Registration Dossier
Registration Dossier
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EC number: 242-354-0 | CAS number: 18472-51-0
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
- Study period:
- 2001-12-12 to 2002-03-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
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:
- D-gluconic acid, compound with N,N''-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine (2:1)
- EC Number:
- 242-354-0
- EC Name:
- D-gluconic acid, compound with N,N''-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine (2:1)
- Cas Number:
- 18472-51-0
- Molecular formula:
- C22H30Cl2N10.2C6H12O7
- IUPAC Name:
- N',N'''''-hexane-1,6-diylbis[N-(4-chlorophenyl)(imidodicarbonimidic diamide)] - D-gluconic acid (1:2)
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix (Aroclor 1254-induced rat liver)
- Test concentrations with justification for top dose:
- Plate incorporation test / Preincubation test: 0, 0.1, 0.316, 1, 3.16 and 10 ug/plate (concentrations are referred to the active ingredient).
The top concentration was chosen based on a preliminary test in TA 100 with 10 concentrations ranging from 0.316 - 5000 ug/plate, where pronounced to complete cytotoxicity was observed at >= 10 µg/plate. - Vehicle / solvent:
- The test substance was dissolved in water and added to the incubation assay.
Controls
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: without metabolic activation: sodium azide (TA 1535, TA 100); 2-nitrofluorene (TA 98); 9-aminoacridine (TA 1537); methylmethanesulfonate (TA 102); with metabolic activation: cyclophosphamide (TA 100, TA 1535); 2-anthraceneamide (TA 98, TA 102, TA 1537)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: plate incorporation and preincubation
Preincubation period: Plate incorporation test: none; Preincubation test: 60 min at 37 °C
Plates: 3 per concentration; 2 independent experiments - Evaluation criteria:
- Number of revertants is significantly increased compared to solvent controls to at least 2-fold (TA 98, TA 100, TA 102) and 3-fold (TA 1535, TA 1537) in both independent experiments
- Statistics:
- U-test according to Mann & Whitney
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- plate incorporation test: without S9 mix: at 10 ug/plate; with S9 mix: no cytotoxicity; preincubation test: without S9 mix: all strains at >= 3.16 ug/plate; with S9 mix: at 10 ug/plate
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- plate incorporation test: without S9 mix: at 10 ug/plate; with S9 mix: no cytotoxicity; preincubation test: without S9 mix: >= 3.16 ug/plate
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- plate incorporation test: without S9 mix: at 10 ug/plate; with S9 mix: no cytotoxicity; preincubation test: without S9 mix: >= 3.16 ug/plate; with S9 mix: at 10 ug/plate
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- plate incorporation test: without S9 mix: at 10 ug/plate; with S9 mix: no cytotoxicity; preincubation test: without S9 mix: >= 3.16 ug/plate; with S9 mix: at 10 ug/plate
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- plate incorporation test: without S9 mix: at >= 3.16 ug/plate; with S9 mix: no cytotoxicity; preincubation test: without S9 mix: at >= 3.16 ug/plate; with S9 mix: at 10 ug/plate
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
No evidence for mutagenic activity in the Salmonella typhimurium assay. - Executive summary:
Mutagenicity study (reverse mutation assay) in Salmonella typhimurium according to OECD guideline 471 with plate incorporation test and preincubation test each with and without metabolic activation by S9 mix from Arochlor 1254-induced rat liver. The concentration of the test substance was based on the observations of a preliminary test with strain TA 100 in which pronounced to complete cytotoxicity was observed at >= 10 µg/plate. Under the conditions of the assay where positive controls exerted the expected mutagenic effects, chlorhexidine digluconate caused no mutagenic effect in the Salmonella typhimurium strains TA 98, TA 100, TA 102, TA 1535 and TA 1537 neither in the plate incorporation nor in the preincubation test each carried out with and without metabolic activation.
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