Amides, C16-C18 (even) , N,N'-ethylenebis

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

significant methodological deficiencies

Remarks:

Strain to detect cross-linking mutagens missing, analytical purity of test substance not specified.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

Strain to detect cross-linking mutagens missingy, analytical purity of test substance not specified.

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Amides, C16-C18 (even) , N,N'-ethylenebis

EC Number:

931-299-4

Cas Number:

68390-94-3

Molecular formula:

not available UVCB

IUPAC Name:

Amides, C16-C18 (even) , N,N'-ethylenebis

Constituent 2

Reference substance name:

Amides, C16-C18 (even), N,N’-ethylenebis

IUPAC Name:

Amides, C16-C18 (even), N,N’-ethylenebis

Test material form:

not specified

Method

Target gene:

His-operon (S. typhimurium), ade/trp-loci (S. cerevisiae)

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

Species / strain 3

Species / strain / cell type:

Saccharomyces cerevisiae

Details on mammalian cell type (if applicable):

D4

Metabolic activation:

with and without

Metabolic activation system:

Liver S9 fraction of Aroclor 1254-pretreated rats

Test concentrations with justification for top dose:

0.1, 1.0, 10.0, 100.0, 500.0 and 1000.0 µg/plate without activation; 0.1, 1.0, 10.0, 100.0 and 500.0 µg/plate with activation

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: water, dimethylsulfoxid (DMSO)

Controls

Controls 1

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

Dimethylsulfoxide (DMSO)

True negative controls:

no

Positive controls:

yes

Positive control substance:

ethylmethanesulphonate

Remarks:

TA1535, TA100, D4 without S9

Controls 2

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

Dimethylsulfoxide (DMSO)

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: QM, 10 µg/plate

Remarks:

TA1537 without S9

Controls 3

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

Dimethylsulfoxide (DMSO)

True negative controls:

no

Positive controls:

yes

Positive control substance:

2-nitrofluorene

Remarks:

TA1538, TA98 without S9

Controls 4

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-anthramin, 2.5 µg/plate

Remarks:

TA1535, TA1537, TA1538, TA98, TA 100 with S9

Controls 5

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

Dimethylsulfoxide (DMSO)

True negative controls:

no

Positive controls:

yes

Positive control substance:

N-dimethylnitrosamine

Remarks:

D4 with S9

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 48 h for TA 1535, TA 1537, TA 1538, TA 98, TA 100; 3 - 5 days for D4

DETERMINATION OF CYTOTOXICITY
- Method: other: direct revertant colony counts

Evaluation criteria:

Strains TA 1535, TA 1537 and TA 1538: If the solvent control value is within the normal range, a chemical that produces a positive dose-response over three concentrations with the lowest increase equal to twice the solvent control value is considered to be mutagenic.
Strains TA 98, TA 100 and D4: If the solvent control value is within the normal range, a chemical that produces a positive dose response over three
concentrations with the highest increase equal to twice the solvent control value for TA 100 and 2 - 3 times the solvent control value for strains TA 98 and D4 is considered to be mutagenic. For these strains, the dose-response increase should start at approximately the solvent control value.

If a chemical produces a response in a single test that cannot be reproduced in one or more additional runs, the initial positive test data lose significance.

Statistics:

no data

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

True negative controls validity:

not examined

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

Slightly toxic to TA 1537 at 500 µg per plate.

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

True negative controls validity:

not examined

Positive controls validity:

valid

Test results 3

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

True negative controls validity:

not examined

Positive controls validity:

valid

Test results 4

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

True negative controls validity:

not examined

Positive controls validity:

valid

Test results 5

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

True negative controls validity:

not examined

Positive controls validity:

valid

Test results 6

Species / strain:

Saccharomyces cerevisiae

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

True negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

ADDITIONAL INFORMATION ON CYTOTOXICITY:
The compound was slightly toxic to the strain TA 1537 at 500 µg per plate.
TA 98 was repeated at 100, 500 and 1000 µg/plate because of the increased number of revertants at 500 µg/plate over the background level. The repeat test was negative.

Applicant's summary and conclusion

Conclusions:

Interpretation of results: negative

Executive summary:

The test substance did not demonstrate mutagenic activity in any of the assays conducted in this evaluation and was considered not mutagenic under these test conditions.