Glycerides, mixed decanoyl and octanoyl

Acute Toxicity: oral

Administrative data

Endpoint:

acute 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.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

lack of details on experimental conditions and on test substance

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Glycerides, mixed decanoyl and octanoyl

EC Number:

277-452-2

EC Name:

Glycerides, mixed decanoyl and octanoyl

Cas Number:

73398-61-5

Molecular formula:

C27H50O6 to C33H62O6

IUPAC Name:

Glycerides, mixed decanoyl and octanoyl

Details on test material:

- Name of test material (as cited in study report): only trade name reported
- Physical state: Straw-coloured clear liquid at room temperature
- Analytical purity: no data

Test animals

Species:

mouse

Strain:

other: Tyler's Original Strain

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Bantin and Kingman Ltd., Yorks, England, U.K.
- Age at study initiation: no data
- Weight at study initiation: 20 +/- 4 g
- Fasting period before study: overnight
- Housing: solid-floor polycarbonate cages
- Diet (e.g. ad libitum): Standard Laboratory Diet, 41B from Dixon and Sons Ltd., Herts, U.K.
- Water (e.g. ad libitum): yes
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED:
not reported

Doses:

12.5, 20 and 25 mL/kg
[equivalent to 11812.5, 18900 and 23625 mg/kg (Density 945 - 949 mg/cm³)]

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: throught the study period
- Necropsy of survivors performed: no data

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 12.5 mL/kg bw

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Remarks on result:

other: mouse

Mortality:

Deaths occurred within 24 - 48 hours in the 20 and 25 mL/kg dose groups. All survivors appeared asymptomatic by day 3, although certain individuals did show a slight loss in weight at day 7. No further details given.

Clinical signs:

other: Ataxia, lethargy, dyspnoe and diuresis were exhibited within 15 min of administration of the test substance. Complete loss of activity was shown in several animals within 2 hours, although other individuals were found to become more active by this time.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information acute oral LD50 in mice > 5000 mg/kg Criteria used for interpretation of results: EU