Registration Dossier
Registration Dossier
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EC number: 231-043-5 | CAS number: 7420-89-5
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 17 JUL 2017 to 15 SEP 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- 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:
- Following OECD 471 and EU B.13/14
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Disodium 1,5-dihydroxypentane-1,5-disulphonate
- Cas Number:
- 7420-89-5
- Molecular formula:
- C5H10Na2O8S2
- IUPAC Name:
- Disodium 1,5-dihydroxypentane-1,5-disulphonate
- Reference substance name:
- Sodium sulfate
- Cas Number:
- 7757-82-6
- IUPAC Name:
- Sodium sulfate
- Reference substance name:
- Sodium hydrogen sulfite
- Cas Number:
- 7631-90-5
- IUPAC Name:
- Sodium hydrogen sulfite
Constituent 1
impurity 1
impurity 2
Method
Species / strain
- Species / strain / cell type:
- other: S. typhimurium TA97a, TA98, TA100, TA102, TA1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- 5000 / 1500 / 500 / 150 / 50 µg/plate
If the maximum dose does not show mutagenic effects, the result will be verified with a further experiment using at least five concentrations under variation of the test parameters (pre-incubation method). In this experiment, the highest non-toxic concentration of the initial experiment will be chosen as highest concentration, factor between concentrations will be 2.0. Detailed experimental design lies in the responsibility of the study director and will be described in the final report. If mutagenic effects are observed, a dose-response-relation will be calculated.
Controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- solvent controls: Dimethylsulfoxide for the positive controls nitrophenylendiamine, benzo-a-pyrene and 2-amino-anthracene Demineralised water for the positive control sodium azide. Ethanol for the test item.
- Positive controls:
- yes
- Remarks:
- mutagenic substances as positive controls: Nitrophenylendiamine, 20 µg/plate: strains TA97a, TA98 and TA102 without S9 mix Sodium azide, 1 µg/plate: strains TA100 and TA1535 without S9 mix Benzo-a-pyrene, 20 µg/plate: strain TA9
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Positive controls validity:
- valid
- Species / strain:
- other: S. typhimurium TA97a
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study it is concluded that Glutardialdehyde bisSodiumbisulfite is mutagenic in the Salmonella typhimurium strains TA100 and TA102 in the absence and presence of metabolic activation under the experimental conditions in this study.
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