2-tetradecyloctadecan-1-ol

Repeated dose toxicity: oral

Administrative data

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: Acceptable, well-documented study report which meets basic scientific principles

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)

Deviations:

yes

Remarks:

e. g. dosing 5d/week, no food consumption measurements, limited pathology

Principles of method if other than guideline:

Internal test protocoll which generally follows OECD 408 principles (which did not exist in 1973).

GLP compliance:

no

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-octyldodecan-1-ol

EC Number:

226-242-9

EC Name:

2-octyldodecan-1-ol

Cas Number:

5333-42-6

Molecular formula:

C20H42O

IUPAC Name:

2-octyldodecan-1-ol

Details on test material:

- Name of test material (as cited in study report): 2-Octyldodecanol
- Physical state: liquid
- Analytical purity: 100%
- Lot/batch No.: not given
- Expiration date of the lot/batch: not given
- Stability under test conditions: stable
- Storage condition of test material: no specific conditions

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Mus Rattus. Brunntal
- Weight at study initiation: 153 g (m), 142 g (f)
- Housing: type III Macrolon cages with 5 animals each
- Diet : ad libitum
- Water: ad libitum
- Acclimation period: 8d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/- 1°C
- Humidity (%): 60 +/- 5%
- Photoperiod (hrs dark / hrs light): natural daylight cycle

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

- Justification for use and choice of vehicle (if other than water): stable in olive oil

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

13 weeks

Frequency of treatment:

daily

Doses / concentrations

Dose / conc.:

1 other: ml/kg bw

Remarks:

actual ingested

No. of animals per sex per dose:

10 m /10 f per dose

Control animals:

yes, concurrent vehicle

Positive control:

none

Examinations

Observations and examinations performed and frequency:

CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily

DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: at termination of the study with half of the animals in the control group/dose group

BODY WEIGHT: Yes
- Time schedule for examinations: weekly
- Body weight gain : Yes

OPHTHALMOSCOPIC EXAMINATION: No

HAEMATOLOGY: Yes
- Time schedule for collection of blood: at termination of the study
- Anaesthetic used for blood collection: No
- Animals fasted: No data
- How many animals: half of dose group and control

CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at termination of the study
- Animals fasted: No data
- How many animals: half of dose group and control

URINALYSIS: Yes
- Time schedule for collection of urine: at termination of the study
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data

NEUROBEHAVIOURAL EXAMINATION: No

Sacrifice and pathology:

GROSS PATHOLOGY: Yes (see table)
HISTOPATHOLOGY: Yes (see table)

Statistics:

Standard t-test

Results and discussion

Results of examinations

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):

not specified

Food efficiency:

not specified

Water consumption and compound intake (if drinking water study):

not specified

Ophthalmological findings:

not examined

Haematological findings:

no effects observed

Clinical biochemistry findings:

no effects observed

Urinalysis findings:

no effects observed

Behaviour (functional findings):

not specified

Organ weight findings including organ / body weight ratios:

no effects observed

Gross pathological findings:

no effects observed

Histopathological findings: non-neoplastic:

no effects observed

Histopathological findings: neoplastic:

no effects observed

Details on results:

CLINICAL SIGNS AND MORTALITY
No clinical signs or mortality was observed.

BODY WEIGHT AND WEIGHT GAIN
There were no statistically significant differences in body weights or body weight gains between the dose and control group.

FOOD AND WATER CONSUMPTION
Food and water consumption was not recorded but was considered to be normal in all groups.

HAEMATOLOGY
There were no differences between dose and control groups in the recorded hematological parameters. All values were within the normal range for animals of this age.

CLINICAL CHEMISTRY
There were no statistically significant differences in clinical chemistry parameters between the dose and control group.

URINALYSIS
There were no statistically significant differences in urine parameters between the dose and control group.

ORGAN WEIGHTS
Organ weights were in the normal range for rats of this age. There were no statistically significant differences in organ weights between dose and control groups.

GROSS PATHOLOGY
No biologically relevant findings were observed in the control or dose animals.

HISTOPATHOLOGY: NON-NEOPLASTIC
No biologically relevant findings were reported for the organs that were histologically investigated. All individual findings were accidental and usual for rats of this age and were found in both, control and dose animals.

Effect levels

Key result

Dose descriptor:

NOEL

Effect level:

>= 1 other: mL/kg bw

Sex:

male/female

Basis for effect level:

other: overall effects

Target system / organ toxicity

Critical effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

There was no indication that 2-octyl dodecanol was toxic in male or female Wistar rats at the limit dose of 1 mL/kg bw.

Executive summary:

2-Octyl dodecanol was investigated in a 13 week subchronic toxicity study in male and female Wistar rats. 1 mL/kg bw of the substance was administered by gavage or the animals received olive oil as a control (vehicle).

No clinical signs or mortality was observed. There were no statistically significant differences in body weights or body weight gains between the dose and control group. Food and water consumption was not specifically recorded but was considered to be normal by observation in all groups.

There were no differences between dose and control groups in the recorded hematological parameters. All values were within the normal range for animals of this age.

There were no statistically significant differences in clinical chemistry parameters between the dose and control group. No statistically significant differences in urine parameters between the dose and control group were observed. Organ weights were in the normal range for rats of this age. There were no statistically significant differences in organ weights between dose and control groups.

No biologically relevant macroscopical findings were observed in the control or dose animals.

No biologically relevant findings were reported for the organs that were histologically investigated. All individual findings were accidental and usual for rats of this age and were found in both, control and dose animals.

There was no indication that 2-octyl dodecanol was toxic in a 13 week subchronic study with male or female Wistar rats at the limit dose of 1 mL/kg bw.