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EC number: 287-094-9 | CAS number: 85409-27-4
- 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
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Not mutagenic or clastogenic in bacterial and/or mammalian cells in vitro.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Adequate information exists to characterise the mutagenicity of Rosin Adducts and Rosin Adducts Salts. These are formed when rosin reacts with maleic anhydride (or maleic acid) or fumaric acid yielding a maleated rosin adduct or a fumarated rosin adduct, respectively; the rosin adduct salts are simply the rosin adducts that have been reacted with an appropriate base. The available data includes includes results of tests conducted using Rosin, fumarated; Rosin, maleated; and Rosin, fumarated, reaction products with formaldehyde which are summarised briefly below.
Bacterial cell mutation
In a bacterial reverse point mutation Ames test with Salmonella typhimurium TA98, TA100, TA1535, and TA1537 and Escherichia coli WP2uvrA conducted according to guideline protocols, 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 (Inveresk Research, 2001). Concurrent positive (N-Ethyl-N'-nitro-N-nitrosoguanidine, 9 -aminoacridine, 2 -nitrofluorene, and sodium azide), and negative (solvent) controls were used.
In a bacterial reverse point mutation Ames test with Salmonella typhimurium TA98, TA100, TA1535, and TA1537 conducted according to guideline protocols, 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 (Life Science Research, 1991d).
In a reverse gene mutation assay with Rosin maleated, a negative response was obtained in S typhimurium strains TA1535, TA1537, TA98, and TA100 exposed to concentrations of 50, 158, 500, 1580, 5000 mcg in the presence and absence of mammalian metabolic activation using the plate-incorporation method (Life Science Research, 1991c). 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.
A study conducted with Rosin, fumarated, reaction products with formaldehyde evaluated Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and Escherichia coli strain WP2uvrA- using both the Ames plate incorporation and pre-incubation methods at up to seven dose levels, in triplicate, both with and without the addition of a rat liver homogenate metabolising system (10% liver S9 in standard co-factors) (Harlan Laboratories Ltd, 2010a). The method conforms to OECD Guidelines for Testing of Chemicals No. 471 "Bacterial Reverse Mutation Test", Method B13/14 of Commission Regulation (EC) Number 440/2008 of 30 May 2008 and the USA, EPA (TSCA) OPPTS harmonised guidelines. The dose levels used ranged between 1.5 and 5000 µg/plate, depending on bacterial tester strain type and exposures in the absence or presence of S9-mix. Additional dose levels and an expanded dose range were selected (where applicable) in order to achieve both four non-toxic dose levels and the toxic limit of the test material. No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material, either with or without metabolic activation or exposure method. The test material was considered to be non-mutagenic under the conditions of this test.
Mammalian chromosomal aberrations
In a mammalian cell cytogenetcis assay, Chinese hamster ovary cells cultured in vitro were exposed to Rosin, fumarated in DMSO (Inveresk, 2002d). 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 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
(Harlan Laboratories Ltd, 2010c). 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.
Justification for classification or non-classification
Not classified according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 or UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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