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Description of key information

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:
other: Acceptable, well-documented study report which meets basic scientific principles
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
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
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
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
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
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.
Key result
Dose descriptor:
NOEL
Effect level:
>= 1 other: mL/kg bw
Sex:
male/female
Basis for effect level:
other: overall effects
Critical effects observed:
not specified
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
839.6 mg/kg bw/day

Repeated dose toxicity: inhalation - systemic effects

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Reference
Endpoint:
sub-chronic toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
other:
Critical effects observed:
not specified
Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

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Reference
Endpoint:
sub-chronic toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
other:
Critical effects observed:
not specified
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

A well documented 13 week subchronic toxicity study is available for 2-octyldodecan-1-ol (C20). Male and female rats received the sustance daily by gavage. There were no indications that 2-octyldodecan-1-ol was toxic at the limit dose of 1 ml/kg bw/d. Due to their structural similarity no effects are expected after repeated oral application of the other Guerbet alcohols of this category either.

Additional data are available for the linear C22-alcohol docosan-1-ol. In a repeated dose toxicity study conducted according to a Guideline similar to OECD Guideline 408 male and female rats received oral doses of up to 1000 mg/kg daily for 26 weeks. No effects were observed resulting in a NOEL of 1000 mg/kg bw.

Justification for classification or non-classification

Available data are conclusive but not sufficient for classfication of 2 -octyldodecan-1-ol with regard to repeated dose toxicity.