3-Cyclohexene-1-methanol, α,4-dimethyl-α-(4-methyl-3-penten-1-yl)-

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:

2002-06-21 - 2002-08-05

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: according to current guideline and GLP; only standard plate test performed

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

(1997)

GLP compliance:

yes (incl. QA statement)

Remarks:

Freiburger Labor für Mutagenitätsprüfung der King & Harnasch GmbH

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

(R*,R*)-α,4-dimethyl-α-(4-methyl-3-pentenyl)cyclohex-3-ene-1-methanol

EC Number:

208-205-9

EC Name:

(R*,R*)-α,4-dimethyl-α-(4-methyl-3-pentenyl)cyclohex-3-ene-1-methanol

Cas Number:

515-69-5

Molecular formula:

C15H26O

IUPAC Name:

6-methyl-2-(4-methylcyclohex-3-en-1-yl)hept-5-en-2-ol

Test material form:

other: liquid

Details on test material:

Bisabolol alpha nat.

Method

Target gene:

His

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254 induced rat liver S9 mix

Test concentrations with justification for top dose:

1.5 - 1500 µg/plate in the presence of S9-mix.
0.5 - 500 µg/plate in the absence of S9-mix.

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: without S9-mix: 9-Aminoacridine, mitomycin C, sodium azide, 2-nitrofluorene; with S9-mix: 2-aminoanthracene

Details on test system and experimental conditions:

Standard Plate Test

DURATION
- Exposure duration: 48h-72h

NUMBER OF REPLICATIONS: 2 independent experiments performed in triplicates

DETERMINATION OF CYTOTOXICITY
- Method: number of revertant colonies and/or a diminution of the background lawn

Statistics:

The estimation of the statistical significance of the difference between the mean number of revertants in the negative controls and the plates at each dosage level was tested using a X²-test (Mohn and Ellenberger, 1977).

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

bacteriotoxic towards the strains TA1535, TA1537, TA98, and TA100 at 150 µg/plate and towards the strain TA102 at 500 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

bacteriotoxic towards the strains TA1535, TA1537, and TA100 at 500 µg/plate and towards the strains TA98 and TA102 at 1500 μg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: was not observed

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Table: Induction of revertants in S. typhimurium by the test subtance in the absence of a metabolizing system (1st Experiment)

Substance	Concentration [µg/plate]	TA 98	TA100	TA 102	TA 1535	TA 1537
Control	0	28	147	268	14	14
Solvent control	0	25	131	267	17	13
Test item	1.5	30	129		16	13
	5	19	137	281	18	9
	15	26	132	250	18	14
	50	12	120	244	16	10
	150	3 T	6 T	206	7 T	0 T
	500			174 T
NaN3	0.7		361		313
2-NF	2.5	448
9-AA	50					153
Mitomycin C	0.15			884

Table: Induction of revertants in S. typhimurium by the test subtance in the presence of a metabolizing system (1st Experiment)

Substance	Concentration [µg/plate]	TA 98	TA100	TA 102	TA 1535	TA 1537
Control	0	40	120	266	19	16
Solvent control	0	40	123	283	16	12
Test item	1.5		129			14
	5	37	126	262	13	12
	15	41	114	272	14	14
	50	39	134	259	14	9
	150	46	127	300	13	11
	500	26		300	9 T
2-AA	0.8	630	636
2-AA	0.9			423	155
2-AA	1.7					86

Table: Induction of revertants in S. typhimurium by the test subtance in the absence of a metabolizing system (2rd Experiment)

Substance	Concentration [µg/plate]	TA 98	TA100	TA 102	TA 1535	TA 1537
Control	0	32	116	263	23	14
Solvent control	0	31	132	260	18	15
Test item	0.5	30				11
	1.5	27	130	264	17	12
	5	33	123	253	21	11
	15	20	132	246	18	9
	50	31	130	249	16	9
	150		7 T	207	1 T
NaN3	0.7		358		326
2-NF	2.5	556
9-AA	50					274
Mitomycin C	0.15			817

Table: Induction of revertants in S. typhimurium by the test subtance in the presence of metabolizing system (2rd Experiment)

Substance	Concentration [µg/plate]	TA 98	TA100	TA 102	TA 1535	TA 1537
Control	0	39	116	311	17	14
Solvent control	0	40	114	312	16	19
Test item	5		113		20	17
	15	40	121	309	20	17
	50	35	101	333	12	17
	150	38	92	367	14	15
	500	21	1 T	292	6 T	0 T
	1500	0 T		151
2-AA	0.8	455	349
2-AA	0.9			535	175
2-AA	1.7					260

T: bacteriotoxic

2-AA: 2-aminoanthracene

2-NF: 2-nitrofluorene

9-AA: 9-aminoacridin