Isotridecan-1-ol

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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

(only four strains tested; 2-aminoanthracene was the sole indicator of S9 efficancy)

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Isotridecan-1-ol

EC Number:

248-469-2

EC Name:

Isotridecan-1-ol

Cas Number:

27458-92-0

Molecular formula:

C13H28O

IUPAC Name:

2-methyldodecan-1-ol

Details on test material:

- Name of test material (as cited in study report): Isotridecanol
- Analytical purity: not stated
- Composition of test material, percentage of components: C10H21OH: 0.6%, C11H23OH: 10.2%, C12H25OH: 22.3%, C13H27OH: 62.2%, C14H29OH: 4.7%, C15H31OH: trace
- Physical state: liquid, colorless
- Lot/batch No.: continuous production
- Test substance No: 88/574
- Storage condition of test material: Room temperature

Method

Target gene:

his-gene

Species / strain

Species / strain / cell type:

other: Salmonella typhimurium TA1535, TA100, TA1537, TA98

Metabolic activation:

with and without

Metabolic activation system:

rat liver S-9 mix (rats pretreated with Aroclor 1254)

Test concentrations with justification for top dose:

20 µg - 5000 µg/plate (SPT), 20 µg - 5000 µg/plate (PIT)

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: Details on test system and conditions

Details on test system and experimental conditions:

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

Standard plate test
-------------------
The experimental procedure is based on the method of Ames et al. (1973, 1975).
Test tubes containing 2 ml portions of soft agar which consists of 100 ml agar (0.6% agar + 0.6 % NaCl) and 10 ml amino acid solution (minimal amino acid solution for the determination of mutants: 0.5 mM histidine + 0.5 mM biotin) are kept in a water bath at 45°C, and the remaining components are added in the following order:

0.1 ml test solution
0.1 ml bacterial suspension
0.5 ml S-9 mix (in tests with metabolic activation)
or
0.5 ml phosphate buffer (in tests without metabolic activation)

After mixing, the samples are poured onto Vogel-Bonner agar plates (minimal glucose agar plates) within approx. 30 seconds.

Preincubation test
-------------------
The experimental procedure is based on the method described by Yahagi et al. (1977) and Matsushima et al. (1980)

0.1 ml test solution, 0.1 ml bacterial suspension and 0.5 ml S-9 mix are incubated at 37°C for the duration of 20 minutes. Subsequently, 2 ml of soft agar is added and, after mixing, the samples are poured onto the Vogel-Bonner agar plates within approx. 30 seconds.

After incubation at 37°C for 48 hours in the dark, the bacterial colonies (his+ revertants) are counted.

NUMBER OF REPLICATIONS: 3 test plates per dose or per control

Positive controls
-----------------
The following positive control substances are used to check the mutability of the bacteria and the activity of the S-9 mix:

with S-9 mix:
10 µg 2-aminoanthracene (dissolved in DMSO) for the strains TA 100, TA 98, TA 1537 and TA 1535

without S-9 mix:
5 µg N-methyl-N'-nitro-N-nitrosoguanidine (MNNG; dissolved in DMSO) for the strains TA 100 and TA 1535
10 µg 4-nitro-o-phenylendiamine (dissolved in DMSO) for the strain TA 98
100 µg 9-aminoacridine chloride monohydrate (dissolved in DMSO) for the strain TA 1537

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:

other: Salmonella typhimurium TA1535, TA100, TA1537, TA98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: The test substance was completely soluble in DMSO.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

1st/2nd experiment, Standard plate test (20 - 5000 µg/plate)
Strain	Metabolic activation system	mean his^+revertant colonies (negative control)	maximum revertant factor (conc. (µg/plate))	dose dependency	Assessment	maximum revertant factor (positive control)
TA 98	no	23	1.2 (2500)	no	negative	29 (NPD)
	yes	34	1.1 (100/500)	no	negative	34.7 (2-AA)
TA 100	no	114	1.0 (20/100)	no	negative	14.8 (MNNG)
	yes	103	1.2 (100)	no	negative	17.2 (2-AA)
TA 1537	no	9	1.1 (20)	no	negative	186.7 (AAC)
	yes	10	1.0 (500)	no	negative	17.6 (2-AA)
TA 1535	no	16	1.4 (500)	no	negative	87.3 (MNNG)
	yes	18	1.1 (5000)	no	negative	8.4 (2-AA)
3rd experiment, Preincubation test (20 - 5000 µg/plate)
Strain	Metabolic activation system	mean his^+revertant colonies (negative control)	maximum revertant factor (conc. (µg/plate))	dose dependency	Assessment	maximum revertant factor (positive control)
TA 98	no	24	1.1 (20/100)	no	negative	39.2 (NPD)
	yes	35	1.1 (100/500)	no	negative	40.2 (2-AA)
TA 100	no	125	0.9 (100/500)	no	negative	9.8 (MNNG)
	yes	111	1.1 (20)	no	negative	16.4 (2-AA)
TA 1537	no	9	1.2 (100)	no	negative	48.6 (AAC)
	yes	12	1.1 (20)	no	negative	14.5 (2-AA)
TA 1535	no	18	1.2 (2500)	no	negative	86.4 (MNNG)
	yes	21	1.0 (2500/5000)	no	negative	7.8 (2-AA)
2-AA: 2-aminoanthracene
MNNG: N-methyl-N'-nitro-N-nitroso-guanidine
NPD: 4-nitro-o-phenylendiamine
AAC: 9-aminoacridine chloride monohydrate