3-methoxy-N,N-dimethylpropan-1-amine

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2021

Report date:

2021

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

1

Reference substance name:

(3-methoxypropyl)dimethylamine

EC Number:

827-772-9

Cas Number:

20650-07-1

Molecular formula:

C6H15NO

IUPAC Name:

(3-methoxypropyl)dimethylamine

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Metabolic activation system:

Rat liver microsomal enzymes (S9 fraction) from male Wistar rats dosed with Aroclor 1254 (500 mg/kg body weight).

Test concentrations with justification for top dose:

First experiment: 5, 1.5, 0.5, 0.15, 0.05, 0.015, 0.005 and 0.0015 µL/plate
First experiment: 5, 2.5, 1.25, 0.63, 0.31, 0.16 µL/plate.
5 µL/plate is the maximum recommended.

Vehicle / solvent:

distilled water

Controls

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

2-nitrofluorene

sodium azide

mitomycin C

other:

Details on test system and experimental conditions:

The test was performed in two independent experiments, both using the direct plate incorporation method. The difference was the concentration spacing, and the concentration of S9 mix (5% v/v and then 10% v/v).

Rationale for test conditions:

Using the maximum recommended concentration

Evaluation criteria:

A positive response (mutagen) is defined as meeting all three criteria:
- at least 3-fold (TA1535, TA1537) or 2-fold (TA98, TA100, and TA102) increase in mean revertant count above mean vehicle control value
- dose-related increase
- reproducible increase

Statistics:

Simple linear regression analysis was performed for tester strains TA1537, TA1535, TA98, TA100, and TA102, separately

Results and discussion

Test results

Key result

Species / strain:

bacteria, other: all 5 tested strains

Metabolic activation:

with and without

Genotoxicity:

negative

Remarks:

No significant dose-related increase in the number of revertant colonies in any strain both in the absence and presence of S9-metabolic activation

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Remarks:

The negative control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.

Positive controls validity:

valid

Remarks:

The strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.

Applicant's summary and conclusion

Conclusions:

Non-mutagenic

Executive summary:

Based on results of this study, it is concluded that DMMOPA Multifunctional Etheramine Additive is non-mutagenic to any strain of Salmonella typhimurium, viz., TA1537, TA1535, TA98, TA100 and TA102, when tested in two experiments up to the maximum recommended concentration of 5 µL/plate, in the absence and presence of metabolic activation system.