Dodecene, branched

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: According to current OECD guideline, but without GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Principles of method if other than guideline:

Both a standard plate test and a preincubation test (with and without metabolic activation) were carried out.

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Dodecene, branched

EC Number:

306-479-5

EC Name:

Dodecene, branched

Cas Number:

97280-83-6

Molecular formula:

C12 H24

IUPAC Name:

(2Z)-4-methylundec-2-ene

Details on test material:

- Name of test material (as cited in study report): Isododecene
- Analytical purity: 99%

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:

S 9 fraction (liver of Aroclor 1254 induced rats)

Test concentrations with justification for top dose:

1st experiment - standard plate test: All strains - 0, 20, 100, 500, 2500 and 5000 µg/plate
2nd experiment - standard plate test: TA 1537 - 0, 100, 500, 2500, 5000 and 7500 µg/plate
3rd experiment - preincubation method: All strains - 0, 20, 100, 500, 2500 and 5000 µg/plate

Vehicle / solvent:

Acetone

Controls

Untreated negative controls:

yes

Remarks:

parallel with each experiment for each tester strain with and without metabolic activation

Negative solvent / vehicle controls:

yes

Remarks:

parallel with each experiment for each tester strain with and without metabolic activation

Positive controls:

yes

Remarks:

with S 9 mix: 2-aminoanthracene for all strains; without S 9 mix: N-methyl-N´-nitro-N-nitrosoguanidine (dissolved in DMSO) for TA100 and TA 1535, 4-nitro-o-phenylendiamine for TA98 and 9-aminoacridine for TA1537

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation) and preincubation

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

Number of plates: 3 test plates per dose or per control each

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 relationshi p
- 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:

other: see Additional information on results

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

ADDITIONAL INFORMATION ON CYTOTOXICITY:
A weakly bacteriotoxic effect ( reduced his background growth, slight decrease in the number of his+ revertants) was only observed in the preincubation test withou t S-9 mix using TA 100 at 5000 µg/plate and with TA 1537 from about 500 Ng/plate onward .

Any other information on results incl. tables

1st experiment (standard plate test)

	TA 1535		TA 1537		TA 98		TA 100
	Quotient + S9	Quotient - S9	Quotient + S9	Quotient - S9	Quotient + S9	Quotient - S9	Quotient +S9	Quotient-S9
Acetone	1.0	1.0	1.0	1.0	1.0	1.0	1.0	1.0
20 µg/plate	1.1	0.7	1.7	0.6	1.1	0.6	1.0	0.9
100 µg/plate	1.3	1.0	1.9	0.6	1.0	0.8	1.0	1.0
500 µg/plate	1.0	1.0	1.9	0.8	1.0	1.1	0.9	1.0
2500 µg/plate	1.2	0.9	1.8	0.7	1.0	1.3	1.0	0.9
5000 µg/plate	1.1	0.9	2.0	0.8	1.0	1.1	1.0	0.9
positive conrol	66.1	11.8	12.5	37.6	28.1	45.4	13.3	12.4

3rd experiment (standard plate test)

	TA 1537
	Quotient +S9	Quotient -S9
Acetone	1.0	1.0
100 µg/plate	1.0	1.0
500 µg/plate	1.0	1.0
2500 µg/plate	0.9	0.7
5000 µg/plate	1.1	0.7
7500 µg/plate	1.0	0.9
positive control	14.4	66 .3

2nd experiment (preincubation method)

	TA 1535		TA 1537		TA 98		TA 100
	Quotient + S9	Quotient - S9	Quotient + S9	Quotient - S9	Quotient + S9	Quotient - S9	Quotient +S9	Quotient-S9
Acetone	1.0	1.0	1.0	1.0	1.0	1.0	1.0	1.0
20 µg/plate	1.0	1.3	0.9	1.4	1.0	0.8	1.1	1.1
100 µg/plate	0.7	1.4	0.8	0.8	1.0	0.7	1.0	1.0
500 µg/plate	0.8	1.3	0.8	1.1	0.9	0.7	0.9	0.9
2500 µg/plate	0.7	1.5	0.6	0.5	0.7	0.8	1.0	0.8
5000 µg/plate	0.8	1.3	0.7	0.7	0.6	0.7	0.9	0.6
positive conrol	8.6	75.4	10.4	65.8	15.6	35 .8	7.2	7.1

According to the results of the present study, the test substance is not mutagenic in the Ames test .

The slight and not dose-dependent increase in the number of revertant colonies using the strain TA 1537 in the 1st standard plate test with S-9 mix could not be confirmed either in a 2nd standard plate test including higher doses or in a preincubation assay . Thus, the findings of the tst study with TA 1537 are regarded as incidental .