Octanoic acid, ester with 1,2,3-propanetriol

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: Basic data given. Dosing concentration unclear.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

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:

lack of details on test substance, only limited examination parameters.

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

73398-61-5

Cas Number:

73398-61-5

IUPAC Name:

73398-61-5

Details on test material:

- Name of test material (as cited in study report): only trade name given
- Physical state: yellowish, odourless liquid
- Analytical purity: no data
- Other: not water soluble

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 120 - 150 g
- Housing: 2 animals
- Diet: standard pellet diet (ssniff R, Intermast GmbH, Germany), ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:

oral: feed

Vehicle:

unchanged (no vehicle)

Analytical verification of doses or concentrations:

no

Duration of treatment / exposure:

90 days

Frequency of treatment:

daily, 7 days/week

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
10000 and 50000 ppm
Basis:
nominal in diet

Doses / concentrations 2

Remarks:

Doses / Concentrations:
approx. 1000 and 5000 mg/kg bw/day
Basis:
other: assuming a mean body weight of 200 g and a mean food intake of 20 g/day over the study period

No. of animals per sex per dose:

20

Control animals:

yes, plain diet

Examinations

Observations and examinations performed and frequency:

CAGE SIDE OBSERVATIONS: Yes, daily

BODY WEIGHT: Yes
- Time schedule for examinations: every 14 days

FOOD CONSUMPTION: Yes

URINALYSIS: Yes
- Time schedule for collection of urine: at the middle and end of study period
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters checked:

CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at the middle and end of study period
- Animals fasted: No data
- How many animals: all animals
- Parameters checked: GOT, GPT, determination of free fatty acids and fatty acid esters

ORGAN WEIGHTS: Yes

Sacrifice and pathology:

GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: No

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):

no effects observed

Food efficiency:

not examined

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

not examined

Ophthalmological findings:

not examined

Haematological findings:

no effects observed

Clinical biochemistry findings:

no effects observed

Urinalysis findings:

no effects observed

Behaviour (functional findings):

not examined

Organ weight findings including organ / body weight ratios:

not examined

Gross pathological findings:

no effects observed

Histopathological findings: non-neoplastic:

not examined

Histopathological findings: neoplastic:

not examined

Details on results:

CLINICAL SIGNS AND MORTALITY
No signs of systemic toxicity and no deaths occured.

BODY WEIGHT AND WEIGHT GAIN
No significant differences in the body weight gain of treated and control animals occured.

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
Food consumption increased from 15 - 17 g/ day to 20 - 22 g/ day during the study period and did not differ significantly from the untreated control group.

HAEMATOLOGY
Hemoglobin, Erythrocyte and Leukocyte parameters did not differ significantly from the control group.

CLINICAL CHEMISTRY
GOT and GPT values did not differ significantly from the control group.
Blood contents on free fatty acids and fatty acid esters did not differ significantly from the control group, indicating that the treatment did not influence the lipid metabolism.

URINALYSIS
The urine did not contain protein, glucose or urobilinogen. pH and urine sediment analysis were not changed.

ORGAN WEIGHTS
No significant differences between treated and control groups observed.

GROSS PATHOLOGY
No abnormalities observed.

Effect levels

Dose descriptor:

NOAEL

Effect level:

5 000 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: see 'Remark'

Target system / organ toxicity

Critical effects observed:

not specified