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EC number: 616-307-3 | CAS number: 76205-19-1
Toxicological information
Genetic toxicity: in vitro
Currently viewing:
Administrative data
- Endpoint:
- genetic toxicity in vitro
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 616-307-3
- EC Number:
- 616-307-3
- Cas Number:
- 76205-19-1
- Molecular formula:
- C9 H7 Cl N2 O
- IUPAC Name:
- 616-307-3
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: L83-44-2
- Purity: 97,6%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Refrigerator
- Solubility and stability of the test substance in the solvent/vehicle:
The stability of the test substance at room temperature in the vehicle DMSO over a period of
4 hours was verified analytically.
Method
Species / strain
- 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:
- liver S9 mix from induced rats
- Test concentrations with justification for top dose:
- 1st Experiment: 0; 33; 100; 333; 1 000; 2 600 and 5 200 μg/plate
due to the purity of the test substance 5.2 mg/plate was used as top dose in the first experiment (standard plate test)
2nd Experiment (preincubation test): 0; 10; 33; 100; 333; 1 000 and 2 600 μg/plate
A 2nd experiment was performed because no mutagenicity was observed in the standard plate test. - Vehicle / solvent:
- DMSO; The substance was not soluble in ultrapure water.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- sterility control; without the addition of tester strains
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (2-AA); with S9 mix; for all tester strains
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylenediamine (NOPD) (w/o S9 mix; for strain TA 98)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
1st Experiment: in agar (plate incorporation); 2nd Experiment: preincubation;
DURATION
- Preincubation period: about 20 minutes (Experiment 2)
- Exposure duration: 48 – 72 hours
NUMBER OF REPLICATIONS:
3 test plates per dose or per control
DETERMINATION OF CYTOTOXICITY
Toxicity detected by a
• decrease in the number of revertants
• clearing or diminution of the background lawn (= reduced his- or trp- background growth)
• reduction in the titer
was recorded for all test groups both with and without S9 mix in all experiments
- Any supplementary information relevant to cytotoxicity:
Precipitation of the test material was recorded. As long as precipitation did not interfere with the colony scoring, 5 mg/plate was generally selected and
analyzed (in cases of nontoxic compounds) as the maximum dose at least in the 1st Experiment even in the case of relatively insoluble test compounds to detect possible mutagenic impurities. - Evaluation criteria:
- The test substance is considered positive in this assay if the following criteria are met:
• A dose-related and reproducible increase in the number of revertant colonies, i.e. about doubling of the spontaneous mutation rate in at least one tester strain either without S9 mix or after adding a metabolizing system.
A test substance is generally considered non-mutagenic in this test if:
• The number of revertants for all tester strains were within the historical negative control range under all experimental conditions in at least two experiments carried out independently of each other.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Remarks:
- Plate incorporation
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A bacteriotoxic effect was observed from 1 000 μg/plate onward with and without S9 mix. Test substance precipitation was found from 2 600 μg/plate onward with and without S9 mix.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Remarks:
- Plate incorporation
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A bacteriotoxic effect was observed from 1 000 μg/plate onward with and without S9 mix. Test substance precipitation was found from 2 600 μg/plate onward with and without S9 mix.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Remarks:
- Plate incorporation
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A bacteriotoxic effect was observed from 1 000 μg/plate onward with and without S9 mix. Test substance precipitation was found from 2 600 μg/plate onward with and without S9 mix.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Remarks:
- Plate incorporation
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A bacteriotoxic effect was observed from 2 600 μg/plate onward with and without S9 mix. Test substance precipitation was found from 2 600 μg/plate onward with and without S9 mix.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Remarks:
- Plate incorporation
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A bacteriotoxic effect was observed from 1 000 μg/plate onward with and without S9 mix. Test substance precipitation was found from 2 600 μg/plate onward with and without S9 mix.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Remarks:
- Preincubation test
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A bacteriotoxic effect was observed from 1 000 μg/plate onward with and without S9 mix. Test substance precipitation was found from 2 600 μg/plate onward with and without S9 mix.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Remarks:
- Preincubation
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A bacteriotoxic effect was observed from 1 000 μg/plate onward with and without S9 mix. Test substance precipitation was found from 2 600 μg/plate onward with and without S9 mix.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Remarks:
- Preincubation
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A bacteriotoxic effect was observed from 1 000 μg/plate onward with and without S9 mix. Test substance precipitation was found from 2 600 μg/plate onward with and without S9 mix.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Remarks:
- Preincubation
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A bacteriotoxic effect was observed from 1 000 μg/plate onward with and without S9 mix. Test substance precipitation was found from 2 600 μg/plate onward with and without S9 mix.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Remarks:
- Preincubation
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A bacteriotoxic effect was observed from 1 000 μg/plate onward with and without S9 mix. Test substance precipitation was found from 2 600 μg/plate onward with and without S9 mix.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Precipitation of the test substance was found from 2 600 μg/plate onward with and without S9 mix.
A bacteriotoxic effect was observed depending on the strain and test conditions from about 1 000 μg/plate onward.
Applicant's summary and conclusion
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