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EC number: 285-547-5
CAS number: 85116-93-4
In vitro genotoxicity:
In an Ames test, Salmonella typhimurium
strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100 were treated with
the test substance, Fatty acids, C16-18, esters with pentaerythritol
(CAS No. 85116-93-4) diluted in Tween 80 according to OECD Guideline 471
(Key, Cognis, Banduhn, 1991, Ames, RL2).Test
substance concentrations of 0, 8, 40, 200, 1000 and 5000 µg/plate were
tested in triplicate, both with and without the addition of a rat liver
homogenate metabolising system (S9). Precipitation of the test substance
was observed at and above 1000 µg/plate. The test material caused no
cytotoxicity up to the highest, precipitating dose. No significant
increases in the frequency of revertant colonies were recorded for any
of the bacterial strains, with any dose of the test material, either
with or without metabolic activation.
No other studies on the genotoxicity of
the test substance were available; therefore data
of a study from structural analogues, conducted according to OECD
Guideline 473 (In Vitro
Mammalian Chromosome Aberration Test),
and OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test) were
used for read-across.
An in vitro mammalian chromosome
aberration test was performed with CAS No. 131459-39-7
(3,5,5-trimethylhexanoic acid mixed tetraesters with PE and valeric
acid) in human lymphocytes (RA-S,
CAS 131459-39-7, Key, Croda, Wright, 1999, ChrAb, human, RL1).The
occurrence of chromosome aberrations was investigated in the presence
and absence of metabolic activation (rat liver S9-mix) with test
substance concentrations of 0, 312.5, 625, 1250, 2500, 5000 µg/mL
diluted with acetone. The test substance did not induce a significant
increase in the number of metaphases with aberrations at any preparation
time and dose level. No relevant cytotoxic effects were reported.
Precipitation of the test substance was observed at and above 1250
µg/ml. Positive controls significantly increased the rate of chromosome
aberrations indicating the sensitivity of the assay. In conclusion, the
test substance did not induce chromosome aberrations in human
lymphocytes, neither in the presence nor in the absence of a
metabolic activation system, under these experimental conditions.
An in vitro Mammalian Cell Gene
Mutation Test was conducted with CAS No. 85186-89-6 (Fatty acids, C8-18
and C18-unsatd., esters with trimethylolpropane) according to OECD
Guideline 476. Mouse lymphoma L5178Y cells were
dosed with 0.3, 1, 3, 10, 33, 100, 333 and 750 µg/ml
with and without metabolic
activation. No signs of toxicity were observed, DMSO was used as
vehicle, precipitation was observed at and above 100 µg/ml. There was no
significant increase in the number of forward
mutations at the thymidine kinase locus of L5178Y mouse lymphoma cells
treated with the test material, indicated by the total number of
colonies per plate (RA-S,
CAS 85186-89-6, Key, Croda, Verspeek-Rip, 2010, gene mut in mamm cells,
In vivo genotoxicity:
No in vivo studies on the
genotoxicity of the test substance were available.Fatty
acids, C5-10, esters with pentaerythritol (CAS No. 68424-31-7) were
found to be not genotoxic in the micronucleus assay in vivo after
maximum tolerated dose (MTD),
5000 mg/kg (obtained by a pretest with a single intraperitoneal
injection without severe reactions of the animals) was applied. No
increase in the incidence of micro-nucleated polychromatic erythrocytes
in any sex or at any time point in mice treated with 5000 mg/kg bw of
the test substance, except for a small but significant decrease of
polychromatic erythrocytes in male mice at 5000 mg/kg bw. Therefore no
clastogenic potential could be detected in this test (RA-S, CAS
68424-31-7, Key, Croda, Griffiths, 1992, CTL/P/3792, Micronuc.).
Considering the clearly negative
results of the available in vitro study together with the
negative in vitro and in vivo experiments used as
read-across and the proven physiological metabolism of fatty acids and
excretion of polyols, it can be assumed that fatty
acids, C16-18, esters with pentaerythritol (CAS No. 85116-93-4) are
not genotoxic, neither in vitro nor in vivo.
According to the DSD and CLP criteria
for classification and labelling of dangerous substances the CAS
No. 85116-93-4 (Fatty acids, C16-18, esters with pentaerythritol) is
not classified as mutagenic.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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