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EC number: 228-779-4 | CAS number: 6358-57-2
- 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:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Acid Red 111
- IUPAC Name:
- Acid Red 111
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 98, TA 100, TA 1535, TA 1537 and TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver metabolic activation system (S9)
- Test concentrations with justification for top dose:
- Range Finder Experiment and Experiment I: 0.32, 1.6, 8, 40, 200 and 1000 µg/plate
- Vehicle / solvent:
- - Solvent: dimethyl formamide
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- other: 2-Aminoanthracene
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA 98, TA 100, TA 1535, TA 1537 and TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- top two dose treatments of TA 1537 in absence of S9
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- When the data from Experiment I were analysed at the 1 % level using Dunnett's test, a statistically signifrcant increase in revertant numbers was observed following TA 1538 treatments in the presence of S9. This increase showed little evidence of a dose-response and was therefore not considered to be indicative of test item mutagenic activity in this strain under the treatment condition. No statistically significant increases in revertant numbers were observed following any other treatments in this study.
TOXICITY
Toxicity ranging from a thinning of the background bacterial lawn to a complete killing of the test bacteria was observed following the top two dose treatments of TA 1537 in the absence of S9.
The top two dose treatment plates were counted manually because the dark colour of the test article prevented accurate automated counting.
PRECIPITATION
No precipitation of test agent was observed following any of the dose treatments in either the presence or absence of S9.
Any other information on results incl. tables
Summary of mean revertant colonies (-S9) - Experiment I
TA 98 | TA 100 | TA 1535 | TA 1537 | TA 1538 | |
Dimethyl formamide 100 µl | 55± 9 | 117±15 | 21±4 | 22±5 | 18±4 |
Test item 0.32 µg/plate | 57 ± 10 | 104±15 | 25±14 | 17±5 | 15±4 |
Test item 1.6 µg/plate | 46 ± 2 | 106±10 | 19±2 | 17±4 | 18±4 |
Test item 8 µg/plate | 50 ± 8 | 105±9 | 23±6 | 17±3 | 15±2 |
Test item 40 µg/plate | 49 ± 7 | 91±25 | 13±6 | 19±9 | 15±4 |
Test item 200 µg/plate | 38 ± 3 (M) | 31±4 (M) | 12±2 (M) | 2±1 (M) | 14±4 (M) |
Test item 1000 µg/plate | 35 ± 7 (M) | 53±4 (M) | 15±4 (M) | -- (T) | 15±2 (M) |
2-Nitrofluorene 5 µg | 345 ± 36 | - | - | - | 147±8 |
Sodium azide 2 µg | - | 739±6 | 552±25 | - | - |
9-Aminoacridine 50 µg | - | - | - | 133±28 | - |
(M) Plates counted manually
Summary of mean revertant colonies (+S9) - Experiment I
TA 98 | TA 100 | TA 1535 | TA 1537 | TA 1538 | |
Dimethyl formamide 100 µl | 62±9 | 116±12 | 21±7 | 19±4 | 21±3 |
Test item 0.32 µg/plate | 58±8 | 121±6 | 20±5 | 19±2 | 24±7 |
Test item 1.6 µg/plate | 66±7 | 119±16 | 22±3 | 18±2 | 29±2 |
Test item 8 µg/plate | 56±11 | 102±13 | 24±10 | 18±3 | 27±3 |
Test item 40 µg/plate | 61±4 | 111±3 | 20±4 | 15±2 | 33±3 |
Test item 200 µg/plate | 41±6 (M) | 118±11 (M) | 16±6 (M) | 14±3 (M) | 25±5 (M) |
Test item 1000 µg/plate | 48±4 (M) | 110±2 (M) | 14±2 (M) | 13±5 (M) | 25±3 (M) |
Benzo[a]pyrene 10 µg | 226±45 | - | - | - | - |
2-Aminoanthracene 5 µ | - | 2203±45 | 209±3 | 533±69 | 680±6 |
(M) Plates counted manually
Applicant's summary and conclusion
- Conclusions:
- The test item did not induce mutation in Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 1538 under the conditions employed.
- Executive summary:
Microbial metabolic activation test was conducted to assess the potential mutagenic effect of the test item, using Salmonella typhimurium TA 1535, TA 1537, TA 1538, TA 100 and TA 98 strains. Dimethyl formamide was used as solvent. The substance was tested at the concentrations of 0.32, 1.6, 8, 40, 200 and 1000 µg/plate. Adequate positive controls were also assayed.
When the data from Experiment I were analysed at the 1 % level using Dunnett's test, a statistically signifrcant increase in revertant numbers was observed following TA 1538 treatments in the presence of S9. This increase showed little evidence of a dose-response and was therefore not considered to be indicative of test item mutagenic activity in this strain under the treatment condition. No statistically significant increases in revertant numbers were observed following any other treatments in this study.
Toxicity ranging from a thinning of the background bacterial lawn to a complete killing of the test bacteria was observed following the top two dose treatments of TA 1537 in the absence of S9.
No precipitation of test agent was observed following any of the dose treatments in either the presence or absence of S9.
Conclusion
It was concluded that test item did not induce mutation in Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 1538 under the conditions employed in this screening study.
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