Soybean oil, oligomerized

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

9 Oct - 6 Nov 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

In compliance with GLP and according to OECD guideline 420

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Soybean oil, polymerized

EC Number:

614-279-7

Cas Number:

68122-64-5

Molecular formula:

Not applicable for UVCB

IUPAC Name:

Soybean oil, polymerized

Details on test material:

- Name of test material (as cited in study report): Soybean oil, polymerized
- Physical state: pale amber coloured liquid
- Lot/batch No.: confidential information
- Storage condition of test material: at room temperature in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories U.K. Ltd.
- Age at study initiation: 8 to 12 weeks
- Fasting period before study: food removed overnight prior to dosingreturned three to four hours after dosing
- Housing: in groups up to four in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): Rodent 2014C Teklad Global Certified Diet (Harlan Laboratories) ad libitum
- Water (e.g. ad libitum): ad libitium
- Acclimation period: at least 5 days
- Other: females were nulliparous and non-pregnant
- Other: bodyweight variation did not exceed appr 20% of the bodyweight of the initially dosed animal

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Justification for choice of vehicle: Test item did not dissolve/suspend in distilled water

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: based on available information on toxicity of the test item

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 (females)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: morbidity/mortality: twice daily, early and late, during normal working days, once daily at weekends. Clinical observations half an hour and 1,2, and 4 hours after dosing, then daily for 14 days. Individual bodyweights recorded on day 0 (prior to dosing), day 7, and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: no

Statistics:

not relevant

Results and discussion

Preliminary study:

Prior to the main test, a sighting test was performed in which 1 female rat was dosed 2000 mg/kg bw). Based on the absence of mortality, 4 additional animals were dosed with 2000 mg/kg bw.

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

other: No signs of systemic toxicity were noted.

Gross pathology:

No abnomalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Remarks:

Based on CLP criteria

Conclusions:

In an acute oral toxicity study which was performed according to guideline OECD420 (fixed-dose procedure) and under GLP conditions, the acute oral toxicity potential of Standolized Soybean Oil was investigated. The acute oral median lethal dose (LD50) of test item in the female Wistar strain rat was observed to be greater than 2000 mg/kg bw, under the conditions of this study. The substance therefore does not need to be classified according to the classification criteria outlined in Annex VI of 67/548/EEC and Annex I of 1272/2008/EC.

Executive summary:

In an acute oral toxicity study which was performed according to guideline OECD420 (fixed-dose procedure) and under GLP conditions, the acute oral toxicity potential of Standolized Soybean Oil was investigated. Following a sighting test at a dose level of 2000mg/kg bw, an additional four fasted female animals were administered a single oral dose of Standolized Soybean Oil as a solution in arachis oil BP, at a dose level of 2000 mg/kg bw. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

No mortality was noted and no signs of systemic toxicity were observed. Furthermore, no abnormalities were noted at necropsy. The oral LD50 of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bw, under the conditions of this study. The substance therefore does not need to be classified according to the classification criteria outlined in Annex VI of 67/548/EEC and Annex I of 1272/2008/EC.