1,1,3,3-tetramethylbutylamine

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: Guideline study with acceptable restrictions (4 tester strains)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Cited as Directive 84/449/EEC, B.14

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

1,1,3,3-tetramethylbutylamine

EC Number:

203-491-1

EC Name:

1,1,3,3-tetramethylbutylamine

Cas Number:

107-45-9

Molecular formula:

C8H19N

IUPAC Name:

2,4,4-trimethylpentan-2-amine

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 (rat)

Test concentrations with justification for top dose:

33.3, 100.0, 333.3, 1000.0, 2500.0, and 5000 ug/plate

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

yes

Remarks:

water

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

Positive controls:

yes

Positive control substance:

other: sodium azide (NaN3), 4-nitro-o-phenylene-diamine (4-NOPD), 2-aminoanthracene, (2-AA)

Details on test system and experimental conditions:

METHOD OF APPLICATION: 1st main experiment: in agar (plate incorporation); 2nd main experiment: preincubation

DURATION
- Preincubation period: 60 minutes
- Exposure duration: 48-72 hours

NUMBER OF REPLICATIONS: 3

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth

Evaluation criteria:

VALIDITY CRITERIA:
- negative controls in the laboratory historical control range (range of spontaneous reversion frequencies)
- positive controls show a distinct enhancement in all tester strains within laboratory historical range
- corresponding background growth on both negative control and test plates should be observed

CRITERIA FOR POSITIVE RESPONSE:
- dose related increase in the number of revertants occurs and/or
- a reproducible biologically relevant positive response in at least one strain with or without metabolic activation
- biologically relevant increase: if in strain TA 100 the number of reversions is at least 2 times the concurrent spontaneous reversion rate (vehicle control group), if in strains TA 1535, TA 1537 and TA 98 is at least 3 times higher than the concurrent spontaneous reversion rate

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:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

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

Under conditions tested, the test item did not induce gene mutations by base pair changes or frame-shifts in the genome of the tester strains used.
Thus, the test item is considered non-mutagenic in this bacterial reverse mutation assay.