2,2,6,6-tetramethylpiperidinooxy

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:

1992

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Strain TA100 used only.

Data source

Reference

Reference Type:

publication

Title:

Mutagenicity of Nitroxyl compounds: structure activity|relationships

Author:

Gallez, B., De Meester, C., Debuys, R.. Dejehet, F., Dumont, P.

Year:

1992

Bibliographic source:

Toxicol. Lett. 63, 35-45

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

Strain TA100 used only.

Principles of method if other than guideline:

The test was carried out according to Maron and Ames (1983, Mutat. Res. 113, 173-215) using Salmonella typhimurium strain TA 100 with and without S9 mix.

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2,2,6,6-tetramethylpiperidinooxy

EC Number:

219-888-8

EC Name:

2,2,6,6-tetramethylpiperidinooxy

Cas Number:

2564-83-2

Molecular formula:

C9H18NO

IUPAC Name:

2,2,6,6-tetramethylpiperidin-1-ol

Test material form:

solid

Details on test material:

obtained from Aldrich Company

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 100

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

0.06, 0.6, 1.5, 3.0, 6.0, 15.0, and 30.0 μmol

Vehicle / solvent:

DMSO

Controls

True negative controls:

yes

Positive controls:

yes

Positive control substance:

sodium azide

other: 2-aminoanthracene when S9 mix was used

Details on test system and experimental conditions:

Aliquots of TEMPO (0.1 ml of a dilution in DMSO corresponding to 0.06, 0.6, 1.5, 3.0, 6.0, 15.0, and 30.0 μmol) were added into the top agar (plate incorporation assay), or into the top agar supplemented with S9 mix (500 μl corresponding to 50 μI of S9). The colonies grown on the minimal glucose-agar plates at 37°C were counted after 48h. Each assay was performed in duplicate with three plates for each concentration.

Statistics:

t-test

Results and discussion

Test results

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

without

Genotoxicity:

positive

Remarks:

180 to 210 revertants/plate, statistically significant

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 30 µmol/plate

Vehicle controls validity:

not specified

Untreated negative controls validity:

valid

Remarks:

140 (mean) revertants/plate

Positive controls validity:

valid

Remarks:

380 (mean) revertants/plate

Additional information on results:

A cytotoxic effect was observed at 30 μmol/plate. A weak but statistically significant (p<0.01) increase of the number of revertants (180 to 210 revertants/plate) was observed between 6 and 15 μmol/plate (assay repeated three times). Thus, a cytotoxic effect could mask partly the mutagenic activity at higher concentrations.

Applicant's summary and conclusion

Conclusions:

The test compound is positive for gene mutations in bacterial tester strain Salmonella typhimurium TA100.