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Toxicological information

Acute Toxicity: oral

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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

Constituent 1
Chemical structure
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
Details on test material:
- Name of test material: Imwitor 308
- Substance type: Product
- Physical state: white waxy solid
- Lot/batch No.: Chg 013
- Expiration date of the lot/batch: not mentioned
- Stability under test conditions: yes
- Storage condition of test material: room temperature

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

 

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.