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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

In one acute oral study (K2), the oral LD50 was found to be superior to 5 g/kg bw

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:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Basic data given, but considered sufficiently reliable for the purpose of hazard assessment
Principles of method if other than guideline:
Standard acute method (limit test)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
No data
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No data
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
No data
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 animals/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Observations for mortality and toxic effects were made daily for 14 days
- Necropsy of survivors performed: No data
Statistics:
None
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
1 mortality was observed at day 8
Clinical signs:
other: No clinical signs were observed (except the death).
Gross pathology:
No data
Other findings:
No data

None

Interpretation of results:
GHS criteria not met
Conclusions:
Under the experimental conditions of this study, the test substance is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.
Executive summary:

In an acute oral toxicity study (limit test), ten rats were given a single oral dose of Fenugrec Aboslute at 5000 mg/kg bw. Animals were observed for mortality and clinical signs for 14 days.

One mortality was observed at day 8. In this study, the oral LD50 was higher than 5000 mg/kg bw in rats.

No other clinical signs were observed.

Under the experimental conditions of this study, the test substance is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In an acute oral toxicity study (limit test), ten rats were given a single oral dose of Fenugrec Aboslute at 5000 mg/kg bw. Animals were observed for mortality and clinical signs for 14 days.

One mortality was observed at day 8. In this study, the oral LD50 was higher than 5000 mg/kg bw in rats.

No other clinical signs were observed.

Under the experimental conditions of this study, the test substance is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.

Justification for classification or non-classification

Self classification:

Acute toxicity via Oral route:

Based on the available data, the substance is not classified according to the Regulation (EC) No. 1272/2008 as the LD50 is greater than 5000 mg/kg bw