Registration Dossier
Registration Dossier
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EC number: 701-340-9 | CAS number: -
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- OECD guideline 471. GLP study.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Sodium polysulfide aluminosilicate with a SOD-type framework structure
- EC Number:
- 701-340-9
- Molecular formula:
- |Na+6-x+y+z (S2•-)y(S3•-)z|[Al6-x Si6+x O24] - SOD Where: 6 ≤ 6-x+y+z ≤ 8 0 ≤ x ≤ 1.2 1 ≤ y+z ≤ 2
- IUPAC Name:
- Sodium polysulfide aluminosilicate with a SOD-type framework structure
- Test material form:
- solid: particulate/powder
- Details on test material:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Daiichi Kasei Kogyo (Hyogo), lot No. E0311323
- Composition: SiO2: 39.60%, Al2O3: 23.76%, Fe2O3: 0.45%, S: 12.08%, Na2O: 22.59%, unknown: 1.52%.
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- -Identity of media: Center of Japanese Baioatsusi
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- -Identity of media: Center of Japanese Baioatsusi
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 from rat liver
- Test concentrations with justification for top dose:
- Test material dose:
0.50 - 1.50 - 5.00 - 15.00 - 50.00 mg/mL (313, 625, 1250, 2500, 5000 µg/plate)
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water for injection
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- without metabolic activation
- Positive control substance:
- other: 2,2-(2-Furyl)-3-(5-nitro-2fuiyl)acrylamide
- Remarks:
- TA 100, WP2 uvrA- 2,2-(2-Furyl)-3-(5-nitro-2fuiyl)acrylamide: 0.01 µg/plate
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water for injection
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- without metabolic activation
- Positive control substance:
- other: 2,2-(2-Furyl)-3-(5-nitro-2fuiyl)acrylamide
- Remarks:
- TA 98- 2,2-(2-Furyl)-3-(5-nitro-2fuiyl)acrylamide: 0.1 µg/plate
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water for injection
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- without metabolic activation
- Positive control substance:
- sodium azide
- Remarks:
- TA 1535- sodium azide: 0.5µg/plate
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water for injection
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA 1537- 9-aminoacridine: 80µg/plate Migrated to IUCLID6: without metabolic activation
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water for injection
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- with metabolic activation
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- TA 100 - 2-Aminoanthracene: 1µg/plate
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water for injection
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- with metabolic activation
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- TA 1535, TA 1537- 2-Aminoanthracene: 2µg/plate
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water for injection
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- with metabolic activation
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- WP2 uvrA- 2-Aminoanthracene: 10 µg/plate
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water for injection
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- with metabolic activation
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- TA 98- 2-Aminoanthracene: 0.5 µg/plate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium made of minimal glucose agar
DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 hours
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- The result was that the test material is not mutagenic (negative).
- Executive summary:
The aim of the test was to assess the potential of test material to induce a point mutation at the histidine-requiring gene locus in strains of Salmonella typhimurium and E.coli.
The test procedure used was the OECD guideline 471.
Test material doses were: 0.50 - 1.50 - 5.00 - 15.00 - 50.00 mg/mL
The result was that the test material is not mutagenic.
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