p-(dimethoxymethyl)anisole

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: Comparable to guideline study with acceptable restrictions

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 4 strains tested

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

p-(dimethoxymethyl)anisole

EC Number:

218-577-4

EC Name:

p-(dimethoxymethyl)anisole

Cas Number:

2186-92-7

Molecular formula:

C10H14O3

IUPAC Name:

1-(dimethoxymethyl)-4-methoxybenzene

Details on test material:

- Name of test material (as cited in study report): Anisaldehyddimethylacetal
- Purity: > 97 %
- Substance No.: 88/957
- Storage: room temperature

Method

Species / strain

Species / strain / cell type:

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

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254-induced rat liver S-9 mix

Test concentrations with justification for top dose:

20, 100, 500, 2500 and 5000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO

Controls

Controls 1

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene (AAC); 10 µg/plate in DMSO for TA 100, TA 98, TA 1537 and TA 1535

Remarks:

with metabolic activation

Controls 2

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: methyl-N'-nitro-N-nitrosoguanidine (MNNG); 5 µg/plate in DMSO for TA 100 and TA 1535

Remarks:

without metabolic activation

Controls 3

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 4-nitro-o-phenylendiamine (NPD); 10 µg/plate in DMSO for TA 98

Remarks:

without metabolic activation

Controls 4

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

without metabolic activation

Migrated to IUCLID6: 100 µg/plate in DMSO for TA 1537

Details on test system and experimental conditions:

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


DURATION
- Preincubation period: 20 min, 37°C
- Exposure duration: 48 h, 37°C

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


DETERMINATION OF CYTOTOXICITY
- Method: reduced background growth; decrease in the number of his revertant

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:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: PIT: >= 2500 µg/plate for all strains; SPT: >=2500 µg/plate for TA 100 without metabolic activation

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS:
- Water solubility: Complete solubility of the test substance in DMSO .

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.