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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:
December 20th, 2013 to January 24th, 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was carried according to OECD guideline 420. A minor deviation (one animal was not observed on day 8) was reported and it is not deemed to affect the scientific validity of the study.

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
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
yes
Remarks:
One animal was not examined on day 8 however since no clinical signs were reported prior and after day 8, this deviation is not deemed to affect the scientific validity of the study.
Qualifier:
according to guideline
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
yes
Remarks:
One animal was not examined on day 8 however since no clinical signs were reported prior and after day 8, this deviation is not deemed to affect the scientific validity of the study
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Soybean oil, epoxidized, ether with ethylene glycol
EC Number:
287-836-1
EC Name:
Soybean oil, epoxidized, ether with ethylene glycol
Cas Number:
85586-34-1
Molecular formula:
UVCB-not applicable
IUPAC Name:
Soybean oil, epoxidized, ether with ethylene glycol
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report):Soybean, epoxydised, ether with ethylene glycol
- Physical state: Viscous liquid
- Lot/batch No.: 39595
- Stability under test conditions: The test material is expected to be stable for the duration of the test.
- Storage condition of test material: 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 UK Ltd.
- Age at study initiation: 8-12 weeks of age
- Weight at study initiation: 168-201 g
- Fasting period before study: Overnight fast immediately before dosing and for approximately 3 to 4 hours after dosing
- Housing: Groups of up to 4 animals in suspended solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): Food (2014C Teklad Global Rodent diet) ad libitum
- Water (e.g. ad libitum): drinking water ad libitum
- Acclimation period: At least 5 days

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

IN-LIFE DATES: From: December 20th, 2012 To: January 24th, 2013

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Remarks:
Arachis oil BP was used because the test item did not dissolve in water.
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 30 mg/mL
- Justification for choice of vehicle: The test substance did not dissolve/suspend in water.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: In the absence of data regarding toxicity, one animal was administered 300 mg/kg of test substance. In the absense of toxicity at the 300 mg/kg dose level, an additional animal was treated at 2000 mg/kg. Since no toxicity was reported at 2000 mg/kg, 4 additional animals were treated at a dose level of 2000 mg/kg,
Doses:
300 and 2000 mg/kg bw
No. of animals per sex per dose:
300 mg/kg: 1 animal
2000 mg/kg: 5 animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days (or other?) 14 days
- Frequency of observations and weighing: clinical observations were made at 30 minutes, 1, 2 and 4 hours after dosing and once daily therafter until study termination. Morbidity and mortality were checked twice daily. Body weights were recorded on the day of administration and on days 7 and 14.
- Necropsy of survivors performed: yes, necropsy was performed at the end of the 14-day observation period.
- Other examinations performed: At necropsy, external examination and opening of the abdominal and thoracic cavities were carried out. The appearance of any macroscopic abnormalities was recorded and no tissues were retained.
Statistics:
Not applicable

Results and discussion

Preliminary study:
No mortality was reported at 300 mg/kg bw in one animal. No mortality was recorded in animals treated with a dose level of 2000 mg/kg bw.
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality at the Limit Dose
Mortality:
There was no mortality at 300 and 2000 mg/kg bw.
Clinical signs:
other: No signs of toxicity were reported during the course of the study.
Gross pathology:
No abnormalities were reported at necrospy
Other findings:
Not applicable

Any other information on results incl. tables

No additional results or findings were reported.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study, the acute oral median lethal dose (LD50) for female rats is greater than 2000 mg/kg bw.
Executive summary:

This study was conducted to determine the acute oral toxicity of soybean, epoxydised, ether with ethylene glycol when administered by gavage to female Wistar rats at the limit dose level 2000 mg/kg bw. The test substance was administered as a solution in arachis oil. In the absence of toxicity data, a preliminary test was performed at 300 mg/kg bw and 2000 mg/kg bw. No effect was reported at these dose levels and 4 additional animals were treated at 2000 mg/kg bw. The animals were fasted overnight prior to dosing. The rats were observed for 14 days following administration. No mortalities were observed; no abnormal clinical findings were reported and all animals gained weight throughout the course of the study. Gross pathology performed at the end of the 14-day observation period did not show abnormal findings. Based on these results under the conditions of this study, the acute oral LD50 was found to exceed 2000 mg/kg bw.