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Toxicological information

Repeated dose toxicity: oral

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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:
OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity 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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 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.