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EC number: 209-667-4 | CAS number: 589-98-0
- 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
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- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
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- Nanomaterial surface chemistry
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- 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 toxicity: Oral
90 days repeated dose oral toxicity study was performed to determine the toxic nature of Octan-3-ol. The study was performed using male and female Wistar rats. The test chemical was dissolved in soyabean oil and used at dose level of 0, 25, 100 or 400 mg/Kg/day. During the study period, the animals were observed for mortality, clinical signs, food consumption, water consumption, body weight and organ weight changes, hematology, clinical chemistry parameters and the treated animals were subjected to gross and histopathology. Two animals in the low-dose group (25 mg/kg/day) died due to accidental intratracheal dosing and were excluded from the study. No effects on the clinical appearance of the rats attributed to dosing were observed. An increase in food consumption and a statistically significant increase in water uptake was observed among rats dosed with the test chemical. Statistically significant increases in terminal body weight were found for female rats dosed with octan-3-ol (100 and 400 mg/Kg/day), compared with the control group. Absolute and relative liver weights of the400 mg/kg/day dosed male rats were significantly higher than those of the control. A slight increase in absolute and relative liver weight was observed in the female rats dosed with 100 and 400 dosed groups compared with the controls. However, the changes were not dose related and only reached statistical significance for the 100 mg/kg/day dosed group (absolute liver weight). The relative heart weight was significantly increased in all dosed male rats except for the 400 mg/Kg/day dose octan-3-ol rats. No effect on relative heart weight was observed in female rats. No further treatment-related changes in organ weights were observed. Treatment-related effects were observed in the kidneys, but in males only. The incidences of tubular karyomegaly and luminal desquamation of tubular epithelial cells in the cortex were increased in rats dosed with the 100 and 400 mg/Kg/day of octan-3-ol, although the incidence of tubular karyomegaly in the 100 mg/Kg/day -dose octan-3-ol group was not significantly increased (P=0.08). The lesions were minimal to mild. In all other organs examined, no treatment-related changes were observed. Based on the observations made, the No observed adverse effect level (NOAEL) for the test compound octan-3-ol is considered to be 25 mg/Kg/day.
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:
- 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:
- 90 days repeated dose oral toxicity study was performed to determine the toxic nature of Octan-3-ol
- GLP compliance:
- not specified
- Limit test:
- no
- Specific details on test material used for the study:
- - Name of test material: Octan-3-ol
- IUPAC name: Octan-3-ol
- Molecular formula: C8H18O
- Molecular weight: 130.229 g/mole
- Smiles : C([C@@H](CC)O)CCCC
- Inchl: 1S/C8H18O/c1-3-5-6-7-8(9)4-2/h8-9H,3-7H2,1-2H3
- Substance type: Organic
- Physical state: Colorless Liquid
- Physical state: 99.7%
- Impurities (identity and concentrations): 0.3% - Species:
- rat
- Strain:
- Wistar
- Remarks:
- Mol:Wist, SPF
- Details on species / strain selection:
- No data
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: M & B A/S (Ll. Skensved, Denmark)
- Age at study initiation: No data
- Weight at study initiation:
Males: 110 ± 5
Females: 102 ± 5
- Fasting period before study:
- Housing: The animals were housedin macrolone cages (two males or females/cage)
- Diet (e.g. ad libitum): chow-diet (Altromin 1324, Altromin GmbH, Germany)
- Water (e.g. ad libitum):
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1 ˚C
- Humidity (%): 55±10%
- Air changes (per hr): 10 times/h
- Photoperiod (hrs dark / hrs light): fluorescent light was on from 21.00 to 09.00
IN-LIFE DATES: From: To: No data - Route of administration:
- oral: gavage
- Details on route of administration:
- The stability of the three substances in the feed was tested at room temperature spread in petri dishes for 72 h. The loss of the substances in the
feed was for octan-3-ol after 24, 48 and 72 h 70, 98, 100%, respectively. The conclusion of the stability test was that the three substances (especially
octan-3-ol) were not stable in the feed, and therefore the substances had to be given to the animals by gavage. Subsequently, the stability of the substances in soybean oil was tested and was found to be stable for at least 1 week - Vehicle:
- soya oil
- Remarks:
- Soyabean oil
- Details on oral exposure:
- Details on oral exposure
PREPARATION OF DOSING SOLUTIONS: The test chemical weekly prepared and was dissolved in Soyabean oil at dose level of 0, 25, 100 or 400 mg/Kg bw
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): Soyabean oil
- Concentration in vehicle: 0, 25, 100 or 400 mg/Kg bw
- Amount of vehicle (if gavage): No data
- Lot/batch no. (if required): No data
- Purity: No data - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- An analytical method for separation and quantification of octan-3-ol was developed (capillary gas chromatography with flame ionisation detector (FID), column: Supelcowax 10, flow: 1 ml He/min, on-column injection, injector and oven temperature: 80 ˚C, 10 ˚C/min until 220˚C, hold 8 min., FID temperature: 250 ˚C, internal standard: decanol, extraction from the feed with diethyl ether, elution times: octan-3-ol 12.0 min).
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- Daily
- Remarks:
- 0, 25, 100 or 400 mg/Kg bw/day
- No. of animals per sex per dose:
- Total: 40 males and 40 females
0 mg/kg/day: 10 males and 10 females
25 mg/kg/day: 10 males and 10 females
100 mg/kg/day: 10 males and 10 females
400 mg/kg/day: 10 males and 10 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 randomised to the same mean body weight
- 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: Twice a day
- Cage side observations checked in table [No.?] were included. No data
DETAILED CLINICAL OBSERVATIONS: No data
- Time schedule: No data
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes, weekly
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: 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 AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: Weekly
OPHTHALMOSCOPIC EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
HAEMATOLOGY: Yes
- Time schedule for collection of blood: During the last week of dosing
- Anaesthetic used for blood collection: No data
- Animals fasted: yes, overnight
- How many animals: All animals
- Parameters checked in table [No.?] were examined. haematocrit, haemoglobin concentration, erythrocyte count, mean cell haemoglobin concentration, mean cell haemoglobin, mean cell volume, platelet count, and total leukocyte count. Prothrombin time and fibrinogen level, Differential leucocyte count
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: During the last week of dosing
- Animals fasted: yes, Overnight
- How many animals: All animals
- Parameters checked in table [No.?] were examined. alanine aminotransferase (ALAT), alkaline phosphatase (ALP), cholesterol, glucose, creatinine,
urea, uric acid, albumin, total protein, lactatede hydrogenase
(LDH), phosphate and calcium.
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: No data - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, At the end of the dosing period, all animals were anaesthetised by carbon dioxide inhalation and killed by exsanguination. A thorough autopsy was performed nand the following organs were excised and weighed: kidneys, adrenals, heart, liver, brain, spleen, thymus, epididymides, testes, ovaries and uterus
HISTOPATHOLOGY: yes, kidneys, adrenals, heart, liver, brain, spleen, thymus, epididymides, testes, ovaries and uterus, lung, trachea, aorta, mesenteric
and axillary lymph nodes, salivary gland, oesophagus,
stomach, duodenum, jejunum, ileum, caecum, colon, rectum, thyroid, parathyroid, pancreas, prostate, seminal vesicles (including coagulation gland), pituitary gland, spinal cord, sciatic nerve, eyes, skin, mammary gland, sternum with marrow and skeletal muscle were preserved in 4% neutral buffered formaldehyde, sectioned at 4–6 mm and stained with haematoxylin–eosin for histopathology.
For the groups given 25 or 100 mg octan-3-ol/kg body weight per day, histopathology was only performed on the kidneys from males and the liver from both males and females. In the presence of treatment- related effects, the sections were evaluated blindly and severity of lesions were scored as: 1=minimal, 2=mild, 3=moderate and 4=marked. For visualization and quantification of the protein droplets in the kidneys, Mallory’s Heidenhain stain was used. - Other examinations:
- No data
- Statistics:
- All data were analysed separately for each sex. Variance in data for body weights, haematology, clinical chemistry and organ weights was checked for homogeneity by judgment of standardized residuals plots. Furthermore, using their standardized residuals, data were tested for normal distribution by Shapiro–Wilks test. If data did not show homogeneity of variance and normal distribution, a non-parametric Kruskal–Wallis test followed by Wilcoxon’s test for pairwise comparisons if significant was performed.
Data on body weight during the study was analysed using a two-way analysis of variance (ANOVA) with repeated measures on one factor and if significant a Student’s t-test was performed (LS means). Data on body weight gain, food consumption, water intake, haematology, clinical chemistry and organ weights were
analysed using a one-way ANOVA, and if significant, followed by a Student’s t-test (LS means). Data from the histopathological examination were analysed by the software program LABCAT (version 4.32). The incidence of changes was analysed by Fisher’s exact statistics, and severity scores by one-way ANOVA followed by Dunnett’s test. In all cases, a p<0.05 was considered significant. All statistical analysis, except the histopathological data, was carried out using SAS system for Windows V8. - Clinical signs:
- no effects observed
- Description (incidence and severity):
- No effects on the clinical appearance of the rats attributed to dosing were observed.
- Mortality:
- no mortality observed
- Description (incidence):
- Two animals in the low-dose group (25 mg/kg/day) died due to accidental intratracheal dosing and were excluded from the study.
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- An increase in food consumption among rats dosed with the test chemical
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Description (incidence and severity):
- A statistically significant increase in water uptake was observed among rats dosed with the test chemical
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- No significant changes were noted in the treated animals as compared to the control animals
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- No significant changes were noted in the treated animals as compared to the control animals
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Statistically significant increases in terminal body weight were found for female rats dosed with octan-3-ol (100 and 400 mg/Kg/day), compared with the control group. Absolute and relative liver weights of the 400 mg/kg/day dosed male rats were significantly higher than those of the control. A slight increase in absolute and relative liver weight was observed in the female rats dosed with 100 and 400 dosed groups compared with the controls. However, the changes were not dose related and only reached statistical significance for the 100 mg/kg/day dosed group (absolute liver weight). The relative heart weight was significantly increased in all dosed male rats except for the 400 mg/Kg/day dose octan-3-ol rats. No effect on relative heart weight was observed in female rats. No further treatment-related changes in organ weights were observed.
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- No macroscopic changes related to dosing were observed in any of the dosed rats. Compared with the control group, treatment-related increases in the incidence of histological lesions were observed in the liver. Incidences of bile duct proliferation were statistically significantly increased in male and female rats dosed with the 400 mg/Kg/day of octan-3-ol. Bile duct proliferation consisted of minimal to mild proliferation of small bile ductules within portal areas. Fatty changes characterized by an accumulation of intracellular vacuoles in the hepatocytes multifocally, most likely containing fat, were seen in three male and one female rat in the 400 mg/kg/day ctan-3-ol.
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Treatment-related effects were observed in the kidneys, but in males only. The incidences of tubular karyomegaly and luminal desquamation of tubular epithelial cells in the cortex were increased in rats dosed with the 100 and 400 mg/Kg/day of octan-3-ol, although the incidence of tubular karyomegaly in the 100 mg/Kg/day -dose octan-3-ol group was not significantly increased (P=0.08). The lesions were minimal to mild. In all other organs examined, no treatment-related changes were observed.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Dose descriptor:
- NOAEL
- Effect level:
- 25 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No significant adverse effects were noted at the mentioned dose level
- Critical effects observed:
- not specified
- Conclusions:
- The No observed adverse effect level (NOAEL) for the test compound octan-3-ol is considered to be 25 mg/Kg/day when male and female Wistar rats were exposed to the test chemical for 90 days.
- Executive summary:
90 days repeated dose oral toxicity study was performed to determine the toxic nature of Octan-3-ol. The study was performed using male and female Wistar rats. The test chemical was dissolved in soyabean oil and used at dose level of 0, 25, 100 or 400 mg/Kg/day. During the study period, the animals were observed for mortality, clinical signs, food consumption, water consumption, body weight and organ weight changes, hematology, clinical chemistry parameters and the treated animals were subjected to gross and histopathology. Two animals in the low-dose group (25 mg/kg/day) died due to accidental intratracheal dosing and were excluded from the study. No effects on the clinical appearance of the rats attributed to dosing were observed. An increase in food consumption and a statistically significant increase in water uptake was observed among rats dosed with the test chemical. Statistically significant increases in terminal body weight were found for female rats dosed with octan-3-ol (100 and 400 mg/Kg/day), compared with the control group. Absolute and relative liver weights of the 400 mg/kg/day dosed male rats were significantly higher than those of the control. A slight increase in absolute and relative liver weight was observed in the female rats dosed with 100 and 400 dosed groups compared with the controls. However, the changes were not dose related and only reached statistical significance for the 100 mg/kg/day dosed group (absolute liver weight). The relative heart weight was significantly increased in all dosed male rats except for the 400 mg/Kg/day dose octan-3-ol rats. No effect on relative heart weight was observed in female rats. No further treatment-related changes in organ weights were observed. Treatment-related effects were observed in the kidneys, but in males only. The incidences of tubular karyomegaly and luminal desquamation of tubular epithelial cells in the cortex were increased in rats dosed with the 100 and 400 mg/Kg/day of octan-3-ol, although the incidence of tubular karyomegaly in the 100 mg/Kg/day -dose octan-3-ol group was not significantly increased (P=0.08). The lesions were minimal to mild. In all other organs examined, no treatment-related changes were observed. Based on the observations made, the No observed adverse effect level (NOAEL) for the test compound octan-3-ol is considered to be 25 mg/Kg/day.
Reference
Table 1: Terminal body weight, body weight gain, and selected organ weights for male and female rats after administration of octan-3-ol in 90 days by gavage
Compound |
Vehicle control |
Octan-3-ol |
||
Dose (mg/kg body weight/day) |
0 |
25 |
100 |
400 |
Males |
|
|
|
|
Terminal body weight (g) |
408±35 |
399±41 |
407±30 |
417±55 |
Body weight gain (g/week) |
22.5±13.4 |
21.7±12.5 |
21.8±13.0 |
23.1±14.7 |
Absolute liver weight (g) |
11.54±0.80 |
11.89±1.77 |
12.08±1.95 |
13.25±2.16* |
Relative liver weight |
2.83±0.16 |
2.97±0.18 |
2.97±0.12 |
3.17±0.16** |
Absolute heart weight (g) |
1.07±0.08 |
1.14±0.13 |
1.17±0.10 |
1.16±0.17 |
Relative heart weight |
0.26±0.02 |
0.29±0.01* |
0.29±0.03** |
0.28±0.02 |
Females |
|
|
|
|
Terminal body weight (g) |
225±14 |
245±19** |
246±17** |
235±13 |
Body weight gain (g/week) |
9.5±8.1 |
10.9±8.9 |
11.2±8.9 |
9.9±8.6 |
Absolute liver weight (g) |
7.32±0.56 |
8.00±1.01 |
8.53±0.85** |
8.04±0.96 |
Relative liver weight |
3.27±0.33 |
3.27±0.39 |
3.48±0.36 |
3.42±0.30 |
Absolute heart weight (g) |
0.76±0.05 |
0.80±0.07 |
0.81±0.07 |
0.79±0.06 |
Relative heart weight |
0.34±0.04 |
0.33±0.03 |
0.33±0.02 |
0.34±0.02 |
Significantly different from the control group at *P<0.05, **P<0.01, ***P<0.001 by Student’s t-test. Pairwise comparison by t-test was only performed if preceded by a significant one-way ANOVA (p<0.05). Values are mean±S.D. The number of animals in each group was 10 males and 10 females unless otherwise stated.
Table 2: Selected hematology and clinical chemistry parameters for male and female rats after administration of octan-3-ol
Compound |
Vehicle control |
Octan-3-ol |
||
Dose (mg/kg body weight/day) |
0 |
25 |
100 |
400 |
Males |
|
|
|
|
White blood cell count (109/l) |
10.4±1.6 |
9.4±1.9 |
10.0±1.9 |
9.9±2.0 |
Mean cell volume (fl) |
48.0±1.3 |
47.4±1.1 |
46.7±1.6* |
48.5±1.3 |
Protrombin (sec) |
15.0±1.3 |
15.2±3.8 |
14.5±0.5 |
14.5±0.9 |
Calcium (mmol/l) |
2.74±0.09 |
2.73±0.13 |
2.72±0.11 |
2.72±0.10 |
Creatinine (mg/dl) |
57±5 |
55±5 |
56±2 |
58±6 |
Females |
|
|
|
|
White blood cell count (109/l) |
5.8±1.5 |
5.7±2.0 |
6.0±1.2 |
6.0±1.1 |
Mean cell volume (fl) |
49.5±2.1 |
48.9±1.5 |
48.3±2.3 |
49.6±1.3 |
Protrombin (sec) |
13.7±0.8 |
13.9±1.5 |
13.0±0.8 |
13.3±1.0 |
Calcium (mmol/l) |
2.71±0.13 |
2.76±0.17 |
2.74±0.13 |
2.72±0.10 |
Creatinine (mg/dl) |
57±4 |
57±3 |
57±7 |
59±5 |
Table 3: Number of rats with histological lesions in the liver after oral administration of octan-3-ol for 90 days
Compound |
Vehicle control |
Octan-3-ol |
||
Dose (mg/kg body weight/day) |
0 |
25 |
100 |
400 |
Males |
|
|
|
|
Granuloma |
6 (1.2) |
0 |
4 (1) |
6 (1.3) |
Periductular leukocyt infiltration |
3 ()1 |
1 (1) |
1(1) |
2 (1) |
Perivascular leukocyt infiltration |
2 (1) |
1 (1) |
0 |
0 |
Extramedullary haematopoiesis |
2 (1) |
0 |
2 (1) |
1 (1) |
Fatty changes |
0 |
0 |
0 |
3 (1) |
Cholangiofibrosis |
0 |
0 |
0 |
1 (1) |
Bile duct proliferation |
1 (1) |
1 (1) |
1 (1) |
6* (1) |
Females |
|
|
|
|
Granuloma |
5 (1) |
6 (1.2) |
6 (1) |
6 (1.3) |
Periductular leukocyt infiltration |
4 (1) |
1 (1) |
1 (1) |
0 |
Perivascular leukocyt infiltration |
2 (1) |
0 |
1 (1) |
4 (1) |
Extramedullary haematopoiesis |
2 (1) |
0 |
2 (1) |
1 (1) |
Fatty changes |
0 |
0 |
0 |
3 (1) |
Cholangiofibrosis |
0 |
0 |
0 |
0 |
Bile duct proliferation |
0 |
2 (1) |
3 (1.3) |
6* (1) |
Significantly different from the control group at *P<0.05 by Fisher’s exact test. Numbers in parentheses refer to average severity of lesions in affected animals: 1=minimal, 2=mild, 3=moderate, 4=marked. The number of animals in each group was 10 males and 10 females unless otherwise stated.
Table 4: Number of male rats with histological lesions in the kidney after oral administration of octan-3-ol for 90 days
Compound |
Vehicle control |
Octan-3-ol |
||
Dose (mg/kg body weight/day) |
0 |
25 |
100 |
400 |
Protein droplets |
10 (2.1) |
6 (1.2) |
6 (1) |
9 (2.7) |
Nephrocalcinosis |
0 |
0 |
3 (1) |
3 (1) |
Tubular karyomegaly |
0 |
0 |
4 (1) |
8*** (1.3) |
Tubular epithelial cell desquamation |
1 (1) |
4 (1) |
8** (1.1) |
7*(1.1) |
Tubular epithelial cell regeneration |
3 (1) |
1 (1) |
6 (1.2) |
4 (1) |
Pelvic inflammation |
1 (2) |
0 |
1 (1) |
1 (1) |
Interstitial lymphocytic infiltrations |
1 (1) |
0 |
1 (1) |
1 (1) |
Isolated tubular epithelial cell degeneration |
0 |
0 |
0 |
0 |
Papillary or cortical cyst(s) |
1 (1) |
0 |
0 |
0 |
Significantly different from the control group at: *P<0.05, **P<0.01, ***P<0.001 by Fisher’s exact test. Numbers in parentheses refer to average severity of lesions in affected animals: 1=minimal, 2=mild, 3=moderate, 4=marked. The number of animals in each group was 10 males and 10 females unless otherwise stated.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 25 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Data is from peer reviewed publication
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Repeated dose toxicity: Oral
Data available for the target chemical was refvied to determine the toxic nature of Octan-3-ol (CAS no 589 -98 -0). The study is as mentioned below:
90 days repeated dose oral toxicity study was performed to determine the toxic nature of Octan-3-ol (CAs no 589 -98 -0). The study was performed using male and female Wistar rats. The test chemical was dissolved in soyabean oil and used at dose level of 0, 25, 100 or 400 mg/Kg/day. During the study period, the animals were observed for mortality, clinical signs, food consumption, water consumption, body weight and organ weight changes, hematology, clinical chemistry parameters and the treated animals were subjected to gross and histopathology. Two animals in the low-dose group (25 mg/kg/day) died due to accidental intratracheal dosing and were excluded from the study. No effects on the clinical appearance of the rats attributed to dosing were observed. An increase in food consumption and a statistically significant increase in water uptake was observed among rats dosed with the test chemical. Statistically significant increases in terminal body weight were found for female rats dosed with octan-3-ol (100 and 400 mg/Kg/day), compared with the control group. Absolute and relative liver weights of the400 mg/kg/day dosed male rats were significantly higher than those of the control. A slight increase in absolute and relative liver weight was observed in the female rats dosed with 100 and 400 dosed groups compared with the controls. However, the changes were not dose related and only reached statistical significance for the 100 mg/kg/day dosed group (absolute liver weight). The relative heart weight was significantly increased in all dosed male rats except for the 400 mg/Kg/day dose octan-3-ol rats. No effect on relative heart weight was observed in female rats. No further treatment-related changes in organ weights were observed. Treatment-related effects were observed in the kidneys, but in males only. The incidences of tubular karyomegaly and luminal desquamation of tubular epithelial cells in the cortex were increased in rats dosed with the 100 and 400 mg/Kg/day of octan-3-ol, although the incidence of tubular karyomegaly in the 100 mg/Kg/day -dose octan-3-ol group was not significantly increased (P=0.08). The lesions were minimal to mild. In all other organs examined, no treatment-related changes were observed. Based on the observations made, the No observed adverse effect level (NOAEL) for the test compound octan-3-ol is considered to be 25 mg/Kg/day.
Based on the data available for the target chemical, Octan-3-ol is not likely to be toxic as per the critera mentioned in CLP regulation.
Justification for classification or non-classification
Based on the data available for the target chemical, Octan-3-ol (CAS no 589 -98 -0) is not likely to be toxic as per the critera mentioned in CLP regulation.
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