Octanoic acid, monoester with glycerol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study performed according to internationally accepted testing guideline, well documented.

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)

Deviations:

no

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

Molecular formula:

C11H22O4

IUPAC Name:

1,3-dihydroxypropan-2-yl octanoate; 2,3-dihydroxypropyl octanoate

Test material form:

other: waxy

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Bantin & Kingman Ltd., Grimston, Aldborough, Hull, U.K.
- Age at study initiation: approx. five to eight weeks
- Weight at study initiation: 128-150 g (females), 137-147 g (males)
- Fasting period before study: overnight before dosing and for approximately two hours after dosing
- Housing: in groups of up to five by sex in solid-floor polypropylene cages with sawdust bedding
- Diet: Rat and Mouse Expanded Diet No. I, Special Diet Services Limited, Witham, Essex, U.K.) ad libitum
- Water: drinking water ad libitum
- Acclimation period: five days

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 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: 5000 mg/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: recording of mortalities and observation of overt toxicity: 1 and 4 hours after dosing and then once daily for 14 days; recording of body weights on days 0, 7 and 14.
- Necropsy of survivors performed: gross necropsy and macroscopic examination on day 14 on all animals, no tissues were retained.

Statistics:

not performed

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

0

Clinical signs:

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

Gross pathology:

No abnormalities were noted at necropsy of animals killed at the end of
the study.

Other findings:

Not mentioned

Any other information on results incl. tables

Table 1: Number of animals dead and with evident toxicity

 

Dose (mg/kg bw)	Mortality (# dead/total)			Time range of deaths (hours)	Number with evident toxicity(#/total)
	Male	Female	Combined		Male	Female	Combined
5000	0	0	0	-	0	0	0

 

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Executive summary:

The acute oral median lethal dose (LD50) of the test material, octanoic acid, monoester with glycerol, to the Sprague-Dawley CFY stain rat was found to be greater than 5000 mg/kg bodyweight.