Registration Dossier
Registration Dossier
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EC number: 219-169-9 | CAS number: 2379-81-9
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- The test was conducted by means of Read Across approach. Further information was attached at section 13
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Ames et al.
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Vat Black 027 - Similar Substance 01
- IUPAC Name:
- Vat Black 027 - Similar Substance 01
- Test material form:
- not specified
Constituent 1
Method
- Target gene:
- Histidine locus
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction
- Test concentrations with justification for top dose:
- 2000 µg/plate
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- other: 2-aminoanthracene, daunorubicin
- Details on test system and experimental conditions:
- DURATION
- Incubation period: 60 to 66 hours at 37 °C
COUNTING
Revertant colonies were counted using an automated electronic colony counter (Biotran, New Brunswick Scientific Instruments) calibrated to count standard plates (accepted accuracy 95 %) - Evaluation criteria:
- A positive response was taken to be a two-fold or greater increase in the mean number of revertant colonies appearing in the test plates over and above the background spontaneous reversion rate observed with the solvent, together with evidence of a dose response at sub-toxic concentrations of the test substance. Observed positive responses were validated by replica plating (Elek and Hilson, 1954). The technique verify whether true reversion to prototrophy
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- not specified
- Genotoxicity:
- other: Results are not available
- Cytotoxicity / choice of top concentrations:
- other: Results are not available
- Vehicle controls validity:
- other: Results are not available
- Untreated negative controls validity:
- other: Results are not available
- True negative controls validity:
- other: Results are not available
- Positive controls validity:
- other: Results are not available
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- When tested at the limit of solubility (2000 µg/plate), this compound gave a negative result in the absence of metabolic activation. In the presence of S9, a positive result was obtained in strain TA1537 at a single dose (500 µg/plate), with no dose-related response at lower plate concentrations. On retesting, this result was not repeatable and would thus appear to be an artifact rather than a true positive result.
Applicant's summary and conclusion
- Conclusions:
- Not genotoxic
- Executive summary:
The substance was tested for its mutagenic potential according to Ames et al. on four strain of Salmonella (TA1535, TA1537, TA98, TA100)
Under test condition the substance resulted not mutagenic.
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