Disodium tartrate

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

/ 2-AA used as sole indicator of S9 mix efficacy; duplicate plating without scientific justification; only 1 plate for some positive controls; no result of 2-AA (+S9 mix) in 1 exp (TA 1537, TA 1538 and WP2 uvr A); AF-2 used as positive control of WP2 uvr A

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Microbial mutagenesis testing of substances compound report: F76-019, Potassium sodium tartrate

Author:

Simmon, V.F. and Eckford, S.L.

Year:

1979

Bibliographic source:

U.S. Departement of Commerce, National Technical Information Service, Springfield, U.S.A

Reference 2

Reference Type:

secondary source

Title:

Bacterial mutagenicity testing of 49 food ingredients givesvery few positive results

Author:

Prival, M.J. et al.

Year:

1991

Bibliographic source:

Mutation Research 260: 321-329

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

21 July 1997

Principles of method if other than guideline:

- Principle of test: similar to OECD 471 but with several differences:
2-AA was used as sole indicator of S9 mix efficacy; duplicate plating without scientific justification; only 1 plate for some positive controls; no result of 2-AA (+S9 mix) in 1 exp (TA 1537, TA 1538 and WP2 uvr A); AF-2 used as positive control of WP2 uvr A

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Potassium sodium tartrate

EC Number:

206-156-8

EC Name:

Potassium sodium tartrate

Cas Number:

304-59-6

Molecular formula:

C4H6O6.K.Na

IUPAC Name:

potassium sodium tartarate

Test material form:

solid

Method

Target gene:

his operon, trp operon

Species / strain

Species / strain 1

Species / strain / cell type:

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

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1538

Species / strain 3

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of male rats, treated with Aroclor 1254 (500 mg/kg bw)

Test concentrations with justification for top dose:

Based on a range-finding study (performed in tester strain TA 100; doses applied: 0.3 - 10000 μg/plate), the following concentrations were used in the main experiments:
TA 1535 / TA 100:
1st exp.: 33.3, 100, 333.3, 1000, 3333.3 and 10000 µg/plate with and without metabolic activation
2nd exp.: 0.3, 3.3, 33.3, 100, 333.3, 1000, 3333.3 and 10000 µg/plate with and without metabolic activation

TA 1537 / TA 1538 / TA 98 / WP2 uvr A:
1st exp.: 0.3, 3.3, 33.3, 100, 333.3, 1000, 3333.3 and 10000 µg/plate with and without metabolic activation
2nd exp.: 33.3, 100, 333.3, 1000, 3333.3 and 10000 µg/plate with and without metabolic activation

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: potassium phosphate buffer

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

potassium phosphate buffer (0.067 M, pH 7)

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

2-nitrofluorene

sodium azide

other: AF-2 (2-(2-Furyl)-3-(5-nitro-2-furyl) acrylamide), 2AA (2-Aminoanthracene)

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium; in agar (plate incorporation) (Range Finding Test, first and second experiment)

DURATION
- Exposure duration: 48 h

NUMBER OF REPLICATIONS: 2

DETERMINATION OF CYTOTOXICITY
- Method: not provided

Statistics:

Mean values were calculated.

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Test results 3

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Test results 4

Key result

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Test results 5

Key result

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Test results 6

Key result

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Additional information on results:

RANGE-FINDING/SCREENING STUDIES: A range finding assay was performed in TA 100. No mutagenicity and toxicity were observed.

Any other information on results incl. tables

Table 1: Summary of test results (Exp. 1, Plate Incorporation Method)

With or without S9-Mix	Test substance concentration (μg/plate)	Mean number of revertant colonies per plate (average of 2 plates)
		Frameshift type			Base-pair substitution type
		TA98	TA1537	TA1538	TA100	TA1535	WP2 uvrA
–	Solvent control (potassium phosphate buffer)	24*	16*	13*	204*	41*	50*
	0.3	22	13	15	-	-	49
	3.3	23	15	13	-	-	51
	33.3	21	18	19	204	49	47
	100	24	12	10	198	43	41
	333.3	22	14	25	201	38	45
	1000	22	11	11	174	48	36
	3333.3	28	19	14	205	47	48
	10000	14	14	16	183	37	53
	Positive controls (µg/plate)	2-NF (5)	9AA (50)	2-NF (5)	SA (0.5)	SA (0.5)	AF2 (0.1)
	Mean No. of colonies/plate (average of 2 plates)	359	185	692	411**	264**	103
	Positive controls (µg/plate)	2AA (2.5)	2AA (1)	2AA (1)	2AA (2.5)	2AA (1)	2AA (10)
	Mean No. of colonies/plate (average of 2 plates)	39**	nt	nt	181**	37**	72**
+	Solvent control (potassium phosphate buffer)	36*	11*	22*	252*	41*	102*
	0.3	47	14	21	-	-	47
	3.3	34	18	17	-	-	53
	33.3	40	16	32	244	69	48
	100	31	18	32	219	78	51
	333.3	38	14	27	246	67	52
	1000	45	12	25	259	59	59
	3333.3	34	13	24	256	62	49
	10000	35	19	34	239	52	54
	Positive controls (µg/plate)	2AA (2.5)	2AA (1)	2AA (1)	2AA (2.5)	2AA (1)	2AA (10)
	Mean No. of colonies/plate (average of 2 plates)	965**	nt	nt	360**	119**	166**

2AA = 2-aminoanthracene

2-NF = 2-nitrofluorene

9AA = 9-aminoacridine

AF-2 = 2-(2-Furyl)-3-(5-nitro-2-furyl) acrylamide

SA = sodium azide

* = 4 results

** = 1 result

Table 2: Summary of test results (Exp. 2, Plate Incorporation Method)

With or without S9-Mix	Test substance concentration (μg/plate)	Mean number of revertant colonies per plate (average of 2 plates)
		Frameshift type			Base-pair substitution type
		TA98	TA1537	TA1538	TA100	TA1535	WP2 uvrA
–	Solvent control (potassium phosphate buffer)	15*	5*	11*	77*	15*	33*
	0.3	-	-	-	77	14	-
	3.3	-	-	-	76	17	-
	33.3	21	5	14	78**	14	35
	100	20	4	9	70	11	36
	333.3	16	5	18	77	14	41
	1000	21	5	11	70	11	34
	3333.3	17	3	15	82	16	36
	10000	15	5	17	67	12	39
	Positive controls (µg/plate)	2-NF (5)	9AA (50)	2-NF (5)	SA (0.5)	SA (0.5)	AF2 (0.1)
	Mean No. of colonies/plate (average of 2 plates)	359**	154**	591**	417	300	1581
	Positive controls (µg/plate)	2AA (2.5)	2AA (1)	2AA (1)	2AA (2.5)	2AA (1)	2AA (10)
	Mean No. of colonies/plate (average of 2 plates)	18**	3**	19**	89**	7**	nt
+	Solvent control (potassium phosphate buffer)	27*	7*	21*	85*	5*	40*
	0.3	-	-	-	65	9	-
	3.3	-	-	-	84	7	-
	33.3	44	9	26	75	7	44
	100	36	9	25	66	6	58
	333.3	27	8	25	84	6	43
	1000	28	8	24	71	5	52
	3333.3	29	5	25	72	6	49
	10000	27	6	21	65	7	57
	Positive controls (µg/plate)	2AA (2.5)	2AA (1)	2AA (1)	2AA (2.5)	2AA (1)	2AA (10)
	Mean No. of colonies/plate (average of 2 plates)	104**	41**	89**	882**	76**	nt

2AA = 2-aminoanthracene

2-NF = 2-nitrofluorene

9AA = 9-aminoacridine

AF-2 = 2-(2-Furyl)-3-(5-nitro-2-furyl) acrylamide

SA = sodium azide

* = 4 results

** = 1 result