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EC number: 237-167-6 | CAS number: 13676-91-0
- Life Cycle description
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
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- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- Toxicological Summary
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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:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- (only four strains were tested)
- GLP compliance:
- no
- Remarks:
- (quality assurance statement was provided)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,8-bis(phenylthio)anthraquinone
- EC Number:
- 237-167-6
- EC Name:
- 1,8-bis(phenylthio)anthraquinone
- Cas Number:
- 13676-91-0
- Molecular formula:
- C26H16O2S2
- IUPAC Name:
- 1,8-bis(phenylsulfanyl)-9,10-dihydroanthracene-9,10-dione
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): TK 13 076 (ORACET Gelb GHS)
- Analytical purity: Commercial grade
- Lot/batch No.: EN 63279.32
- Expiration date of the lot/batch: Ensured by sponsor
- Stability under test conditions: Ensured by sponsor
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: EN 63279.32
Method
- Target gene:
- Histidine gene
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 20, 80, 320, 1280 and 5120 µg/0.1 mL
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Dimethylformamide (DMF)
- Justification for choice of solvent/vehicle: The test substance was soluble in DMF.
Controlsopen allclose all
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: daunorubicin-HCl
- Remarks:
- (for strain TA 98 without metabolic activation)
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- (for strain TA 100 without metabolic activation)
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: N-methyl-N'-nitro-N-nitrosoguanidine
- Remarks:
- (for strain TA 1535 without metabolic activation)
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: 9(5)aminoacridine hydrochloride
- Remarks:
- (for strain TA 1537 without metabolic activation)
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- (for strain TA 1535 with metabolic activation)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
Each Petri dish contained:
1) approx. 20 mL of minimum agar (Vogel-Bonner Medium E) and glucose,
2) 0.1 mL of the solution of the test substance or the vehicle and 0.1 mL of a bacterial culture in 2.0 mL of soft agar.
The soft agar was composed of: 100 mL of 0.6 % agar solution with 0.6% NaCl and 10 mL of a solution of 1-histidine, 0.5 mM and +biotin 0.5 mM. In the experiments in which the substance was metabolically activated, 0.5 mL of an activation mixture was added also. 1 mL activation mixture contained: 0.3 mL S9 fraction of liver from rats (Tif:RAIf(SPF)) induced with Aroclor 1254 and 0.7 mL of a solution of cofactors. In the experiments without and with the addition of microsomal activation mixture three Petri dishes were prepared per strain and per group (i.e. per concentration or per control group). The plates were incubated for about 48 h at 37±1.5⁰C in darkness. - Evaluation criteria:
- When the colonies had been counted, the arithmetic mean was calculated. The test substance is generally considered to be non-mutagenic if the colony count in relation to the negative control is not doubled at any concentration.
- Statistics:
- no data
Results and discussion
Test resultsopen allclose all
- 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
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- 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
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- 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
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- 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
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- In the experiments performed without and with microsomal activation, comparison of the number of histidine-prototrophic mutants in the controls and after treatment with the test substance revealed no marked differences. At the concentrations of 320 µg/0.1 mL and above the substance precipitated in soft agar.
Applicant's summary and conclusion
- Conclusions:
- The test substance was not considered to be mutagenic in the Salmonella typhimurium reverse mutation assay.
- Executive summary:
The test substance (of commercial grade purity) was tested for mutagenic effects on histidine auxotrophic mutants of Salmonella typhimurium in compliance/equivalent to OECD 471 with deviation, i.e. only four strains were tested. The investigations were performed on strains TA 98, TA 100, TA 1535 and TA 1537 with and without microsomal activation at 20, 80, 320, 1280 and 5120 µg/0.1 mL. In order to confirm the results, the experiments were repeated. In the experiments performed with and without microsomal activation, comparison of the number of back-mutant colonies in the controls and the cultures treated with the various concentrations of the test substance revealed no marked deviations. At 320 µg/0.1 mL and above, the substance precipitated in soft agar. Under the study conditions, the test substance was not considered to be mutagenic in the Salmonella typhimurium reverse mutation assay.
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