Registration Dossier
Registration Dossier
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EC number: 402-010-4 | CAS number: 4463-59-6
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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- only two strains were used for the experiments
- Deviations:
- yes
- Remarks:
- only two strains were used for the experiments
- Principles of method if other than guideline:
- only two strains were used for the experiments
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial forward mutation assay
Test material
- Reference substance name:
- 1-(2-bromoethoxy)-2-methoxybenzene
- EC Number:
- 402-010-4
- EC Name:
- 1-(2-bromoethoxy)-2-methoxybenzene
- Cas Number:
- 4463-59-6
- Molecular formula:
- C9H11BrO2
- IUPAC Name:
- 1-(2-bromoethoxy)-2-methoxybenzene
- Details on test material:
- - Name of test material (as cited in study report): Carvedilol 5th intermediate (Bromoethoxy-guaiacol)
- Physical state: reddish brown crystalline powder
- Lot/batch No.: 9803
- Expiration date of the lot/batch: June 2001
- Storage condition of test material: at room temperature
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: CAR-593
- Expiration date of the lot/batch:december 2017
- Purity test date: december 2016
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in a well-closed vial between 2-8 °C
Method
- Target gene:
- GC
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- post-mitochondrial fraction S9
- Test concentrations with justification for top dose:
- 50, 160, 500, 1000, 1600, 3200, 5000
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- other: 4-Nitro-1,2-phenylenediamine, NPD
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar
DURATION
- Preincubation period: 11-14 hours
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: 2
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- 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
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: no mutagen potential
Applicant's summary and conclusion
- Conclusions:
- The reported data of this mutagenicity assay show that under the experimental conditions applied, the test item as direct acting mutagen compound and its metabolized forms induced gene mutations by base pair substitutions and in the genome of the Salmonella typhimurium TA100 tester strain. No positive effect was seen in the performed experiments in S. typhimurium TA98 (±S9 Mix).
In conclusion, the test item Bromethoxy-qvajacol (CVD 21) has mutagenic activity on Salmonella typhimurium TA100 carrying base-pair substitution in the absence and presence of exogenous metabolic activation, under the test conditions used in this study.
Unless results originated from in vivo and other in vitro mutagenicity assays, based on the results of the present bacterial reverse mutation assay the test item could be considered (categorized) as a Category 2 mutagen
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