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. 2020 Jun 12;18(6):e06146. doi: 10.2903/j.efsa.2020.6146
Ref. Experimental test system (aim of the study) Test substance/relevance Exposure conditions Results Comments/reliability Relevance of the results
Aggarwal et al. (2016) S. Typhimurium TA98, TA100, TA102, TA1535 TA1537

Curcuminoids‐essential oil complex (CEC, with 95% curcuminoid complex), provided by Arjuna Natural Extracts Ltd. (Aluva, India), highly bioavailable (sevenfold higher than normal curcumin)

Relevance: high vehicle DMSO

Plate incorporation assay (+/− rat liver S9) five doses tested, from 1,000 to 5,000 μg/plate

No treatment‐related increase in revertant colonies

Adequate response of positive controls

Negative

Reliable with restriction

(According to OECD TG 471 (1997), however, not all results reported in detail, unclear if triplicate plates, enzyme induction not reported, only one experiment)

Limited
Damarla et al. (2018) S. Typhimurium TA98, TA100, TA102, TA1535, TA1537

Synthetic curcumin (99.4% purity) manufactured by Laurus Labs (Visakhapatnam, India), batch 25027‐1VSP10410915 (August 2015)

Relevance: High

vehicle DMSO

Plate incorporation assay, triplicate (+/− rat liver S9)

Preliminary assay (TA98 and TA100): eight doses tested (from 1.6–5,000 μg/plate), precipitation observed at 5,000 μg/plate five doses tested, from 5.0 to 1,600 μg/plate

No treatment‐related increase in revertant colonies

Adequate response of positive controls

Negative

GLP compliant

Reliable with minor restriction (According to OECD TG 471 (1997), however, not reported if liver enzymes were induced, only one experiment)

High to limited
Jensen (1982) S. Typhimurium TA98, TA100, TA1535

Curcumin (powder with 90 ± 2.5% curcumin)

Turmeric oleoresin (curcumin content about 20%)

Relevance: high (powder), low (oleoresin) vehicle DMSO

Preliminary assay (TA100): six doses tested (1.28–20,000 μg/plate), toxicity observed at 160 μg/plate for both test items five doses tested, from 1.28 to 160 μg/plate, five parallel plates (+/− rat liver S9), tests were performed twice

No treatment‐related increase in revertant colonies for both test items

Adequate response of positive controls

Negative

According to Ames et al. (1975) as referenced by Jensen (1982) pre‐OECD

Reliable with restriction (only three strains used, not reported if liver enzymes were induced)

Evaluated by JECFA, FAS 17 as negative

Limited
Liju et al. (2015) S. Typhimurium TA98, TA100, TA102

Curcumagalactomannosides (CGM), a water soluble formulation containing 40.2% curcumin

Manufactured by Akay Flavours & Aromatics Pvt Ltd (Kerala, India) from commercial curcumin (95%)

Relevance: limited vehicle DMSO

Plate incorporation assay, triplicate (+/− rat liver S9) five doses tested, from 100 to 5,000 μg/plate

No treatment‐related increase in revertant colonies

Adequate response of positive controls

Negative

According to Ames et al. (1975) as referenced in Liju et al. (2015) OECD TG 471 not mentioned

Reliable with restriction (only three strains used, not reported if liver enzymes were induced, only one experiment)

Limited
Nagabhushan and Bhide (1986)

S. Typhimurium TA98, TA100, TA1535, TA1538

Aim of the study: mutagenicity and antimutagenicity of different test items

Alcoholic extract of fresh or dried turmeric extract (10 g in 100 mL alcohol)

Individual components (I‐III) separated

Pyrolysed products (10 mg each of turmeric powder and curcumin suspended in 5 mL water and kept at 160°C for 1 h)

Relevance: limited (individual components, identity unclear)

Pre‐incubation assay: one dose tested of each test item, 50 μL corresponding to 360 μg/plate (fresh turmeric extract), 250 μg/plate (dried turmeric extract), 200 μg/plate (pyrolysed products)

Individual components (I‐III) tested in TA100 and TA98 at four doses (60.2–500 μg/plate) (+/− rat liver S9)

Antimutagenicity tested (interaction with chili extract and capsaicin) in TA98 with S9

No increase in revertant colonies for fresh and dried turmeric extracts, pyrolysed turmeric and curcumin at the dose tested

No treatment‐related increase in revertant colonies for the three individual components

Adequate response of positive controls

Negative

With S9 in TA98, dose‐dependent decrease of mutagenicity of chili extract and capsaicin

According to Ames et al. (1975), as referenced in Shah and Netrawali (1988), OECD TG 471 not mentioned

Reliable with restriction (only four strains used, only one concentration tested, only two plates per concentration, identity of the test substances unclear)

Evaluated by JECFA, FAS 35 as negative for mutagenicity

Limited
Nagabhushan et al. (1987)

S. Typhimurium TA98 and TA100

Aim of the study: antimutagenicity of curcumin

Curcumin (Sigma Chemical Co., purity > 94%)

Relevance: high vehicle DMSO

Antimutagenicity of curcumin tested against bidi smoke condensate, cigarette smoke condensate, tobacco and masheri extracts, B[a]P and B[a]anthracene: 50 μL curcumin + 50 μL mutagen (+/− rat liver S9)

Five curcumin doses tested (0‐250 μg/plate)

Curcumin inhibited mutagenicity in a dose‐dependent manner, only in the presence of S9 mix

According to Ames et al. (1975), OECD TG 471 not mentioned

Antimutagenicity only Limited number of strain tested

Evaluated by JECFA, FAS 35

Low
Nagabhushan and Bhide (1987)

S. Typhimurium TA98

Aim of the study: antimutagenicity of turmeric extract

Alcoholic extract of turmeric (10 g powder in 100 mL)

The extract dried under vacuum contains 40% curcumin

Relevance: limited

vehicle DMSO

Antimutagenicity of turmeric extract against benzo(a)pyrene and dimethylbenzanthracene (B[a]p and DMBA): 50 μL curcumin + 50 μL mutagen (+/− rat liver S9) The alcoholic extract of turmeric inhibited mutagenicity of B[a]P and DMBA in strain TA98 and with S9 mix, in a dose‐dependent manner (50% inhibition at 125 μg/plate, 75% at 500 μg/plate)

According to Ames et al. (1975), OECD TG 471 not mentioned

Antimutagenicity only

Only one strain and only one dose tested

Evaluated by JECFA, FAS 35

Low
NTP (1993) S. Typhimurium TA98, TA100, TA1535, TA1538

Turmeric oleoresin with a high curcumin content (79‐85%)

CAS No. 8024‐37‐1

Relevance: high

vehicle DMSO

Pre‐incubation assay (+/− rat liver S9)

Five doses tested, up to 333 μg/plate, selection of the highest dose based on toxicity observed at higher doses

No treatment‐related increase in revertant colonies

Adequate response of positive controls

Negative

According to Mortelmans et al. (1986) as referenced by NTP (1993) OECD TG 471 not mentioned

Reliable with minor restriction (only four strains tested)

Evaluated by JECFA, FAS 35 as negative

High to limited
Ravikumar et al. (2018) S. Typhimurium TA98, TA100, TA1535, TA1537, E.coli WP2uvrA

CuroWhite (Aurea Biolabs, Ltd., Kerala, India), defined as 25–27% standardised hydrogenated curcumin powder.

Obtained from turmeric rhizome powder by extraction, hydrogenation, encapsulation with beta‐cyclodextrin and spray drying

Relevance: limited vehicle DMSO

Preliminary solubility test (1,000–5,000 μg/plate): test item soluble in DMSO only

Preliminary cytotoxicity test (50–5,000 μg/plate) (+/‐ rat liver S9)

Plate incorporation and pre‐incubation assay, each in triplicate

Seven doses tested (62–5,000 μg/plate) (+/− rat liver S9)

No treatment‐related increase in revertant colonies

Adequate response of positive controls

Historical control range given

Negative

GLP compliant

According to OECD TG 471 (1997)

Reliable without restriction

Limited
Shah and Netrawali (1988) S. Typhimurium TA98, TA100 and TA97a

Ethanol soluble extract obtained from turmeric powder of dry rhizhome (100 g in 400 mL ethanol/water 70/30, v/v), curcumin content: 33–35%

Relevance: limited

Vehicle ethanol

Plate incorporation assay (+/− rat liver S9)

Three doses tested 50, 100 and 200 μg/plate corresponding to 17.5, 35, 50 μg curcumin/plate), five replicates of four separate experiments (each dose)

No treatment‐related increase in revertant colonies

Adequate response of positive controls

Negative

According to Ames et al. (1975), Shah and Netrawali (1988), OECD TG 471 not mentioned

Reliable with restriction (only three strains tested, only three concentrations)

Evaluated by JECFA, FAS 35 as negative

Limited
Sivaswamy et al. (1991) S. Typhimurium TA1535, TA1537, TA1538

Food item (turmeric, source, characterisation not available)

Relevance: very low

vehicle DMSO

Two doses tested (50 and 100 μg/plate)

Turmeric was not mutagenic

Negative

Not reliable (limited information, only summary report, only three strains, only two concentrations, negative controls resulted in unusually high revertant frequencies)

Evaluated by JECFA, FAS 35 as negative (weak positive at 50 μg/plate)

Low
Spalding (1983) unpublished report (NIH) S. Typhimurium TA98, TA100,TA1535, TA1537

Turmeric oleoresin

Relevance: low

+/− rat liver S9

Not mutagenic

Negative

Not reliable (paper could not be retrieved, limited information)

Evaluated by JECFA, FAS 21 as negative

Low
Srividya et al. (2013) S. Typhimurium TA98 and TA100

Curcumin (Sami labs, India, purity not specified) and 50% hydro alcoholic extracts from Curcuma aromatica and Curcuma zedoaria

Relevance: limited

One dose tested (50 μg/mL), triplicate experiments

(+/− rat liver S9)

Slight increase in revertant colonies compared to control (not significant)

Adequate response of positive controls

Negative

Not reliable (test carried out with modifications (Meshram et al., 1992, as referenced in Srividya et al., 2013), only two strains, only one concentration, negative controls resulted in low revertant frequencies, test items poorly described) Low