Registration Dossier
Registration Dossier
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EC number: 220-562-2 | CAS number: 2814-77-9
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
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1-[(2-chloro-4-nitrophenyl)azo]-2-naphthol
- EC Number:
- 220-562-2
- EC Name:
- 1-[(2-chloro-4-nitrophenyl)azo]-2-naphthol
- Cas Number:
- 2814-77-9
- Molecular formula:
- C16H10ClN3O3
- IUPAC Name:
- 1-[(2-chloro-4-nitrophenyl)diazenyl]-2-naphthol
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- E. coli WP2 uvr A
- Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- S. typhimurium TA 1537
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9-mix
- Test concentrations with justification for top dose:
- Experiment I (including the additional experiment with strain TA 98): 3; 10; 33; 100; 333; 1000; 2500; and 5000 ug/plate.
Experiment II: 33; 100; 333; 1000; 2500; and 5000 ug/plate
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:
positive with metabolic activation
Under the experimental conditions reported, the test item induced gene mutations by frameshifts in the genome of the strain TA 98 in the presence of metabolic activation. Therefore, C.I Pigment Red 4 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 C.I. Pigment Red 4 to induce gene mutations according to the plate incorporation assay with rat liver S9 (experiment I), and the pre-incubation test with hamster liver S9 (experiment II) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 and the Escherichia coli strain WP2 uvrA.
The assay was performed in two complete experiments with and without liver microsomal activation and one additional experiment solely with strain TA 98 in the presence of metabolic activation. The results of the additional experiment are reported as part of experiment I. Each concentration, including the controls, was tested in triplicate. The test item was tested at the following concentrations:
Experiment I (including the additional experiment with strain TA 98): 3; 10; 33; 100; 333; 1000; 2500; and 5000mg/plate.
Experiment II: 33; 100; 333; 1000; 2500; and 5000mg/plate
The plates incubated with the test item showed normal background growth up to 5000mg/plate with and without metabolic activation in bath independent experiments.
No toxic effects, evident as a reduction in the number of revertants, occurred in the test groups with and without metabolic activation. No substantial increase in revertant colony numbers was observed following treatment with C.I Pigment Red 4 at any dose level, neither in the presence nor absence of metabolic activation (S9 mix) in strains TA 1535, TA 1537, TA 100, and WP2 uvrA. However, a substantial increase was observed in strain TA 98 in the presence of metabolic activation in both independent experiments. The required threshold of two times the mutation frequency of the corresponding solvent control was well exceeded at concentrations as low as 3mg/plate in experiment I and 33mg/plate in experiment II. To verify the results of experiment I, an additional plate incorporation test was performed with strain TA 98 in the presence of metabolic activation. In this additional experiment the result of the first experiment was confirmed.
Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.
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