Glycerol trioctanoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

08 Feb - 08 Mar 1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Lack of details on test material

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted in 1987

Deviations:

yes

Remarks:

Lack of details on test material

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Octanoic acid, monoester with glycerol

EC Number:

247-668-1

EC Name:

Octanoic acid, monoester with glycerol

Cas Number:

26402-26-6

IUPAC Name:

2,3-dihydroxypropyl octanoate

Test material form:

solid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Remarks:

CFY strain

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Bantin & Kingman Ltd., Hull, UK
- Age at study initiation: 5-8 weeks
- Weight at study initiation: males: 137-147 g, females: 128-150 g (range)
- Fasting period before study: yes, overnight
- Housing: in groups of 5 animals in solid floor polypropylene cages with sawdust bedding
- Diet: ad libitum, commercial rat diet
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 40-65
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: 08 Feb 1989 - 22 Feb 1989

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 500 mg/mL
The test material was freshly prepared as a suspension at the appropriate concentration in arachis oil B.P.
The preparation was warmed to aid solubilisation.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 1 and 4 hours after dosing and subsequently once daily for 14 days. Body weights were determined on day of treatment (Day 0), Day 7 and Day 14.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

There were no deaths.

Clinical signs:

other: No overt signs of toxicity were noted during the study.

Gross pathology:

No abnormalities were noted at necropsy of animals.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.