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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Test guidelineopen allclose all
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

Test material

Constituent 1
Reference substance name:
Extract from the seeds of Trigonella foenum-graecum (Fabaceae) obtained by extraction with polar solvents
EC Number:
950-727-0
Molecular formula:
Fenugreek extract
IUPAC Name:
Extract from the seeds of Trigonella foenum-graecum (Fabaceae) obtained by extraction with polar solvents
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

Test animals

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

Administration / exposure

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)

Results and discussion

Effect levels
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

Applicant's summary and conclusion

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.

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