Fatty acids, C14-18 and C16-18-unsatd., ammonium salts

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

Study period:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study summary, acceptable for assessment with restrictions, no study available for review, only four strains tested.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Oleic acid

EC Number:

204-007-1

EC Name:

Oleic acid

Cas Number:

112-80-1

Molecular formula:

C18H34O2

IUPAC Name:

octadec-9-enoic acid

Method

Species / strain

Species / strain / cell type:

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

Metabolic activation:

with and without

Metabolic activation system:

induced male Sprague Dawley rat liver S9 and induced male Syrian hamster liver S9

Test concentrations with justification for top dose:

0.1, 0.3, 1, 3.3, 10, 33, 100, 333 µg/plate

Vehicle / solvent:

- Vehicle/solvent used: DMSO

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation

Results and discussion

Test results

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 observed at the highest dose group

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Table 1: Results of the genetic toxicity study with oleic acid on Salmonella typhimurium strain TA100

Dose [µg/plate]	No activation	No activation	10 % RLI	10 % RLI	10 % HLI	10 % HLI
0.1	147	105
0.3	126	98
1	132	98
3.3	142*	87*	128	106	143	102
10	115*	73*	136	116	136	108
33			133	115	133	100
100			141	102	133	92
333			117*	86*	127*	86*
Vehicle control	143	98	135	117	142	109
Positive control	1138	1060	895	774	1340	1082

*Slight toxicity observed

 

Table 2: Results of the genetic toxicity study with oleic acid on Salmonella typhimurium strain TA1535

Dose [µg/plate]	No activation	No activation	10 % RLI	10 % RLI	10 % HLI	10 % HLI
0.1	20	17
0.3	25	15
1	23	14
3.3	22*	11*	13	16	10	11
10	18*	12*	14	8	11	11
33			11	11	13	13
100			11	11	10	10
333			9*	8*	7*	8*
Vehicle control	24	20	13	8	12	10
Positive control	894	760	64	72	84	76

*Slight toxicity observed

 

Table 3: Results of the genetic toxicity study with oleic acid on Salmonella typhimurium strain TA1537

Dose [µg/plate]	No activation	No activation	10 % RLI	10 % RLI	10 % HLI	10 % HLI
0.1	7	7
0.3	5	4
1	6	4
3.3	5	4	5	3	6	5
10	4*	5*	6	5	6	5
33			6	6	7	7
100			7	5	5	6
333			7*	4*	6*	6*
Vehicle control	4	6	7	4	5	10
Positive control	326	223	59	49	92	81

*slight toxicity observed

 

Table 4: Results of the genetic toxicity study with oleic acid on Salmonella typhimurium strain TA98

Dose [µg/plate]	No activation	No activation	10 % RLI	10 % RLI	10 % HLI	10 % HLI
0.1	16	14
0.3	14	15
1	13	14
3.3	15	14	24	19	23	18
10	16	13	32	23	26	24
33			25	29	23	26
100			31	20	26	30
333			23*	24	29	25
Vehicle control	18	15	26	16	20	24
Positive control	1319	1263	386	792	819	1169

*slight toxicity observed

 

Applicant's summary and conclusion

Conclusions:

Ames test: The substance 9-octadecenoic acid was not mutagenic in a bacterial reverse mutation assay.