EFSA Compendium of Botanicals

Draft - work in progress

Aloe vera (as plant) // Aloe barbadensis Mill. // Aloe vera (L.) Burm.f. // Aloe vulgaris Lam.

Family:: Xanthorrhoeaceae
Approval state:: Approved
Number of articles retrieved:: 7610
Number of processed references:: 6

Compositions

#1: Anthrones (barbaloin and isobarbaloin) in whole leaf extract and latex #2: Anthraquinones (emodin; aloe-emodin and dathron) in whole leaf extract and latex

Endpoint Studies

#1: carcinogenicity following 2-year oral administration in rats. #2: carcinogenicity following 2-year administration to mice #3: proliferation in mesenteric lymph nodes #4: reproduction toxicity #5: hepatotoxicity #6: mortality (LD50)

Genotoxicity

#1: increased the number of micronucleated polychromatic erythrocytes in mouse bone marrow #2: Comet in mice - DNA damage #3: genotoxicity Escherichia coli #4: mutagenicity #5: genotoxic #6: chromosome aberrations

Composition #1: Zhang, Z., Mei, N., Chen, S., Guo, L., Guo, X. Assessment of Genotoxic Effects of Selected Herbal Dietary Supplements. nutraceuticals: efficacy, safety and toxicity, 2016, p. 883–892. DOI: 10.1016/B978-0-12-802147-7.00062-0. [DOI link]

Language:

English (en)
Plant part:

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

Solvent extraction (A0BZR)
Additional extraction description:

unspecified
Substance:

anthrones (RF-00010811-PAR)
Additional substance description:

Babrbaloin (Aloin A) and isobarbaloin (Aloin B)
Analytical method code:

Unspecified (F598A)
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Qualitative Value (Binary) (BIN)
Internal remarks:

Anthrones (barbaloin and isobarbaloin) in whole leaf extract and latex

Composition #2: Zhang, Z., Mei, N., Chen, S., Guo, L., Guo, X. Assessment of Genotoxic Effects of Selected Herbal Dietary Supplements. nutraceuticals: efficacy, safety and toxicity, 2016, p. 883–892. DOI: 10.1016/B978-0-12-802147-7.00062-0. [DOI link]

Language:

English (en)
Plant part:

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

Solvent extraction (A0BZR)
Additional extraction description:

unspecified
Substance:

anthraquinones (RF-00004343-PAR)
Additional substance description:

emodin; aloe-emodin and danthron
Analytical method code:

Unspecified (F598A)
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Qualitative Value (Binary) (BIN)
Internal remarks:

Anthraquinones (emodin; aloe-emodin and dathron) in whole leaf extract and latex

Endpoint study #1: Zhang, Z., Mei, N., Chen, S., Guo, L., Guo, X. Assessment of Genotoxic Effects of Selected Herbal Dietary Supplements. nutraceuticals: efficacy, safety and toxicity, 2016, p. 883–892. DOI: 10.1016/B978-0-12-802147-7.00062-0. [DOI link]

Study relevance:

Human health
Plant part:

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

Solvent extraction (A0BZR)
Additional plant/substance description:

whole leaf extract in drinking water
Type of toxicological test:

chronic/long term toxicity (CHD004TT)
Tested organism:

Rat (as animal) (A0CNV)
Sex:

Male/Female
Route of exposure:

ORAL: DRINKING WATER (OECD2229PL)
Exposure duration:

2.0
Unit of exposure duration:

Year (G207A)
Number of organisms dosed:

48
Control groups used:

yes
Endpoint measured:

Concentration level (CHD013EP)
Concentration unit:

Percent (G138A)
Effect concentration:

0.5-1.5
Critical effect:

Other toxicities (TOX19A)
Target tissue:

Digestive (TT002A)
Effect description:

Cancers of the large intestine occurred in treated male and female rats as well as hyperplasia in the lare and small intestine, stomach and lymph nodes.
Effect or parameter linked to the endpoint:

Carcinogenic (CHD036BE)
Internal remarks:

carcinogenicity following 2-year oral administration in rats.

Endpoint study #2: Zhang, Z., Mei, N., Chen, S., Guo, L., Guo, X. Assessment of Genotoxic Effects of Selected Herbal Dietary Supplements. nutraceuticals: efficacy, safety and toxicity, 2016, p. 883–892. DOI: 10.1016/B978-0-12-802147-7.00062-0. [DOI link]

Study relevance:

Human health
Plant part:

Live plants (as part-nature) (A0BA0)
Preparation/Extraction method:

Solvent extraction (A0BZR)
Additional plant/substance description:

whole leaf extract in drinking water
Type of toxicological test:

chronic/long term toxicity (CHD004TT)
Tested organism:

House mouse (as animal) (A0CNT)
Sex:

Male/Female
Route of exposure:

ORAL: DRINKING WATER (OECD2229PL)
Exposure duration:

2.0
Unit of exposure duration:

Year (G207A)
Number of organisms dosed:

48
Control groups used:

yes
Endpoint measured:

Concentration level (CHD013EP)
Concentration unit:

Percent (G138A)
Effect concentration:

1-3
Critical effect:

Other toxicities (TOX19A)
Target tissue:

Digestive (TT002A)
Effect description:

Cancer of the large intestine in male and female mice and hyperplasia of different organs.
Effect or parameter linked to the endpoint:

Carcinogenic (CHD036BE)
Internal remarks:

carcinogenicity following 2-year administration to mice

Endpoint study #3: Guo, X., Mei, N. Aloe vera: A review of toxicity and adverse clinical effects. journal of environmental science and health - part c environmental carcinogenesis and ecotoxicology reviews, 2016, vol. 34, no. 2, p. 77–96. DOI: 10.1080/10590501.2016.1166826. [DOI link]

Study relevance:

Human health
Plant part:

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

Powder (A06JD)
Type of toxicological test:

subchronic (CHD013TT)
Tested organism:

Rat (as animal) (A0CNV)
Strain of test organism:

Sprague-Dawley (CHD012ST)
Sex:

No data
Exposure duration:

90.0
Unit of exposure duration:

Day (G134A)
Number of organisms dosed:

88
Control groups used:

yes
Endpoint measured:

Dose level (CHD014EP)
Concentration unit:

Grams per kilogram body weight (G226A)
Effect concentration:

2-8
Critical effect:

IMMUNOTOXICITY (TOX09A)
Target tissue:

cardiovascular / haematological: Lymph Nodes (TT013A)
Effect description:

proliferation in mesenteric lymph nodes
Effect or parameter linked to the endpoint:

immunology (CHD026BE)
Internal remarks:

proliferation in mesenteric lymph nodes

Endpoint study #4: Guo, X., Mei, N. Aloe vera: A review of toxicity and adverse clinical effects. journal of environmental science and health - part c environmental carcinogenesis and ecotoxicology reviews, 2016, vol. 34, no. 2, p. 77–96. DOI: 10.1080/10590501.2016.1166826. [DOI link]

Study relevance:

Human health
Plant part:

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

Powder (A06JD)
Type of toxicological test:

reproduction toxicity (CHD009TT)
Tested organism:

Rat (as animal) (A0CNV)
Strain of test organism:

Sprague-Dawley (CHD012ST)
Sex:

Male/Female
Exposure duration:

3.0
Unit of exposure duration:

Month (G206A)
Control groups used:

yes
Endpoint measured:

Dose level (CHD014EP)
Concentration unit:

Milligrams per kilogram body weight per day (G211A)
Effect concentration:

100
Critical effect:

REPRODUCTIVE (TOX05A)
Target tissue:

urogenital: Testes (TT050A)
Effect description:

sperm damage, hematological changes, inflammation, and mortality
Effect or parameter linked to the endpoint:

reproduction (CHD014BE)
Internal remarks:

reproduction toxicity

Endpoint study #5: Guo, X., Mei, N. Aloe vera: A review of toxicity and adverse clinical effects. journal of environmental science and health - part c environmental carcinogenesis and ecotoxicology reviews, 2016, vol. 34, no. 2, p. 77–96. DOI: 10.1080/10590501.2016.1166826. [DOI link]

Study relevance:

Human health
Plant part:

Leaves (as part-nature) (A0EKT)
Type of toxicological test:

case report (CHD060TT)
Tested organism:

Human (as organism) (A056J)
Sex:

Male/Female
Number of organisms dosed:

8
Endpoint measured:

Dose not reported (CHD066EP)
Critical effect:

HEPATOTOXICITY (TOX02A)
Target tissue:

digestive: Liver (TT023A)
Effect description:

toxic hepatitis
Effect or parameter linked to the endpoint:

histopathology non neoplastic (CHD025BE)
Internal remarks:

hepatotoxicity

Endpoint study #6: Logarto Parra, A., Silva Yhebra, R., Guerra Sardinas, I., Iglesias Buela, L. Comparative study of the assay of Artemia salina L. and the estimate of the medium lethal dose (LD50 value) in mice, to determine oral acute toxicity of plant extracts. . phytomedicine : international journal of phytotherapy and phytopharmacology, 2001, vol. 8, no. 5, p. 395–400. .

Study relevance:

Human health
Plant part:

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

Solvent extraction (A0BZR)
Additional plant/substance description:

unspecified
Type of toxicological test:

acute toxicity (CHD016TT)
Guideline used:

According to
Guideline:

OECD Guideline 401 (Acute Oral Toxicity) (OECD718PL)
Tested organism:

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

Swiss (CHD005ST)
Route of exposure:

ORAL: GAVAGE (OECD2231PL)
Exposure duration:

24.0
Unit of exposure duration:

Hour (G099A)
Endpoint measured:

Lethal dose rate in 50% of experimental organisms (CHD029EP)
Concentration unit:

Milligram/kilogram (G061A)
Effect concentration:

120.65
Critical effect:

Other toxicities (TOX19A)
Effect description:

death
Effect or parameter linked to the endpoint:

mortality (CHD010BE)
Internal remarks:

mortality (LD50)

Genotox #1: Wan, Jin-zhi., Xu, Xin-jun., Luo, Xuan., Fang, Wei., Fang, Zi-sheng. The genotoxicity of the aloe extract primarily evaluated by micronucleus test. zhongguo xinyao zazhi, 2008, p. 931–933. .

Study category:

Genotoxicity
Type of toxicological test:

micronucleus assay (CHD051TT)
Method type:

in vivo
Tested organism:

House mouse (as animal) (A0CNT)
Sex:

Male/Female
Exogenous metabolic activation applied:

no data
Exposure duration for in vivo:

4.0
Unit of exposure duration:

Day (G134A)
Endpoint measured:

DNA damage and/or repair
Is genotoxic:

Positive
Remarks on genotox study:

increased the number of micronucleated polychromatic erythrocytes in mouse bone marrow
Internal remarks:

increased the number of micronucleated polychromatic erythrocytes in mouse bone marrow
Internal ID:

CAPLUS_2008:922178

Genotox #2: Zhang, Z., Mei, N., Chen, S., Guo, L., Guo, X. Assessment of Genotoxic Effects of Selected Herbal Dietary Supplements. nutraceuticals: efficacy, safety and toxicity, 2016, p. 883–892. DOI: 10.1016/B978-0-12-802147-7.00062-0. [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 vivo
Tested organism:

House mouse (as animal) (A0CNT)
Sex:

Male/Female
Exposure duration for in vivo:

3.0
Unit of exposure duration:

Hour (G099A)
Control groups used:

no data
Endpoint measured:

DNA damage and/or repair
Is genotoxic:

Positive
Remarks on genotox study:

primary DNA damage in the colon was observed between 3h and 6h after two oral administrations at 500, 1,000, and 2,000mg/ kg body weight
Internal remarks:

Comet in mice - DNA damage
Internal ID:

eid=2-s2.0-84967121161

Genotox #3: Paes-Leme, AA., Motta, ES., De Mattos, JCP., Dantas, FJS., Bezerra, RJAC., Caldeira-De-Araujo, A. Assessment of Aloe vera (L.) genotoxic potential on Escherichia coli and plasmid DNA . journal of ethnopharmacology, 2005, vol. 102, no. 2, p. 197–201. DOI: 10.1016/j.jep.2005.06.013. [DOI link]

Study category:

Genotoxicity
Type of toxicological test:

bacterial reverse mutation assay (CHD028TT)
Method type:

in vitro
Tested organism:

Escherichia coli (as organism) (A0CQA)
Control groups used:

yes
Endpoint measured:

DNA damage and/or repair
Is genotoxic:

Positive
Remarks on genotox study:

genotoxic action
Internal remarks:

genotoxicity Escherichia coli
Internal ID:

WOS:000233183500010

Genotox #4: Kayraldiz, Ahmet., Kocaman, Ayse Yavuz., Rencuzogullari, Eyyup., Istifli, Erman Salih., Ila, Hasan Basri., Topaktas, Mehmet., Daglioglu, Yusuf Kenan. The genotoxic and antigenotoxic effects of Aloe vera leaf extract in vivo and in vitro . turkish journal of biology, 2010, vol. 34, no. 3, p. 235–246. DOI: 10.3906/biy-0812-27. [DOI link]

Study category:

Mutagenicity
Type of toxicological test:

bacterial reverse mutation assay (CHD028TT)
Method type:

in vitro
Tested organism:

Salmonella typhimurium (as organism) (A0CPZ)
Route of exposure:

OTHER (OECD0PL)
Control groups used:

yes
Endpoint measured:

gene mutation
Is genotoxic:

Positive
Remarks on genotox study:

mutagenicity
Internal remarks:

mutagenicity
Internal ID:

WOS:000281781500002

Genotox #5: Kayraldiz, Ahmet., Kocaman, Ayse Yavuz., Rencuzogullari, Eyyup., Istifli, Erman Salih., Ila, Hasan Basri., Topaktas, Mehmet., Daglioglu, Yusuf Kenan. The genotoxic and antigenotoxic effects of Aloe vera leaf extract in vivo and in vitro . turkish journal of biology, 2010, vol. 34, no. 3, p. 235–246. DOI: 10.3906/biy-0812-27. [DOI link]

Study category:

Genotoxicity
Type of toxicological test:

in vitro mammalian cell micronucleus test (CHD033TT)
Method type:

in vitro
Tested organism:

Human (as organism) (A056J)
Route of exposure:

OTHER (OECD0PL)
Control groups used:

yes
Endpoint measured:

DNA damage and/or repair
Is genotoxic:

Positive
Remarks on genotox study:

genotoxic
Internal remarks:

genotoxic
Internal ID:

WOS:000281781500002

Genotox #6: Kayraldiz, Ahmet., Kocaman, Ayse Yavuz., Rencuzogullari, Eyyup., Istifli, Erman Salih., Ila, Hasan Basri., Topaktas, Mehmet., Daglioglu, Yusuf Kenan. The genotoxic and antigenotoxic effects of Aloe vera leaf extract in vivo and in vitro . turkish journal of biology, 2010, vol. 34, no. 3, p. 235–246. DOI: 10.3906/biy-0812-27. [DOI link]

Study category:

Genotoxicity
Type of toxicological test:

in vitro mammalian chromosome aberration test (CHD032TT)
Method type:

in vitro
Tested organism:

Human (as organism) (A056J)
Route of exposure:

OTHER (OECD0PL)
Control groups used:

yes
Endpoint measured:

chromosome aberration
Is genotoxic:

Positive
Remarks on genotox study:

chromosome aberrations
Internal remarks:

chromosome aberrations
Internal ID:

WOS:000281781500002