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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

Constituent 1
Chemical structure
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.