Resin acids and Rosin acids, reaction products with formaldehyde, calcium salts

Endpoint summary

Additional information

For testing of mutagenicity in bacteria, the substance was dissolved in DMSO and processed as required by OECD testing guideline 471 (BASF 2012). Five tester strains were used. A slight bacteriotoxic effect was observed at doses exceeding 1 mg per plate.

The substance did not cause an increase in mutant frequency and was found to be non mutagenic.

Rosin dissolved in tetrahydrofuran was evaluated for its potential to induce structural chromosomal aberrations in human lymphocytes in vitro (Harlan 2010). 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 and GLP. 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.

The mutagenic potential of rosin has also been evaluated in a mouse lymphoma assay using the L5178Y mouse lymphoma cell line (Harlan 2010b). The method used met the requirements of the OECD (476) and GLP. 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. For further details on the read-across, it is referred to the end of the CSR (Chapter 11).

Short description of key information:
The substance is not mutagenic in bacteria. The related substance rosin is not mutagenic and clastogenic in mammalian cells in vitro.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for mutagenicity under Directive 67/548/EEC, as amended for the 31st time in Directive2009/2/EG.

 

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for mutagenicity under Regulation (EC) No. 1272/2008, as amended for the third time in Directive (EC 618/2012).