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Reaction mass of 1,5-Naphthalenedisulfonic acid, 3,3'-[(4-methyl-1,2-phenylene)bis[imino(6-chloro-1,3,5-triazine-4,2-diyl)imino[2-(acetylamino)-5-methoxy-4,1-phenylene]-2,1-diazenediyl]]bis-, sodium salt (1:4) and 1,5-Naphthalenedisulfonic acid, 3,3'-[(3-methyl-1,2-phenylene)bis[imino(6-chloro-1,3,5-triazine-4,2-diyl)imino[2-(acetylamino)-5-methoxy-4,1-phenylene]-2,1-diazenediyl]]bis-, sodium salt (1:4)
EC number: 947-857-5 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 3,3'-(3-methyl-1 ,2-phenylenebis[imino(6chloro-s-triazin-4,2-diyl)imino(2-acetylamino-5methoxy- 4, 1-phenylene)azo])-bis-1 ,5naphthalenedisulfonic acid and 3,3'-(4-methyl-1 ,2phenylenebis[imino(6-chloro-s-triazin-4,2-diyl)imino(2acetylamino- 5-methoxy-4, 1-phenylene)azo])-bis-1 ,5naphthalenedisulfonic acid, both as mixed sodium/potassium salts.
- Cas Number:
- 72906-24-2
- Molecular formula:
- CS1H42N,sO,sCI2S4
- IUPAC Name:
- 3,3'-(3-methyl-1 ,2-phenylenebis[imino(6chloro-s-triazin-4,2-diyl)imino(2-acetylamino-5methoxy- 4, 1-phenylene)azo])-bis-1 ,5naphthalenedisulfonic acid and 3,3'-(4-methyl-1 ,2phenylenebis[imino(6-chloro-s-triazin-4,2-diyl)imino(2acetylamino- 5-methoxy-4, 1-phenylene)azo])-bis-1 ,5naphthalenedisulfonic acid, both as mixed sodium/potassium salts.
- Test material form:
- solid
- Details on test material:
- Identity: H109363
Batch number: BASF 277/1B
Purity: 85.07 g/100g (main component)
Appearance: Red brown powder
Storage: Room temperature
Constituent 1
- Specific details on test material used for the study:
- Identity: H109363
Batch number: BASF 277/1B
Purity: 85.07 g/100g (main component)
Appearance: Red brown powder
Storage: Room temperature
Method
- Target gene:
- Histidine
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: See remarks
- Remarks:
- rfa: deep rough (defective lipopolysaccharide cellcoat); gal: mutation in galacto se metabolism; chl: mutation in nitrate reductase; bio defective biotin synthesis; uvrB: loss of the excision repair system (deletion of the ultraviolet-repair B gene)
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- other: See remarks
- Remarks:
- rfa: deep rough (defective lipopolysaccharide cellcoat); gal: mutation in galacto se metabolism; chl: mutation in nitrate reductase; bio: defective biotin synthesis; uvrB: loss of the excision repair system (deletion of the ultraviolet-repair B gene)
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S-9 mix and uninduced hamster liver S-9 mix.
- Test concentrations with justification for top dose:
- Ames standard plate test with and without rat liver S-9 mix: 0, 23.6, 1118, 590, 2950 and 5950 µg/plate, no toxicity was observed at highest dose also.
Prival preincubation test with and without hamster liver S-9 mix: 0, 23.6, 1118, 590, 2950 and 5950 µg/plate, slight decrease in the number of revertants was observed depending on the experiment at doses > 2950 µg/plate. - Vehicle / solvent:
- Water for test substance and DMSO for positive controls
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- congo red
- other: See remarks
- Details on test system and experimental conditions:
- The test was performed in two tests:
1) Ames standard plate test (with and without induced Rat liver system)
2) Prival preincubation test (With andd without uninduced hamster liver system - Rationale for test conditions:
- Based on the most recent OECD and EC guidelines.
- Evaluation criteria:
- Evaluation criteria:
The test substance is considered positive in this assay if the following criteria met:
A dose related and reproducible increases in the number of revertant colonies, that is about doubling of the spontaneous mutations rate in at least one tester strain either with or without metabolic activation.
A test substance is generally considered non-mutagenic in this test if:
The number of revertants for all tester strains were within the historical negative control range under all experimental conditions in two experiments carried out independently of each other. - Statistics:
- No formal hypothesis testing was done.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- other: Ames standard plate test
- Remarks:
- TA1535, TA100, TA 1537, T98 and E.coli WP2 uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- other: Prival preincubation test
- Remarks:
- TA1535, TA100, TA1537, TA 98
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Remarks:
- Slightly elevated at 5900 µg/plate
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Remarks:
- Slightly elevated figures (factor < 2.0) without any dose dependency
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with
- Genotoxicity:
- ambiguous
- Remarks:
- Mutagenicity observed from 590 µg/plate (1st test factor 2.7), 118 µg/plate (2nd test, factor 2.1) onwards with a maximum increase in the number of revertant colonies by a factor of 5.3 at 2950 µg/plate (1st test) or of 3.1 at 590 µg/plate (2nd test)
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Even though mutagenic potential was observed in TA 98 strain in the presence of a hamster metabolic activation system, the results are not sufficient to classify the test substance as mutagenic. Under the study conditions, the mutagenic potential of the test substance was therefore inconclusive.
- Executive summary:
A study was conducted to determine the in vitro genetic toxicity of the test substance according to OECD Guideline 471 and EU Method B.13/14, in compliance with GLP. Salmonella typhimurium strains TA1535, TA1537, TA100 and TA98 and Escherichia coli strain WP2uvrA were exposed to the substance at concentrations of 0, 23.6, 118, 590, 2950 and 5950 μg/plate, and also to negative or positive controls. Two types of studies were run: 1) an Ames standard plate test with and without metabolic activation (Arochlor-induced rat liver S9 mix), 2) a Prival preincubation assay with and without metabolic activation (uninduced hamster liver S9 mix).
In experiment 1, the Ames standard plate test, no increase in the number of his* or trp* revertants occurred under any study conditions.
In experiments 2 and 3 conducted according to the Prival preincubation plate assay method, no increase in the number of his* revertants was seen in any tester strain in the absence of metabolic activation. However when hamster liver S9 mix was added, the following observations were made:
- TA 1535: slightly elevated figures at 5900 µg/plate (factor 2.1),
- TA 100: no increase in the number of his* revertants,
- TA 1537: slightly elevated figures (factor <2.0) without any dose-dependency
- TA 98: mutagenicity was observed from about 590 µg/plate (1st test, factor 2.7) onward or 118 µg/plate (2nd test, factor 2.1) onwards with a maximum increase in the number of revertant colonies by a factor of 5.3 at 2950 µg/plate (1st test) or of 3.1 at 590 µg/plate (2nd test).
No bacteriotoxic effects were reported in the Ames standard plate test. In the Prival preincubation assay, a slight decrease in the number of revertant occurred in TA 98 at doses ≥ 2950 µg/plate.
Even though mutagenic potential was observed in TA 98 strain in the presence of a hamster metabolic activation system, the results are not sufficient to classify the test substance as mutagenic. Under the study conditions, the mutagenic potential of the test substance was therefore inconclusive (Engelhardt, 1998).
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