Octan-3-ol

Endpoint summary

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

Reference

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

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 (10^9/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 (10^9/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.

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.

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.