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EC number: 946-888-1 | CAS number: -
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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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- other company data
- 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 143
- IUPAC Name:
- Acid Red 143
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 (S-9)
- Test concentrations with justification for top dose:
- Range Finder Experiment and Experiment 1: 1.6, 8, 40, 200, 1000 and 5000 µg/plate, with and without metabolic activation
- Vehicle / solvent:
- - Vehicle: sterile purified water.
Controls
- Untreated negative 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- When the data from the Range-Finder Experiment were analysed at the 1 % level using Dunnett's test a statistically significant increase in revertant numbers was observed following TA 100 treatments in the presence of S-9. As this increase was small in magnitude and was observed at the lowest dose treatment, this was not considered to be indicative of test item mutagenic activity in this strain under this treatment condition. No other test item treatments induced statistically significant increases in revertant numbers, when the data were analysed at the 1 % level using Dunnett's test.
TOXICITY
No clear evidence of toxicity, as manifest by a marked decrease in revertant numbers or a thinning of the background bacterial lawn was observed following the any of the dose treatments in any of the strains in the presence or the absence of S-9.
PRECIPITATION
No precipitation of test agent was observed following any of the treatments in either the presence or absence of S-9.
Any other information on results incl. tables
Summary of mean revertant colonies (-S9) - Experiment 1
Dose Level µg/plate | TA 98 | TA 100 | TA 1535 | TA 1537 | TA 1538 |
Water | 36± 5 | 117± 12 | 13± 1 | 15± 2 | 19± 6 |
Test item 1.6 | 41± 9 | 118± 7 | 10± 5 | 13± 4 | 18± 5 |
Test item 8 | 32± 10 | 132± 12 | 9± 1 | 16± 2 | 17± 7 |
Test item 40 | 39± 4 | 122± 1 | 13± 1 | 9± 1 | 17± 2 |
Test item 200 | 42± 7 (M) | 116± 3 | 13± 3 (M) | 12± 5 (M) | 14± 4 (M) |
Test item 1000 | 43± 7 (M) | 110± 11 (M) | 8± 2 (M) | 12± 4 (M) | 20± 3 (M) |
Test item 5000 | 36± 2 (M) | 94± 9 (M) | 11± 6 (M) | 12± 2 (M) | 18± 7 (M) |
2-Nitrofluorene 5 | 664± 35 | 338± 25 | |||
Sodium azide 2 | 763± 22 | 443± 18 | |||
9-Aminoacridine 50 | 136± 23 |
(M) Plates counted manually
Summary of mean revertant colonies (+S9) - Experiment 1
Dose Level µg/plate | TA 98 | TA 100 | TA 1535 | TA 1537 | TA 1538 |
Water | 40± 5 | 171± 15 | 14± 3 | 13± 4 | 27± 4 |
Test item 1.6 | 39± 5 | 209± 17 | 10± 2 | 15± 2 | 32± 3 |
Test item 8 | 49± 6 | 168± 20 | 18± 1 | 17± 6 | 22± 6 |
Test item 40 | 49± 7 | 185± 4 | 22± 7 | 12± 2 | 24± 8 |
Test item 200 | 40± 6 | 156± 8 | 17± 2 | 15± 2 (M) | 25± 6 (M) |
Test item 1000 | 44± 2 (M) | 118± 12 (M) | 16± 4 (M) | 13± 6 (M) | 23± 6 (M) |
Test item 5000 | 37± 4 (M) | 107± 14 (M) | 9± 5 (M) | 17± 1 (M) | 26± 1 (M) |
Benzo[a]pyrene 10 | 247± 35 | ||||
2-Aminoanthracene 5 | 1831± 55 | 164± 17 | 358± 44 | 961± 46 |
(M) Plates counted manually
Applicant's summary and conclusion
- Conclusions:
- It was concluded that test item did not induce mutation in Salmonella typhimurium strains TA 98, TA l00, TA l535, TA 1537 and TA 1538 under the conditions employed in the screening study.
- Executive summary:
A screening study was conducted on test substance to determine reverse mutation in five histidine-requiring strains of Salmonella typhimuium. The strains tested were TA 98, TA 100, TA 1535, TA 1537 and TA 1538. Both the range finder experiment and experiment 1 were conducted at the concentrations of 1.6, 8, 40, 200, 1000 and 5000 µg/plate, with and without metabolic activation.
When the data from the Range-Finder Experiment were analysed at the 1 % level using Dunnett's test a statistically significant increase in revertant numbers was observed following TA 100 treatments in the presence of S9. As this increase was small in magnitude and was observed at the lowest dose treatment, this was not considered to be indicative of test item mutagenic activity in this strain under this treatment condition. No other test item treatments induced statistically significant increases in revertant numbers, when the data were analysed at the 1 % level using Dunnett's test.
No clear evidence of toxicity, as manifest by a marked decrease in revertant numbers or a thinning of the background bacterial lawn was observed following the any of the dose treatments in any of the strains in the presence or the absence of S9.
No precipitation of test agent was observed following any of the 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 l00, TA l535, TA 1537 and TA 1538 under the conditions employed in the screening study.
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