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The available data and available weight of
evidence demonstrate that the C9-C14 aliphatic, <2% aromatics are highly
unlikely to be carcinogenic and are not classifiable as carcinogens.
These findings do not warrant the
classification of C9-C14 aliphatic, <2% aromatic hydrocarbons as a
carcinogen under the Regulation (EC) 1272/2008 on classification,
labeling and packaging of substances and mixtures (CLP) or under the
Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC
The weight of evidence is derived from study
records reported for the C9-C14 aliphatic, <2% aromatics. C9-C14
aliphatic, <2% aromatics are not genotoxic and are not classifiable as
mutagens based upon the results of reliablein vitroandin vivostudies.
In bacterial reverse mutation studies, the C9-C14 aliphatic, <2%
aromatics were not mutagenic in the presence or absence of metabolic
activation (IUCLID section 7.6.1). In mammalian cellsin vitro,
and in ratsin vivothere were no mutagenic, clastenogenic or
aneugenic effects reported in read-across from studies on C9-C14
aliphatic, <2% aromatics: a negative chromosome aberration (Human
Periferal Lymphocyte Chromosomal Aberration Test, Chinese Hamster Ovary
Sister Chromatid Exchange Assay); and anin vivoinhalation
exposure bone marrow chromosomal aberration study and micronucleus test
(IUCLID sections 7.6.1 and 7.6.2).
Stoddard solvent IIC – There was no evidence
of carcinogenic activity of Stoddard solvent IIC in female F344/N rats
or in B6C3F1 male mice exposed to 2200 mg/m3. The NTP
concluded there was equivocal evidence of carcinogenic activity of
Stoddard solvent IIC in female B6C3F1 mice based on increased incidences
of hepatocellular adenoma. The NOAEC for male rats was determined to be
138 mg/m3. The incidences of benign
pheochromocytoma in 550 and 1100 mg/m3male rats and benign or
malignant pheochromocytoma exceeded the historical chamber control
ranges, suggesting that exposure to Stoddard solvent IIC caused the
increased incidences of these adrenal medulla neoplasms. The incidence
of malignant pheochromocytoma was noted as 1 malignant tumor in control
animals and 2 malignant tumors in 1100 mg/m3 male rats. However, the
adrenal pheochromocytoma are not considered relevant to humans. The
relevance of the pheochromocytoma in humans is equivocal at best. The
increased incidences of adrenal pheochromocytoma that occurred in male
rats are rarely observed in humans and other animals (Nyska et al.,
1999; Hartwig 2009). Pheochromocytomas that occur in animals by
secondary mechanisms are not considered to be releant to humans or
should be used as a basis for classification (Hartwig, 2009).
Decalin - There was no evidence of
carcinogenic activity of decalin in female F344/N rats or in B6C3F1 male
mice exposed to 400 ppm. Male rats exposed to 50 ppm of decalin had
higher rates of tumors of the kidney. These male rat kidney tumors
appears to have been associated with an alpha-2u-globulin mediated
metabolism. This mechanism is specific to male rats and is not relevant
to humans. Female mice displayed increases in liver and uterus tumors
however, because the highest neoplasm incidence increase occurred in 25
ppm females, there was not a significant response in the 100 ppm group,
and there were no supporting increases in neoplasm multiplicity, it was
unclear if the increased neoplasm incidences in females were related to
decalin. In the absence of an exposure concentration related response in
either sex, the hepatocarcinogenic effect of decalin in female mice was
considered an equivocal finding.
Skin tumor promotion - Evidence of increased
tumor promotion was observed in the skin of mice treated with PMA
(positive control, 29/30) or with 100% v/v normal paraffin test material
(15/30). The skin tumors were predominately of epithelial origin and
were papillomas, keratoacanthomas and squamous-cell carcinomas. These
tumors were generally well- differentiated with the exception of a few
of the squamous-cell carcinomas which were anaplastic with some
spindle-cell formations. Early studies that examine structurally
analogous test materials, kerosene and jet fuels, were noted to promoter
dermal tumors in mice. It was noted that tumor development was
associated with moderate to severe skin irritation. Since the materials
contain very low or no polycyclic aromatic components (PAC’s), it was
suggested that tumor development may have resulted from chronic skin
irritation. Therefore, a series of studies were conducted to examine the
effect of skin irritation on the tumorigenicity of kerosene. In studies
conducted by the American Petroleum Institute (API) and CONCAWE, the
absence of skin irritation resulted in no statistically significant
differences in tumorigenicity between control animals and animals
treated with the test materials (Nessel, Craig S., James J. Freeman,
Richard C. Forgash, and Richard H. McKee 1999; CONCAWE 1991)).
Accordingly, it was concluded that the tumors were the consequence of
repeated dermal irritation and not kerosene or jet fuel per se.
Similar findings were noted in the tests of
normal paraffins. The tumor promotion activity was
greatest in the treated groups displaying the highest degree of dermal
irritation, i.e. 100% v/v normal paraffin test material. A low tumor
incidence occurred in the groups receiving 50% or 28.6% /v normal
paraffin test material (not statistically different from the control
group), which correlated to low degrees of dermal irritation. The skin
tumor promoting properties of these substances are considered related to
repeated dermal irritation (Nessel, 1999).
Hartwig, Greim H, A
Reuter, U Richter-Reichhelm HB ,Thielmann HW. Chemically induced
pheochromocytomas in rats: mechanisms and relevance for human risk
assessment. Crit Rev Toxicol 2009;39(8):695-718.
Nessel, Craig S., James J. Freeman, Richard
C. Forgash, and Richard H. McKee. 1999. The Role of Dermal Irritation in
the Skin Tumor Promoting Activity of Petroleum Middle Distillates. Toxicological
Sciences 49, 48-55 (1999).
Nyska, A., Haseman, J.K., Hailey, J.R.,
Smetana, S., and Maronpot, R.R. (1999). The association between severe
nephropathy and pheochromocytoma in the male F344 rat - the National
Toxicology Program experience. Toxicol. Pathol. 27, 456-462.
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