N-butyl-2,2,6,6-tetramethylpiperidin-4-amine

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

RTC, Rome, Italy

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

N-butyl-2,2,6,6-tetramethylpiperidin-4-amine

EC Number:

252-899-6

EC Name:

N-butyl-2,2,6,6-tetramethylpiperidin-4-amine

Cas Number:

36177-92-1

Molecular formula:

C13H28N2

IUPAC Name:

N-butyl-2,2,6,6-tetramethylpiperidin-4-amine

Details on test material:

- Name of test material (as cited in study report): N-Butyl-2,2,6,6-tetramethyl-4-piperidinamine (N-Butyl-TAD)
- Substance type: colourless liquid
- Physical state: liquid

Method

Target gene:

his

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:

S9 mix from Phenobarbital (i.p.) and beta-Naphtoflavone (oral) induced rat liver

Test concentrations with justification for top dose:

50, 158, 500, 1580, 5000 µg/plate (pre-test);
313, 625, 1250, 2500, 5000 µg/plate (main test)

Vehicle / solvent:

sterile distilled water

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

(sterile distilled water and DMSO)

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

2-nitrofluorene

sodium azide

cumene hydroperoxide

other: 2- Aminoanthracene

Details on test system and experimental conditions:

METHOD OF APPLICATION: 1. experiment: plate incorporation, 2. experiment: preincubation

DURATION:
- Preincubation period: approx. 30 min
- Exposure duration: 72 h

SELECTION AGENT (mutation assays): test item

NUMBER OF REPLICATIONS: 3

DETERMINATION OF CYTOTOXICITY: relative total growth

Evaluation criteria:

- negative control in the laboratory historical range for each tester strain
- positive control chemicals produces responses in all tester strains within laboratory historical range
- Mean plate count should be at least two times the concurrent vehicle control group mean at two consecutive dose levels or at the highest practicable dose-level. Additionally, a dose-response relationship showing increasing numbers of mutant colonies with increasing dose-levels must be evident.
- 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 applicable

Results and discussion

Test results

Key result

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

Slight signs of toxicity were observed at the highest dose-level in some tester strains.

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation

Under conditions tested, test item is considered to be non-mutagenic in Salmonella typhimurium tester strains with and without metabolic activation.