Ginger, ext.

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

GLP compliance:

yes

Type of assay:

bacterial forward mutation assay

Test material

Test material information

1

Reference substance name:

Ginger, ext.

EC Number:

283-634-2

EC Name:

Ginger, ext.

Cas Number:

84696-15-1

Molecular formula:

N/A

IUPAC Name:

Essential oil extract of Zingiber officinalis (Zingiberaceae) root GINGER ESSENTIAL OIL Ginger Oil Ginger Oleoresin Ginger, ext Ginger, ext. Ginger, Extrakt HE Zingiber officinalis INCI name: Zingiber Officinale (Ginger) Root Extract OILS, GINGER Reaction mass of camphene and pin-2(3)-ene and 7-methyl-3-methyleneocta-1,6-diene and pin-2(10)-ene and cineole and [S-(R*,S*)]-5-(1,5-dimethylhexen-4-yl)-2-methyl-1,3-cyclohexa-1,3-diene and (R)-p-mentha-1,8-diene Zingiber officinalis, Zingiberaceae.

Specific details on test material used for the study:

The test item Ginger, ext. was tested in the Salmonella typhimurium reverse mutation as-say with five strains of Salmonella typhimurium (TA97a, TA98, TA100, TA102 and TA1535)

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

cytotoxicity

Untreated negative controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

Table8.1‑a   Mean Revertants Experiment 1a

Strain		TA97a		TA98		TA100		TA102		TA1535
Induction		-S9	+S9	-S9	+S9	-S9	+S9	-S9	+S9	-S9	+S9
Demin. water	Mean	75	85	25	35	77	93	287	376	12	11
	sd	4.7	5.3	2.6	6.0	7.2	8.3	28.1	0.0	4.4	3.5
DMSO	Mean	80	78	32	40	74	77	345	403	11	11
	sd	4.6	7.4	4.6	11.3	8.1	11.4	22.7	60.6	2.1	0.0
Ethanol	Mean	75	85	30	32	79	84	344	285	15	17
	sd	14.1	2.6	5.5	3.1	13.6	20.0	71.1	68.0	3.2	2.5
Positive Controls*	Mean	603	456	301	103	667	1221	1248	1259	353	216
	sd	148.7	136.7	77.4	1.2	43.1	136.1	145.5	24.4	38.9	6.9
	f(I)	7.54	5.85	9.41	2.58	8.66	15.86	3.62	3.12	29.42	19.64
5 µL/plate	Mean	80	69	1	3	29	13	287	245	10	13
	sd	7.8	7.9	0.0	1.5	4.0	1.0	22.0	25.7	0.0	3.5
	f(I)	1.07	0.81	0.03	0.09	0.37	0.15	0.83	0.86	0.67	0.76
1.5 µL/plate	Mean	83	76	7	8	74	85	343	329	22	12
	sd	9.2	3.2	1.2	2.1	22.1	10.0	34.5	26.6	4.0	3.8
	f(I)	1.11	0.89	0.23	0.25	0.94	1.01	1.00	1.15	1.47	0.71
0.5 µL/plate	Mean	82	82	14	18	68	80	301	254	13	14
	sd	13.1	6.7	3.5	4.2	9.5	11.9	26.6	91.0	4.6	3.2
	f(I)	1.09	0.96	0.47	0.56	0.86	0.95	0.88	0.89	0.87	0.82
0.15 µL/plate	Mean	72	94	15	12	80	76	264	395	14	13
	sd	10.7	8.0	2.3	0.0	15.9	13.5	10.6	37.8	0.0	4.7
	f(I)	0.96	1.11	0.50	0.38	1.01	0.90	0.77	1.39	0.93	0.76
0.05 µl/plate	Mean	95	72	32	33	76	72	277	303	15	18
	sd	11.4	13.7	11.4	2.9	16.9	8.0	54.3	38.0	4.0	0.6
	f(I)	1.27	0.85	1.07	1.03	0.96	0.86	0.81	1.06	1.00	1.06

Table8.2‑a   Mean Revertants Experiment 1b

Strain		TA100		TA1535
Induction		-S9	+S9	-S9	+S9
Demin. water	Mean	94	108	19	20
	sd	22.5	12.2	2.0	3.5
DMSO	Mean	83	86	20	15
	sd	1.2	7.5	2.5	3.6
Ethanol	Mean	98	93	15	16
	sd	12.4	2.5	4.6	4.6
Positive Controls*	Mean	327	557	219	144
	sd	39.3	12.2	68.0	17.8
	f(I)	3.48	6.48	11.53	9.60
5 µL/plate	Mean	2	33	2	3
	sd	1.2	10.1	1.2	1.2
	f(I)	0.02	0.35	0.13	0.19
1.5 µL/plate	Mean	86	82	17	18
	sd	3.8	2.1	1.2	4.0
	f(I)	0.88	0.88	1.13	1.13
0.5 µL/plate	Mean	73	80	12	17
	sd	10.5	9.1	1.5	1.0
	f(I)	0.74	0.86	0.80	1.06
0.15 µL/plate	Mean	72	119	17	15
	sd	14.0	9.9	3.8	3.8
	f(I)	0.73	1.28	1.13	0.94
0.05 µl/plate	Mean	85	95	16	14
	sd	7.6	15.0	3.5	2.0
	f(I)	0.87	1.02	1.07	0.88
0.015 µl/plate	Mean	94	117	17	19
	sd	6.0	26.4	4.9	4.0
	f(I)	0.96	1.26	1.13	1.19

Table8.2‑b   Mean Revertants Experiment 1b

Strain		TA98
Induction		-S9	+S9
Demin. water	Mean	35	38
	sd	2.0	8.6
DMSO	Mean	35	37
	sd	3.2	4.0
Ethanol	Mean	35	43
	sd	4.0	9.1
Positive Controls*	Mean	493	299
	sd	69.0	18.5
	f(I)	14.09	8.08
0.15 µL/plate	Mean	0	0
	sd	0.0	0.0
	f(I)	0.00	0.00
0.05 µL/plate	Mean	34	37
	sd	2.0	4.0
	f(I)	0.97	0.86
0.015 µL/plate	Mean	41	38
	sd	4.5	8.1
	f(I)	1.17	0.88
0.005 µL/plate	Mean	38	38
	sd	3.1	7.0
	f(I)	1.09	0.88
0.0015 µl/plate	Mean	36	35
	sd	7.6	2.6
	f(I)	1.03	0.81
0.0005 µl/plate	Mean	38	41
	sd	3.2	3.0
	f(I)	1.09	0.95

Table8.3‑a  Mean Revertants Experiment 2

Strain		TA97a		TA102
Induction		-S9	+S9	-S9	+S9
Demin. water	Mean	90	79	307	356
	sd	9.0	7.6	10.1	10.6
DMSO	Mean	88	83	291	329
	sd	4.0	10.4	11.5	39.3
Ethanol	Mean	80	81	260	363
	sd	9.8	8.7	65.5	41.1
Positive Controls*	Mean	365	915	1235	1235
	sd	14.7	28.1	119.8	180.0
	f(I)	4.15	11.02	4.24	3.75
5 µL/plate	Mean	1	4	188	252
	sd	0.0	3.2	42.1	21.2
	f(I)	0.01	0.05	0.72	0.69
2.5 µL/plate	Mean	7	2	203	284
	sd	4.7	1.0	17.0	45.1
	f(I)	0.09	0.02	0.78	0.78
1.25 µL/plate	Mean	82	91	249	291
	sd	9.6	9.5	75.1	25.7
	f(I)	1.03	1.12	0.96	0.80
0.63 µL/plate	Mean	81	94	260	260
	sd	5.9	5.8	46.1	30.2
	f(I)	1.01	1.16	1.00	0.72
0.31 µL/plate	Mean	71	92	283	377
	sd	4.6	7.0	67.0	115.5
	f(I)	0.89	1.14	1.09	1.04
0.16 µL/plate	Mean	80	97	339	280
	sd	9.1	19.6	78.9	36.0
	f(I)	1.00	1.20	1.30	0.77
0.08 µL/plate	Mean	84	72	252	352
	sd	9.6	5.2	36.7	174.4
	f(I)	1.05	0.89	0.97	0.97

Table8.3‑b Mean Revertants Experiment 2

Strain		TA100		TA1535
Induction		-S9	+S9	-S9	+S9
Demin. water	Mean	114	100	22	23
	sd	18.7	16.4	3.5	2.9
DMSO	Mean	114	109	20	21
	sd	3.5	8.1	0.6	1.2
Ethanol	Mean	109	96	15	17
	sd	5.0	15.9	5.0	4.0
Positive Controls*	Mean	341	816	346	153
	sd	20.1	83.1	50.3	12.9
	f(I)	2.99	7.49	15.73	7.29
1.5 µL/plate	Mean	9	31	2	4
	sd	1.5	5.9	1.2	2.1
	f(I)	0.08	0.32	0.13	0.24
0.75 µL/plate	Mean	15	44	3	4
	sd	3.1	2.1	1.5	2.9
	f(I)	0.14	0.46	0.20	0.24
0.38 µL/plate	Mean	77	87	17	13
	sd	14.7	18.7	2.5	4.2
	f(I)	0.71	0.91	1.13	0.76
0.19 µL/plate	Mean	76	80	14	14
	sd	10.1	13.9	4.4	3.6
	f(I)	0.70	0.83	0.93	0.82
0.09 µL/plate	Mean	85	115	17	18
	sd	10.0	5.3	6.0	6.2
	f(I)	0.78	1.20	1.13	1.06
0.05 µL/plate	Mean	79	120	14	15
	sd	5.9	4.6	2.6	3.8
	f(I)	0.72	1.25	0.93	0.88
0.02 µL/plate	Mean	90	128	17	18
	sd	5.6	13.5	5.9	3.1
	f(I)	0.83	1.33	1.13	1.06

Table8.3‑c  Mean Revertants Experiment 2

Strain		TA98
Induction		-S9	+S9
Demin. water	Mean	35	37
	sd	6.9	5.3
DMSO	Mean	40	39
	sd	11.8	4.0
Ethanol	Mean	38	38
	sd	9.9	3.0
Positive Controls*	Mean	685	188
	sd	92.4	38.0
	f(I)	17.13	4.82
0.05 µL/plate	Mean	29	30
	sd	4.9	11.8
	f(I)	0.76	0.79
0.025 µL/plate	Mean	37	40
	sd	2.5	4.6
	f(I)	0.97	1.05
0.0125 µL/plate	Mean	32	35
	sd	2.1	3.8
	f(I)	0.84	0.92
0.0063 µL/plate	Mean	35	37
	sd	1.0	5.0
	f(I)	0.92	0.97
0.0031 µL/plate	Mean	29	36
	sd	1.2	2.6
	f(I)	0.76	0.95
0.0016 µL/plate	Mean	37	36
	sd	3.5	4.6
	f(I)	0.97	0.95
0.0008 µL/plate	Mean	35	33
	sd	6.1	2.1
	f(I)	0.92	0.87

Applicant's summary and conclusion

Conclusions:

Based on the results of this study it is concluded that Ginger, ext. is not mutagenic in the Salmonella typhimurium test strains TA97a, TA98, TA100, TA102 and TA1535 in the absence and presence of metabolic activation under the experimental conditions in the present study.