N-[2-[2-(2-methoxyethoxy)ethoxy]ethyl]-2-methyl-propan-2-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:

2018

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

Constituent 1

Reference substance name:

12,12-dimethyl-2,5,8-trioxa-11-azatridecane

EC Number:

814-433-5

Cas Number:

926622-96-0

Molecular formula:

C11 H25 N O3

IUPAC Name:

12,12-dimethyl-2,5,8-trioxa-11-azatridecane

Test material form:

liquid

Details on test material:

- State of aggregation: liquid
- Purity: 99.8 corrected area-% by GC/FID For details see analytical report 17L00283.

- Storage stability: The stability of the test item under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
- Storage conditions: Room temperature
- Physical state / color: Liquid / colorless, clear
- Density [g/mL]: 0.921 (determined by Bioassay Laboratories)

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Metabolic activation:

with and without

Metabolic activation system:

liver S9 mix from induced rats

Test concentrations with justification for top dose:

DOSE RANGE:
33 μg - 5000 μg/plate (SPT)
33 μg - 5000 μg/plate (PIT)

Vehicle / solvent:

water

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

9-aminoacridine

N-ethyl-N-nitro-N-nitrosoguanidine

other:

Details on test system and experimental conditions:

DURATION
- Exposure duration: 48 - 72 hours at 37 °C

Evaluation criteria:

Individual plate counts, the mean number of revertant colonies per plate and the standard deviations were given for all dose groups as well as for the positive and negative (vehicle) controls in all experiments. In general, six doses of the test substance were tested with a maximum of 5 mg/plate, and triplicate plating was used for all test groups

Statistics:

Not applicable

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Test results 3

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Test results 4

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Applicant's summary and conclusion

Conclusions:

According to the results of the present study, the test substance did not lead to a biologically relevant increase in the number of revertant colonies without S9 mix or after adding a metabolizing system

Besides, the results of the negative as well as the positive controls performed in parallel corroborated the validity of this study, since the values fulfilled the acceptance criteria.

Executive summary:

Under the experimental conditions chosen here, it is concluded that 2-Propanamine, N-[2-[2 - (2-methoxyethoxy)ethoxy]ethyl]-2-methyl- is not a mutagenic test substance in the bacterial reverse mutation test in the absence and the presence of metabolic activation.