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EC number: 295-442-6
CAS number: 92045-60-8
A complex combination of hydrocarbons obtained by subjecting a petroleum naphtha to a sweetening process to convert mercaptans or to remove acidic impurities. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C5, predominantly C5, and boiling in the range of approximately minus 10°C to 35°C (14°F to 95°F).
Carcinogenicity - NOEL, 0.5 ml. Chronic dermal application of blended gasoline did not significantly change the incidence of liver hemangiomas, lung adenomas, or of malignant lymphomas in treated animals compared to negative and historical controls.
Carcinogenicity - NOEL, 292 ppm (~1400 mg/m3). Male rat kidney tumors and female mouse liver tumors were observed following chronic inhalation exposure (OECD TG 453). If these effects are discounted as not being relevant to humans, NOAEL is 2056 (~10,000 mg/m3).
toxicity studies were conducted by standard procedures and under good
laboratory practice guidelines. The
majority of the mechanistic data have been published in the open
literature. No further testing for carcinogenic potential is necessary. With
respect to regulatory purposes, one important question relates to the
relevance of data on “wholly vaporized gasoline” to humans who are
exposed predominantly to the more volatile constituents. This
is particularly important in assessing the significance of the female
mouse liver tumors as they were apparently the consequence of increased
metabolic activity in the liver. The
substances that have the largest effects on metabolism are the higher
boiling aromatic constituents that constitute a very small fraction of
gasoline vapor but a much more substantial fraction of wholly vaporized
analogous situation pertains to the kidney tumors in male rats. The
constituents that are the most potent inducers of tumors of this type
are high molecular weight isoparaffins which are present in wholly
vaporized gasoline but not gasoline vapor. Considering
the questions about the relevance of the various tumor types produced,
as well as questions relating to the exposure conditions, it seems more
appropriate to rely on data from gasoline vapor studies than the data
from wholly vaporized gasoline for human health risk assessment. As
the volatile fraction of gasoline has not been tested in chronic
studies, the results of repeated dose and developmental and reproductive
toxicity studies of gasoline "light ends" should be used as the basis
for risk assessment. According
to EU CLP Regulation (EC No. 1272/2008), the data do not support
classification of gasoline per se for carcinogenic potential, although
there is a regulatory requirement to classify as carcinogenic gasoline
and naphtha streams containing > 0.1% benzene.
The animal data indicate that gasoline
exposure by inhalation at high levels can produce kidney tumors in male
rats and liver tumors in female mice. There
is also evidence that some of the naphtha streams can produce skin
tumors following repeated dermal application. The
mechanistic data suggest that both the male rat kidney tumors and the
female mouse liver tumors were the consequence of promotional processes. The
male rat kidney tumors were the consequence of a process that does not
occur in humans, and, therefore, are not relevant to human risk
mouse liver tumors may have been the consequence of a hormonal imbalance
although there is no direct evidence that that was the case. Nevertheless,
the absence of such tumors in female rats or of male rats or mice brings
into question the direct relevance of these tumors to humans. The
overall no adverse effect level was 292 ppm (or approximately 1400 mg/m3).
However, if the kidney and liver tumors are discounted as not being
relevant to humans, the overall NOAEL is 2056 ppm or approximately
The mechanism of skin tumor induction by
"low boiling," petroleum-derived materials i.e., gasoline and distillate
fuel-range materials has been under investigation for some time. It
has been suggested that these skin tumors could be the result of a
promotional process secondary to repeated skin injury (e.g., McKee et
al., 1989). In
support of that hypothesis, Nessel et al., (1998; 1999) have shown that
when irritation is ameliorated by dilution in a non-irritating carrier,
tumors do not develop. Further,
as discussed in section 7.6 Genetic Toxicity, the genetic toxicity data
for gasoline and naphtha blending stocks suggest that mutagenicity does
not play a role in tumor development. Thus
it seems most likely that the low levels of dermal tumors associated
with repeated application of some of the naphtha blending stocks are the
consequence of repeated irritation and/or skin injury acting via a
promotional process on pre-existing, spontaneously initiated cells
(Przygoda et al., 1994). Thus, skin
tumors could be avoided by the use of good industrial hygiene practice
to avoid excessive skin contact.
Justification for selection of carcinogenicity via inhalation route endpoint:
well conducted chronic inhalation study with many follow-up mechanistic studies
Justification for selection of carcinogenicity via dermal route endpoint:
one of many long-term skin painting studies with low boiling point naphthas.
Tumours arose due to a non genotoxic mechanism caused by repeated skin damage
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