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Key in vitro mutagenicity data is available for Resin acids and rosin acids, manganese salts(CAS# 9008-34-8). This data is provided in addition to key and supporting data available for other members of the category 'Rosins and their salts'.

In a key bacterial reverse mutation assay (BASF, 2017), the test material (CAS# 9008-34-8; purity 83%) was tested in Salmonella typhimurium strainsTA 1535,TA 1537,TA 98,TA 100 and Escherichia coli strain WP2 at concentrationsof 0; 33; 100; 333; 1000; 3200 and 6400 μg/plate in an acetone vehicle in the presence and absence of metabolic activation (±S9). Solvent controls were used in the study along with positive controls 2-aminoanthracene (2-AA); N-methyl-N'-nitro-N-nitrosoguanidine (MNNG); 4-nitro-o-phenylenediamine (NOPD); 9-aminoacridine (AAC); and 4-nitroquinoline-N-oxide (4-NQO).

 

The test material was not mutagenic under the experimental conditions of this Ames test.

The above in vitro mutagenicity data for Resin acids and rosin acids, manganese salts (CAS# 9008-34-8) is consistent with the genotoxicity information available for other members of the category Rosins and their salts, that are 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).

The following information on genotoxicity in mammalian cells in vitro is available for rosin:

Mammalian chromosomal aberrations

Rosin dissolved in THF has been evaluated for its potential to induce structural chromosomal aberrations in human lymphocytes in vitro (Harlan Cytotest Cell Research GmbH, 2010a). The test was run using two independent experiments, with two parallel cultures analysed per study. Per culture, 100 metaphase plates were scored for structural chromosomal aberrations. The highest applied concentration in this study (3500.0 µg/mL of the test item) was chosen with regard to the solubility properties of the test item and with respect to the current OECD Guideline 473. Dose selection of the cytogenetic experiment was performed considering the toxicity data and the occurrence of test item precipitation in accordance with OECD Guideline 473. In Experiment 1 in the absence and presence of S9 mix, no cytotoxicity was observed up to the highest evaluated concentration. However, in the presence of S9 mix, the highest applied concentration showed clear cytotoxic effects, but was not evaluable for cytogenetic damage. In Experiment 2 in the absence of S9 mix, cytotoxicity was observed at the highest evaluated concentration. In the presence of S9 mix, no cytotoxicity was observed up to the highest applied concentration. In both independent experiments, neither a statistically significant nor a biologically relevant increase in the number of cells carrying structural chromosomal aberrations was observed after treatment with the test item. No evidence of an increase in polyploid metaphases was noticed after treatment with the test item as compared to the control cultures. An appropriate response (statistically significant increases (p < 0.05) in cells with structural chromosomal aberrations) was obtained with the positive controls.

Mammalian cell mutation

The mutagenic potential of Rosin has also been evaluated in a mouse lymphoma assay using the L5178Y mouse lymphoma cell line (Harlan Laboratories Ltd, 2010k). The method used met the requirements of the OECD (476) and EU Method B17. Two independent experiments were performed, with the maximum dose level limited by test material induced toxicity (Experiment 1: 2.5 to 40 µg/mL in the absence of metabolic activation, 10 to 80 µg/mL in the presence of metabolic activation. Experiment 2: 2.5 to 45 µg/mL in the absence of metabolic activation, 10 to 55 µg/mL in the presence of metabolic activation). 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.


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