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Diss Factsheets
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EC number: 942-381-4 | 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Link to relevant study records
- 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant guideline study, available as unpublished report, restriction in design (no E.coli WP2 or S.typhimurium TA 102 used and only one positive control used to test efficacy of the S9-mix), but adequate for assessment
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- , no E.coli WP2 or S.typhimurium TA 102 used and only one positive control used to test efficacy of the S9-mix
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- EEC Directive 84/449, B14. Mutageniticy (Salmonella typhimurium - reverse mutation assay)
- Deviations:
- yes
- Remarks:
- , no E.coli WP2 or S.typhimurium TA 102 used and only one positive control used to test efficacy of the S9-mix
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- His-locus
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor-1254 induced rat liver S-9 mix
- Test concentrations with justification for top dose:
- 1st and 2nd experiment: 0, 100, 500, 2500, 5000 µg/plate
3rd experiment: 500, 1000, 1500, 2000 µg/plate - Vehicle / solvent:
- Vehicle used: DMSO
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 2.5 µg/plate
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- All strains tested with metabollic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 5 µg/plate
- Positive control substance:
- other: N-methyl-N'-nitro-N-nitrosoguanidine
- Remarks:
- TA 100, TA 1535; without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 10 µg/plate
- Positive control substance:
- other: 4-nitro-o-phenylendiamine
- Remarks:
- TA 98; without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 100 µg/plate
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA 1537; without metabolic activation
- Details on test system and experimental conditions:
- --> 1st EXPERIMENT
METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS:
- 3 test plates per dose or per control
DETERMINATION OF CYTOTOXICITY
- Method: Reduces his- background growth, decrease in the number of his+ revertants
--> 2nd and 3rd EXPERIMENT
METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
NUMBER OF REPLICATIONS:
- 3 test plates per dose or per control
DETERMINATION OF CYTOTOXICITY
- Method: Reduces his- background growth, decrease in the number of his+ revertants - Evaluation criteria:
- In general, a substance to be characterized as positve in the Ames test has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results - Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- ADDITIONAL INFORMATION ON CYTOTOXICITY:
A bacteriotoxic effect (reduced his- background growth, decrease in the number of his+ revertants) was observed in the standard plate test at doses ≥ 2500 µg/plate. In the preincubation test bacteriotoxicity was observed from about 1000 µg - 1500 µg onward.
TEST-SPECIFIC CONFOUNDING FACTORS
No test substance precipitation was found. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the experimental conditions, it is concluded that the test substance is not a mutagenic substance in the bacterial reverse mutation test in the absence and the presence of metabolic activation. - Executive summary:
The substance was tested for its mutagenic potential, in an OECD 471 guideline study (compliant with GLP), based on the ability to induce back mutation in selected loci in several strains of Salmonella typhimurium (TA 1535, TA 100, TA 1537, TA 98) in the Ames test. Bacteria were exposed to 20 - 5000 μg/plate in a standard plate test and a preincubation test both with and without metabolic activation (Aroclor-induced rat liver S9 mix). No precipitation of the test substance was found. A bacteriotoxic effect was observed at doses ≥ 2500 µg in the standard plate test and from about 1000 - 1500 µg/plate onward in the preincubation assay. An increase in the number of his+ revertants was not observed both in the standard plate test and in the preincubation test either without S-9 mix or after the addition of this metabolizing system. The test substance is not mutagenic in the Ames test under these experimental conditions.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
The substance was tested for its mutagenic potential, in an OECD 471 guideline study (compliant with GLP), based on the ability to induce back mutation in selected loci in several strains of Salmonella typhimurium (TA 1535, TA 100, TA 1537, TA 98) in the Ames test (BASF 1994). Bacteria were exposed to 20 - 5000 μg/plate in a standard plate test and a preincubation test both with and without metabolic activation (Aroclor-induced rat liver S9 mix). No precipitation of the test substance was found. A bacteriotoxic effect was observed at doses ≥ 2500 µg in the standard plate test and from about 1000 - 1500 µg/plate onward in the preincubation assay. An increase in the number of his+ revertants was not observed both in the standard plate test and in the preincubation test either without S-9 mix or after the addition of this metabolizing system. The test substance is not mutagenic in the Ames test under these experimental conditions.
Justification for selection of genetic toxicity endpoint
One genetic toxicity in vitro study is available. This study is adequate for covering this endpoint.
Justification for classification or non-classification
The test substance is non-mutagenic in a bacterial reverse mutation assay. Therefore classification in accordance with EU Directive 67/548 (DSD) and EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008 is not warranted.
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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