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EC number: 931-299-4 | CAS number: 68390-94-3
Toxicological information
Genetic toxicity: in vitro
Currently viewing:
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:
- 1 978
- 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
- 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
- Reference substance name:
- Amides, C16-C18 (even), N,N’-ethylenebis
- IUPAC Name:
- Amides, C16-C18 (even), N,N’-ethylenebis
- Test material form:
- not specified
Constituent 1
Constituent 2
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.
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