groups and controls at the interim termination
Clinical chemistry: No
Interim kill at day 45: There were no significant differences between the control and the treated groups which could be treatment related
At week 13: No significant differences between the control and the treated groups which could be treatment related were observed. Single instances of statistically significant deviations from control were observed for albumin, potassium, and alanine aminotransferase. However, since the observed
differences were small and not evident in other treatment groups, they were not judged to be biologically important.
Urinanalysis: No data available
Neurobehaviour: No data available
Organ weights:
Interim kill at day 45: The absolute liver weights in both the 1000 mg/Kg dose males and females were elevated compared to control values, although
the differences were statistically significant only for high-dose females. When liver weights were expressed as a ratio to body weight, the differences compared to those of control were statistically significant for both the high-dose males and females.
At week 13: Absolute liver weights in the 1000 mg/Kg male and female animals were elevated compared to those of the controls, although the differences were not statistically significant. When expressed on a relative basis (organ weight to body weight ratio), the liver weights in the 500 and 1000 mg/Kg animals of both sexes were significantly elevated over corresponding control values. In addition, relative kidney weights of the 1000 mg/Kg male and female animals were significantly increased compared to those of the controls. All other organ weights in the treated groups were comparable to control values.
Gross pathology
Interim kill at day 45: No treatment related effect effects were noted on gross pathology parameters
At week 13: An increased incidence in the mid- and high-dose groups of mottled lung discoloration was observed at the terminal necropsy. In general, the mottled appearance consisted of scattered red/ dark red foci on the surface of the lungs. This observation most likely stemmed from occasional instances in which the test material was aspirated. Other miscellaneous signs noted at necropsy were observed with comparable incidences across all groups and were not considered to have been treatment related.
Histopathology
At week 13: Microscopic evaluation of the kidneys revealed evidence of mild tubular nephropathy only in the 1000 mg/Kg male rats. The specific findings consisted of an increased incidence of dilated renal tubules (cortical-medullary zone) containing granular casts and regenerative hyperplasia in proximal convoluted tubules. These findings were not observed in 1000 mg/Kg females or in either sex of the 500 and 100 mg/Kg dosed animals. Other histopathological changes observed in the array of tissues examined were limited to naturally occurring lesions which were present in approximately equal frequency in all groups, including controls. - Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: No evidence of significant systemic toxicity was observed
- Critical effects observed:
- not specified
- Conclusions:
- The No Observed Adverse Effect Level (NOAEL) for octyl acetate is 500 mg/kg/day in Sprague-Dawley rats.
- Executive summary:
Repeated dose oral toxicity study of octyl acetate was conducted in rats.The substance was administration to rats via oral gavage, 5 days per week for 13 weeks at dose level 0, 100, 500 and 1000mg/kg/day. After 13 weeks of dosing all animals were terminated and necropsied. Blood samples were obtained and selected organs were weighed and prepared for subsequent histological examination. Several treatment-related effects were observed in the 1000 mg/kg group animals. These effects included slight reductions in body weight and food consumption, increased liver and kidney weights, and evidence of hydrocarbon nephropathy in 1000 mg/Kg/day males only. Relative kidney weights of the 1000 mg/Kg/day male and female animals were significantly increased. The liver weights in the 500 and 1000 mg/Kg/day animals of both sexes were significantly elevated over corresponding control values. Kidneys revealed evidence of mild tubular nephropathy only in the 1000 mg/Kg/day male rats. An increased incidence of dilated renal tubules (cortical-medullary zone) containing granular casts and regenerative hyperplasia in proximal convoluted tubules. No other treatment related effects were noted in the 1000 mg/Kg bw group. Therefore, No Observed Adverse Effect Level (NOAEL) for octyl acetate is 500 mg/kg/day in Sprague-Dawley rats.
Reference
MEAN BODY WEIGHTS (g) FOR RATS DOSED WITH OCTYL ACETATE
Treatment group |
Time (Days) |
||||||
0 |
14 |
28 |
42 |
56 |
70 |
84 |
|
Males |
|||||||
Control |
222±14 |
328±20 |
398±28 |
451±30 |
497±30 |
524±41 |
550±44 |
100 mg/Kg |
221±12 |
329±18 |
401±24 |
454±28 |
506±28 |
542±30 |
567±32 |
500 mg/Kg |
220±12 |
320±26 |
387±36 |
439±40 |
490±45 |
526±49 |
550±52 |
1000 mg/Kg |
222±13 |
309±23* |
371±44 |
419±51* |
468±60 |
501±68 |
532±69 |
Females |
|||||||
Control |
176±11 |
219±20 |
248±21 |
267±24 |
277±19 |
289±21 |
299±21 |
100 mg/Kg |
176±12 |
218±13 |
247±16 |
265±16 |
277±18 |
289±17 |
298±22 |
500 mg/Kg |
174±13 |
221±23 |
255±26 |
274±30 |
284±27 |
297±31 |
307±32 |
1000 mg/Kg |
174±12 |
216±20 |
243±29 |
260±31 |
269±27 |
277±28 |
288±32 |
LIVER/BODY WEIGHT RATIOS
Treatment group |
Body Weight |
Liver Weight |
Liver Weight/ Body weight ration (%) |
Males |
|||
Control |
443±26 |
16.8±1.9 |
3.8±0.3 |
100 mg/Kg |
440±36 |
16.2±2.3 |
3.7±0.3 |
500 mg/Kg |
410±36 |
17.9±2.5 |
4.4±0.3 |
1000 mg/Kg |
399±41 |
19.6±3.6 |
4.9±0.5* |
Females |
|||
Control |
296±25 |
11.1±1.1 |
3.8± 0.1 |
100 mg/Kg |
274±22 |
10.2±0.8 |
3.7±0.2 |
500 mg/Kg |
280±27 |
11.5±1.3 |
4.1±0.2 |
1000 mg/Kg |
285±34 |
13.7±1.2* |
4.8±0.3* |
* Significantly different from control (p≤0.01).
WEEK 13 TERMINATION: ORGAN WEIGHT DATA
Organ/body weight ratio (%) |
Treatment group |
|||
Control |
100 mg/Kg |
500 mg/Kg |
1000 mg/Kg |
|
Males |
||||
Liver |
3.5 ± 0.2 |
3.6 ±0.2 |
3 9 ± 0.3** |
4.1 ±0.3** |
Kidneys |
0.62 ±0.04 |
0.61 ±0.06 |
0.64 ± 0.06 |
0.68 ± 0.08* |
Brain |
0.37 ±0.03 |
0.36 ±0.03 |
0.37 ± 0.04 |
0.38 ±0.04 |
Testes |
0.62 ± 0.07 |
0.58 ±0.05 |
0.61 ±0.07 |
0.62 ±0.09 |
|
Females |
|||
Liver |
3.4 ±0.3 |
3.4 ±0.2 |
3.7 ±0.3* |
4.1 ±0.3** |
Kidneys |
0.66 ± 0.06 |
0.67 ± 0.07 |
0.69 ± 0.06 |
0.74 ± 0.06** |
Brain |
0 63 ± 0.04 |
0.63 ±0.06 |
0.63 ±0.07 |
0.65 ± 0.05 |
*Significantly different from control (p≤0.05).
** Significantly different from control (p≤0.01).
CLINICAL CHEMISTRY VALUES
Parameters |
Sex |
Treatment group |
|||
Control |
100 mg/Kg |
500 mg/Kg |
1000 mg/Kg |
||
Males |
|||||
Potassium (meq/liter) |
Males |
5.1 ±0.7 |
5.0 ±0.3 |
5.2 ±0.4 |
5 2 ±0.3 |
Female |
4.4 ±0.4 |
4.6 ±0.4 |
4.7 ±0.3 |
4.9 ± 0.3** |
|
Albumin (g/dl) |
Males |
3.3 ±0.2 |
3.3 ±0.1 |
3.4 ±0.2 |
3.5 ± 0.3** |
Female |
3.5 ±0.4 |
3.5 ±0.3 |
3.5 ±0.2 |
3.5 ±0.2 |
|
Alanine aminotransferase (IU/liter) |
Males |
33 ±9 |
35 ± 10 |
29 ±4 |
29 ±5 |
Female |
42 ± 14 |
54 ±67 |
37± 13 |
32 ±6* |
INCIDENCE OF RENAL MICROSCOPIC FINDINGS IN MALE RATS DOSED WITH OCTYL ACETATE
Treatment group |
Dilated renal tubules of the corticalmedullary zone |
Granular casts in dilated tubules |
Hyaline droplets in proximal convoluted tubule cells |
Regenerative hyperplasia in proximal convoluted tubules |
Control |
0/15 |
0/15 |
15/15 |
0/15 |
100 mg/Kg |
0/15 |
0/15 |
15/15 |
0/15 |
500 mg/Kg |
3/15 |
1/15 |
15/15 |
1/15 |
1000 mg/Kg |
5/14* |
5/14* |
14/14* |
4/14* |
• Significantly different from control; p < 0.05.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 500 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Data is from K2 prre reviewed publication
Additional information
Repeated dose toxicity: Oral
Data from various peer reviewed publication were reviewed and are summarized below to determine the toxic nature of Octyl acetate upon repeated exposure by oral route of administration:
Repeated dose oral toxicity study of octyl acetate (CAS no 112 -14 -1) was conducted in rats by Wayne C. Daughtrey, Mark Eutermoser, Samuel W. Thompson, And Robert W. Biles (1989).The substance was administration to rats via oral gavage, 5 days per week for 13 weeks at dose level 0, 100, 500 and 1000mg/kg/day. After 13 weeks of dosing all animals were terminated and necropsied. Blood samples were obtained and selected organs were weighed and prepared for subsequent histological examination. Several treatment-related effects were observed in the 1000 mg/kg group animals. These effects included slight reductions in body weight and food consumption, increased liver and kidney weights, and evidence of hydrocarbon nephropathy in 1000 mg/Kg/day males only. Relative kidney weights of the 1000 mg/Kg/day male and female animals were significantly increased. The liver weights in the 500 and 1000 mg/Kg/day animals of both sexes were significantly elevated over corresponding control values. Kidneys revealed evidence of mild tubular nephropathy only in the 1000 mg/Kg/day male rats. An increased incidence of dilated renal tubules (cortical-medullary zone) containing granular casts and regenerative hyperplasia in proximal convoluted tubules. No other treatment related effects were noted in the 1000 mg/Kg bw group. Therefore, No Observed Adverse Effect Level (NOAEL) for octyl acetate is 500 mg/kg/day in Sprague-Dawley rats.
In another study by W. C. Daughtrey, P. J. Wier, K. A. Traul, R. W. Biles, And G. F. Egan (1989), Repeated dose toxicity study in the form of teratogenicity was studied for octyl acetate (CAS no 112 -14 -1). The chemical dissolved in distilled water was given to female pregnant Sprague Dawley rats at a dose level of 0, 100, 500 or 1000 mg/Kg/day from gd 6- gd 15 once daily. The dams were weighed and observed for clinical signs of toxicity during pregnancy, and food consumption was measured. On Gestation Day 20 the dams were sacrificed and the fetuses were examined for external, visceral, and skeletal malformations and variations. The 500 and 1000 mg/Kg dose levels resulted in maternal toxicity as evidenced by reductions in body weight gain and food consumption. There were no statistically significant effects on embryo-fetal lethality or fetal growth for any treatment group. The no observed adverse effect level (NOAEL) for Octyl acetate is 100 mg/Kg bw.
Based on the data available, Octyl acetate is not likely to classify as a toxicant upon repeated exposure by oral route.
Justification for classification or non-classification
Based on the data available, Octyl acetate is not likely to classify as a toxicant upon repeated exposure by oral route.
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