Registration Dossier
Registration Dossier
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EC number: 248-778-2 | CAS number: 28016-00-4
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:
- 21-01-2014 to 06-02-2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: study according to the guideline under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
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)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Zinc bis(dinonylnaphthalenesulphonate)
- EC Number:
- 248-778-2
- EC Name:
- Zinc bis(dinonylnaphthalenesulphonate)
- Cas Number:
- 28016-00-4
- Molecular formula:
- Zn[C28H43O3S]2
- IUPAC Name:
- Zinc bis(di C8-C10, branched, C9 rich, alkylnaphthalenesulphonate))
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Name Zinc bis(di C8-C10, branched, C9 rich, alkylnaphthalene sulphonic acid)
Storage Store tightly sealed original container in a cool, dry place away from any direct source of heat, light and moisture
Constituent 1
Method
- Target gene:
- Histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: LT2, TA 1535, TA 97a, TA 98, TA 100 and TA 102
- Details on mammalian cell type (if applicable):
- TA97a: hisD6610, uvrB, pKM 101, rfa
TA 98: hisD3052, uvrB, pKM 101, rfa
TA 100: hisG46, uvrB, pKM 101, rfa
TA102: hisG428, pKM 101, rfa
TA1535 : hisG46, uvrB, rfa.
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 produced from the livers of male Sprague-Dawley rats which were treated with 500 mg Aroclor 1254/kg body weight ip (rTinova Biochem. Gießen (Batch no. 3067)
- Test concentrations with justification for top dose:
- exp 1: 0.050, 0.150, 0.500, 1.500 and 5.000 mg/plate.
exp 2 (TA 100 and TA 102): 0.016, 0.032, 0.125, 0.250 and 0.500 mg/plate
exp 3 (TA97a, TA 98 and TA 1535): 0.016, 0.032, 0.125, 0.250 and 0.500 mg/plate - Vehicle / solvent:
- - Vehicle used: ethanol
- Justification for choice of solvent/vehicle: the test substance was sufficiently soluble, and no effects on the viability of the bacteria or the number of spontaneous revertants are expected.
Controls
- Untreated negative controls:
- yes
- Remarks:
- DMSO (positive control solvent)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- yes
- Remarks:
- H2O
- Positive controls:
- yes
- Remarks:
- without metabolic activarion TA 97a, TA98 and TA102 : 4-Nitro-1,2-phenylene diamine; TA 1535 and TA 100 : Sodium azide ; with metabolic activation TA 97a, TA 100, TA 102 and TA 1535 : Aminoanthracene ; TA98: Benzo-a-pyrene
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- other: 4-Nitro-1,2-phenylene diamine, aminoanthracene
- Details on test system and experimental conditions:
- Cell cultures: Salmonella typhimurium (all strains used) were obtained from TRINOVA BioChem
METHOD OF APPLICATION: in medium; exp 1 preincubation; exp 2 and 3 in agar (plate incorporation)
DURATION
- Preincubation period (exp 1): 20 min
- Exposure duration: 48 h at 37 °C
SELECTION AGENT (mutation assays): histidine
CELL COUNT: visually
NUMBER OF REPLICATIONS: 4 per strain and concentration
NUMBER OF CELLS: titre determined to be 1.5E09 to 3.5E09 cells/mL - Evaluation criteria:
- positive when: significant, reproducible increase of revertant colonies per plate (increase factor > 2) in at least one strain. A concentration-related increase over the range tested can also be taken as a sign of mutagenic activity .
biological relevance is taken into account first - Statistics:
- none performed
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:
- at 1500 and 5000 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 97a
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 1500 and 5000 ug/plate
- Vehicle controls validity:
- valid
- 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:
- at 1500 and 5000 ug/plate
- Vehicle controls validity:
- valid
- 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:
- at 1500 and 5000 ug/plate
- Vehicle controls validity:
- valid
- 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:
- at 1500 and 5000 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test substance did not induce mutations in 5 strains of Salmonella typhimurium both in presence and absence of metabolic activation - Executive summary:
The test substance was tested in a plate incorporation and pre-incubation assay in Salmonella thypimurium strains TA100, TA102, TA97a, TA 98 and TA 1535 in presence and absence of metabolic activation. No mutagenic effects were seen in three experiments. The number of revertant colonies was not increased in comparison with the spontaneous revertants. Therefore the test substance is considered not mutagenic under the test conditions.
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