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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
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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
No signs of systemic toxicity were noted.
Body weight:
All animals showed expected gains in bodyweight over the observation period.
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.