Decanoic acid

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions

Data source

Reference

Reference 1

Reference Type:

other: NTP database entry

Title:

Unnamed

Year:

1985

Reference 2

Reference Type:

publication

Title:

Salmonella Mutagenicity Tests. IV. Results from the Testing of 300 Chemicals

Author:

Zeiger, E. et al.

Year:

1988

Bibliographic source:

Environ Molec Mutagen 11(12):1-158

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

strain with AT base pair as primary reversion site missing

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Decanoic acid

EC Number:

206-376-4

EC Name:

Decanoic acid

Cas Number:

334-48-5

Molecular formula:

C10H20O2

IUPAC Name:

decanoic acid

Method

Target gene:

his 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 97

Metabolic activation:

with and without

Metabolic activation system:

induced male Sprague Dawley rat liver S9 (10% and 30% S9 in S9-mix) and induced male Syrian hamster liver S9 (10% and 30% S9 in S9-mix)

Test concentrations with justification for top dose:

10, 33, 100, 333 and 666 µg/plate with and without metabolic activation
3, 10, 33, 100, 333 and 666 µg/plate without metabolic activation

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

no

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-nitrofluorene or alternatively 4-nitro-o-phenylenediamine (-S9, TA98); sodium azide (-S9, TA100 and TA1535); 9-aminoacridine (-S9, TA97 and TA1537); 2-aminoanthracene (+S9, all strains)

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20 min
- Exposure duration: 48 hours

Evaluation criteria:

If the test chemical was mutagenic to any particular strain of bacterium, the number of histidine-independent colonies arising on those plates will be significantly greater than the corresponding control plates for that strain.
The number of mutant colonies appearing on the positive control plates must be significantly increased over the spontaneous control number for the test to be considered valid. Failure of the positive control chemical to induce mutation is reason to discard the experiment.
If no increase in mutant colonies is seen after testing several strains under several different culture conditions, the test chemical is considered to be nonmutagenic in the Ames test.

Statistics:

Mean values and standard deviation were calculated.

Results and discussion

Test results

Test results 1

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

slight toxicity for all strains tested at 666 µg/plate without S9 and for TA 1535 at 666 µg/plate with 10% rat liver S9

Vehicle controls validity:

not examined

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 97

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

slight toxicity at 666 µg/plate without S9-mix

Vehicle controls validity:

not examined

Untreated negative controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

Table 1. Test results for decanoic acid

 

With or without S9-Mix	Test substance concentration (μg/plate)	Mean number of revertant colonies per plate ± standard deviation
		Base-pair substitution type		Frameshift type
		TA100	TA1535	TA97	TA98	TA1537
–	0	145 ± 10.5	13 ± 2	138 ± 6.6	17 ± 0.3	7 ± 0.7
–	10	130 ± 7.2	14 ± 1.5	150 ± 5.6	21 ± 1.5	8 ± 0.7
–	33	119 ± 15.1	15 ± 2.1	131 ± 14	16 ± 2.6	7 ± 0.6
–	100	109 ± 6.2	11 ± 2.2	151 ± 9	21 ± 0.6	6 ± 0.6
–	333	106 ± 4.8	14 ± 3.8	114 ± 7.5	15 ± 1.2	6 ± 1
–	666	59s ± 2.8	7s ± 1.2	15s ± 8.1	3s ± 2.1	2s ± 0.3
–	Positive controls	SA	SA	9AA	2NF or 4NPD	9AA
	Mean No. of colonies/plate ± SD	532 ± 11.9	428 ± 21.9	793 ± 106.2	615 ± 2.3	305 ± 22.6
–	0	157 ± 8.6	21 ± 1.2	149 ± 11	17 ± 2.7	7 ± 1.7
–	3	119 ± 9.3	17 ± 2	167 ± 4	13 ± 0.9	7 ± 0.3
–	10	119 ± 3.8	11 ± 2.2	161 ± 10.1	16 ± 1.2	7 ± 0.9
–	33	106 ± 3.3	14 ± 1.5	154 ± 2.6	18 ± 2	9 ± 2.1
–	100	103 ± 11	17 ± 2.4	143 ± 3.6	15 ± 2.1	5 ± 1.2
–	333	135 ± 12.2	13 ± 4.2	120 ± 12.1	18 ± 1.9	4 ± 0.9
–	Positive controls	SA	SA	9AA	2NF or 4NPD	9AA
	Mean No. of colonies/plate ± SD	478 ± 8.8	444 ± 4.8	823 ± 90.6	580 ± 22	416 ± 43.7
+ (10% HLI)	0	102 ± 6.3	12 ± 2.1	173 ± 19.5	28 ± 2.6	9 ± 2.1
+ (10% HLI)	10	104 ± 5.8	10 ± 1.7	158 ± 10.8	28 ± 3.5	6 ± 1.9
+ (10% HLI)	33	82 ± 2.7	12 ± 3.1	157 ± 12.8	26 ± 5.5	7 ± 0.9
+ (10% HLI)	100	101 ± 4	7 ± 0.9	151c ± 15	25 ± 4	5 ± 1.8
+ (10% HLI)	333	92 ± 8	6 ± 0.7	142 ± 10.1	15 ± 2.3	5 ± 1.5
+ (10% HLI)	666	83 ± 5.9	6 ± 1.5	108 ± 7.5	15 ± 3.2	4 ± 2
+ (10% HLI)	Positive controls	2AA	2AA	2AA	2AA	2AA
	Mean No. of colonies/plate ± SD	479 ± 19.2	202c ± 9.5	386 ± 13.6	339 ± 25.9	52 ± 1.8
+ (30% HLI)	0	154 ± 9.7	8 ± 1.2	179 ± 3.3	27 ± 3.2	14 ± 1.7
+ (30% HLI)	10	134 ± 10.9	9 ± 2.5	198 ± 5.5	28 ± 0.3	4 ± 0.6
+ (30% HLI)	33	145 ± 19.8	9 ± 1.5	194 ± 6.8	24 ± 2.1	6 ± 0.6
+ (30% HLI)	100	134 ± 7.9	9 ± 0.9	194 ± 4.3	25 ± 1.8	6 ± 0.9
+ (30% HLI)	333	142 ± 9.8	6 ± 1.2	185 ± 6.7	24 ± 1.7	8 ± 1.5
+ (30% HLI)	666	150 ± 5.2	6 ± 0.3	140 ± 16.3	24 ± 4.2	5 ± 1
+ (30% HLI)	Positive controls	2AA	2AA	2AA	2AA	2AA
	Mean No. of colonies/plate ± SD	541 ± 13.5	459 ± 37.3	414 ± 25.2	294 ± 3.2	47 ± 3.2
+ (10% RLI)	0	129 ± 11.7	9 ± 1.2	165 ± 1.3	19 ± 2.7	10 ± 2.2
+ (10% RLI)	10	126 ± 17.5	9 ± 1.5	189 ± 5.3	18 ± 4.6	7 ± 1.5
+ (10% RLI)	33	138c ± 13	8 ± 1.3	188 ± 11.6	18 ± 4.1	8 ± 1.2
+ (10% RLI)	100	108 ± 14.8	10 ± 1.3	122 ± 5.8	24 ± 1.5	4 ± 0.6
+ (10% RLI)	333	87 ± 7.5	7 ± 0.3	146 ± 1.8	15 ± 1.7	3 ± 0
+ (10% RLI)	666	73 ± 2.9	1s ± 0.9	57 ± 9	12 ± 1.7	3 ± 1
+ (10% RLI)	Positive controls	2AA	2AA	2AA	2AA	2AA
	Mean No. of colonies/plate ± SD	390 ± 22.9	190 ± 12.5	364 ± 5.7	201 ± 18.3	45 ± 2.6
+ (30% RLI)	0	142 ± 10.7	15 ± 0.7	170 ± 15.7	27 ± 3.9	12 ± 2.3
+ (30% RLI)	10	148 ± 15.5	19 ± 3.8	214 ± 12	26 ± 2.7	8 ± 2.3
+ (30% RLI)	33	139 ± 2.2	14 ± 0.6	214 ± 13.1	22 ± 3.5	7 ± 0.6
+ (30% RLI)	100	138 ± 20	14 ± 0.6	187 ± 3.5	24 ± 2.6	7 ± 0.7
+ (30% RLI)	333	132 ± 5.2	8 ± 1.2	187 ± 3.8	17 ± 2.1	7 ± 2.1
+ (30% RLI)	666	148 ± 8.1	10 ± 2.3	98 ± 19.5	17 ± 3.3	4 ± 0.6
+ (30% RLI)	Positive controls	2AA	2AA	2AA	2AA	2AA
	Mean No. of colonies/plate ± SD	787 ± 42.9	187 ± 12.5	351 ± 7.9	159 ± 17.1	53 ± 0.6

SA = sodium azide

9AA = 9-aminoacridine

4NPD = 4-nitro-o-phenylenediamine

2NF = 2-nitro-fluorene

2AA = 2-aminoanthracene

SD = standard deviation

HLI = induced male Syrian hamster liver S9

RLI = induced male Sprague Dawley rat liver S9

s = slight toxicity

c = contamination

 

Applicant's summary and conclusion

Conclusions:

Under the experimental conditions described, the test substance was not mutagenic in the Ames test using the Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and TA97 with and without metabolic activation.