Soybean oil, epoxidized, reaction products with methanol

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: Non GLP, non-guideline, animal experimental study. Restrictions in reporting but otherwise adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The acute oral toxicity of Cetiol R was tested in an approximate manner on 5 male and 5 female rats. A quantity of 2000 mg of the test substance/kg bodyweight in a 2 % aqueous carboxymethyl cellulose preparation (w/w) was administered to the test animals on one single occasion by gavage. After
treatment the animals were observed over a period of 14 days.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Soybean oil, epoxidized, reaction products with methanol

EC Number:

287-837-7

EC Name:

Soybean oil, epoxidized, reaction products with methanol

Cas Number:

85586-35-2

Molecular formula:

C H4 O . Unspecified

IUPAC Name:

1-({13-[(1-{2,3-bis[(9,13-dihydroxy-10,12-dimethoxyoctadecanoyl)oxy]propoxy}-10-methoxy-1-oxooctadecan-9-yl)oxy]-9-hydroxy-10,12-dimethoxyoctadecanoyl}oxy)-3-[(9-hydroxy-10-methoxyoctadecanoyl)oxy]propan-2-yl 9,13-dihydroxy-10,12-dimethoxyoctadecanoate; 1-[(9,13-dihydroxy-10,12-dimethoxyoctadecanoyl)oxy]-3-[(9-hydroxy-10-methoxyoctadecanoyl)oxy]propan-2-yl 9,13-dihydroxy-10,12-dimethoxyoctadecanoate; 3-({8-[3-(3-hydroxy-2-methoxyoctyl)oxiran-2-yl]octanoyl}oxy)-2-[(8-{3-[(3-pentyloxiran-2-yl)methyl]oxiran-2-yl}octanoyl)oxy]propyl 9-hydroxy-10-methoxyoctadecanoate; 3-[(8-{3-[3-({1-[3-({8-[3-(3-hydroxy-2-methoxyoctyl)oxiran-2-yl]octanoyl}oxy)-2-[(8-{3-[(3-pentyloxiran-2-yl)methyl]oxiran-2-yl}octanoyl)oxy]propoxy]-10-methoxy-1-oxooctadecan-9-yl}oxy)-2-methoxyoctyl]oxiran-2-yl}octanoyl)oxy]-2-[(8-{3-[(3-pentyloxiran-2-yl)methyl]oxiran-2-yl}octanoyl)oxy]propyl 9-hydroxy-10-methoxyoctadecanoate

Details on test material:

- Name of test material (as cited in study report): Cetiol R
- Physical state: clear, yellow, viscous liquid.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Average male body weight: 219 g
- Average female body weight: 165 g
- Animals were fasted for 16 hours prior to dosing

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

Concentration in vehicle: 2%


VEHICLE
- Concentration in vehicle:
- Amount of vehicle (if gavage):
- Justification for choice of vehicle:
- Lot/batch no. (if required):
- Purity:

MAXIMUM DOSE VOLUME APPLIED:

DOSAGE PREPARATION (if unusual):

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:

Doses:

2000 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 weighing: 48 hours, 7 and 14 days
- Necropsy of survivors performed: yes, by means of an overdose of aranaesthetic and dissected.
- Other examinations performed: clinical signs, body weight, pathology.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: No intoxication symptoms were observed.

Gross pathology:

No anatomicopathological changes in the inner organs or in the body cavities were found.