Registration Dossier
Registration Dossier
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EC number: 279-091-6 | CAS number: 79135-90-3
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- well performed guideline like study with GLP but without confirmation of negative results in a second experiment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Ames et al, Mutation Res. (1975) 31, 347-364
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Trisodium trihydrogen 5,5',5''-(1,3,5-triazine-2,4,6-triyltriimino)tris[5-sulphonatosalicylate]
- EC Number:
- 279-091-6
- EC Name:
- Trisodium trihydrogen 5,5',5''-(1,3,5-triazine-2,4,6-triyltriimino)tris[5-sulphonatosalicylate]
- Cas Number:
- 79135-90-3
- Molecular formula:
- C24H18N6O18S3.3Na
- IUPAC Name:
- trisodium 3-({4,6-bis[(3-carboxy-2-hydroxy-5-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)-5-carboxy-4-hydroxybenzene-1-sulfonate
Constituent 1
Method
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
- Metabolic activation:
- with and without
- Metabolic activation system:
- AROCLOR 1254 induced rat liver S-9 mix
- Test concentrations with justification for top dose:
- 1.58 / 5 / 15.8 / 50 / 158 / 500 / 1580 and 5000 µg/plate
- Vehicle / solvent:
- DIMETHYLSULFOXIDE
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: methylmethanesulphonate, 9-aminoacridine, 2-nitrofluorene, N-ethyl-N-nitro-N-nitrosoguanidine without metabolic activation; 2-aminoanthracene, benzo(a)pyrene with metabolic activation.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: plate incorporation
NUMBER OF REPLICATIONS: each compound concentration including controls is tested in triplicate, without confirmation of negative results by further testing - Evaluation criteria:
- SPECIAL ATTENTION WAS GIVEN TO A REPRODUCIBLE DOSE-EFFECT RELATIONSHIP.
A MUTAGENIC ACTIVITY WAS ASSUMED IF AT LEAST A TWO FOLD (FOR TA 100: ONE AND HALF FOLD) INCREASE OF THE NUMBER OF INDUCED REVERTANTS WAS OBTAINED IN COMPARISON WITH THE SPONTANEOUS REVERTANTS OF THE CORRESPONDING CONTROLS.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and 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
- Positive controls validity:
- valid
- Key result
- 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
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- DURING THIS IN VITRO SALMONELLA/MAMMALIAN-MICROSOME ASSAY NO GENE MUTAGENIC ACTIVITY COULD BE DEMONSTRATED UNDER THE EXPERIMENTAL CONDITIONS REPORTED.
- Executive summary:
THE TEST ITEM WAS TESTED FOR DETECTING ITS POTENTIAL GENE MUTAGENIC ACTIVITY ACCORDING TO THE PLATE INCORPORATION METHOD OF AMES ET AL. USING THE SALMONELLA THYPHIMURIUM STRAINS TA 98, TA 100, TA 1535, TA 1537 AND TA 1538.
THE TEST WAS PERFORMED WITH AND WITHOUT LIVER MICROSOMAL ACTIVATION. THE TEST MATERIAL WAS TESTED AT EIGHT CONCENTRATION: 1.58 / 5 / 15.8 / 50 / 158 / 500 / 1580 AND 5000 µg PER PLATE. EACH COMPOUND CONCENTRATION INCLUDING CONTROLS WAS TESTED IN TRIPLICATE.
A VERY SLIGHT PRECIPITATION OF THE TEST MATERIAL WAS OBSERVED AFTER POURING THE CONTENT OF THE TEST TUBE OVER THE SURFACE OF THE SELECTIVE AGAR PLATE AT THE CONCENTRATIONS OF 1580 AND 5000 µg PER PLATE. THE REVERTANTS WERE EASILY RECOGNIZABLE AND THE PLATES COULD BE EVALUATED.
UP TO THE HIGHEST TESTED DOSE, WITH AND WITHOUT MICROSOMAL ACTIVATION, NO RELEVANT INCREASE OF THE REVERTANT COLONY NUMBERS WAS OBTAINED IN ANY SALMONELLA THYPHIMURIUM STRAIN IN COMPARISON WITH THE CORRESPONDING CONTROLS.
NO TOXIC EFFECTS OF THE TEST MATERIAL WERE OBSERVED.
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