Reaction Product of Rosin, fumarated, Tall-Oil Rosin, Ca(OH)2 and MgO

Endpoint summary

Additional information

Ca-/Mg-salt of Fumarated Tall Oil Rosin was tested in the Ames test (S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102) according to OECD TG 471 and GLP using test concentrations up to 5000 µg/plate dissolved in ethylene glycol dimethylether (EGDE) in the presence and in the absence of a metabolic activation system (S9 -mix). Evidence of mutagenic activity of Ca-/Mg-salt of Fumarated Tall Oil Resin was not seen. No biological relevant increase in the mutant count, in comparison to the negative controls, was observed in any of the strains tested, with and without S9-mix, in the plate incorporation as well as in the preincubation modification, under the experimental conditions applied (Bayer HealthCare 2011).

Additional evidence for no effects of the substance concerning genetic toxicity is given in supporting studies with different study designs:

Bacterial cell mutation

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, 2010b). 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.

Mammalian chromosomal aberrations

In a mammalian cell gene mutation assay, Chinese hamster ovary cells cultured in vitro were exposed to rosin, fumarated in DMSO (Inveresk, 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 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 4‑hour exposure group in the presence of metabolic activation (1% S9) and a 24‑hour 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.

Short description of key information:
Ca-/Mg-salt of Fumarated Tall Oil Rosin was tested in the Ames test (S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102) according to OECD TG 471 and GLP using test concentrations up to 5000 µg/plate dissolved in ethylene glycol dimethylether (EGDE) in the presence and in the absence of a metabolic activation system (S9 -mix). Evidence of mutagenic activity of Ca-/Mg-salt of Fumarated Tall Oil Resin was not seen.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available data no classification or labelling is required.