Amides, C8-18 (even numbered) and C18 (unsaturated) alkyl, N-[3-(dimethylamino)propyl]

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: Well conducted and documented study according to guidelines, but limitation due to report language (german); not tested in E. coli WP2 uvra or S. typhimurium TA102

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Amides, C8-18, C18 unsatd, N-[3-(dimethylamino)propyl]

IUPAC Name:

Amides, C8-18, C18 unsatd, N-[3-(dimethylamino)propyl]

Method

Target gene:

his operon

Species / strain

Species / strain 1

Species / strain / cell type:

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

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1538

Metabolic activation:

with and without

Metabolic activation system:

postmitrochondrial supernatant fluids fram the liver of male rats treated with Aroclor 1254

Test concentrations with justification for top dose:

0.8. 4, 8, 20, 40, 100, 200, 500, 1000 and 5000 µg test item per plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: Tween 80 in Wasser
- Justification for choice of solvent/vehicle: common solvent for suspensions

Controls

Untreated negative controls:

no

Remarks:

Suspension of tween 80 was used as negative control

Negative solvent / vehicle controls:

yes

Remarks:

Suspension of tween 80 in dest. water

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: Natriumazidm, 4-Nitro-o-phenylendiamine, 9-Am;noacridin, 2-Aminoanthracen

Details on test system and experimental conditions:

METHOD OF APPLICATION: in suspension

DURATION
- Exposure duration: 48h

SELECTION AGENT (mutation assays): histidine

NUMBER OF REPLICATIONS:3

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth

Evaluation criteria:

- No growth inhibition of non reverted bacteria compared to negative controls
- Spontaneous mutation in the range of characteristic spontaneous mutation (table given in report).
- Positive controls shows a minimum mutation rate two times higher (TA 100, three times for all other strains) then control.
- A result is rated as positive if for more than one concentration the test substance increases the mutation rate two times compared t o the control for TA 100 and three times compared to the control for all other strains.

Statistics:

No specific statistical tests used.

Results and discussion

Test results

Test results 1

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:

observed in the highest tested concentrations

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

observed in the highest tested concentrations

Vehicle 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 with and without acroclor induced S9 mix metabolic activation

The examined test substance (Amides, C8-18, C18 unsatd, N-[3-(dimethylamino)propyl]) does not induce reverse mutation in the tested bacteria strains TA 1535, TA 100, TA 1537, TA 1538 and TA 98 with and without metabolic activation (aroclor induced rat liver S-9 mix).

Executive summary:

The sample of Amides, C8-18, C18 unsatd, N-[3-(dimethylamino)propyl] was tested for mutagenic activity in the bacterial tester strains Salmonella typhimurium TA 1535, TA 100, TA 1537, TA 1538 and TA 98. The test was conducted on agar plates in the absence or presence of postmitrochondrial supernatant fluids from the liver of male rats treated with Aroclor 1254 (S-9 mix). Suspensions of the test compound were freshly made up with Tween 80 in water just before use. The following concentrations were tested: 0.8, 4, 8, 20, 40, 100, 200, 500, 1000 and 5000 µg test item per plate.

Amides, C8-18, C18 unsatd, N-[3-(dimethylamino)propyl] did not induce reverse mutations in the presence and absence of S-9 mix in the tester strains TA 1535, TA 100, TA 1537, TA 1538 and TA 98. The test item did not show mutagenic activity in vitro.

The adopted OECD TG 471 (1997) requires the use of E. coli WP2 strains or Salmonella typhimurium TA 102 to detect certain oxidizing mutagens, cross-linking agents and hydrazines. However, the test substance is not a highly reactive agent and is therefore not expected to be a cross-linking agent, has no oxidizing properties and is no hydrazine. Thus, a test according to EU Method B.13/14 (Version Commission Directive 92/69/EEC without E. coli WP2 strains or Salmonella typhimurium TA 102 is considered as sufficient to evaluate the mutagenic activity of the test substance in this bacterial test system.