N-benzyl-4-methoxy-α-methylphenethylamine

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:

1999-04-27 to 1999-04-29

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

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:

N-benzyl-4-methoxy-α-methylphenethylamine

EC Number:

256-155-1

EC Name:

N-benzyl-4-methoxy-α-methylphenethylamine

Cas Number:

43229-65-8

Molecular formula:

C17H21NO

IUPAC Name:

N-benzyl-1-(4-methoxyphenyl)propan-2-amine

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): TH 1165 II
- Physical state: Yellow liquid
- Analytical purity: Not indicated by sponsor; treated as 100% pure
- Lot/batch No.: 61
- Expiration date of the lot/batch: 8 april 2000 (allocated at NOTOX, 1 year after receipt of the test substance)
- Stability under test conditions: dimethylsulfoxide: not indicated
- Storage condition of test material: At room temperature in the dark
- Density: 1.05 mg/l (determined at NOTOX)

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 98

Additional strain / cell type characteristics:

not specified

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 100

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

S 9 mix

Test concentrations with justification for top dose:

3, 10, 33, 100, 333, 1000, 3330, 5000 µg per plate

Vehicle / solvent:

- Vehicle(s): DMSO

Controls

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

methylmethanesulfonate

other: Daunomycine and 2-aminoanthracene

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation) and pre-incubation

DURATION
- Exposure duration: 48 hrs

NUMBER OF REPLICATIONS: 3 each per concentration level and control

Rationale for test conditions:

recommended test system in international guidelines (e.g. EPA, OECD, EEC)

Evaluation criteria:

A Salmonella typhimurium reverse mutation assay is considered acceptable if it meets the following criteria:
a) The negative control data (numbwer of spontaneous revertants per plate) should be within the laboratory background historical range for each tester strain.
b) The positive control chemicals should produce responses in all tester strains which are within the laboratory historical range documented for each positive control substance.
c) The selected dose range should include a clearly toxic concentration or should exhibit limited solubility as demonstrated by the preliminary toxicity range finding test or should extend to 5 mg/plate

Statistics:

not regarded necessary as per OECD guidelines

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity, but tested up to precipitating concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity, but tested up to precipitating concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

TH 1165 II precipitated in the top agar at concentrations of 3330 and 5000 µg/plate. Precipitation of TH 1165 II was not observed on the plates at the start or at the end of the incubation period both tester strains.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Based on the results of this study it is concluded that TH 1165 II is not mutagenic in the Salmonella typhimurium reverse mutation assay.