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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Adequate information exists to characterise the genetic toxicity of Rosin Esters.

1) In vitro bacterial reverse mutation assay (OECD 471) - Negative

2) In vitro mammalian gene mutation assay (mouse lymphoma; OECD 476) - Negative

3) In vitro chromosome aberration assay (OECD 473) - Negative

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Adequate information exists to characterise the genetic toxicity of Rosin Esters.

Bacterial mutation in vitro:

In the bacterial reverse gene mutation assay on Resin acids and rosin acids, hydrogenated, Me esters, conducted according to OECD Guideline 471, there was no increase in cytotoxicity or mutation frequency in E. coli or any strain of Salmonella typhimurium at concentrations up to 5000 ug/plate in the presence or absence of metabolic activation (Inveresk Research, 2001f). The two highest concentrations tested caused precipitation of the test substance but no cytotoxicity or increase in mutant colonies over background.

In a reverse gene mutation assay in bacteria, strains TA 98, TA 100, TA 1535, TA 1537, and TA 1538 of S. typhimurium were exposed to PC 12-99 (Resin acids and Rosin acids, esters with pentaerythritol) in DMSO at concentrations of 100, 333, 1000, 3333, and 10000 µg per plate in the presence and absence of mammalian metabolic activation using the plate incorporation method (Pharmakon International Research Inc., 1989d). There was no evidence of an increase in induced mutant colonies over background with the test substance at any concentration tested, while the positive controls induced the appropriate responses in the corresponding strains.

In a reverse gene mutation assay in bacteria, strains TA 98, TA 100, TA 1535 and TA 1537 of S. typhimurium were exposed to Zonester® 25 (Resin acids and rosin acids, esters with diethylene glycol) in acetone at concentrations of 0, 50, 150, 500, 1500, and 5000 µg/plate in the presence and absence of mammalian metabolic activation using the direct plate incorporation method (Safepharm Laboratories Ltd, 1997d). At the highest concentration tested, a precipitate was observed, but this did not affect the scoring of revertant colonies. There was no evidence of an increase in induced mutant colonies over background with the test substance at any concentration tested, while the positive and vehicle controls induced the appropriate responses in the corresponding strains.

In an OECD Guideline 471, bacterial reverse mutation assay (Envigo Research Limited, 2017d), the mutagenicity of Resin acids and Rosin acids, esters with trimethylolpropane was determined usingSalmonella Typhimurium strains TA98, TA100, TA1535 and TA1537 and E.coli strain Wp2uvrA. Based on the results of the study, Resin acids and Rosin acids, esters with trimethylolpropane was considered to be non-mutagenic to the bacterial strains tested.

Mammalian mutagenicity in vitro:

In a mammalian cell mutation test (Harlan Laboratories Ltd, 2010a), the mutagenic potential of Resin acids and rosin acids, hydrogenated, Me esters, toward the thymidine kinase locus of L5178Y mouse lymphoma cells was determined according to OECD Guideline 476. The test material did not induce any toxicologically significant dose-related increases in the mutant frequency at dose levels up to 40-60 ug/ml either in the absence or presence of metabolic activation.

In an in vitro mammalian gene mutation assay, L5178Y mouse lymphoma cells were exposed to Resin acids and rosin acids, esters with pentaerythritol in the absence and in the presence of exogenous metabolic activation (Harlan Laboratories, 2009a). The experiment was perfomed twice, initially using a dose range of 39.06 to 625 µg/mL followed by 39.06 to 1250 µg/mL in the second study. A satisfactory response was obtained with the vehicle (solvent) controls and the positive control materials.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. Resin acids and rosin acids, esters with pentaerythritol, was non-mutagenic to L5178Y cells under the conditions of the test.

Mammalian cytogenicity in vitro:

In the mammalian in vitro chromosome aberration assay using Resin acids and rosin acids, hydrogenated, Me esters (Inveresk Research, 2001g), conducted according to OECD Guideline 473, there was no increase in chromosome aberrations or polyploidy in Chinese Hamster Ovary cells tested at concentrations up to 40 ug/mL in the presence and absence of metabolic activation, even at dose levels that caused cytotoxicity. In all studies, the vehicle and positive controls induced the appropriate responses.

In an in vitro cytogenetics assay (Harlan Laboratories, 2011a), cultures of human lymphocytes were exposed to 0, 2.5, 5, 10, 20, 40 and 80 ug/mL Resin acids and rosin acids, esters with pentaerythritol. Three treatment conditions were used for the study, i. e. 4 hours exposure in the absence of metabolic activation (S9) with a 20 hour expression period, 4 hours in the presence of S9, at a 2% final concentration with cell harvest after a 20 hour expression period and a 24 hour continuous exposure in the absence of S9. Duplicate cultures were evaluated for chromosome alterations at three dose levels, together with vehicle and positive controls which responded within the expected ranges. The test article was non-toxic and did not induce any statistically significant increases in the frequency of cells with aberrations. Resin acids and rosin acids, esters with pentaerythritol was non-clastogenic to human lymphocytes in vitro.


Justification for selection of genetic toxicity endpoint
Information is available on the genotoxic potential of Rosin esters when tested in bacterial (Resin acids and rosin acids, hydrogenated, Me esters, Resin acids and rosin acids, esters with diethylene glycol, Resin acids and Rosin acids, esters with pentaerythritol) and mammalian (Resin acids and rosin acids, hydrogenated, Me esters and Resin acids and rosin acids, esters with pentaerythritol) systems. The results demonstrate that Rosin esters are not mutagenic or clastogenic in vitro.

Short description of key information:
Not mutagenic or clastogenic in bacterial and/or mammalian cells in vitro.

Endpoint Conclusion: No adverse effect observed (negative)

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 orUN Globally Harmonized System of Classification and Labelling of Chemicals (GHS).