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Toxicological information

Genetic toxicity: in vitro

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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

Constituent 1
Chemical structure
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 / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
S. typhimurium TA 1538
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)
Controlsopen allclose all
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
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
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
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
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 resultsopen allclose all
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
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
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
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
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
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.