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EC number: 456-900-2 | CAS number: 51285-81-5 GADOLINIUMSULFIT-TRIHYDRAT
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- 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
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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:
- 19 February 2003 - 27 May 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Gadoliniumsulfite trihydrate
- EC Number:
- 456-900-2
- EC Name:
- Gadoliniumsulfite trihydrate
- Cas Number:
- 51285-81-5
- Molecular formula:
- Gd2(SO3)3*3H2O
- IUPAC Name:
- digadolinium(3+) trihydrate trisulfite
- Test material form:
- solid: particulate/powder
- Details on test material:
- Off white, crystalline powder
Batch number FSG 3896 or 02-FW-095
Constituent 1
Method
- Target gene:
- TA 98 (his D 3052, uvrB, rfa + R-factor)
TA 100 (his G 46, uvrB, rfa + R-factor)
TA 102 (his G 428, rfa + R-factor)
TA 1535 (his G 46, uvrB, rfa)
TA 1537 (his C 3076, uvrB, rfa)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Details on mammalian cell type (if applicable):
- The Salmonella strains TA 98, TA 100, and TA 1535 were obtained from B.
N. Ames, University of Berkeley, California, USA, on August 15, 1985. Salmonella
typhimurium TA 102 was obtained from B. Diener, Institute of Toxicology,
University of Mainz, Germany, on June 24, 1992. Salmonella strain
TA 1537 was obtained from J. Hengstler, Institute of Toxicology, University
ofMainz, Germany, on December 8, 2000.
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- Escherichia coli WP2 uvrA was distributed by the National Collections of Industrial
& Marine Bacteria Ltd., Aberdeen, Scotland (NCIMB 11188 from
Aug. 18, 1977) and obtained from H. Träger, Knall AG, Ludwigshafen, Germany,
on December 23, 1994.
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- 5.00, 15.8, 50.0, 158, 500, 1580 and 5000 µg per plate
The test material concentrations used were selected according to the EEC and OECD guidelines for this test system and the requirements ofthe Labor Ministry ofJapan. If the test material is soluble in the solvent of choice it should be investigated in the first experimental series at seven concentrations, separated by half-log intervals (i.e. a factor of root 10), ranging from 5 to 5000 µg per plate. In the second experimental series, usually 5 concentrations including at least 4 nontoxic concentrations should be tested. Signs of toxicity to the bacteria are a reduction in the number of spontaneaus revertants or a clearing of background lawn of non-revertant bacteria. Precipitation of the test material, if it occurs, should not interfere with scoring of the colonies. Depending upon the precipitation characteristics of the test material and toxicity data ascertained in the first series, high concentrations may be omitted or lower concentrations may additionally be tested in the second experimental series. - Vehicle / solvent:
- 0.5n HCl for the highest testmaterial concentration further diluted with distilled water for the next lower concentrations.
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- cumene hydroperoxide
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- Preparation of bacteria suspension
Fresh suspensions of the tester strains were prepared for each day's experiments. For each strain, 100 mL Standard I Nutrient Broth were inoculated by 500 µg/L of a frozen permanent culture and incubated overnight in a + 37°C shaking incubator. For the Refactor strains, ampicillin was added to the nutrient broth (25 µg/mL). S. typhimurium TA 102 was incubated overnight in the presence of 200 µg tetracycline per 100 mL nutrient broth. Cell density of the overnight cultures was checked by measuring the optical density of the cell suspensions and corrected if necessary. The suspensions were then maintained at ice-bath temperature until use.
Technique for testing
Salmonella typhimurium and Escherichia coli strains were tested in accordance with the plate incorporation method described by Ames et al. (1975) and the OECD and EEC guidelines for this test system. The methods were extensively harmonized to follow the requirements of the Labor Ministry of Japan - Notification dated June 13, 1979 and the Notification No. 1-24 of the Pharmaceutical Affairs bureau, Ministry of Health and Welfare, dated September 11, 1989.
Number of plates used:
3 parallel plates were used for each concentration step of the test material and the positive controls. Twice as many solvent control plates were used for each bacterial strain.
Type of plates used:
Commercially available Glucose-Agar plates were used for all strains except for S. typhimurium strain TA 102. Forthat strain, Minimal-Glucose plates were self-plated using DIFCO Agar (DIFCO 0140-01).
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- Toxicity to the bacteria was observed at the highest concentration tested, i.e. 5000 µg/plate.
- Cytotoxicity / choice of top concentrations:
- 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
- Remarks:
- Toxicity to the bacteria was observed at the highest concentration tested, i.e. 5000 ug/plate.
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- With and without addition of S9 mix as the external metabolizing system Gadoliniumsulfite trihydrate was not mutagenic under the experimental conditions described.
- Executive summary:
The investigations for mutagenic potential were performed using Salmonella typhimurium tester strains TA 98, TA 100, TA 102, TA 1535 and TA 1537, and Escherichia coli WP2 uvrA. The plate incorporation test with and without addition of liver S9 mix from Aroclor 1254-pretreated ratswas used. Two independent experimental series were performed. In the two series with S9 mix, 10 % and 30 % S9 in the S9 mix were used in the 1st and 2nd series, respectively. For the highest testmaterial concentration, Gadoliniumsulfite trihydrate was dissolved in 0.5n HCl, and it was further diluted with distilled water for the next lower concentrations. It was tested at concentrations ranging from 5.00 to 5000 µg/plate. Precipitation of the test material on the agar plates occurred at concentrations >= 1580 µg/plate or at 5000 µg/plate, depending upon the experimental condition. Taxicity to the bacteria was observed at the highest concentration tested, i.e. 5000 µg/plate. Daunomycin, N-ethyl-N'-nitro-N-nitrosoguanidine, 9-aminoacridine and cumene hydroperoxide served as strain specific positive control test materials in the absence of S9 mix. 2-Aminoanthracene and benzo[a]pyrene were used for testing the bacteria and the activity of the S9 mix. Each treatment with the test materials used as positive controls led to a clear increase in revertant colonies, thus, showing the expected reversion properties of all strains and good metabolic activity ofthe S9 mix used. With and without addition of S9 mix as the external metabolizing system, Gadoliniumsulfite trihydrate was not mutagenic under the experimental conditions described.
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