3,4-dimethoxyphenethylamine

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

Study period:

1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

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:

OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)

Test guideline 3

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:

3,4-dimethoxy-N-methylphenethylamine

EC Number:

222-483-9

EC Name:

3,4-dimethoxy-N-methylphenethylamine

Cas Number:

3490-06-0

Molecular formula:

C11H17NO2

IUPAC Name:

2-(3,4-dimethoxyphenyl)-N-methylethanamine

Details on test material:

- Name of test substance: N-Methylhomoveratrylamin
- Batch No.: P. 73/1996
- CAS No.: 003490-06-0
- Date of manufacturing: August 23, 1996
- Test substance No.: 96/484
- Degree of purity: 97.3%
- Appearance, consistency: Colorless to light yellow liquid
- Storage: Room temperature (protected from light)

Method

Target gene:

trp, his

Species / strain

Species / strain 1

Species / strain / cell type:

E. coli WP2 uvr A

Species / strain 2

Species / strain / cell type:

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

Metabolic activation:

with and without

Metabolic activation system:

Aroclor induced rat liver S-9 mix.

Test concentrations with justification for top dose:

20; 100; 500; 2,500 and 5,000 µg/ml

Vehicle / solvent:

water

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: information given below: "any other information on material and methods incl. tables".

Details on test system and experimental conditions:

1st Experiment:
- Strains: TA 1535, TA 100, TA 1537, TA 98 and E . coli WP2 uvrA
- Doses: 0; 20 ; 100 ; 500 ; 2,500 and 5,000 µg/plate
- Vehicle: water
- Type of test, standard plate test with and without test condition: S-9 mix
- Number of plates: 3 test plates per dose or per control

2nd Experiment:
- Strains : TA 1535, TA 100, TA 1537, TA 98 and E . coli WP2 uvrA
- Doses: 0; 20 ; 100 ; 500 ; 2,500 and 5,000 µg/plate
- Vehicle: water
- Type of test, preincubation test with and without test condition: S-9 mix
- Number of plates: 3 test plates per dose or per control

Evaluation criteria:

In general, a substance to be characterized as positive in the bacterial tests 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

Test results 1

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: bacteriotoxicity observed at doses >= 2,500 µg/plate.

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

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: bacteriotoxicity observed at doses >= 2,500 µg/plate.

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

A bacteriotoxic effect (reduced his+ or trp- background growth, decrease in the number of his+ or trp- revertants) was observed in the preincubation test at doses >= 2,500 µg/plate.

Applicant's summary and conclusion

Conclusions:

According to the results of the present study, the test substance N-Methylhomoveratrylamin is not mutagenic in the Ames test and in the Escherichia coli - reverse mutation assay under the experimental conditions chosen here. Due to the structrural similarity, the test result is regarded to be also assignable for homoveratrylamin.