Glycine max. (L.) Merr. (Fabacee) aqueous alcoholic ext., concentrate by sequential extractions and filtration

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 06 - 26, 2013

Reliability:

1 (reliable without restriction)

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 423 (Acute Oral toxicity - Acute Toxic Class Method)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: OPPTS 870.1000

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Glycine max. (L.) Merr. (Fabacee) aqueous alcoholic ext., concentrate by sequential extractions and filtration

EC Number:

938-980-5

IUPAC Name:

Glycine max. (L.) Merr. (Fabacee) aqueous alcoholic ext., concentrate by sequential extractions and filtration

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Name: Soybean (Glycine max) dry purified extract
Batch No.: 29167/M1
Physical State: powder
Colour: yellow to light brown
Purity: 100%
Storage Conditions: at room temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Age at the beginning of the study: 8 – 9 weeks old
Body weight on the day of administration:
STEP1/animals no. 1- 3:142-165g
STEP2 / animals no. 4-6:141-151g

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

cotton seed oil

Doses:

For all animals of the first step, 2g of the test item were suspended in the vehicle to gain a final volume of 10mL and to achieve a dose of 200 mg/kg body weight at a dose volume of 10 mL/kg body weight.
For all animals of the secon step, 1.5g of the test item were suspended in the vehicle to gain a final volume of 7.5mL and to achieve a dose of 200 mg/kg body weight at a dose volume of 10 mL/kg body weight.

No. of animals per sex per dose:

3 per step

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality

Clinical signs:

Only animals of the second step showed signs of toxicity (reduced spontaneous activity, piloerection and half eyelid-closure), fully reversible within 4 hrs.

Body weight:

In the normal range of variation for this strain.

Gross pathology:

No macroscopic findings in any animals of any step.

Any other information on results incl. tables

All animal of both steps survived until the end of the study, but only animals of the second step showed signs of toxicity, which were fully reversible within 4 hours after administration of the test substance. The most relevant clinical findings in the animals of the second step treated with the test item at a dose of 2000 mg/kg bw were reduced spontaneous activity, piloerection and half eyelid-closure. Throughout the 14-day observation period, the weight gain of the animals was within the normal range of variation for this strain. At necropsy, no macroscopic findings were observed in any animal of any step.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The median lethal dose of Soybean (Glycine max) dry purified extract after a single oral administration to female rats, observed over a period of 14 days is: LD50 cut-off (rat): 5000 mg/ kg bw