3,4-dimethoxyphenethylamine

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

- negative Ames test with and without metabolic activation with N-methylhomoveratrylamine

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Qualifier:

according to guideline

Guideline:

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

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

Target gene:

trp, his

Species / strain / cell type:

E. coli WP2 uvr A

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

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

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

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

There were no data available for Homoveratrylamine but for the read across substance N-Methylhomoveratrylamine.

The substance N-Methylhomoveratrylamine was tested for its mutagenic potential based on the ability to induce back mutations in selected loci of several bacterial strains in the Ames test and in the Escherichia coli - reverse mutation assay (BASF, 1998). Strains TA 1535, TA 100, TA 1537, TA 98 and E. coli WP2 uvrA were used at dose range 20 µg - 5000 µg/plate. Standard plate test and preincubation test both with and without metabolic activation (Aroclor induced rat liver S-9 mix).

No precipitation of the test substance was found. A bacteriotoxic effect was observed in the preincubation test at doses >= 2500 µg/plate. An increase in the number of his+ or trp+ revertants was not observed both in the standard plate test and in the preincubation test either without S-9 mix or after the addition of a metabolizing system. According to the results of the present study, the test substance N-Methylhomoveratrylamine is not mutagenic in the Ames test and in the Escherichia coli - reverse mutation assay under the experimental conditions chosen here.

Justification for classification or non-classification

Based on the results, the test item is no subject to classification and labelling according to Regulation (EC) No 1272/2008 (CLP).