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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

The acute toxicity of 90% ehanolic extract of Indigofera tinctoria was determined as per the OECD guideline no. 423 (Acute Toxic Class Method). It was observed that the test extract was not mortal even at 2000mg/kg dose. Other studies support this result. The other oral toxicity study informs that LD0 is 4000 -5000 mg/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:
other: Journal of Pharmaceutical Sciences and Research, 2009
Adequacy of study:
key study
Study period:
na
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
not specified
Test type:
acute toxic class method
Specific details on test material used for the study:
The leaves of Indigofera tinctoria Linn. was collected from abirami botanicals of Tuticorin, Tamilnadu, India
Species:
mouse
Strain:
not specified
Sex:
male
Details on test animals or test system and environmental conditions:
Male albino mice (20-25g) were obtained from the animal house in C.L. Baid Metha College of Pharmacy, Chennai. The animals were maintained in a wellventilated room with 12:12 hour light/dark cycle in polypropylene cages. The animals were fed with standard pellet feed
(Hindustan Lever Limited., Bangalore) and water was given ad libitum.
Route of administration:
oral: unspecified
Vehicle:
ethanol
Doses:
2000mg/kg
No. of animals per sex per dose:
not specified
Control animals:
not specified
Sex:
male
Dose descriptor:
LD0
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
It was observed that the test extract was not mortal even at 2000mg/kg dose.
Clinical signs:
not specified
Body weight:
Not specified
Interpretation of results:
GHS criteria not met
Conclusions:
The acute toxicity of 90% ehanolic extract of Indigofera tinctoria was determined as per the OECD guideline no. 423 (Acute Toxic Class Method). It was observed that the test extract was not mortal even at 2000mg/kg dose.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Key study is OECD guideline study.

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

Justification for classification or non-classification

The product is not classified. LD50 is over 2000mg/kg bw.