[(2E)-3-(5,5-dimethyl-1,3-dioxan-2-yl)-2-butenyl]triphenylphosphonium chloride

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: see 'Remark'

Remarks:

GLP - Guideline study. However, only 4 strains of Salmonella typhimurium were used; testing with Salmonella typhimurium TA102 or Escherichia coli was not carried out. Therefore, the study does not completely fulfill the reliability criteria of today's guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

[(2E)-3-(5,5-dimethyl-1,3-dioxan-2-yl)-2-butenyl]triphenylphosphonium chloride

EC Number:

613-004-8

Cas Number:

62285-89-6

Molecular formula:

C28 H32 O2 P . Cl

IUPAC Name:

[(2E)-3-(5,5-dimethyl-1,3-dioxan-2-yl)-2-butenyl]triphenylphosphonium chloride

Details on test material:

- Name of test material (as cited in study report): C5-NPG-ACETAL
- Substance Number: 92/128
- Physical state: white powder
- Analytical purity: 99 %
- Lot/batch No.: 92/33 - 1 (Technikum B 15 S)
- Stability under test conditions: The stability of the test substance in aqua bidest. for at least 4 hours was confirmed by analysis.
- Storage condition of test material: refrigerator; exclusion of moisture

Method

Target gene:

For Salmonella typhimurium strains, the amino acid histidine locus is the target gene, for the E.coli WP2 uvrA strain the amino acid tryptophan locus is the target gene.

Species / strain

Species / strain / cell type:

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

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

S-9 mix from Arochlor 1254 induced liver of male Sprague-Dawley rats

Test concentrations with justification for top dose:

4 - 5000 µg/plate (standard plate test), 0.8 - 500 µg/plate (preincubation test)

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO;
- Justification for choice of solvent/vehicle: no data

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Remarks:

with S-9 mix

Positive control substance:

other: 2-aminoanthracene (2-AA), dissolved in DMSO for the strains TA100, TA98, TA1537 and TA1535

Controls 2

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Remarks:

without S-9 mix

Positive control substance:

other: N-methyl-N'-nitro-N-nitrosoguanidine (MNNG) (5 µg; dissolved in DMSO) for TA100 and TA1535; 4-nitro-o-phenylendiamine (NPD) (10 µg; dissolved in DMSO) for TA98; 9-aminoacridine chloride monohydrate (AAC) (100 µg; dissolved in DMSO) for TA1537.

Details on test system and experimental conditions:

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

DURATION
- Preincubation period: In the plate incorporation plate test (standard plate test) there is no preincubation period (with the test substance). In the preincubation test: 20 min., before the mixture of the bacteria, test substance and medium are poured to the selective minimal agar.
- Exposure duration: 48 h
- Selection time (if incubation with a selection agent): 48 h

SELECTION AGENT (mutation assays): Minimal agar without histidine

NUMBER OF REPLICATIONS: 3

INDICATION FOR MUTAGENICITY: An increase in the number of revertants (his+).

DETERMINATION OF CYTOTOXICITY
- relative total growth; (reduced background growth of histidine-negative bacteria, decrease in the number of histidine-positive revertants)

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

Statistics:

The mean number of revertant colonies per plate, titer, and the standard deviations were calculated for all dose groups as well as for the positive and negative (vehicle) controls in all experiments.

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:

from about 500 µg - 1000 µg/plate onward

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No test substance precipitation was found.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'. Remarks: Standard plate test and preincubation test