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EC number: 276-911-4 | CAS number: 72829-25-5
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
- Study period:
- February 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- February 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Refer chapter 13 for the detailed analogue justification.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- only 4 tester strains tested which was in line with OECD technical guideline 471 as available in 1978.
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- see Table 1 (any other information on material and methods)
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver S9
- Test concentrations with justification for top dose:
- Experiment I: 0.2, 2.0, 20, 200 and 2000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used:
Deionised water. The solvent was chosen because of its solubility properties. - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other:
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: Thio tepa
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
plate incorporation
The product was tested in Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 at five dose levels : 0.2, 2.0, 20, 200 and 2000,ug per Petri dish. Simultaneously, positive controls were assayed. - Statistics:
- not applicable (no toxicity)
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- not determined
- Vehicle controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- not examined
- 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:
- valid
- 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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:
- valid
- 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:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- Optimization of Concentration of Liver Activating Enzymes
In a preliminary trial with known mutagens, twenty-five microliters was selected as the concentration of liver homogenate yielding maximum numbers of revertants.
Assay
The product was tested in Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 at five dose levels : 0.2, 2.0, 20, 200 and 2000,ug per Petri dish. Simultaneously, positive controls were assayed. - Remarks on result:
- other: all strains/cell types tested
- Conclusions:
- FAT 400034/A did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. Therefore, the test material is considered to be non-mutagenic in this Salmonella typhimurium reverse mutation assay.
Under the experimental conditions defined in the protocol, and employing a doubling of the spontaneous reversion rate as a criterion of mutagenicity, product FAT 40034/A was not mutagenic for Salmonella ty-phimurium strains TA 1535, TA1537, TA 98 and TA 100.
The lack of evidence for mutagenicity existed both in the absence and presence of a liver microsomal enzyme preparation (S9-mix) from male rats pretreated vith Aroclor 1251 and over a concentration range of 0.2 to 2000 µg of product per Petri dish.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- only 4 tester strains tested which was in line with OECD technical guideline 471 as available in 1978.
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Trisodium 5-[[4-chloro-6-(ethylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate
- EC Number:
- 276-911-4
- EC Name:
- Trisodium 5-[[4-chloro-6-(ethylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate
- Cas Number:
- 72829-25-5
- Molecular formula:
- C27H22ClN7O10S3.3Na
- IUPAC Name:
- trisodium 5-({4-chloro-6-[ethyl(phenyl)amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(2-sulfonatophenyl)diazenyl]naphthalene-2,7-disulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Method
- Target gene:
- see Table 1 (any other information on material and methods)
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:
- Aroclor 1254-induced rat liver S9
- Test concentrations with justification for top dose:
- Experiment I: 0.2, 2.0, 20, 200 and 2000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used:
Deionised water. The solvent was chosen because of its solubility properties.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other:
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: Thio tepa
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
plate incorporation
The product was tested in Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 at five dose levels : 0.2, 2.0, 20, 200 and 2000,ug per Petri dish. Simultaneously, positive controls were assayed. - Statistics:
- not applicable (no toxicity)
Results and discussion
Test resultsopen allclose all
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- not examined
- 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:
- valid
- 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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:
- valid
- 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:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- Optimization of Concentration of Liver Activating Enzymes
In a preliminary trial with known mutagens, twenty-five microliters was selected as the concentration of liver homogenate yielding maximum numbers of revertants.
Assay
The product was tested in Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 at five dose levels : 0.2, 2.0, 20, 200 and 2000,ug per Petri dish. Simultaneously, positive controls were assayed. - Remarks on result:
- other: all strains/cell types tested
Any other information on results incl. tables
Under the experimental conditions defined in the protocol, and employing a doubling of the spontaneous reversion rate as a criterion of mutagenicity, product FAT 40034/A was not mutagenic for Salmonella ty-phimurium strains TA 1535, TA1537, TA 98 and TA 100.
The lack of evidence for mutagenicity existed both in the absence and presence of a liver microsomal enzyme preparation (S9-mix) from male rats pretreated vith Aroclor 1251 and over a concentration range of 0.2 to 2000 µg of product per Petri dish.
Applicant's summary and conclusion
- Conclusions:
- FAT 400034/A did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. Therefore, the test material is considered to be non-mutagenic in this Salmonella typhimurium reverse mutation assay.
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