2,2,6,6-tetramethyl-4-piperidylamine

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study, without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

1981

Principles of method if other than guideline:

acc. to Ames et al. 1975

GLP compliance:

no

Remarks:

prior to GLP settings

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2,2,6,6-tetramethyl-4-piperidylamine

EC Number:

253-197-2

EC Name:

2,2,6,6-tetramethyl-4-piperidylamine

Cas Number:

36768-62-4

Molecular formula:

C9H20N2

IUPAC Name:

2,2,6,6-tetramethylpiperidin-4-amine

Details on test material:

no data

Method

Species / strain

Species / strain / cell type:

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

Metabolic activation:

with and without

Metabolic activation system:

S9 mix from Arochlor induced rat liver

Test concentrations with justification for top dose:

10, 100, 500, 1000 ug/pl.

Vehicle / solvent:

water

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

water

Positive controls:

no

Positive control substance:

benzo(a)pyrene

Remarks:

Migrated to IUCLID6: TA 100 in DMSO

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation; plate with agar

DURATION
- Preincubation period: 30 min


NUMBER OF REPLICATIONS: 2


DETERMINATION OF CYTOTOXICITY
not explicit reported, but from the number of revertants, no cytotoxicity was observed

Evaluation criteria:

According to Ames et al. 1975
Substances, which showed no effects even with 500 µg/plate, no mutagenic effects are expected. To give higher safety, the highest concentration chosen was 1000 µg/plate

Statistics:

none

Results and discussion

Test results

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

not examined

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'.

Any other information on results incl. tables

Values presented as mean of mutants per plate (three replicates) and standard deviation in brackets

with S9 mix

strain /conentration [µg/plate]	control (water)	10	100	500	1000
TA 98	29 (7.7)	24 (2)	28 (6.6)	31 (1.1)	28 (9.2)
TA 100	31 (9.5)	25 (7.5)	34 (5.1)	36 (2.6)	35 (2.6)
TA 1535	12 (2.3)	11 (4.1)	10 (2.5)	13 (5.6)	12 (3.6)
TA 1537	11 (3.5)	6 (2.9)	11 (1.7)	9 (4.3)	11 (7)
TA 1538	27 (8.6)	27 (5.5)	26 (1.5)	27 (1)	27 (7.5)

without S9 mix

strain /conentration [µg/plate]	control (water)	10	100	500	1000
TA 98	16 (3.2)	15 (5.1)	16 (2.8)	15 (1.1)	20 (4.7)
TA 100	37 (10.5)	44 (19.5)	39 (10.4)	37 (0.5)	34 (6.2)
TA 1535	11 (2.5)	9 (2.8)	12 (2.6)	6 (4.3)	8 (3.6)
TA 1537	11 (3.4)	9 (2.5)	9 (1.5)	12 (1.9)	8 (1.7)
TA 1538	15 (6.6)	16 (4.1)	13 (3.6)	15 (5.5)	12 (3)

Applicant's summary and conclusion

Conclusions:

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

Under the present conditions, no mutagenic effects in all tested strains were observed in the bacterial gene mutation assay up to concentrations of 1000 µg/plate.