EFSA Compendium of Botanicals

Draft - work in progress

Neem (as plant) // Azadirachta indica A.Juss. // Melia azadirachta L.

Family:: Meliaceae
Approval state:: Approved
Number of articles retrieved:: 15014
Number of processed references:: 6

Compositions

#1: allkaloids in leaves #2: azadirone in flowers and leaves #3: nimbolide in flowers and leaves #4: azadirone in flowers and leaves

Endpoint Studies

#1: Autopsy on an infant revealed histopathological and electron microscopic features resembling those in Reye's syndrome. over 100 children with convulsions following ingestion and a 90% mortality rate. #2: Structural and numerical changes and significant increase in the frequency of sperms with abnormal head morphology and decrease in mean sperm count

Genotoxicity

#1: increased incidence of chromosome aberrations #2: chromosome aberation in allium cepa model #3: positive results of modified Ames test

Composition #1: Priya, G., Bhagavathy, S., Najeeb, Nasreen., Suganthi, M. Genotoxic effects of Azadirachta indica and Cynodon dactylon on Allium cepa meristamatic tissue. international journal of scientific research and reviews, 2019, vol. 8, no. 2, p. 4080–4087. .

Language:

English (en)
Plant part:

Leaves (as part-nature) (A0EKT)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

water
Substance:

Alkaloids (RF-00004360-PAR)
Analytical method code:

Colorimetry, Spectroscopy (Spectrometry) and Photometry (F008A)
Analytical method - additional description:

Mayer´s test, Wagner´s test
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Qualitative Value (Binary) (BIN)
Internal remarks:

allkaloids in leaves

Composition #2: Mitra, Tulika., Bhattacharya, Rahul. Phytochemicals modulate cancer aggressiveness: A review depicting the anticancer efficacy of dietary polyphenols and their combinations. journal of cellular physiology, 2020 . DOI: 10.1002/jcp.29703. [DOI link]

Language:

English (en)
Plant part:

Aerial part of plants (as part-nature) (A166F)
Additional extraction description:

unspecified
Substance:

Azadirachtin (RF-0030-001-PPP)
Analytical method - additional description:

unspecified
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Qualitative Value (Binary) (BIN)
Internal remarks:

azadirone in flowers and leaves

Composition #3: Mitra, Tulika., Bhattacharya, Rahul. Phytochemicals modulate cancer aggressiveness: A review depicting the anticancer efficacy of dietary polyphenols and their combinations. journal of cellular physiology, 2020 . DOI: 10.1002/jcp.29703. [DOI link]

Language:

English (en)
Plant part:

Aerial part of plants (as part-nature) (A166F)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

unspecified
Substance:

nimbolide (RF-00003947-PAR)
Analytical method - additional description:

unspecified
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Qualitative Value (Binary) (BIN)
Internal remarks:

nimbolide in flowers and leaves

Composition #4: Mitra, Tulika., Bhattacharya, Rahul. Phytochemicals modulate cancer aggressiveness: A review depicting the anticancer efficacy of dietary polyphenols and their combinations. journal of cellular physiology, 2020 . DOI: 10.1002/jcp.29703. [DOI link]

Language:

English (en)
Plant part:

Aerial part of plants (as part-nature) (A166F)
Additional extraction description:

unspecified
Substance:

azadirone (RF-00003703-PAR)
Analytical method - additional description:

unspecified
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Qualitative Value (Binary) (BIN)
Internal remarks:

azadirone in flowers and leaves

Endpoint study #1: Sinniah, D., Schwartz, P.H., Mitchell, R.A., Arcinue, E.L. Margosa oil and Reye's syndrome. acta paediatrica japonica (overseas edition), 1986, vol. 28, no. 5, p. 656–662. .

Study relevance:

Human health
Plant part:

Seed (as part-nature) (A066P)
Type of toxicological test:

acute toxicity (CHD016TT)
Tested organism:

Human (as organism) (A056J)
Sex:

No data
Route of exposure:

ORAL: UNSPECIFIED (OECD2234PL)
Endpoint measured:

Dose not reported (CHD066EP)
Critical effect:

NEUROTOXICITY (TOX04A)
Target tissue:

Neurologic (TT004A)
Effect description:

Autopsy on an infant revealed histopathological and electron microscopic features resembling those in Reye's syndrome. over 100 children with convulsions following ingestion and a 90% mortality rate.
Effect or parameter linked to the endpoint:

mortality (CHD010BE)
Internal remarks:

Autopsy on an infant revealed histopathological and electron microscopic features resembling those in Reye's syndrome. over 100 children with convulsions following ingestion and a 90% mortality rate.

Endpoint study #2: Khan, PK., Awasthy, KS. Cytogenetic toxicity of neem. food and chemical toxicology, 2003, vol. 41, no. 10, p. 1325–1328. DOI: 10.1016/S0278-6915(03)00123-6. [DOI link]

Study relevance:

Human health
Plant part:

Leaves (as part-nature) (A0EKT)
Preparation/Extraction method:

Solvent extraction (A0BZR)
Additional plant/substance description:

ethanol 80%
Type of toxicological test:

reproduction toxicity (CHD009TT)
Limit test:

Not applicable
Tested organism:

House mouse (as animal) (A0CNT)
Strain of test organism:

Swiss (CHD005ST)
Sex:

Male
Route of exposure:

ORAL: GAVAGE (OECD2231PL)
Exposure duration:

7.0
Unit of exposure duration:

Day (G134A)
Number of organisms dosed:

10
Control groups used:

yes, concurrent vehicle
Endpoint measured:

Dose level (CHD014EP)
Concentration unit:

Grams per kilogram body weight (G226A)
Effect concentration:

0.5
Critical effect:

REPRODUCTIVE (TOX05A)
Target tissue:

urogenital: Testes (TT050A)
Effect description:

strustural and numerical changes in the spermatocyte chromosomes, disturbance in them at their first metaphase
Effect or parameter linked to the endpoint:

reproduction (CHD014BE)
Internal remarks:

Structural and numerical changes and significant increase in the frequency of sperms with abnormal head morphology and decrease in mean sperm count

Genotox #1: Awasthy, KS., Chaurasia, OP., Sinha, SP. Prolonged murine genotoxic effects of crude extracted from neem. phytotherapy research, 1999, vol. 13, no. 1, p. 81–83. DOI: 10.1002/(SICI)1099-1573(199902)13:1<81::AID-PTR385>3.0.CO;2-W. [DOI link]

Study category:

Genotoxicity
Type of toxicological test:

chromosome aberration assay (CHD047TT)
Method type:

in vivo
Guideline used:

No guideline followed
Tested organism:

House mouse (as animal) (A0CNT)
Strain of test organism:

Swiss (CHD005ST)
Sex:

No data
Exogenous metabolic activation applied:

not applicable
Route of exposure:

ORAL: GAVAGE (OECD2231PL)
Exposure duration for in vivo:

7.0
Unit of exposure duration:

Day (G134A)
Number of organisms dosed:

6
Control groups used:

yes, concurrent vehicle
Endpoint measured:

chromosome aberration
Is genotoxic:

Positive
Remarks on genotox study:

positive at the dose 5 mg/bw/day
Internal remarks:

increased incidence of chromosome aberrations
Internal ID:

WOS:000078797300020

Genotox #2: Akintonwa, Alade., Awodele, Olufunsho., Afolayan, Gbenga., Coker, Herbert A. B. Mutagenic screening of some commonly used medicinal plants in Nigeria. journal of ethnopharmacology, 2009, vol. 125, no. 3, p. 461–470. DOI: 10.1016/j.jep.2009.07.013. [DOI link]

Study category:

Mutagenicity
Type of toxicological test:

chromosome aberration assay (CHD047TT)
Method type:

in vitro
Guideline used:

No guideline followed
Tested organism:

Other (A07XE)
Strain of test organism:

Other (CHD049ST)
Exogenous metabolic activation applied:

without
Control groups used:

yes
Endpoint measured:

chromosome aberration
Is genotoxic:

Positive
Remarks on genotox study:

increased frequency chromosome aberation in concentration 0.1 mg/ml of extract
Internal remarks:

chromosome aberation in allium cepa model
Internal ID:

WOS:000270763100014

Genotox #3: Akintonwa, Alade., Awodele, Olufunsho., Afolayan, Gbenga., Coker, Herbert A. B. Mutagenic screening of some commonly used medicinal plants in Nigeria. journal of ethnopharmacology, 2009, vol. 125, no. 3, p. 461–470. DOI: 10.1016/j.jep.2009.07.013. [DOI link]

Study category:

Mutagenicity
Type of toxicological test:

bacterial gene mutation assay (CHD027TT)
Method type:

in vitro
Guideline used:

No guideline followed
Tested organism:

Escherichia coli (as organism) (A0CQA)
Strain of test organism:

Other (CHD049ST)
Exogenous metabolic activation applied:

with and without
Control groups used:

yes
Endpoint measured:

gene mutation
Is genotoxic:

Positive
Remarks on genotox study:

positive modified Ames test
Internal remarks:

positive results of modified Ames test
Internal ID:

WOS:000270763100014