N-(2,2,6,6-tetramethylpiperidin-4-yl)acetamide

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:

23.04.1996 to 01.07.1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

N-(2,2,6,6-tetramethylpiperidin-4-yl)acetamide

EC Number:

255-137-0

EC Name:

N-(2,2,6,6-tetramethylpiperidin-4-yl)acetamide

Cas Number:

40908-37-0

Molecular formula:

C11H22N2O

IUPAC Name:

N-(2,2,6,6-tetramethylpiperidin-4-yl)acetamide

Test material form:

solid: crystalline

Method

Species / strain

Species / strain / cell type:

other: S. typhimurium TA 98, 100, 1535, 1537

Metabolic activation:

with and without

Test concentrations with justification for top dose:

50 - 5000 µg/plate

Vehicle / solvent:

water

Controls

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

9-aminoacridine

2-nitrofluorene

sodium azide

Details on test system and experimental conditions:

Sampling times 16 and 26 hours.
Count of 100 Metaphases per culture (duplicates).
Two independent experiments were performed; plate incorporation and preincubation test.
Concentrations tested: -S9:  50 -  600 µg/ml; +S9: 600 - 5000 µg/ml

Results and discussion

Test results

Key result

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: >= 5000 µg/plate

Additional information on results:

Cytotoxicity was only observed in the preincubation test in TA1537 at the top dose level of 5000 µg/plate.

Remarks on result:

other: other: S. typhimurium TA 98, 100, 1535, 1537

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

ACETYL·TAD was tested for its ability to induce reverse mutations in an in vitro bacterial system. Salmonella typhimurium strains TA 98, TA 100, TA 1535 and TA 1537were treated with the test compound by the Ames test plate incorporation as well as the preincubation method. Five dose levels covering the range between 50 and 5000 μg,'plate, in triplicate both with and without the addition of a metabolising system (Aroclor 1254 induced rat liver S9 mix) were employed.
All four bacterial strains exhibited mutagenic responses to the appropriate positive control substances. Solvent controls were also tested with each strain and the mean numbers of spontaneous revertants were in an acceptable range. Mutagenic activity of the test compound to one or more of the tester strains was not observed in either experiment with and without metabolic activation.
It is therefore concluded, that ACETYL-TAD is not a bacterial mutagen.