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Diss Factsheets
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EC number: 946-856-7 | 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
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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:
- 31 October – 13 November 2018
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- July 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: modified method by Prival et al. (1984) for azo dyes
- Version / remarks:
- 1984
- Principles of method if other than guideline:
- None
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Test material form:
- solid: particulate/powder
Constituent 1
Method
- Target gene:
- histidine operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Hamster S9
- Test concentrations with justification for top dose:
- 0.40 - 6.30 mg/plate
- Vehicle / solvent:
- yes
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- congo red
- cumene hydroperoxide
- other: 2-Aminoanthracene
- Details on test system and experimental conditions:
- The test substance is preincubated with the tester strain and sterile buffer (for
volume compensation) or the metabolic activation system for 30 minutes +/- 5 min. at 30°C
+/- 3°C. Subsequently the overlay agar is added and the mixture is poured on the surface of a
minimal agar plate. In addition deviating from the standard method a reductive metabolic
activation system with the reductive agent Flavinemononucleotide and with 30% uninduced
hamster S9 is applied. - Evaluation criteria:
- The colonies were counted manually with a colony counter (Heathro Scientific LLC). The
mean value and standard deviation of the three resp. five replicates were calculated
(Microsoft Excel®). The resulting induction rates (IR = number of revertant colonies in the
plate with test substance / mean number of revertant colonies in the negative control plate
[NC]) were calculated for each test concentration and each tester strain.
Cytotoxic effects of the test item can be determined if the growth of the micro colonies in the
background lawn deviates from the negative control plates. A decrease in micro colonies
density or gaps in the bacterial background lawn are indicators for cytotoxic effects. These
are discovered by microscopic evaluation of the plates. Often such effects can be observed
in combination with reduced number of revertant colonies in comparison to the number of
spontaneous revertant colonies on the negative control plates (induction rate < 1). Toxic
effects to the bacteria are reported.
According to OECD Guideline 471 a sample is mutagenic if there is a concentration-related
increase over the range tested and/or a reproducible increase at one or more concentrations
in the number of revertant colonies per plate in at least one strain with or without the
metabolic activation system. 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 result. For the evaluation of the results of the tests performed in this study the increase of revertants
in a sample is expressed as the induction rate [IR], (IR = number of revertants in the
sample/number of revertants in the control). In the case of a reproducible increase of the
number of revertants and if additionally a statistically significant difference between the mean
values can be demonstrated for example with the U-test according to Mann & Whitney e.g.,
the sample is evaluated as positive.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- With the highest test concentrations of 5 mg/plate and 2.5 mg/plate there were some hints of
cytotoxic effects for the tester strains of TA 98 (+/- S9), TA 1535 (-S9) and TA 1537 (+/- S9).
Applicant's summary and conclusion
- Conclusions:
- BLACK 407 is evaluated as mutagenic in the Ames Test modified by Prival.
- Executive summary:
In the study five concentrations between 6.30 mg/plate and 0.40 mg/plate of the test item corresponding to 5 mg/plate to 0.31 mg/plate of the active test substance were applied. The test was performed with and without reductive metabolic activation with preincubation and non-induced Hamster S9. In four of the tester strains (TA 98, TA 100, TA 1535 and TA 1537) a dose dependent increase of revertant colonies or a reproducible increase at one or more concentrations in the number of revertant colonies per plate with or without metabolic activation were occurred.
The test item is evaluated as mutagenic in the Ames Test modified by Prival.
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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