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EC number: 945-517-0 | 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From the 8th to the 29th of July, 1988
- Reliability:
- 1 (reliable without restriction)
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From the 8th to the 29th of July, 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: read-across from supporting substance (structural analogue or surrogate)
- Remarks:
- Study conducted according to internationally accepted testing guideline
- Justification for type of information:
- Justification for Read Across is detailed in the endpoint summary and it is further detailed in the report attached to the IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Principles of method if other than guideline:
- The test has been conducted following the Environmental Protection Agency, Code of Federal Regulations, Title 40, Subpart F-Genetic Toxicity, Revision July 1st, 1986 "The salmonella Typhimurium Reverse Mutation Assay".
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Mammalian Microsomal Fraction S9 Mix
- Test concentrations with justification for top dose:
- 10.0 µg/plate; 100.0 µg/plate; 333.3 µg/plate; 1000.0 µg/plate; 5000.0 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Water bidest- Justification for choice of solvent/vehicle: the solvent was chosen to its solubility properties and its relative nontoxicity for the bacteria.
- Untreated negative controls:
- yes
- Remarks:
- concurrent untreated
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: Without metabolic activation: NaN3 (TA 1535, TA 100); 4-NOPD (TA 1537, TA 1538, TA 98); With metabolic activation: DMSO
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
Preincubation period: 6 hours at 37 °C in a shaking water bath
Exposure duration: After solidification the plates wew incubated upside down for 72 hours at 37 °C in the dark
NUMBER OF REPLICATIONS: Two indipendent study, three replicates for each concentration - Evaluation criteria:
- The generally accepted conditions for the evaluation of the results are:
Corresponding background growth on both negative control and test plates
Normal range of spontaneous rerversion tates.
Range of spontaneous reversion frequencies (5,9)TA 1535 (3 - 37); TA 1537 (4 - 31); TA 1538 (12 - 37); TA 98 (15 - 60); TA 100 (75 - 200)
Due to the international guidelines a statistical evaluation of the results is recommended. However, no evaluated statistical procedure can be recommended for analysis of data from the bacterial assays at this time.
A test article is considered as positive if either a significant dose
- related increase in the number of revertants nor a significant and reproducible increase for at least one test concentration is induced.A test article producing neither a significant dose
-related increase in the number of revertants nor a significant and reproducible positive response at any one of the test points is considered non mutagenic in this system.
A positive response is described as follows:
A test article is considered as mutagen if in strain TA 100 the number of reversions is at least twice as high and in strains TA 1535, TA 1537, TA 1538, and TA 98 it is at least three times higher as compared to the spontaneous reversion rate.Also a dose dependent increase in the number of revertants is regarded as an indication of possibly existing mutagenic potential of the teest article regardless whether the highest dose induced the above described enhancement factors or not. - Statistics:
- No appropriate statistical method is available
- Species / strain:
- other: S. typhimurium TA 1537, TA 1538, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- other: S. typhimurium TA 1537, TA 1538 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: other: Independent test n. 2
- Conclusions:
- Positive with and without metabolic activation. Under the test condition the substance did induce point mutation by base pair change or frameshifts in the genome of the strains TA 1537, TA 1538, TA 98 and TA 100
- Executive summary:
Method
The test has been conducted on the Similar substance 01, according to the OECD Guideline 471 and to the EU Method B.14 in order to evaluate the potential of the test item to induce gene mutations according to the plate incorporation test.
During the test the Salmonella typhimurium strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100 have been used. The assay has been performed in two independent experiments, using identical procedures, both with and without microsomal activation. Each concentration, including the controls, has been tested in triplicate. The substance has been tested at the concentrations: 10, 100, 333.3, 1000 and 5000 µg/plate.
Observations
No toxic effects, evidenced by a reduction in the number of spontaneous revertants, occurred in any of the test groups with and without metabolic activation.
The plates incubated showed normal background growth up to 5000 µg/plate with and without S9 mix in all strains used.
Up to the highest investigated dose, a significant and reproducible dose-dependent increase in revertant colony numbers was obtained with the strains TA 1537, TA 1538, TA 98 and TA 100. The presence of liver microsomal activation did not influence the genotoxic effect, However the positive response in strain TA 98 was not reproduced in the independent experiment in the presence of S9 mix.
Results
Under the test condition the substance did induce point mutation by base pair change or frameshifts in the genome of the strains TA 1537, TA 1538, TA 98 and TA 100. The test article is considered to be mutagenic in this assay.
In Strain TA 98 a distinct mutagenic effect occurred without S9 -mix in both experiments. In the presence of metabolic activation no positive response was obtained in Experiment 1. In te experiment 2 a weak increase in the number of revertants was found at 1000 and 5000 µg/plate.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Principles of method if other than guideline:
- The test has been conducted following the Environmental Protection Agency, Code of Federal Regulations, Title 40, Subpart F-Genetic Toxicity, Revision July 1st, 1986 "The salmonella Typhimurium Reverse Mutation Assay".
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Similar substance 01 of Acid Brown 314:1
- IUPAC Name:
- Similar substance 01 of Acid Brown 314:1
- Test material form:
- solid: particulate/powder
Constituent 1
Method
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:
- Mammalian Microsomal Fraction S9 Mix
- Test concentrations with justification for top dose:
- 10.0 µg/plate; 100.0 µg/plate; 333.3 µg/plate; 1000.0 µg/plate; 5000.0 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Water bidest- Justification for choice of solvent/vehicle: the solvent was chosen to its solubility properties and its relative nontoxicity for the bacteria.
Controls
- Untreated negative controls:
- yes
- Remarks:
- concurrent untreated
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: Without metabolic activation: NaN3 (TA 1535, TA 100); 4-NOPD (TA 1537, TA 1538, TA 98); With metabolic activation: DMSO
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
Preincubation period: 6 hours at 37 °C in a shaking water bath
Exposure duration: After solidification the plates wew incubated upside down for 72 hours at 37 °C in the dark
NUMBER OF REPLICATIONS: Two indipendent study, three replicates for each concentration - Evaluation criteria:
- The generally accepted conditions for the evaluation of the results are:
Corresponding background growth on both negative control and test plates
Normal range of spontaneous rerversion tates.
Range of spontaneous reversion frequencies (5,9)TA 1535 (3 - 37); TA 1537 (4 - 31); TA 1538 (12 - 37); TA 98 (15 - 60); TA 100 (75 - 200)
Due to the international guidelines a statistical evaluation of the results is recommended. However, no evaluated statistical procedure can be recommended for analysis of data from the bacterial assays at this time.
A test article is considered as positive if either a significant dose
- related increase in the number of revertants nor a significant and reproducible increase for at least one test concentration is induced.A test article producing neither a significant dose
-related increase in the number of revertants nor a significant and reproducible positive response at any one of the test points is considered non mutagenic in this system.
A positive response is described as follows:
A test article is considered as mutagen if in strain TA 100 the number of reversions is at least twice as high and in strains TA 1535, TA 1537, TA 1538, and TA 98 it is at least three times higher as compared to the spontaneous reversion rate.Also a dose dependent increase in the number of revertants is regarded as an indication of possibly existing mutagenic potential of the teest article regardless whether the highest dose induced the above described enhancement factors or not. - Statistics:
- No appropriate statistical method is available
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: S. typhimurium TA 1537, TA 1538, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- other: S. typhimurium TA 1537, TA 1538 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: other: Independent test n. 2
Any other information on results incl. tables
In Strain TA 98 a distinct mutagenic effect occurred without S9 -mix in both experiments. In the presence of metabolic activation no positive response was obtained in Experiment 1. In te experiment 2 a weak increase in the number of revertants was found at 1000 and 5000 µg/plate.
Applicant's summary and conclusion
- Conclusions:
- Positive with and without metabolic activation.
Under the test condition the substance did induce point mutation by base pair change or frameshifts in the genome of the strains TA 1537, TA 1538, TA 98 and TA 100 - Executive summary:
Method
The test has been conducted according to the OECD Guideline 471 and to the EU Method B.14 in order to evaluate the potential of the test item to induce gene mutations according to the plate incorporation test.
During the test the Salmonella typhimurium strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100 have been used. The assay has been performed in two independent experiments, using identical procedures, both with and without microsomal activation. Each concentration, including the controls, has been tested in triplicate. The substance has been tested at the concentrations: 10, 100, 333.3, 1000 and 5000 µg/plate.
Observations
No toxic effects, evidenced by a reduction in the number of spontaneous revertants, occurred in any of the test groups with and without metabolic activation.
The plates incubated showed normal background growth up to 5000 µg/plate with and without S9 mix in all strains used.
Up to the highest investigated dose, a significant and reproducible dose-dependent increase in revertant colony numbers was obtained with the strains TA 1537, TA 1538, TA 98 and TA 100. The presence of liver microsomal activation did not influence the genotoxic effect, However the positive response in strain TA 98 was not reproduced in the independent experiment in the presence of S9 mix.
Results
Under the test condition the substance did induce point mutation by base pair change or frameshifts in the genome of the strains TA 1537, TA 1538, TA 98 and TA 100. The test article is considered to be mutagenic in this assay.
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