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EC number: 244-320-0 | CAS number: 21295-57-8
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
An Ames test was performed to investigate the potential of Macrolex Fluoreszenzrot 4B to induce gene mutations according to the plate incorporation test (experiment I and Ia) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100, and the Escherichia coli strain WP2 uvrA, following OECD TG 471. Under the experimental conditions of the test, Macrolex Fluoreszenzrot 4B did induce gene mutations by frameshifts in the genome of strain TA 1537 in the presence of S9 mix. Therefore, Macrolex Fluoreszenzrot 4B is considered to be mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- This study was performed to investigate the potential of Macrolex Fluoreszenzrot 4B to induce gene mutations according to the plate incorporation test (experiment I and Ia) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100, and the Escherichia coli strain WP2 uvrA, following OECD TG 471.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 Mix
- Test concentrations with justification for top dose:
- 3; 10; 33; 100; 333; 1000; 2500; and 5000 μg/plate.
In the pre-experiment the concentration range of the test item was 3 – 5000 μg/plate. - Vehicle / solvent:
- On the day of the experiment, the test item Macrolex Fluoreszenzrot 4B was suspended in DMSO (purity > 99%). The solvent was chosen because of its solubility properties and its relative nontoxicity to the bacteria.
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine, 4-NOPD; 2-aminoanthracene, 2-AA
- Details on test system and experimental conditions:
- This study was performed to investigate the potential of Macrolex Fluoreszenzrot 4B to induce gene mutations according to the plate incorporation test (experiment I and Ia) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100, and the Escherichia coli strain WP2 uvrA, following OECD TG 471.
The assay was performed in two independent experiments. Experiment I was performed with and without liver microsomal activation using all 5 strains, whereas experiment Ia was performed with liver microsomal activation only and solely using TA 1537. Each concentration, including the controls, was tested in triplicate. The test item was tested as solution in DMSO at the following concentrations in both experiments:
3; 10; 33; 100; 333; 1000; 2500; and 5000 μg/plate - Rationale for test conditions:
- Pre-Experiment for Toxicity:
To evaluate the toxicity of the test item a pre-experiment was performed with all strains used. Eight concentrations were tested for toxicity and mutation induction with each 3 plates. The experimental conditions in this pre-experiment were the same as described for the experiment I below (plate incorporation test).
Toxicity of the test item results in a reduction in the number of spontaneous revertants (below a factor of 0.5) or a clearing of the bacterial background lawn.
The pre-experiment is reported as main experiment I since the acceptance criteria are met.
Dose Selection
In the pre-experiment the concentration range of the test item was 3 – 5000 μg/plate. The pre-experiment is reported as experiment I. Since a positive result was obtained in the first experiment, a second experiment was not performed. - Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the number of revertants of twofold or above (strains TA 98, TA 100, and WP2 uvrA) or threefold or above (strains TA 1535 and TA 1537) the spontaneous mutation rate of the corresponding solvent control is observed.
A dose dependent increase is considered biologically relevant if the threshold is reached or exceeded at more than one concentration.
An increase of revertant colonies equal or above the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant. - Statistics:
- According to the OECD guideline 471, a statistical analysis of the data is not mandatory.
- Key result
- Species / strain:
- other: Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100, and the Escherichia coli strain WP2 uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Remarks:
- TA 1537 was positive in the presence of S9 mix.
- Cytotoxicity / choice of top concentrations:
- other: No toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occurred in all strains with and without metabolic activation.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- During the described mutagenicity test and under the experimental conditions reported, the test item did induce gene mutations by frameshifts in the genome of strain TA 1537 in the presence of S9 mix.
- Conclusions:
- Macrolex Fluoreszenzrot 4B is considered to be mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay.
- Executive summary:
This study was performed to investigate the potential of Macrolex Fluoreszenzrot 4B to induce gene mutations according to the plate incorporation test (experiment I and Ia) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100, and the Escherichia coli strain WP2 uvrA, following OECD TG 471.
The assay was performed in two independent experiments. Experiment I was performed with and without liver microsomal activation using all 5 strains, whereas experiment Ia was performed with liver microsomal activation only and solely using TA 1537. Each concentration, including the controls, was tested in triplicate. The test item was tested as solution in DMSO at the following concentrations in both experiments:
3; 10; 33; 100; 333; 1000; 2500; and 5000 μg/plate
The test item precipitated in the overlay agar in the test tubes from 1000 to 5000 μg/plate. The test item partially adhered in the test tubes from 333 μg/plate onwards in the presence of S9 mix. No precipitation of the test item, but a strong coloring of the overlay agar on the incubated agar plates (densely colored plates) was observed from 2500 to 5000 μg/plate.
The plates incubated with the test item showed normal background growth up to 5000 μg/plate with and without S9 mix in all strains used.
No toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occurred in all strains with and without metabolic activation.
A moderate but dose dependent increase in revertant colony numbers was observed following treatment with Macrolex Fluoreszenzrot 4B in strain TA 1537 in the presence of metabolic activation (S9 mix). The threshold of three times the revertant colony number of the corresponding solvent control was exceeded at only one concentration (1000 μg/plate). To validate the positive response strain TA 1537 with S9 mix was repeated under the same conditions as experiment I. The repeated experiment is reported as experiment Ia. Also in the repeated experiment an increase in revertant colony count was observed. The threshold of threefold the number in revertant colony count of the corresponding solvent control was exceeded at 5000 μg/plate. Therefore the positive effect observed in experiment I is considered as reproducible and the test item Macrolex Fluoreszenzrot 4B as mutagenic in this Ames test.
Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.
Conclusion
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did induce gene mutations by frameshifts in the genome of strain TA 1537 in the presence of S9 mix.
Therefore, Macrolex Fluoreszenzrot 4B is considered to be mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (positive)
Genetic toxicity in vivo
Description of key information
Due to the positive results of the Ames test according to OECD Guideline 471 (Bacterial Reverse Mutation Assay Test) the conduction of an in-vivo Comet assay is proposed to evaluate potential mutagenic activity in vivo.
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
To assess the relevance of the positive outcome of a bacterial mutagenesis test (Ames Test) for the in vivo situation an in vivo Comet-assay is proposed. As long as the results of this test are not available, the registered substance is considered as 'inconclusive' with regard to mutagenicity.
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