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EC number: 232-476-2
CAS number: 8050-15-5
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 417, 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.
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
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.
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
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