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EC number: 265-058-3
CAS number: 64741-57-7
A complex combination of hydrocarbons produced by the vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and boiling in the range of approximately 350°C to 600°C (662°F to 1112°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
A number of samples of heavy fuel oil components have been tested in both in-vitro and in-vivo tests. Variable results were seen but heavy fuel oil components showed no consistent evidence of mutagenic activity in a range of in vivo and in vitro assays other than in the Ames test.
Additional information from genetic toxicity in vitro:
are available from a number of investigations that have examined the
mutagenicity and genotoxicity of Heavy Fuel Oil Components in vitro and
in vivo using GLP-compliant and/or guideline study designs.
sample of heavy vacuum gas oil was positive in a bacterial mutagenicity
assay (Modified Ames Assay; Mobil, 1986a). The same sample did not cause
chromosomal damage in an in vivo micronucleus assay (Mobil,
1987a). These data do not provide convincing evidence of the
mutagenicity of this material.
Heavy Fuel Oil Components have been tested in eight bacterial
mutagenicity assays (Modified Ames Assay; API, 1986b; Pryzgoda, 1999;
Feuston, 1994) and all but one of the assays was positive, the exception
being visbreaker gas oil (Feuston, 1994). Other studies conducted
included an in vitro mouse lymphoma assay (API, 1985b) which was
positive with metabolic activation but only weakly positive without
metabolic activation, two in vitro mammalian cell gene mutation
assays (using Chinese Hamster Ovary (CHO) cells) one of which was
negative (API, 1985c), while the second was positive in the presence of
Aroclor 1254-induced rat S9 fraction and weakly positive in the absence
of S9 fraction (API, 1985d). Additionally Cracked Heavy Fuel Oil
Components have also been demonstrated to be negative in an in vitro cell
transformation assay (API, 1986c) in the absence and presence of
a supporting study (Verspeek-Rip, 2015), 9 fume condensates of heavy
fuel oils labelled CONCAWE A (01,02,03), CONCAWE-B (01,02,03) and
CONCAWE-C (01,02,03), were examined for mutagenic activity in one
histidine dependent auxotroph of Salmonella typhimurium, strain TA98
using the modified AMES test according to the ASTM Standard Test Method
E 1687. Although some variations in control reproducibility were seen
and issues with infected plates affected some of the results, overall
the samples tested in this assay are judged to have a high probability
of being non-carcinogenic in a mouse skin-painting bio-assay.
in vivo sister chromatid exchange assay (API, 1985e) which tested
catalytic cracked clarified oil was positive with and without metabolic
activation, while the same sample was negative in an in vivo
chromosome aberration test (API, 1985b). A cracked sample has also been
demonstrated to cause unscheduled DNA synthesis in an in vivo study
(API, 1985f). Eight in vivo micronucleus assays have also been
conducted, all but two of which were negative (Pryzgoda, 1999; Mobil,
1990a, 1990b; 1987a, 1986b), while one was weakly positive (Mobil,
1989a), and the other positive (Mobil, 1991a).
has long been recognised that the standard Ames assay is not
sufficiently sensitive, even for petroleum streams that contain
significant levels of 3-7 ring PAC, and this led to the development of
the Modified Ames Assay which was able to identify those materials that
were likely to be carcinogenic in skin painting bioassays. It was
demonstrated further that activity in the Modified Ames assay was
related to the 3-7 ring PAC content and also to the carcinogenic
activity of the petroleum stream. Results from the modified Ames Assays
that have been conducted on the Heavy Fuel Oil Components are therefore
not sufficient alone to demonstrate mutagenic activity.
mixed results from the other in vitro and in vivo studies
do not provide consistent evidence of genotoxic activity and are not
considered sufficient to conclude that heavy fuel oil components should
be classified as mutagenic.
Justification for selection of genetic toxicity endpoint
The mutagenic activity of a number of samples of heavy fuel oil components have been assessed in both in-vitro and in-vivo test systems. Equivocal results were obtained but modified Ames tests gave positive responses in most cases.
The mutagenic potential of Heavy Fuel Oil
Components has been extensively studied in a range of in vivo and in
vitro assays. The majority of the studies showed no consistent
evidence of mutagenic activity, particularly in in-vivo systems, and no
classification is required under the EU
CLP Regulation (EC No. 1272/2008).
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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