EFSA Compendium of Botanicals

Draft - work in progress

Crotalaria retusa L.

Family:: Fabaceae
Approval state:: Approved
Number of articles retrieved:: 196
Number of processed references:: 4

Compositions

Endpoint Studies

#1: Neurotoxicity linked to monocrotaline #2: Acute hepatotoxicity #3: Chronic hepatotoxicity #4: Hepatotoxic in pigs #5: Nephrotoxic in pigs #6: lung toxicity in pigs #7: congenital abnormalities in pigs #8: Hepatotoxic in chickens #9: Nephrotoxicity in chickens

Genotoxicity

#1: increase in the frequency of DNA strand breaks (genotoxic)

Composition #1: Anjos, Bruno Leite., Nobre, Veronica M. T., Dantas, Antonio F. M., Medeiros, Rosane M. T., Oliveira Neto, Temistocles S., Molyneux, Russell J., Riet-Correa, Franklin. Poisoning of sheep by seeds of Crotalaria retusa: Acquired resistance by continuous administration of low doses. TOXICON, 2010, vol. 55, no. 1, p. 28–32. DOI: 10.1016/j.toxicon.2009.06.028. [DOI link]

Language:

English (en)
Plant part:

Seed (as part-nature) (A066P)
Substance:

Monocrotaline (RF-00000238-TOX)
Analytical method code:

Nuclear Magnetic Resonance (NMR) (F061A)
Analytical method - additional description:

NMR + TLC
Result unit:

Percent (G138A)
Result expression:

Dry matter (B002A)
Result type:

Numerical Value (VAL)
Value (concentration, content):

6.84
Internal remarks:

monocrotaline

Composition #2: Silva-Neto, J. P., Barreto, R. A., Pitanga, B. P. S., Souza, C. S., Silva, V. D., Silva, A. R., Velozo, E. S., Cunha, S. D., Batatinha, M. J. M., Tardy, M., Ribeiro, C. S. O., Costa, M. F. D., El-Bacha, R. S., Costa, S. L. Genotoxicity and morphological changes induced by the alkaloid monocrotaline, extracted from Crotalaria retusa, in a model of glial cells. TOXICON, 2010, vol. 55, no. 1, p. 105–117. DOI: 10.1016/j.toxicon.2009.07.007. [DOI link]

Language:

English (en)
Plant part:

Seed (as part-nature) (A066P)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

aqueous
Substance:

Monocrotaline (RF-00000238-TOX)
Analytical method code:

Nuclear Magnetic Resonance (NMR) (F061A)
Analytical method - additional description:

nuclear magnetic resonance, and infrared spectroscopy.
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Qualitative Value (Binary) (BIN)
Internal remarks:

Monocrotaline

Endpoint study #1: Seara Pitanga, Bruno Penas., Nascimento, Ravena P., Silva, Victor Diogenes A., Costa, Silvia L. The role of astrocytes in metabolism and neurotoxicity of the pyrrolizidine alkaloid monocrotaline, the main toxin of Crotalaria retusa. FRONTIERS IN PHARMACOLOGY, 2012, vol. 3 . DOI: 10.3389/fphar.2012.00144. [DOI link]

Study relevance:

Human health
Substance:

Monocrotaline (RF-00000238-TOX)
Plant part:

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

case report (CHD060TT)
Tested organism:

Cattle (as animal) (A057E)
Route of exposure:

ORAL: FEED (OECD2230PL)
Endpoint measured:

Dose not reported (CHD066EP)
Critical effect:

NEUROTOXICITY (TOX04A)
Target tissue:

neurologic: Central Nervous System (TT035A)
Effect description:

presence of clinical neurological signs in animals intoxicated with Crotalaria retusa
Effect or parameter linked to the endpoint:

neurology (CHD027BE)
Internal remarks:

Neurotoxicity linked to monocrotaline

Endpoint study #2: Anjos, Bruno Leite., Nobre, Veronica M. T., Dantas, Antonio F. M., Medeiros, Rosane M. T., Oliveira Neto, Temistocles S., Molyneux, Russell J., Riet-Correa, Franklin. Poisoning of sheep by seeds of Crotalaria retusa: Acquired resistance by continuous administration of low doses. TOXICON, 2010, vol. 55, no. 1, p. 28–32. DOI: 10.1016/j.toxicon.2009.06.028. [DOI link]

Study relevance:

Human health
Substance:

Monocrotaline (RF-00000238-TOX)
Plant part:

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

acute toxicity (CHD016TT)
Tested organism:

Sheep (as animal) (A057G)
Sex:

No data
Route of exposure:

ORAL: FEED (OECD2230PL)
Exposure duration:

1.0
Unit of exposure duration:

Day (G134A)
Number of organisms dosed:

3
Control groups used:

no
Endpoint measured:

Dose level (CHD014EP)
Concentration unit:

Milligram/kilogram (G061A)
Effect concentration:

205.2
Critical effect:

HEPATOTOXICITY (TOX02A)
Target tissue:

digestive: Liver (TT023A)
Effect description:

periacinar liver necrosis
Effect or parameter linked to the endpoint:

mortality (CHD010BE)
Internal remarks:

Acute hepatotoxicity

Endpoint study #3: Anjos, Bruno Leite., Nobre, Veronica M. T., Dantas, Antonio F. M., Medeiros, Rosane M. T., Oliveira Neto, Temistocles S., Molyneux, Russell J., Riet-Correa, Franklin. Poisoning of sheep by seeds of Crotalaria retusa: Acquired resistance by continuous administration of low doses. TOXICON, 2010, vol. 55, no. 1, p. 28–32. DOI: 10.1016/j.toxicon.2009.06.028. [DOI link]

Study relevance:

Human health
Substance:

Monocrotaline (RF-00000238-TOX)
Plant part:

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

chronic/long term toxicity (CHD004TT)
Tested organism:

Sheep (as animal) (A057G)
Sex:

No data
Route of exposure:

ORAL: FEED (OECD2230PL)
Exposure duration:

70.0
Unit of exposure duration:

Day (G134A)
Number of organisms dosed:

2
Control groups used:

no
Endpoint measured:

Dose level (CHD014EP)
Concentration unit:

Milligram/kilogram (G061A)
Effect concentration:

273.6
Critical effect:

HEPATOTOXICITY (TOX02A)
Target tissue:

digestive: Liver (TT023A)
Effect description:

liver fibrosis and megalocytosis
Effect or parameter linked to the endpoint:

mortality (CHD010BE)
Internal remarks:

Chronic hepatotoxicity

Endpoint study #4: HOOPER, PT., SCANLAN, WA. CROTALARIA-RETUSA POISONING OF PIGS AND POULTRY. AUSTRALIAN VETERINARY JOURNAL, 1977, vol. 53, no. 3, p. 109–114. DOI: 10.1111/j.1751-0813.1977.tb00129.x. [DOI link]

Study relevance:

Animal (target species) health
Substance:

Monocrotaline (RF-00000238-TOX)
Plant part:

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

short-term toxicity (CHD017TT)
Tested organism:

Pig (as animal) (A057F)
Sex:

No data
Route of exposure:

ORAL: FEED (OECD2230PL)
Exposure duration:

21.0
Unit of exposure duration:

Day (G134A)
Number of organisms dosed:

28
Control groups used:

yes
Endpoint measured:

Dose level (CHD014EP)
Concentration unit:

Percent (G138A)
Effect concentration:

0.5
Critical effect:

HEPATOTOXICITY (TOX02A)
Target tissue:

digestive: Liver (TT023A)
Effect description:

hepatic megalocytosis
Effect or parameter linked to the endpoint:

mortality (CHD010BE)
Internal remarks:

Hepatotoxic in pigs

Endpoint study #5: HOOPER, PT., SCANLAN, WA. CROTALARIA-RETUSA POISONING OF PIGS AND POULTRY. AUSTRALIAN VETERINARY JOURNAL, 1977, vol. 53, no. 3, p. 109–114. DOI: 10.1111/j.1751-0813.1977.tb00129.x. [DOI link]

Study relevance:

Animal (target species) health
Substance:

Monocrotaline (RF-00000238-TOX)
Plant part:

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

short-term toxicity (CHD017TT)
Tested organism:

Pig (as animal) (A057F)
Sex:

No data
Route of exposure:

ORAL: FEED (OECD2230PL)
Exposure duration:

21.0
Unit of exposure duration:

Day (G134A)
Number of organisms dosed:

28
Control groups used:

yes
Endpoint measured:

Dose level (CHD014EP)
Concentration unit:

Percent (G138A)
Effect concentration:

0.5
Critical effect:

NEPHROTOXICITY (TOX03A)
Target tissue:

urogenital: Kidneys (TT046A)
Effect description:

advanced nephrosis
Effect or parameter linked to the endpoint:

mortality (CHD010BE)
Internal remarks:

Nephrotoxic in pigs

Endpoint study #6: HOOPER, PT., SCANLAN, WA. CROTALARIA-RETUSA POISONING OF PIGS AND POULTRY. AUSTRALIAN VETERINARY JOURNAL, 1977, vol. 53, no. 3, p. 109–114. DOI: 10.1111/j.1751-0813.1977.tb00129.x. [DOI link]

Study relevance:

Animal (target species) health
Substance:

Monocrotaline (RF-00000238-TOX)
Plant part:

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

short-term toxicity (CHD017TT)
Tested organism:

Pig (as animal) (A057F)
Sex:

No data
Route of exposure:

ORAL: FEED (OECD2230PL)
Exposure duration:

21.0
Unit of exposure duration:

Day (G134A)
Number of organisms dosed:

28
Control groups used:

yes
Endpoint measured:

Dose level (CHD014EP)
Concentration unit:

Percent (G138A)
Effect concentration:

0.5
Critical effect:

PULMONARY AND CARDIAC (TOX08A)
Target tissue:

respiratory: Lung (TT041A)
Effect description:

Interstitial pneumonias were mainly characterised by oedema, fibrosis, epithelialisation, and large alveolar cells
Effect or parameter linked to the endpoint:

mortality (CHD010BE)
Internal remarks:

lung toxicity in pigs

Endpoint study #7: HOOPER, PT., SCANLAN, WA. CROTALARIA-RETUSA POISONING OF PIGS AND POULTRY. AUSTRALIAN VETERINARY JOURNAL, 1977, vol. 53, no. 3, p. 109–114. DOI: 10.1111/j.1751-0813.1977.tb00129.x. [DOI link]

Study relevance:

Animal (target species) health
Substance:

Monocrotaline (RF-00000238-TOX)
Plant part:

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

reproduction toxicity (CHD009TT)
Tested organism:

Pig (as animal) (A057F)
Sex:

No data
Route of exposure:

ORAL: FEED (OECD2230PL)
Exposure duration:

21.0
Unit of exposure duration:

Day (G134A)
Number of organisms dosed:

28
Control groups used:

yes
Endpoint measured:

Dose level (CHD014EP)
Concentration unit:

Percent (G138A)
Effect concentration:

0.5
Critical effect:

TERATOGENIC (TOX06A)
Target tissue:

Muscle, Skeletal (TT055A)
Effect description:

congenital abnormalities, particularly cleft palates, in piglets born to sows fed the contaminated grain
Effect or parameter linked to the endpoint:

morphology (CHD013BE)
Internal remarks:

congenital abnormalities in pigs

Endpoint study #8: HOOPER, PT., SCANLAN, WA. CROTALARIA-RETUSA POISONING OF PIGS AND POULTRY. AUSTRALIAN VETERINARY JOURNAL, 1977, vol. 53, no. 3, p. 109–114. DOI: 10.1111/j.1751-0813.1977.tb00129.x. [DOI link]

Study relevance:

Animal (target species) health
Substance:

Monocrotaline (RF-00000238-TOX)
Plant part:

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

chronic/long term toxicity (CHD004TT)
Tested organism:

Gallus gallus (chicken) (as animal) (A057Z)
Sex:

No data
Route of exposure:

ORAL: FEED (OECD2230PL)
Number of organisms dosed:

4
Control groups used:

yes
Endpoint measured:

Dose level (CHD014EP)
Concentration unit:

Percent (G138A)
Effect concentration:

0.05
Critical effect:

HEPATOTOXICITY (TOX02A)
Target tissue:

digestive: Liver (TT023A)
Effect description:

hepatic necrosis followed by megalocytosis and bile duct proliferation
Effect or parameter linked to the endpoint:

mortality (CHD010BE)
Internal remarks:

Hepatotoxic in chickens

Endpoint study #9: HOOPER, PT., SCANLAN, WA. CROTALARIA-RETUSA POISONING OF PIGS AND POULTRY. AUSTRALIAN VETERINARY JOURNAL, 1977, vol. 53, no. 3, p. 109–114. DOI: 10.1111/j.1751-0813.1977.tb00129.x. [DOI link]

Study relevance:

Animal (target species) health
Substance:

Monocrotaline (RF-00000238-TOX)
Plant part:

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

chronic/long term toxicity (CHD004TT)
Tested organism:

Gallus gallus (chicken) (as animal) (A057Z)
Sex:

No data
Route of exposure:

ORAL: FEED (OECD2230PL)
Number of organisms dosed:

4
Control groups used:

yes
Endpoint measured:

Dose level (CHD014EP)
Concentration unit:

Percent (G138A)
Effect concentration:

0.05
Critical effect:

NEPHROTOXICITY (TOX03A)
Target tissue:

urogenital: Kidneys (TT046A)
Effect description:

Moderate tubule megalocytosis, glomerular atrophy and the development of cuboidal or columnar epithelium in the lining cells of Bowman’s capsules
Effect or parameter linked to the endpoint:

mortality (CHD010BE)
Internal remarks:

Nephrotoxicity in chickens

Genotox #1: Silva-Neto, J. P., Barreto, R. A., Pitanga, B. P. S., Souza, C. S., Silva, V. D., Silva, A. R., Velozo, E. S., Cunha, S. D., Batatinha, M. J. M., Tardy, M., Ribeiro, C. S. O., Costa, M. F. D., El-Bacha, R. S., Costa, S. L. Genotoxicity and morphological changes induced by the alkaloid monocrotaline, extracted from Crotalaria retusa, in a model of glial cells. TOXICON, 2010, vol. 55, no. 1, p. 105–117. DOI: 10.1016/j.toxicon.2009.07.007. [DOI link]

Study category:

Genotoxicity
Type of toxicological test:

single cell gel/comet assay in mammalian cells for detection of DNA damage (CHD040TT)
Method type:

in vitro
Tested organism:

Human (as organism) (A056J)
Sex:

No data
Route of exposure:

OTHER (OECD0PL)
Control groups used:

yes
Endpoint measured:

DNA damage and/or repair
Is genotoxic:

Positive
Remarks on genotox study:

Exposure of human glioblastoma cell line GL-15 to 500 mM dehydromonocrotaline induced a significant increase in the frequency of DNA strand breaks (53%)
Internal remarks:

increase in the frequency of DNA strand breaks (genotoxic)
Internal ID:

WOS:000273921500014