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EC number: - | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- July to September 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Compliant to OECD 471 and GLP guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- Principles of method if other than guideline:
- Due to the positive test result in the Initial Mutation Test (standard plate incorporation method), the same test method was used in the Confirmatory Mutation Test. The Prival modification was therefore skipped.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Details on test material:
- Name: Golden Yellow Continuous
Constituent 1
Method
- Target gene:
- Salmonella typhimurium:
TA98 hisD3052 Frameshift
TA100 hisG46 Base pair substitution
TA1535 hisG46 Base pair substitution
TA1537 hisC3076 Frameshift
Escherichia coli:
WP2uvrA trpE Base pair substitution
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: histidine dependent
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- other: tryptophan dependent
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-Mix
- Test concentrations with justification for top dose:
- Initial Mutation Test and Confirmatory Mutation Test : 5000; 1581; 500; 158.1; 50; 15.81, 5 and 1.581 µg/plate
- Vehicle / solvent:
- Dimethyl sulfoxide (DMSO)
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- w/o S9
Migrated to IUCLID6: TA100, TA1535
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- w/o S9
Migrated to IUCLID6: TA1537
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-1,2-phenylene-diamine
- Remarks:
- TA98: w/o S9
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- w/o S9
Migrated to IUCLID6: WP2uvrA
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with S9: TA98, TA100, TA1535, TA1537, WP2uvrA
- Details on test system and experimental conditions:
- Since the result of the Initial Mutation Test was positive and in accordance with the Study Plan, in the Confirmatory Mutation Test the same experimental procedure was used as in the Initial Mutation Test to reproduce the observed positive results. There was no need to use the pre-incubation procedure (Prival and Mitchell), as it was proposed in the Study Plan in case of a negative Initial Mutation Assay.
Mutation Tests were performed using a standard plate incorporation procedure. Bacteria (cultured in Nutrient Broth No.2) were exposed to the test item both in the presence and absence of an appropriate metabolic activation system. Molten top agar was prepared and kept at 45°C. 2 mL of top agar was aliquoted into individual test tubes (3 tubes per control or concentration level). The equivalent number of minimal glucose agar plates was properly labelled. The test item and other components were prepared freshly and added to the overlay (45°C).
The content of the tubes:
top agar 2000 µL
solvent or solution of test item (or reference controls) 100 (50) µL
overnight culture of tester strain 100 µL
phosphate buffer (pH: 7.4) or S9 mix 500 µL
This solution was mixed and poured on the surface of minimal agar plates. For activation studies, instead of phosphate buffer, 0.5 mL of the S9 mix was added to each overlay tube. The entire test consisted of non-activated and activated test conditions, with the addition of negative and positive controls. After preparation, the plates were incubated at 37°C for 48 hours. - Evaluation criteria:
- The colony numbers on the untreated/negative/positive control and test plates were determined. The mean number of revertants per plate, the standard deviation and the mutation factor values were calculated for each concentration level of the test item and for the controls using Microsoft Excel software.
Criteria for a Positive Response:
A test item was considered mutagenic if:
- a dose–related increase in the number of revertants occurs and/or;
- a reproducible biologically relevant positive response for at least one of the dose groups occurs in at least one strain with or without metabolic activation.
An increase was considered biologically relevant if:
- in Salmonella typhimurium TA100 strain: the number of reversions was at least twice as high as the reversion rate of the vehicle control
- in Salmonella typhimurium TA98, TA1535, TA1537 and Escherichia coli WP2 uvrA strains: the number of reversions was at least three times higher than the reversion rate of the vehicle control
According to the guidelines, statistical methods may be used as an aid in evaluating the test results. However, statistical significance should not be the only determining factor for a positive response.
Criteria for a Negative Response:
A test article was considered non-mutagenic if it produced neither a dose-related increase in the number of revertants nor a reproducible biologically relevant positive response at any of the dose groups, with or without metabolic activation.
VALIDITY OF THE TESTS
Positive and negative controls were run concurrently. The mean values of revertant colony numbers of untreated and DMSO solvent control plates were within the historical control data range. The reference mutagens showed a distinct increase of induced revertant colonies. The viability of the bacterial cells was checked by a plating experiment in each test.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- precipitates at 5000 and 1581 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The highest concentration of test item with no positive results was 15.81 µg/plate.
- Remarks on result:
- other: strain/cell type:
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Spontaneous Reversion of Tester Strain Laboratory's historical control values for s spontaneous revertants (revertants/plate)for untreated control plates without metabolic activation in the period of 1999 to 2008 are as follows: Salmonella typhimurium TA98: 9-54, TA100: 58-211, TA1535: 4-31, TA1537: 1-24, Escherichia coliWP2uvrA: 9-66.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive Salmonella strains
In conclusion, the test item Golden Yellow Continuous had a positive mutagenic activity on the growth of the bacterium tester strains under the test conditions used in this study. - Executive summary:
The test item Golden Yellow Continuouswas tested for potential mutagenic activity using the Bacterial Reverse Mutation Assay.
The experiments were carried out using histidine-requiring auxotroph strains of Salmonella typhimurium (Salmonella typhimurium TA98, TA100, TA1535 and TA1537), and the tryptophan-requiring auxotroph strain of Escherichia coli (Escherichia coliWP2uvrA) in the presence and absence of metabolic activation system (±S9 Mix), which was a cofactor-supplemented post-mitochondrial S9 fraction prepared from activated (phenobarbital/β-naphtoflavone) rat liver.
The study included a Preliminary Solubility Test, a Preliminary Range Finding Test (Informatory Toxicity Test), an Initial Mutation Test and a Confirmatory Mutation Test. In the Range Finding Test as well as in the Initial Mutation Test and Confirmatory Mutation Test, the plate incorporation method was used.
Based on the results of the Solubility Test, the test item was dissolved in DMSO. Concentrations of5000; 2500; 1000; 316; 100; 31.6 and 10 mg/plate wereexamined in the Range Finding Test. Based on the results of the Range Finding Test, the test item concentrations in the two independently performed main experiments (Initial Mutation Test and Confirmatory Mutation Test) were:5000; 1581; 500; 158.1; 50; 15.81; 5 and 1.581 µg/plate. The test item concentrations, including the controls (untreated , solvent and positive reference) were tested in triplicate.
Biologically relevant, substantial increases were observed in the Initial Mutation Test and Confirmatory Mutation Test in all of the examined Salmonella typhimurium tester strains, and the resulting mutation factors followed a dose-response relationship. The positive results observed in the Initial Mutation Test were repeated in the Confirmatory Mutation Test. The increased numbers of revertant colonies observed inEscherichia coliWP2 uvrA tester strain did not reach the biologically relevant threshold value in the performed experiments.
Cytotoxic effect of the test item(absent background lawn and / or no revertant grew on the plates or reduced number of revertant colonies grew on the plates)was observed at the highest dose (5000 µg/plate) with or without metabolic activation in some cases.
Precipitate was observed in all the examined bacterial strains with and without metabolic activation system at 5000 and 1581 mg/plate in both of the main experiments.
The mean values of revertant colonies of the untreated and DMSO control plates were within the historical control data range, the reference mutagens showed the expected increase in the number of revertant colonies, the viability of the bacterial cells was checked by a plating experiment in each test. The tests were considered to be valid.
The reported data of this mutagenicity assay show that under the experimental conditions applied the test item induced gene mutations by base pair changes or frameshifts in the genome of all the Salmonella typhimurium strains used.No mutagenic activity of the test item was observed in Escherichia coli tester strain. Usually, stronger effects of the test item were observed in the experiments with metabolic activation system. Furthermore, higher mutation factors were observed in the Salmonella typhimurium tester strains susceptible to frameshift mutations (TA98 and TA1537).
In conclusion, the test item Golden Yellow Continuous had a positive mutagenic activity on the growth of the bacterium tester strains under the test conditions used in this study.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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