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EC number: 500-451-8 | CAS number: 160901-14-4
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study to then current Guideline and subject to GLP audit.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
Materials and methods
Test guideline
- Qualifier:
- according 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:
- Rosin, maleated
- EC Number:
- 232-480-4
- EC Name:
- Rosin, maleated
- Cas Number:
- 8050-28-0
- Molecular formula:
- Not applicable as the substance is a UVCB
- IUPAC Name:
- Rosin, maleated
- Details on test material:
- - Name of test material (as cited in study report): rosin maleated
- Substance type: chemically modified UVCB
- Physical state: solid
- Analytical purity:100%
- Purity test date:Certificate of analysis dated 15 April 1991
- Lot/batch No.: 05991041.9
- Stability under test conditions:assumed stable
- Storage condition of test material: room temperature in original container
- Other: Trade name Dynakoll VS 50M; 15.5% maleated
Constituent 1
Method
- Target gene:
- His
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:
- Aroclor 1254 induced rat liver S-9
- Test concentrations with justification for top dose:
- 50, 158, 500, 1580, 5000 mcg
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle:substance soluble in it
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation);
DURATION
- Exposure duration: 2 days
NUMBER OF REPLICATIONS:two independant assays, triplicate plates - Evaluation criteria:
- Increase in number of revertants
- Statistics:
- Mean and standard deviation
Results and discussion
Test 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:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Negative with and without metabolic activation
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Positive controls (sodium azide, 2 -aminoanthracene, 9 -aminoacridine, 2 -nitrofluorene, benzo(a)pyrene
gave the expected responseApplicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
Based on an absence of genotoxic/mutagenic effects in a bacterial reverse mutation test with Salmonella typhimurium strains TA 98, TA 100, TA 1535 or TA 1537, with or without metabolic activation, rosin, maleated is not classifiable for Germ Cell Mutagenicity according to Directive 67/548/EEC, the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) or the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008. - Executive summary:
In a reverse gene mutation assay in bacteria, strains TA1535, TA1537, TA98, and TA100 of S. typhimurium were exposed to rosin, maleated (CAS 8050-20-28) in ethanol at concentrations of 50, 158, 500, 1580, 5000 mcg in the presence and absence of mammalian metabolic activation using the plate-incorporation method.
Rosin, maleated was tested up to limit concentrations, and cytotoxicity was not reported. Based on the test conditions used in this study, rosin, maleated was not found to be mutagenic with or without metabolic activation regardless of strain or dose.The positive controls induced the appropriate responses in the corresponding strains.
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