N,N-dimethyldodecanamide

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 from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study according OECD guideline, GLP, well documented

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

N,N-dimethyldecan-1-amide

EC Number:

238-405-1

EC Name:

N,N-dimethyldecan-1-amide

Cas Number:

14433-76-2

Molecular formula:

C12H25NO

IUPAC Name:

N,N-dimethyldecanamide

Details on test material:

- Name of test material (as cited in study report): SAT 990 560
- Chemical name: N,N-Dimethyldecan-1-amide
- Physical state: liquid
- Purity: 100 % active substance
- Lot/batch No.: 10048316
- Expiration date of the lot/batch: November 2001
- Storage condition of test material: room temperature

Method

Target gene:

his operon

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 102

Additional strain / cell type characteristics:

not applicable

Species / strain 2

Species / strain / cell type:

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

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

S9 (Phenobarbital, ß-Napthoflavone)

Test concentrations with justification for top dose:

Experiment I (TA 98, TA 100): 3; 10; 33; 100 and 1000 µg/plate
Experiment I (TA 1535, TA 1537, TA102): 33; 66; 100; 333; 666 and 1000 µg/plate
Experiment II (all strains): 33; 66; 100; 333; 666 and 1000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: chosen because of the test item solubility

Controls

Untreated negative controls:

yes

Remarks:

untreated controls

Negative solvent / vehicle controls:

yes

Remarks:

solvent controls

Positive controls:

yes

Positive control substance:

other: sodium azide, 4-nitro-o-phenylene-diamine, methyl methane sulfonate, 2-aminoanthracene

Details on test system and experimental conditions:

METHOD OF APPLICATION: pre mixed suspension (test solution, S9mix or buffer, bacteria suspension, overlay agar) were poured onto agar plates

Evaluation criteria:

according to guideline

Statistics:

no

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

in higher concentrations, tested up to cytotoxic concentration

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

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

Remarks:

in higher concentrations, tested up to cytotoxic concentration

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

ADDITIONAL INFORMATION ON CYTOTOXICITY:
Cytotoxicity was checked for higher concentration in pre-experiment. The backround growth was reduced at 2500 µg/plate with and without S9 mix

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

The test item did not induce gene mutations under the experimental conditions with the tested strains
SAT 990560 is considered to be non-mutagenic in the salmonella typhimurium reverse mutation assay

Executive summary:

This study was performed to investigate the potential of SAT 990560 (N,N-Dimethyldecan-1 -amide) to induce gene muta­tions according to the plate incorporation test (experiment I) and the pre-incubation test (experiment II) using the Salmonella typhimurium strainsTA1535,TA1537,TA98,TA100,and TA102.

The assay was performed with and without liver microsomal activation. Due to technical reasons the results of experiment II had to be dismissed and an additional experiment was performed under identical conditions. The results of this additional experiment are included in this report as experiment II. Each concentration, including the controls, was tested in triplicate. The test item was tested at the following concentrations:

Experiment I(TA98,TA100): 3; 10; 33; 100; 333; and 1000 ug/plate

Experiment I(TA1535,TA1537,TA102): 33; 66; 100; 333; 666; and 1000 ug/plate Experiment II (all strains): 33; 66; 100; 333; 666; and 1000 ug/plate

Toxic effects, evident as a reduction in the number of revertants, occurred at the following concentrations:

Strain	Experiment I(µg/plate)		Experiment II (µg/plate)
	withoutS9mix	with S9 mix	withoutS9mix	withS9mix
TA1535	333 - 1000	666 - 1000	333 - 1000	666 - 1000
TA1537	333 - 1000	666 - 1000	666 - 1000	666 - 1000
TA98	333 - 1000	/	666- 1000	1000
TA100	333 - 1000	1000	666- 1000	666 - 1000
TA102	666 - 1000	/	666 - 1000	/

/ no relevant toxic effects observed

In experiment I, the background growth was reduced at the higher concentrations with and without S9 mix in all strains.

No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with SAT 990560 (N,N-Dimethyldecan-1 -amide) at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.

Appropriate reference mutagens were used as positive controls and showed a distinct in­crease of induced revertant colonies.

Conclusion

In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.

Therefore, SAT 990560 (N,N-Dimethyldecan-1 -amide) is considered to be non-mutagenic in this Salmonella typhimurium reverse mutation assay.