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EC number: 241-769-4 | CAS number: 17791-81-0
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
- Study period:
- 1994-01-06 and 1994-04-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-conform, according to OECD guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1983
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Version / remarks:
- 1987
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Hexasodium 4,4'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-morpholino-1,3,5-triazine-4,2-diyl]imino]]bis[5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate]
- EC Number:
- 241-769-4
- EC Name:
- Hexasodium 4,4'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-morpholino-1,3,5-triazine-4,2-diyl]imino]]bis[5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate]
- Cas Number:
- 17791-81-0
- Molecular formula:
- C60 H46 N16 Na6 O22 S6
- IUPAC Name:
- 4,4'-[1,2-ethenediylbis[(3-sulfo-4,1-phenylene)imino[6-(4-morpholinyl)-1,3,5-triazine-4,2-diyl]imino]]bis[5-hydroxy-6-(2-phenyldiazenyl)-2,7-naphthalenedisulfonic acid] hexasodium salt
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- post mitochondrial supernatant (S9 fraction) induced by Aroclor 1254
- Test concentrations with justification for top dose:
- 61.73, 185.19, 555.56, 1666.67, 5000.00 µg/plate
- Vehicle / solvent:
- distilled water
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO and bidistilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: with S9: 2-aminoanthracene (TA 100, TA 102, TA 98, TA 1537), cyclophosphamide (TA 1535); without S9: sodium azide (TA 100, TA 1535), mitomycin-C (TA 102), 2-nitrofluorene ( TA 98), 9-aminoacridine (TA 1537)
- Remarks:
- with metabolic activation:
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 hours
DETERMINATION OF CYTOTOXICITY
- Method: counting the colonies
The test was run 2 times to confirm the results. - Evaluation criteria:
- At least a reproducible meaningful increase of the mean number of revertants per plate above that of the negative control at any concentration for one or more of the strains tested. A concentration-related effect should be demonstrable.
- Statistics:
- not required
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES: strain TA 100 (six concentrations ranging from 20.6 to 5000.0 µg/plate), with and without metabolic activation, normal background growth was observed, the numbers of revertant colonies were reduced at the upper concentrations
COMPARISON WITH HISTORICAL CONTROL DATA: yes
ADDITIONAL INFORMATION ON CYTOTOXICITY: The numbers of revertant colonies were reduced at the upper concentrations. The test substance thus exerted a slight inhibitory effect on the growth of the bacteria. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
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