Linalyl acetate

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 GLP guideline study, only 4 strains tested

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

only 4 strains tested

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Linalyl acetate

EC Number:

204-116-4

EC Name:

Linalyl acetate

Cas Number:

115-95-7

Molecular formula:

C12H20O2

IUPAC Name:

1,5-dimethyl-1-vinylhex-4-en-1-yl acetate

Details on test material:

- Name of test material (as cited in study report): Linalylacetate, substance No.: 91/244
- Physical state: Colorless liquid
- Analytical purity: 97.3%
- Storage condition of test material: +4°C to +6°C (N2 conditions)
- Other: day of manufacturing May 8, 1991

Method

Target gene:

histidine-operon

Species / strain

Species / strain / cell type:

other: Salmonella typhimurium TA 98, TA100, TA1535, TA1537

Metabolic activation:

with and without

Metabolic activation system:

liver S9 fraction (Aroclor 1254-induced)

Test concentrations with justification for top dose:

0, 20, 100, 500, 2500 and 5000 µg/plate (1st experiment);
0, 20, 100, 500, 1000 and 2000 µg/plate (2nd experiment);
0, 3, 6, 12, 25 and 50 µg/plate (3rd experiment)

Vehicle / solvent:

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

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: see remarks

Remarks:

with S-9: 2.5 µg and 10 µg 2-aminoanthracene; without S9: 5 µg N-methyl-N-nitro-N-nitrosoguanidine (TA 100, TA 1535); 10 µg 4-nitro-o-phenylendiamine (TA98); 100 µg 9 -aminoacridine chloride monohydrate (TA 1537)

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (standard plate incorporation) and in bacterial suspension (preincubation test)


DURATION
- Preincubation period: 20 min

Evaluation criteria:

In general, a substance to be characterized as positive in the Ames test has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results.

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

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Complete solubility of the test substance in DMSO.

ADDITIONAL INFORMATION ON CYTOTOXICITY:
A bacteriotoxic effect was observed in the SPT at doses >= 2500 µg/plate. In the PIT bacteriotoxicity was found depending on the strain and test conditions from about 12 µg- 50 µg/plate onward.

Remarks on result:

other: other: Salmonella typhimurium TA 98, TA100, TA1535, TA1537

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Standard plate test:

Strain	Dose µg/plate	Revertants/plate  without S9 mix		Revertants/plate with S9 mix
		mean	SD	mean	SD
TA 100	negative ctrl	108	7	116	9
	20	97	6	115	9
	100	114	12	118	7
	500	105	7	112	6
	2500	35	5	64	7
	5000	29	4	48	11
	positive ctrl	1020	17	1233	59
TA98	negative ctrl	25	3	36	2
	20	19	2	33	5
	100	22	2	32	5
	500	24	3	28	3
	2500	11	4	22	2
	5000	11	3	22	11
	positive ctrl	1327	64	947	107
TA 1535	negative ctrl	14	2	16	3
	20	15	4	15	2
	100	14	2	15	4
	500	13	2	11	1
	2500	7	2	8	4
	5000	-	-	9	2
	positive ctrl	750	48	116	12
TA 1537	negative ctrl	10	2	10	2
	20	10	2	11	1
	100	10	2	11	3
	500	8	2	8	1
	2500	4	2	2	1
	5000	-	-	-	-
	positive ctrl	812	25	135	18

Preincubation test:

Strain	Dose µg/plate	Revertants/plate  without S9 mix		Revertants/plate with S9 mix
		mean	SD	mean	SD
TA 100	negative ctrl	132	11	129	8
	20	131	10	118	15
	100	49	4	96	22
	500	30	3	68	4
	1000	25	12	66	15
	2000	32	9	55	25
	positive ctrl	503	54	713	250
TA98	negative ctrl	25	4	35	2
	20	27	9	32	2
	100	27	5	38	6
	500	20	4	33	3
	1000	24	5	28	3
	2000	19	6	29	9
	positive ctrl	847	239	428	162
TA 1535	negative ctrl	16	1	18	2
	20	20	3	14	1
	100	-	-	12	3
	500	-	-	12	4
	1000	-	-	-	-
	2000	-	-	-	-
	positive ctrl	341	40	117	10
TA 1537	negative ctrl	9	0	12	2
	20	10	2	9	4
	100	7	1	8	2
	500	7	2	7	2
	1000	7	1	-	-
	2000	-	-	-	-
	positive ctrl	467	128	80	2

Preincubation test:

Strain	Dose µg/plate	Revertants/plate  without S9 mix		Revertants/plate with S9 mix
		mean	SD	mean	SD
TA 100	negative ctrl	135	26	119	7
	3	120	9	128	13
	6	124	10	116	14
	12	119	3	137	9
	25	69	15	139	9
	50	75	3	112	4
	positive ctrl	606	59	864	52
TA98	negative ctrl	21	5	33	6
	3	25	1	34	4
	6	19	4	36	5
	12	21	5	37	5
	25	15	2	29	3
	50	10	1	19	2
	positive ctrl	648	60	485	11
TA 1535	negative ctrl	17	3	18	5
	3	20	4	21	4
	6	24	5	24	4
	12	26	3	23	2
	25	15	1	25	2
	50	8	1	33	1
	positive ctrl	423	20	177	8
TA 1537	negative ctrl	9	2	11	4
	3	11	2	9	2
	6	14	4	9	2
	12	10	2	10	3
	25	-	-	7	2
	50	-	-	6	2
	positive ctrl	351	47	94	10