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EC number: 947-367-1 | 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:
- key study
- Study period:
- October 09, 2017 to November 03, 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Diammonium 1,1'-methylenebis[(phenylmethyl)naphthalene-2-sulphonate]
- EC Number:
- 284-353-8
- EC Name:
- Diammonium 1,1'-methylenebis[(phenylmethyl)naphthalene-2-sulphonate]
- Cas Number:
- 84852-41-5
- Molecular formula:
- C35H38N2O6S2.2H3N
- IUPAC Name:
- Diammonium 1,1'-methylenebis((phenylmethyl)naphthalene-2-sulphonate)
- Reference substance name:
- Benzyl methylene-bis-napthalene-2-sulphonic acid ammonium salt
- IUPAC Name:
- Benzyl methylene-bis-napthalene-2-sulphonic acid ammonium salt
- Reference substance name:
- Isomers of Benzyl methylene-bis-naphthalene trisulphonic acid ammonium salt
- Molecular formula:
- Not applicable
- IUPAC Name:
- Isomers of Benzyl methylene-bis-naphthalene trisulphonic acid ammonium salt
- Reference substance name:
- Ammonium sulphate
- EC Number:
- 231-984-1
- EC Name:
- Ammonium sulphate
- Cas Number:
- 7783-20-2
- Molecular formula:
- (NH4)2SO4
- IUPAC Name:
- diammonium sulfate
- Reference substance name:
- Unidentified isomers formed during the reaction
- Molecular formula:
- Not applicable
- IUPAC Name:
- Unidentified isomers formed during the reaction
- Reference substance name:
- Formaldehyde
- EC Number:
- 200-001-8
- EC Name:
- Formaldehyde
- Cas Number:
- 50-00-0
- Molecular formula:
- C H2 O
- IUPAC Name:
- formaldehyde
- Test material form:
- solid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Method
- Target gene:
- Cytotoxicity test (range-finding study): Salmonella typhimurium TA100.
Mutation assay: S. typhimurium TA98, TA100, TA1535, and TA1537; Escherichia coli WP2 uvrA (pKM101).
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium, other: TA100
- Remarks:
- Cytotoxicity test
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Sodium phenobarbitone and β-naphthoflavone induced rat liver S9 homogenate
- Test concentrations with justification for top dose:
- Cytotoxicity test (range-finding study) concentrations selected according to the results of a precipitation test: 0.7, 0.8, 0.9, 1, 2, 3, 4, and 5 mg/plate.
Mutation assay: 0.05, 0.16, 0.5, 1.6, and 5 mg/plate (with half-log dose interval). - Vehicle / solvent:
- - Vehicle used: Distilled water (Batch number: 7461).
- Justification for choice of vehicle: The test item at the given concentration of 50 mg/mL was soluble in distilled water.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-Aminoanthracene
- Details on test system and experimental conditions:
- On the basis of test item solubility and precipitation tests, an initial cytotoxicity experiment was performed at 0.7, 0.8, 0.9, 1, 2, 3, 4, and 5 mg/plate. The cytoxicity experiment was performed with Salmonella typhimurium TA100 both in the presence and absence of metabolic activation system.
The test strains used in the mutation assay were Salmonella typhimurium TA98, TA100, TA1535, and TA1537 and Escherichia Coli WP2 uvrA (pKM101).
For the ultimate genetic mutation assay, concentrations were selected according to the results of solubility, precipitation, and the cytotoxicity test: 0.05, 0.16, 0.5, 1.6, and 5 mg/plate. Two independent trials (trial I and II) were carried out by plate incorporation for a 67-hour and 30-minute incubation duration and pre-incubation for a 69-hour incubation duration in the presence and absence of metabolic activation. A vehicle control (distilled water) and five appropriate positive controls were tested simultaneously.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: not applicable
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- 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:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: not applicable
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: not applicable
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: not applicable
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- No significant increase in the number of revertant colonies was observed in any bacterial strain relative to the vehicle control following exposure to aryl sulphonate condensate, with and without metabolic activation. The registered substance can subsequently be regarded as non-mutagenic under the conditions of the test.
- Executive summary:
OECD Guideline 471 (Bacterial Reverse Mutation Assay), in conjunction with Good Laboratory Practise (GLP) standards, were followed in order to determine the potential genetic toxicity of aryl sulphonate condensate. The in vitro gene mutation experiment consisted on an initial cytotoxicity test at 0.7, 0.8, 0.9, 1, 2, 3, 4, and 5 mg/plate with Salmonella typhimurium TA100, with and without metabolic activation, that was based on the results of a previous precipitation (no precipitation ≤5 mg/plate) and solubility test (soluble in distilled water at 50 mg/mL). A concurrent vehicle control consisting of distilled water was prepared. The test item did not induce cytotoxicity up to 5 mg/plate. On the basis of the cytotoxicity test, 5 mg/plate was considered to be the highest concentration suitable for the reverse mutation assay. The following test concentrations were subsequently selected for use in the main test: 0.05, 0.16, 0.5, 1.6, and 5 mg/plate, using bacterial strains S. typhimurium TA98, TA100, TA1535, and TA1537 and Escherichia coli WP2 uvrA, without and without metabolic activation. A vehicle control and five positive controls were used alongside the test. An initial trial was performed using the plate incorporation method and a second trial using the preincubation method.
The vehicle and positive controls were considered valid and the acceptability criteria of the test fulfilled. The results obtained in trial I (plate incorporation) and trial II (preincubation) for all strains and test concentrations closely resembled the vehicle controls when tested in both the presence and absence of metabolic activation, with no significant increase in the mean number of revertant colonies/plate. The treated bacterial background lawns were not observed to be different to the vehicle control. A viable plate count demonstrated that all bacterial strains were within an acceptable range of 1 to 2x10^9 Colony Forming Units (CFU)/mL. It can be concluded that, under the conditions of the experiment, Aryl sulphonate condensate was non-mutagenic up to 5 mg/plate.
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