Registration Dossier
Registration Dossier
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EC number: 283-892-6 | CAS number: 84775-63-3 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Indigofera tinctoria, Leguminosae.
Acute Toxicity: oral
Administrative data
- 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
Data source
Reference
- Reference Type:
- publication
- Title:
- Evaluation of the antinociceptive properties from Indigofera tinctoria leaves extracts
- Author:
- Saravana Kumar A., 1Gandhimathi R., 1Mohana Lakshmi S., 1Rahul Nair.,
1Ashok.Kumar.C.K - Year:
- 2 009
- Bibliographic source:
- J. Pharm. Sci. & Res. Vol.1(2), 2009, 31-37.
- Report date:
- 2009
Materials and methods
Test guideline
- 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
Test material
- Reference substance name:
- Indigofera tinctoria, ext.
- EC Number:
- 283-892-6
- EC Name:
- Indigofera tinctoria, ext.
- Cas Number:
- 84775-63-3
- Molecular formula:
- n/a
- IUPAC Name:
- Indigofera tinctoria, ext.
- Test material form:
- solid: particulate/powder
- Details on test material:
- The leaves of Indigofera tinctoria Linn. was collected from abirami botanicals of Tuticorin, Tamilnadu, India.
Constituent 1
- Specific details on test material used for the study:
- The leaves of Indigofera tinctoria Linn. was collected from abirami botanicals of Tuticorin, Tamilnadu, India
Test animals
- 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.
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- ethanol
- Doses:
- 2000mg/kg
- No. of animals per sex per dose:
- not specified
- Control animals:
- not specified
Results and discussion
Effect levels
- 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
Applicant's summary and conclusion
- 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.
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