Potassium propionate

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Salmonella Mutagenicity Tests: V. Results from the Testing of 311 Chemicals.

Author:

Errol Zeiger, Beth Anderson, Steve Haworth, Timothy Lawlor, and
Kristien Mortelmans

Year:

1992

Bibliographic source:

Environmental and Molecular Mutagenesis Volume 19, Supplement 21 :2-141 (1 992)

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

Variations in the preincubation protocol among the tested chemicals reflect the evolution of the protocol originally described by Haworth et al. [1983].Please refer to any additional information on materials and methods.

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Propionic acid

EC Number:

201-176-3

EC Name:

Propionic acid

Cas Number:

79-09-4

Molecular formula:

C3H6O2

IUPAC Name:

propionic acid

Method

Target gene:

his locus

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA97, TA98, TA100, and TA1535, with some additional use of strain TA1537

Metabolic activation:

with and without

Metabolic activation system:

Type and composition of metabolic activation system:
- source of S9
- method of preparation of S9 mix
- concentration or volume of S9 mix and S9 in the final culture medium
- quality controls of S9 (e.g., enzymatic activity, sterility, metabolic capability)

Controls

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

sodium azide

methylmethanesulfonate

mitomycin C

other: 2-aminoanthracene (with metabolic acivation), 4-nitro-o-phenylenediamine (TA97/TA1537, without metabolic activation)

Details on test system and experimental conditions:

NUMBER OF REPLICATIONS:
- Number of cultures per concentration triplicate
- Number of independent experiments at least two

METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding (if applicable): Not reported
- Test substance added in medium; preincubation

METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method, e.g.: Toxic concentrations were defined as those that produced a decrease in the number of his+ colonies, or a clearing in the density of the
background lawn, or both.

Evaluation criteria:

Please refer to the Any other infomation on materials and methods section

Results and discussion

Test results

Key result

Species / strain:

S. typhimurium, other: TA97, TA98, TA100, TA1535, TA1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

slight clearing of backgroud lawn at 10000 µg/plate with metabolic acitvation

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

True negative controls validity:

not examined

Positive controls validity:

valid

Any other information on results incl. tables

Results:

 

Dose	TA100										TA1535
	NA (-)		10% HLI (-)		30% HLI (-)		10% RLI (-)		30% RLI (-)		NA (-)		10% HLI (-)		30% HLI (-)		10% RLI (-)		30% RLI (-)
µg/plate	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM
0.0	83	2.0	90	6.1	120	11.7	100	10.5	126	4.5	22	4.8	12	2.8	11	1.8	12	1.5	13	2.2
100.0	82	1.2	84	5.5	105	3.5	95	3.0	108	5.3	16	2.5	13	1.5	10	0.9	9	1.5	14	2.1
333.0	84	3.2	92	5.0	120	6.7	97	6.2	138	8.1	14	0.7	12	2.0	10	1.5	15	0.9	14	1.5
1000.0	88	2.3	92	2.3	111	7.6	81	7.5	112	7.5	15	2.7	10	2.0	9	2.2	9	1.5	12	0.6
3333.0	85	8.2	102	4.7	108	5.5	92	1.2	130	9.0	18	0.7	8p	0.7	12	1.5	8p	2.9	14	3.8
6667.0	70	1.2									12	0.9
10000.0			99s	11.6	52s	21.1	t		84s	0.3			7s	2.2	8s	1.3	4s	2.3	7s	2.9
POS	382	13.9	402	10.3	529	14.5	303	11.3	769	30.6	272	4.7	101	5.7	94	3.8	117	6.6	79	7.4

Dose	TA1537
	NA (-)		30% HLI (-)		30% RLI (-)
µg/plate	Mean	SEM	Mean	SEM	Mean	SEM
0.0	7	0.7	7	0.7	6	0.6
100.0	6	0.3	8	0.7	9	0.7
333.0	6	0.9	9	1.0	11	1.3
1000.0	6	0.9	9	2.2	8	1.5
3333.0	5	0.9	8	0.3	10	0.9
6667.0	4	0.6
10000.0			5s	0.3	9s	2.6
POS	53	4.6	117	7.2	54	3.4

Dose	TA97										TA98
	NA (-)		10% HLI (-)		30% HLI (-)		10% RLI (-)		30% RLI (-)		NA (-)		10% HLI (-)		30% HLI (-)		10% RLI (-)		30% RLI (-)
µg/plate	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM
0.0	88	8.5	110	5.5	130	6.2	117	6.4	175	2.0	16	2.3	25	2.3	27	3.5	25	1.5	33	0.9
100.0	89	10.2	109	7.9	135	6.8	121	1.8	168	3.6	19	0.3	22	3.8	30	3.5	26	1.5	21	2.0
333.0	80	3.8	97	2.5	125	7.0	111	2.7	154	13.6	12	1.7	23	2.0	27	0.9	23	4.0	23	5.5
1000.0	73	2.0	108	4.5	115	6.7	110	8.8	176	4.5	13	1.2	34	1.8	21	4.1	21	1.8	27	4.4
3333.0	44	6.2	102	3.0	114	11.1	98	3.0	193	9.9	17	0.3	21	1.9	21	1.9	22	1.3	28	1.5
6667.0	10s	5.1									15	0.6
10000.0			13s	3.0	45s	2.8	t		95s	5.7			7s	0.7	12s	2.2	10s	4.5	9s	1.8
POS	261	3.0	511	13.5	778	7.9	635	12.1	389	16.6	220	4.2	211	15.5	105	3.2	173	11.0	297	2.0

NA, not activated; HLI, Aroclor 1254-induced hamster liver S-9; RLI, Aroclor 1254-induced rat liver S-9; s, slight clearing of background lawn; t, complete clearing of background lawn (colonies not counted); p, precipitate present in plates; x, precipitate present with toxicity; +, mutagenic; +W, weakly mutagenic; ?, questionable response; - , nonmutagenic.

 

 

 

Applicant's summary and conclusion

Conclusions:

In the publication of Zeiger et al., 1992, 311 chemicals were tested for their mutagenic potential in a bacterial reverse mutation assay conducted according to Ames et al., 1975. S. typhimurium tester strains were exposed to 0, 100, 333, 1000, 3333, 6667, and 10000 µg/plate with the preincubation method for 48 h. There was no increase of the number of revertants in any tester strain at concentrations up to occurring toxicity, thus propionic acid is not considered mutagenic under the conditions of the test.

Executive summary:

In a reverse gene mutation assay in bacteria OECD TG 471, strains TA97, TA98, TA100, TA1535, TA1537 of S. typhimurium were exposed to Propionic acid at concentrations of 0, 100, 333, 1000, 3333, 6667, and 10000 µg/plate with the preincubation method in the presence and absence of mammalian metabolic activation for 48 h.

Propionic acid was tested up to cytotoxic concentrations, as indicated by the slight reduction of background lawn seen in the highest concentration in all tester strains. The positive controls induced  the appropriate responses in the corresponding strains. There was no evidence of induced mutant colonies over background.

This study is classified as acceptable. This study satisfies the requirement for Test Guideline OECD 471 for in vitro mutagenicity (bacterial reverse gene mutation) data.