Dimantine

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

From 29 February 1996 to 1 April 1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Similar to guideline, but only two bacterial strains tested

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

only two bacterial strains tested

GLP compliance:

not specified

Type of assay:

bacterial gene mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Decyldimethylamine

EC Number:

214-302-7

EC Name:

Decyldimethylamine

Cas Number:

1120-24-7

Molecular formula:

C12H27N

IUPAC Name:

N,N-dimethyldecan-1-amine

Method

Target gene:

Histidine

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 100

Details on mammalian cell type (if applicable):

contains a histidine missense mutation but is also deficient in a DNA repair system and has a defective lipopolysaccharide coat on the cell wall

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 98

Details on mammalian cell type (if applicable):

contains a histidine frameshift mutation. Again it has a definitive DNA repair system and lipopolysaccharide coat

Metabolic activation:

with and without

Metabolic activation system:

Liver extract from Aroclor 1254-induced male Sprague-Dawley rats

Test concentrations with justification for top dose:

A solution of the substance was prepared in ethanol at 5 mg/mL, and four half-log dilutions were prepared from this solution. Aliquots (0.1mL) of each concentration of the substance were placed in sterile tubes.
Test material (µg per plate): 2500 (sterility check), 5000, 500, 50, 5, 2500, 250, 25, 2.5, 0, 0 (0.2 mL solvent).

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: ethanol

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

benzo(a)pyrene

Remarks:

in both strains with and without metabolic activation

Controls 2

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

in TA100 without metabolic activation

Controls 3

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

2-nitrofluorene

Remarks:

in TA98 without metabolic activation

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 500 µg and above

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 500 µg and above

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'.

Any other information on results incl. tables

Standard tests for bacterial sensitivity:

	TA100	TA98
2-Aminofluorene (10µg/plate) with activation	+	+
9-Aminoacridine (80µg/plate) non-activated	-	-
Sodium azide (2µg/plate) non-activated	+	-
Ampicillin (8mg/mL in purified water)	Resistant	Resistant

+ Increased reversion (his - to his +) over solvent controls

- No increase in reversion

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

The test material did not exhibit any mutagenic activity under the conditions of test.

Executive summary:

The material was examined for mutagenic activity in two histidine-dependent auxotrophs of Salmonella typhimurium, strains TA 98 and TA 100, using plate-incorporation assays.

The studies, which were conducted in the presence and absence of an activiting system derived from rat liver (S-9 mix), employed a range of levels of the substance from 5 to 500 µg per plate, selected following a preliminary toxicity test in strain TA 98. The test included solvent (ethanol) controls with and without S-9 mix.

The substance did not exhibit any mutagenic activity under the conditions of test. Positive controls were effective, such indicating the validity of the test system.