Soybean oil, epoxidized

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January 22, 1981 - February 4, 1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: May not be GLP compliant. Control animals were not mentioned. As no signs of toxicity were seen in 10 rats it is safe to assume that Soybean oil, epoxidised is not toxic therefore this deviation should not be an issue.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

no guideline available

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Conduct of the study predates formal adoption of the test guideline but in principle the OECD 401 limit method was followed. No vehicle control animals were included. The vehicle, designated PAG in the report, was not tested separately.

Principles of method if other than guideline:

Although pre-dating the formal guideline, the study was conducted in general concordance with a limit test as described in OECD method 401. The vehicle selected was described as PAG with no elucidation. It is assumed that it was polyethylene glycol (PEG), which was comonly used for acute gavage administration and this would explain the absence of a separate vehicle control group.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

TK 11'278

IUPAC Name:

TK 11'278

Constituent 2

Reference substance name:

Soybean oil, epoxidized

EC Number:

232-391-0

EC Name:

Soybean oil, epoxidized

Cas Number:

8013-07-8

Molecular formula:

Not necessary, substance is a UVCB.

IUPAC Name:

Soybean oil, epoxidized

Details on test material:

- Name of test material (as cited in study report): TK 11278
- Physical state: Liquid
- Lot/batch No.: prod. Oct. 80


Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.
The test material was dispersed in PAG - probably polyethylene glycol (PEG) and administered in a dose volume of 20 mL/kg bw.

Test animals

Species:

rat

Strain:

other: Tif: RAIf (SPF) Strain

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Healthy random bred rats of the Tif:RAIf (SPF) strain , which were raised on the Ciba-Geigy Ltd, Basle, laboratory premises
- Age at study initiation: 7 to 8 weeks old
- Weight at study initiation: male mean = 185g; female mean = 174g
- Fasting period before study: rats were fasted overnight prior to treatment
- Housing: in groups of 5 in Macrolan cages
- Diet (e.g. ad libitum): NAFAG, Gossau SG
- Water (e.g. ad libitum): potable water source not specified in report
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 55 ± 10 %
- Air changes (per hr): Not specified
- Photoperiod (hrs dark / hrs light): 14/10

IN-LIFE DATES: From: 22 January 1981 To: 4 February 1981

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: PAG. Assumed to be PEG = polyethylene glycol

Details on oral exposure:

The report indicates PAG was used as a vehicle (it is assumed this is a typographical error and that PEG, polyethylene glycol was actually used).
The test material was dispensed at 20 ml/kg bw.

Animals were fasted overnight and treated by single oral intubation.

Doses:

5000 mg/kg

No. of animals per sex per dose:

5 animals per group

Control animals:

not specified

Details on study design:

Bodyweights were recorded immediately prior to dosing and after 7 and 14 days. Physical condition and mortality were monitored throughout the observation period.

Statistics:

LD50 including 95 % confidence limits are calculated by the logit model.

Results and discussion

Preliminary study:

Not relevant

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No confidence intervals or median lethal dose calculated for the 5g/kg bw limit test

Mortality:

None of the rats died

Clinical signs:

other: See Table 2 below Evidence of slight dyspnoea, slightly ruffled fur, slight diarrhoea and a slightly curved body position were noted primarily on Day 1 (1-24 h after administration). Some cases of ruffled fur and curved body position persisted on days 2

Gross pathology:

No gross organ changes were observed

Other findings:

No further information supplied

Any other information on results incl. tables

Table 1: Bodyweight change

	Dose – 5000 mg/kg
	Mean (g)	Standard Deviation (g)
Day 1 (Male)	185	1.8
Day 1 (Female)	174	1.2
Day 7 (Male)	236	5.1
Day 7 (Female)	186	1.8
Day 14 (Male)	289	5.7
Day 14 (Female)	215	2.9

  

Table 2: Clinical Signs

Dose – 5000 mg/kg

Signs and Symptoms

Hours

Days

1

2

3

5

24

2

3

4

5

6

7

8

9

10

11

12

13

14

Sedation

Dyspnoea

+

+

Dacryorrhoea

Chromodacryorrhoea

Rinorrhoea

Epistaxis

Exophthalmos

Salivation

Ruffled fur

+

+

+

+

+

+

+

+

Pallor

Cyanosis

Diarrhoea

+

+

+

Body Position (ventral)

Body Position (lateral)

Body Position (curved)

+

+

+

+

+

+

Ataxia

Trismus

Tremor

Tonic clonic muscle spasms

Convulsions

 + = slight

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 of TK 11'278 in rats of both sexes observed over a period of 14 days is greater than 5000 mg/kg. The test material is therefore practically non toxic to the rat by this route of administration. According to Directive 67/548/EEC, no classification is warranted. According to Regulation (EC) No. 1272/2008, no classification is warranted.

Executive summary:

The acute oral LD50 of TK 11'278 in rats of both sexes observed over a period of 14 days is greater than 5000 mg/kg. The test material is therefore practically non toxic to the rat by this route of administration. According to Directive 67/548/EEC, no classification is warranted. According to Regulation (EC) No. 1272/2008, no classification is warranted.