(2-ethyl-2-methyl-1,3-dioxolan-4-yl)methyl prop-2-enoate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 Jun 2006 - 20 Jul 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

(2-ethyl-2-methyl-1,3-dioxolan-4-yl)methyl prop-2-enoate

EC Number:

807-159-2

Cas Number:

69701-99-1

Molecular formula:

C10H16O4

IUPAC Name:

(2-ethyl-2-methyl-1,3-dioxolan-4-yl)methyl prop-2-enoate

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 19892501
- Purity: 97.5%

Method

Species / strain

Species / strain 1

Species / strain / cell type:

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

Additional strain / cell type characteristics:

not specified

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

Source: Dr. T. Matsushima, Japan Bioassay Laboratory, Japan Industrial Safety and Health Association, Hadano-city, Kanagawa.
Bacterial cultures were freshly prepared in Oxoid nutrient broth #2 (248458), by inoculating bacteria from frozen stock cultures (kept at -80 °C). 30µL stock solution was inoculated into the 15 mL broth and incubated for 10 hours at 37 °C and 120 rpm using rotary shaker.

S9 and S9 mix:
- Lot No: 06051202
- Source: Oriental Yeast Corporation, Tokyo, Japan.
- Date of preparation: 12 May 2006
- Preparation: prepared by a slight modification of the method described by Ames, McCann, and Yamazaki: 5,6-Benzoflavone (BF) and phenobarbital (PB) were used as an incuder of drug-metabolising enzyme system.

Animals:
- Species/ Strain: Rat/ Sprague-Dawley
- Sex: Male
- Age: 7 weeks
- Body weight: 217.5 ± 10.9 g
- Amount of inducing substance (g/kg bw): PB – 4 times, 0.03-0.06; BF – 1 time, 0.08

The S9 mix contained 4mM NADPH, 4mM NADH, 5mM Glucose-6-Phosphate, 8mM MgCl2, 33 mM KCl, 100mM sodium phosohate buffer (pH 7.4) and 10% (50µL S9 per plate).

Test concentrations with justification for top dose:

Range finder test (µg/ plate): 0, 4.88, 19.5. 78.1. 313, 1250 and 5000
Mutgenicity test (µg/ plate): 0, 156, 313, 625, 1250, 2500 and 5000

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: solubility

Controls

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

9-aminoacridine

sodium azide

other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide); 2-aminoamthracene

Details on test system and experimental conditions:

METHOD OF APPLICATION:
The mutagenicity was assayed from a maximum level of 5000 µg test substance/ plate by the pre-incubation method (37 °C, 20 min) with and without metabolic activation system.

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 5000 µg/plate

Vehicle controls validity:

not specified

Positive controls validity:

not specified

Test results 2

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 2500 µg/plate

Vehicle controls validity:

not specified

Positive controls validity:

not specified

Test results 3

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 5000 µg/plate

Vehicle controls validity:

not specified

Positive controls validity:

not specified

Test results 4

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 5000 µg/plate

Vehicle controls validity:

not specified

Positive controls validity:

not specified

Test results 5

Key result

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 5000 µg/plate

Vehicle controls validity:

not specified

Positive controls validity:

not specified

Test results 6

Key result

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 5000 µg/plate

Vehicle controls validity:

not specified

Positive controls validity:

not specified

Additional information on results:

MEDOL-10 did not increase revertant colonies when tested up to 5000 µg/plate with or without metabolic activation.
Toxicity was observed at 5000µg/plate with or without metabolic activation for all bacteria tested.
Toxicity was also observed at 2500 µg/plate without metabolic activation for Salmonella Typhimurium TA100.
No test item precipitation was observed.

Remarks on result:

no mutagenic potential (based on QSAR/QSPR prediction)

Applicant's summary and conclusion

Conclusions:

Test item did not show mutagenicity in any bacteria strain by the preincubation method with or without metabilic activation system.