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EC number: 293-625-5 | CAS number: 91081-22-0
- 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
- Study period:
- 30-04-2014 to 26-05-2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to the guidelines, under GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Salmonella typhimurium: histidine
E-coli: tryptophan - Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 from rats induced with Phenobarbitone/ß-Naphthoflavone
- Test concentrations with justification for top dose:
- plate incorporation (test 1): 1.5, 5. 15, 50, 150, 500, 1500 and 5000 ug/plate
pre-incubation assay (tet 2): 50, 150, 500, 1500 and 5000 ug/plate - Vehicle / solvent:
- acetone
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- Positive controls:
- yes
- Remarks:
- for TA100, TA1535 and WP2uvrA without metabolic activation
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- Positive controls:
- yes
- Remarks:
- for TA100, TA1535, TA 1537 and WP2uvrA with metabolic activation
- Positive control substance:
- other: 2-aminoanthracene
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- Positive controls:
- yes
- Remarks:
- for TA98 without metabolic acivation
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- Positive controls:
- yes
- Remarks:
- for TA98 with metabolic activation
- Positive control substance:
- benzo(a)pyrene
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- Positive controls:
- yes
- Remarks:
- for TA1537 without metabolic activation
- Positive control substance:
- 9-aminoacridine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: 1st test in agar (plate incorporation); 2nd test preincubation
DURATION
- Preincubation period: 20 min at 37°C
- Exposure duration: 48 hours at 37°C
NUMBER OF REPLICATIONS: 3/concentration
DETERMINATION OF CYTOTOXICITY
- Method: growth rate bacterial bachground lawn
COLONY COUNT:
Domino colony counter - Evaluation criteria:
- A test item will be considered mutagenic (positive) in the test system if one or more of these criteria are met
1. A dose-related increase in mutant frequency over the dose range tested (De Serres and Shelby (1979)).
2. A reproducible increase at one or more concentrations.
3. Biological relevance against in-house historical control ranges.
4. Statistical analysis of data as determined by UKEMS (Mahon et al (1989)).
5. Fold increase greater than two times the concurrent solvent control for any tester strain (especially if accompanied by an out-of-historical range response). - Statistics:
- Not specified according to UKEMS
- 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, but tested up to precipitating concentrations
- Remarks:
- film at 5000 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- film at 5000 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative without metabolic activation
negative with metabolic activation
The test substance did not induce mutations (base-pair substitution and frame-shift type) in Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537 as well as in E. coli WP2 uvr A both in presence and absence of metabolic activation. - Executive summary:
The test substance was tested in an Ames test at concentrations upto the preciptation level (5000 ug/plate). In a plate incorporation and a pre-incubation assay (both performed in triplicate), the test substance did not induce mutations (base-pair substitution and frame-shift type) in Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537, as well as in E. coli WP2 uvr A both in presence and absence of metabolic activation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Genetic toxicity in bacteria
Resin acids and rosin acids, fumarated, compds. with triethanolamine was tested in an Ames test at concentrations up to the
precipitation level (5000 ug/plate) (Harlan 2014). In a plate incorporation and a pre-incubation assay (both performed in triplicate), the test substance did not induce mutations (base-pair substitution and frame-shift type) in Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537, as well as in E. coli WP2 uvr A both in presence and absence of metabolic activation.
In a bacterial reverse point mutation Ames test with Salmonella typhimurium TA98, TA100, TA1535, and TA1537 and Escherichia coli WP2uvrA conducted according to GLP and OECD 471, Rosin, fumarated was negative in increasing the number of revertant colonies when tested at 17, 50, 167, 500, 1667, and 5000 ug/plate with and without metabolic activation system from liver of rats treated with Aroclor 1254 (Stevenson, 2001).
In a bacterial reverse point mutation Ames test with Salmonella typhimurium TA98, TA100, TA1535, and TA1537 conducted according to GLP and OECD 471, Rosin, fumarated was negative in increasing the number of revertant colonies when tested at 50, 158, 500, 1580, 500 ug/mL3 with and without metabolic activation (May, 1991).
Mammalian chromosomal aberrations in vitro
In a mammalian cell gene mutation assay conducted in accordance with GLP and OECD 473, Chinese hamster ovary cells cultured in vitro were exposed to Rosin, fumarated in DMSO (Murie, 2002). The following concentrations were tested: 10, 20, and 40 ug/mL, +S9, for Test 1; 39, 78, and 156 ug/mL, -S9, for Test 1; 30, 40 and 50 ug/mL, +S9, for Test 2; 80, 95, and 110 ug/mL, -S9, for Test 2 at the 24-hour harvest; 40, 80, and 120 ug/mL, -S9, for Test 2 at 48-hour harvest. Rosin, fumarated did not show clastogenic effects under the conditions of the study, both in the presence and absence of activation system.
Mammalian gene-cell mutation
A study conducted with Rosin, fumarated evaluated the potential mutagenicity of the test material on the thymidine kinase, TK +/-, locus of the L5178Y mouse lymphoma cell line (Flanders, 2010). The method used meets the requirements of the OECD (476) and Method B17 of Commission Regulation (EC) No. 440/2008 of 30 May 2008. Two independent experiments were performed. In Experiment 1, L5178Y TK +/- 3.7.2c mouse lymphoma cells (heterozygous at the thymidine kinase locus) were treated with the test material at eight dose levels, in duplicate, together with vehicle (solvent) and positive controls using 4-hour exposure groups both in the absence and presence of metabolic activation (2% S9). In Experiment 2, the cells were treated with the test material at up to ten dose levels using a 4hour exposure group in the presence of metabolic activation (1% S9) and a 24hour exposure group in the absence of metabolic activation. The dose range for the first experiment was 2.5 to 80 µg/ml in the absence of metabolic activation, and 5 to 160 µg/ml in the presence of metabolic activation. For the second experiment the dose range was 5 to 80 µg/ml in the absence of metabolic activation, and 5 to 120 µg/ml in the presence of metabolic activation. The maximum dose level used in the mutagenicity test was limited by test material induced toxicity. Precipitate of test material was not observed at any of the dose levels in the mutagenicity test. The vehicle (solvent) controls had acceptable mutant frequency values that were within the normal range for the L5178Y cell line at the TK +/- locus. The positive control materials induced marked increases in the mutant frequency indicating the satisfactory performance of the test and of the activity of the metabolising system. The test material did not induce any toxicologically significant dose-related increases in the mutant frequency at any dose level, either with or without metabolic activation, in either the first or the second experiment. The test material was considered to be non-mutagenic to L5178Y cells under the conditions of the test.
The overall data on the mutagenic potential of resin acids and rosin acids, fumarated, compds. with triethanolamine do not show
mutagenic or clastogenic activity in bacterial and/or mammalian cells in vitro in tests performed with either the test substance or the component Rosin, fumarated.Justification for selection of genetic toxicity endpoint
study according to the guidelines under GLP with the test substance, which confirms the findings found on components of the UVCB test substance
Justification for classification or non-classification
The available data on genetic toxicity of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.
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