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Diss Factsheets
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EC number: 469-110-8 | CAS number: -
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 February - 20 February 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was performed according to OECD and EC guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Details on test material:
- - Name of test material (as cited in study report): AD-1000
- Substance type: white powder
- Physical state: powder
- Storage condition of test material: at room temperature in the dark
Constituent 1
Method
- Target gene:
- Histidine gene in S. typhimurium
Tryptophan gene in E. coli
Species / strain
- Species / strain / cell type:
- bacteria, other: Salmonella typhimurium (TA1535, TA1537, TA100 and TA98) and Escherichia coli (WP2uvrA).
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9-mix induced by a combination of phenobarbital and ß-naphthoflavone.
- Test concentrations with justification for top dose:
- Dose range finding test: 3, 10, 33, 100, 333, 1000, 3330 and 5000 µg/plate in the absence and presence of S9-mix
Concentration range in the main test (with metabolic activation): 3, 10, 33, 100, 333, 1000 µg/plate
Concentration range in the main test (without metabolic activation): 3, 10, 33, 100, 333, 1000 µg/plate - Vehicle / solvent:
- Solvent: Dimethyl sulfoxide
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- dimethyl sulfoxide
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide (SA) 5µg in Saline for TA1535
- Remarks:
- Without metabolic activation
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Without metabolic activation
Migrated to IUCLID6: 60 µg in Milli-Q water for TA1537
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- Without metabolic activation
Migrated to IUCLID6: 10 µg in DMSO for TA98
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- Without metabolic activation
Migrated to IUCLID6: 650 µg in DMSO for TA100
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- Without metabolic activation
Migrated to IUCLID6: 10 µg in DMSO for WP2uvrA
- Positive control substance:
- other: 2-aminoanthracene (5 and/or 10%) for all strains
- Remarks:
- With metabolic activation
- Details on test system and experimental conditions:
- Concentration of the test substance resulting in precipitation: 100 µg/plate
METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48h
NUMBER OF REPLICATIONS: doses of the test substance were tested in triplicate in each strain. Two independent experiments were
conducted.
OTHER EXAMINATIONS:
precipitation of test substance - Evaluation criteria:
- No formal hypothesis testing was done.
A test substance is considered negative (not mutagenic) in the test if:
a) The total number of revertants in any tester strain at any concentration is not greater than two times the solvent control value, with or without metabolic activation.
b) The negative response should be reproducible in at least one independently repeated experiment.
A test substance is considered positive (mutagenic) in the test if:
a) It induces at least a 2-fold, dose related increase in the number of revertants with respect to the number induced by the solvent control in any of the tester strains, either with or without metabolic activation. However, any mean plate count of less than 20 is considered to be not biologically relevant.
b) In case a positive response will be repeated, the positive response should be reproducible in at least one independently repeated experiment.
The preceding criteria were not absolute and other modifying factors might enter into the final evaluation decision.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: Salmonella typhimurium (TA1535, TA1537, TA100 and TA98) and Escherichia coli (WP2uvrA).
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- >=1000 µg/plate
- Species / strain:
- other: Salmonella typhimurium (TA1535, TA1537, TA100 and TA98) and Escherichia coli (WP2uvrA).
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- >= 100 µg/plate
- Additional information on results:
- Observations:
The test substance did not induce a dose-related, two-fold
increase in the number of revertant (His+) colonies in each
of the four tester strains (TA1535, TA1537, TA98 and TA100) and in the number of revertant (Trp+) colonies in tester strain WP2uvrA both in the absence and presence of S9- metabolic activation. These results were confirmed in an independently repeated experiment. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'. Remarks: preliminary test
Any other information on results incl. tables
In the first and second experiment 5% (v/v) and 10% (v/v) S9
-mix was used, resepectively.
In this study, the negative and strain-specific positive
control values were within our laboratory historical control
data ranges indicating that the test conditions were
adequate and that the metabolic activation system functioned properly.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
All bacterial strains showed negative responses over the entire dose range, i.e. no dose-related, two-fold, increase in the number of revertants in two independently repeated experiments.
The negative and strain-specific positive control values were within our laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
Based on the results of this study it is concluded that AD-1000 is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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