Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
study completion date: 02 MAY 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study is performed according to OECD guideline and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Vegeflux soy
- Substance type: UVCB
- Physical state: viscous liquid
- Stability under test conditions: data not available
- Storage condition of test material: at room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Animal House, SGS Life Sciences Services
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 210 - 244 g
- Fasting period before study: data not available
- Housing: animals were housed group wise (3 animals per cage) in standard polypropylene cages with stainless steel top grill
- Diet: rat pellet feed (Amrut brand), ad libitum
- Water: potable water, ad libitum
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19.9 - 22.5 °C
- Humidity: 60 - 69%
- Air changes (per hr): data not available
- Photoperiod (hrs dark / hrs light): data not available

IN-LIFE DATES: from 14 March 2008 to 5 April 2008

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 2% DMSO in distilled water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: data not available
- Amount of vehicle (if gavage): 10 mL / kg bw
- Justification for choice of vehicle: data not available

CLASS METHOD
- Rationale for the selection of the starting dose: data not available
Doses:
300 and 2000 mg/kg bw
No. of animals per sex per dose:
6 female animals per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
> general health and mortality: animals were observed daily for mortality and morbidity. Clinical signs were recorded at 30 minutes and then at 1h interval till 4h on the day of dosing and daily thereafter for a period of 14 days
> body weight: body weight of each animal was recorded prior to dosing and at weekly interval thereafter
- Necropsy of survivors performed: yes
Statistics:
not applicable

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: no mortality
Mortality:
No mortality was observed in any of the animals treated with the test item
Clinical signs:
All the animals treated with the test item were found normal throughout the 14 day observation period
Body weight:
No marked changes were observed in the body weight gain of animals treated with the test item
Gross pathology:
The lesions observed were found in the study matched with the historical gross pathology data. Hence the lesions observed can not be related to the test item

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 of Vegeflux Soy is > 2000 mg/kg bw by oral intake
Executive summary:

In an acute oral toxicity study (Venkatasubramani R, 2008), groups of 8-12 weeks old Wistar rats (2 x 3 females per group) were given a single oral dose of Vegeflux Soy in 2% DMSO at doses of 300 and 2000 mg/kg bw and observed for 14 days. The test was performed according to OECD test guideline 423 and GLP.

 

Oral LD50 Females > 2000 mg/kg bw

No mortality, clinical signs, body weight changes or gross pathology changes were observed during the observation period.

 

Vegeflux Soy is of low toxicity based on the LD50 in females by gavage. Vegeflux soy is not classified as dangerous according to EU criteria, by oral intake.