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EC number: 202-000-8 | CAS number: 90-51-7
- 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
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Well documented bacterial reverse mutation assay, but not conducted in accordance with current guideline and only two strains tested.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- as adopted 1983-05-26
- Principles of method if other than guideline:
- The mutagenicity evaluation was performed using the Salmonella/microsome test, also termed the Ames Test, as described by Ames et al. (1973a, 1975) and Maron and Ames (1983). In this case, only two strains (TA 100 & TA 98) were tested.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 6-amino-4-hydroxynaphthalene-2-sulphonic acid
- EC Number:
- 202-000-8
- EC Name:
- 6-amino-4-hydroxynaphthalene-2-sulphonic acid
- Cas Number:
- 90-51-7
- Molecular formula:
- C10H9NO4S
- IUPAC Name:
- 6-amino-4-hydroxynaphthalene-2-sulphonic acid
1
Method
- Target gene:
- his-
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 100 & TA 98
- Additional strain / cell type characteristics:
- other: pKM 101
- Metabolic activation:
- with and without
- Metabolic activation system:
- induced S9
- Test concentrations with justification for top dose:
- 0, 625, 1250, 2500, 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: deionised water (test item); DMSO (positive controls)
- Justification for choice of solvent/vehicle: The used solvent was chosen out of the following solvents, in the order given: water, methanol, ethanol, acetone, DMSO, DMF, and ethylene glycol dimethylether according to information given by the internal sponsor.
Controls
- Untreated negative controls:
- yes
- Remarks:
- vehicle
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: nitrofuranthion; 4-nitro-1,2-phenylene diamine, 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: 30 sec
- Exposure duration: 48 h
- Fixation time (start of exposure up to fixation or harvest of cells): 48 h
SELECTION AGENT (mutation assays): his-negative agar
NUMBER OF REPLICATIONS: 4 plates per strain, dose, ± S9
DETERMINATION OF CYTOTOXICITY
- Method: The toxicity of the substance was assessed in three ways. The first was a gross appraisal of background growth on the plates for mutant determination. If a reduction in background growth was observed, it was indicated in the tables by the letter "b" after the mutant count. Where only a single "b", without any other values, is noted for a concentration, this "b" represents four plates with background growth. (The same applies to the signs "c", "v", "p", "n" or "%", which may also be used in the tables.) Secondly, a toxic effect of the substance was assumed when there was a marked and dose-dependent reduction in the mutant count per plate, compared to the negative controls. Thirdly, the titer was determined. Total bacterial counts were taken on two plates for each concentration studied with S9 mix. However, if an evaluation was performed only without S9 mix, the bacterial count was taken without S9 mix. - Evaluation criteria:
- A reproducible and dose-related increase in mutant counts of at least one strain is considered to be a positive result. For TA 100 and TA 98 this increase should be about twice the amount of negative controls. Otherwise, the result is evaluated as negative. However, these guidelines may be overruled by good scientific judgement. In case of questionable results, investigations should continue, possibly with modifications, until a final evaluation is possible.
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium, other: TA 100 & TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- ADDITIONAL INFORMATION ON CYTOTOXICITY:
At all doses, the substance had a strain-specific bacteriotoxic effect. Nevertheless, they could all be used for assessment purposes.
Applicant's summary and conclusion
- Conclusions:
- The mutagenicity evaluation was performed using the Salmonella/microsome test, also termed the Ames Test, as described by Ames et al. (1973a, 1975) and Maron and Ames (1983). The testing was sufficiently documented, positive and negative controls gave the appropriate response, but only two strains (TA 100 & TA 98) were tested. A dose-dependent and biologically relevant increase of the mutant figures to the double of the negative controls could not be observed with any of the two strains used. This applied to the examinations with and without the S-9 mix. In consequence, the substance is considered to be non-mutagenic under the conditions of this test.
- Executive summary:
In a reverse gene mutation assay in bacteria (Ames Test as described by Ames et al. (1973a, 1975) and Maron and Ames (1983)), histidine-auxotrophic strains TA 100, and TA 98 of S. typhimurium were exposed to gamma acid in deionized water at concentrations of 0, 625, 1250, 2500, 5000 µg/plate in the presence and absence of mammalian metabolic activation (induced S9) via plate co-incubation.
The test substance was tested up to limit concentration 5000 µg/plate. The positive controls induced the appropriate responses in the corresponding strains. There was no evidence or a concentration related positive response of induced mutant colonies over background.
At all doses, the substance had a strain-specific bacteriotoxic effect. Nevertheless, they could all be used for assessment purposes. None of the two strains concerned showed a dose-related and biologically relevant increase in mutant counts over those of the negative controls. This applied both to the tests with and without S9 mix and was confirmed by the results of the repeat tests.
Although the study has not been conducted according to the current guideline and only two strains have been tested, it is used in a weight of evidence approach as it shows that the purified substance obtains different results than the substance with a higher content of impurities (T50334404).
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