Extract from the seeds of Trigonella foenum-graecum (Fabaceae) obtained by extraction with polar solvents

Endpoint summary

Description of key information

No acute oral toxicity (not classified)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

03 September 2019 - 17 December 2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

up-and-down procedure

Limit test:

yes

Specific details on test material used for the study:

Identification/Synonym FENUGREEK EXTRACT
Substance type UVCB substance
EC No. 950-727-0
Storage conditions room temperature, protected from light

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Females nulliparous and non-pregnant
- Rationale for use of males (if applicable)
- Age at study initiation: 6 - 7 weeks
- Weight at study initiation: 173.7 - 181.4 grams
- Housing: Polisulfone solid bottomed cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 °C±2 °C
- Humidity: 55%±15%
- Air changes: 15 to 20 air changes per hour
- Photoperiod (dark / light): 12 / 12 hours

Route of administration:

oral: gavage

Vehicle:

water

Doses:

2000 mg/kg

No. of animals per sex per dose:

1 female rat per group (5 groups in total)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: on dosing, 0.5 h, 2 h, 4 h and daily after dosing
- Necropsy of survivors performed: yes
- Clinical signs including body weight observed

Statistics:

median lethal dose (LD50)

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Mortality did not occur

Clinical signs:

No clinical signs observed

Body weight:

Wthin the expected range

Interpretation of results:

GHS criteria not met

Conclusions:

These results indicate that the test item did not induce toxic effects in the rat following oral administration of a single dose at a level of 2000mg/kg. The lack of mortality demonstrates the acute toxicity estimate (ATE) to be greater than 2000 mg/kg body weight.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed