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EC number: 265-062-5
CAS number: 64741-60-2
A complex combination of hydrocarbons produced by the distillation of products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C11 through C30 and boiling in the range of approximately 205°C to 450°C (401°F to 842°F). It contains a relatively large proportion of tricyclic aromatic hydrocarbons.
No repeat dose toxicity studies have been identified for cracked gas oils, following inhalation or oral exposure.
The sub-chronic inhalation study of diesel fuel (OECD 413, a read-across study from VGO/HGO/Distillate Fuels) resulted in a conservative sub-chronic NOAEC of 0.88 mg/L determined for local effects on the lung (increased relative wet weight in the absence of histopathological change). A NOAEC of ≥1.71 mg/L was established for systemic effects, based on no significant findings at this level.
In a 28-day sub-acute study (OECD 410), dermal exposure to a light catalytically cracked distillate resulted in limited systemic changes and a NOAEL of 500 mg/kg body weight/day. In a 90-day sub-chronic study (OECD 411), dermal exposure to light catalytically cracked distillate resulted in a systemic NOAEL of 25 mg/kg body weight/day for males, and 125 mg/kg body weight/day for females, based upon reductions in thymus weight. In another 90-day sub-chronic study (OECD 411), dermal exposure to coker light gas oil resulted in a systemic LOAEL of 30 mg/kg body weight/day for males and females, based upon clinical signs and irritation noted at all doses.
dose toxicity studies have been identified for cracked gas oils,
following inhalation or oral exposure.
In a 28-day
sub-acute study, dermal exposure to a light catalytically cracked
distillate resulted in limited systemic changes and a NOAEL of 500 mg/kg
body weight/day. In
a 90-day sub-chronic study, dermal exposure to light catalytically
cracked distillate resulted in a systemic NOAEL of 25 mg/kg body
weight/day for males, and 125 mg/kg body weight/day for females, based
upon reductions in thymus weight and associated histopathology. In
an additional 90-day subchronic study, dermal exposure to coker light
gas oil resulted in changes in some clinical parameters (glucose, ALAT,
calcium), decreased lymphocyte counts and histological alterations in
kidney tissue, as well as marked skin irritation at all doses. No
NOAEL could be determined, so the LOAEL for systemic toxicity from this
study was 30 mg/kg body weight/day.
sub-chronic inhalation study of diesel fuel (a read-across study from
VGO/HGO/Distillate Fuels) resulted in a conservative sub-chronic NOAEC
of 0.88 mg/L determined for local effects on the lung (increased
relative wet weight in the absence of histopathological change). A NOAEC
of ≥1.71 mg/L was established for systemic effects, based on no
significant findings at this level.
from VGO/HGO/Distillate Fuels is justified based on similar
physical/chemical composition and properties to Cracked Gas Oils.
In a 90-day
sub-chronic inhalation toxicity study on diesel fuel (read across from
VGO/HGO/Distillate Fuels), groups of male and female Sprague-Dawley rats
were exposed whole body to 250, 750 or 1500 mg/m3aerosol
(MMAD 0.43-0.75 microns) 4 hour per day, two days per week for 13 weeks
(total of 26 exposures) (analytical concentrations:0.35,
0.88, and 1.71 mg/L) (Lock
et al., 1984). There were no deaths during the exposure phase or during
the 2-month recovery period. Animals were described as inactive during
treatment but no overt clinical signs were present. Body weight was
decreased in both the sham control and the diesel-exposed groups
relative to animal room controls at the start of exposure (that is, when
the animals were first introduced into the chambers). Terminal body
weights (after 25 exposures) were significantly decreased in the groups
of females, relative to the sham controls. Body weights for exposed
males were comparable to the sham control group by the third week of the
recovery period, whereas statistically significant decreases remained in
mid- and high-dose females until recovery weeks 7 and 5, respectively.
demonstrate statistically significant alterations in a number of
parameters (body weight, food consumption, startle reflex, certain lung
function parameters) in rats following sub-chronic inhalation exposure
to diesel aerosol, however the magnitude of these changes was small
suggesting that they are of doubtful biological relevance. Statistically
significant increases in relative liver weight and relative wet lung
weight were observed in animals exposed to 1.71 mg/L (analytical
concentration) diesel aerosol for 13 weeks, however there was no
histopathological involvement, again making the relevance of these
findings unclear. It is noted that the use of whole body exposure
probably resulted in ingestion of the test sample during grooming, and
may account for the systemic findings that were observed. All of the
changes present following 13 weeks exposure were reversed after a
2-month recovery period. A conservative sub-chronic NOAEC of 0.88 mg/mL
is determined for local effects on the lung (increased relative wet
weight in the absence of histopathological change). A NOAEC of ≥ 1.71
mg/L is established for systemic effects, based on no significant
findings at this level.
A key 28
-day sub-acute dermal study was conducted on rats using a light
catalytically cracked distillate (Klimisch score = 1, API 1985).The test
material covered an area of approximately 10% total body surface, under
occlusion in 4 male and 4 female rabbits. A dose-related decrease in
body weight gain was noted in mid-dose and high-dose groups. The test
substance produced a significant 9% decrease in final body weight in
males treated with 500 or 1000 mg/kg body weight/day for 28 days. The
female test animals were unaffected. Draize scores of 2.2, 4.3 and 5.4
recorded at study termination for the low-dose, mid-dose and high-dose
groups, respectively were recorded, which the study authors reported to
be moderate to severe dermal irritation. Microscopic examination of skin
from the test site revealed minimal to moderately severe inflammatory
changes after application of 1000 to 2000 mg/kg body weight/day, with
concurrent increased granulopoiesis in bone marrow from these animals
(lower dose groups not examined). Serum alkaline phosphatase activity
was also decreased by approximately 50-60% in animals treated with one
sample at 2000 mg/kg body weight/day. Based on these limited changes, a
systemic NOAEL of 500 mg/kg body weight/day is derived.
supporting 28-day dermal toxicity study, rats were exposed to FCCU light
cycle oil at dose levels of 0.001 (10% dilution with acetone), 0.01, and
1.0 ml/kg (Klimisch score = 1, ARCO 1992h). No mortality or adverse
effects on body or organ weights were noted. There were no significant
findings in haematology or clinical chemistry of treated animals
compared to sham/vehicle controls. At necropsy, mild to moderate dermal
irritation and/or eschar were observed at the test site in a
dose-dependent manner, and these were the only treatment-related
findings. Under the study conditions, the NOEL was 0.001 ml/kg for males
and less than 0.001 ml/kg for females based on dermal irritation. The
systemic NOEL was determined to be 1.0 ml/kg for males and females.
supporting 28-day dermal toxicity study, rats were exposed to FCC light
cycle oil under semi-occlusive conditions at dose levels of 0.05, 0.5,
or 1.0 ml/kg/day (Klimisch score = 1, ARCO 1991b). Very slight erythema
was observed in male and female animals on day 2 at all dose levels
tested. No dermal irritation was noted in the sham control group. A
statistically significant increase in creatinine levels of the 0.05
mg/kg group females was not considered treatment-related. A
statistically significant increase in relative liver weights in the male
0.5 and 1.0 ml/kg groups was not considered treatment-related or
biologically relevant. Treatment-related pathology included acanthotic
and hyperkarototic epidermal lesions and inflammatory dermal lesions in
the male and female rats dosed with 1.0 ml/kg/day test material.
Dose-related changes in dermal irritation were observed in male and
females rats at 0.05, 0.5, and 1.0 ml/kg/day.Since dermal irritation was
observed at the lowest dose level tested (0.05 ml/kg/day), a NOAEL could
not be established.
supporting 28-day dermal toxicity study, rats were exposed to light
thermocracked distillate at dose levels of 0.001 (10% dilution in
acetone), 0.01, and 1.0 ml/kg/day (ARCO 1992i, Klimisch score = 1).No
mortality or treatment-related differences in body or organ weight were
observed. Very slight to severe dermal irritation was observed in the
0.01 and 1.0 ml/kg/day dose groups. Open lesions were observed in the
1.0 ml/kg/day group on day 5. A secondary response to dermal irritation
(higher percentage of neutrophils and lower percentage of lymphocytes)
was observed in the 1.0 ml/kg/day group. Histopathological findings
revealed moderate irritation at the high dose testing site. Based on the
study results, the NOEL is 0.001 ml/kg (in 10% acetone) based on dermal
irritation, and the systemic NOEL is 1.0 ml/kg.
supporting 28-day dermal toxicity study, rats were exposed to light
thermocracked distillate at dose levels of 0.0001 (0.01 ml/kg 1%
dilution in acetone), 0.005 (0.01 ml/kg 50% dilution in acetone), or
0.01 ml/kg (ARCO 1992j, Klimisch score = 1). No mortality or
treatment-related differences in body or organ weight were observed. No
test-article related clinical signs were observed. Very slight to severe
dermal irritation was observed in the 0.005 and 0.01 ml/kg/day dose
groups. Oedema and fissuring were also noted. Based on the study
results, the NOEL is 0.0001 ml/kg (0.01 ml/kg 1% dilution in acetone)
due to dermal irritation, and the systemic NOEL is 0.01 ml/kg.
In a key 90
-day sub-chronic dermal exposure rats were exposed to light
catalytically cracked distillate at dose levels of 0, 8, 25, 125, 500 or
1250 mg/kg body weight/day (Klimisch score = 2, Mobil 1985c). All rats
dosed with 1250 mg/kg body weight/day were sacrificed during the second
week of the study because of the severity in response to the test
material. Males dosed with 500 mg/kg body weight/day had reduced growth
rates and weighed approximately 25% less than the controls at the end of
the study. The females in the 500 mg/kg/day group were similarly
affected and weighed approximately 4% less than the controls at the end
of the study. Severe skin reactions were observed for rats dosed at 1250
and 500 mg/kg/day. Rats dosed with 125 mg/kg/day experienced moderate
skin reactions and slight skin reaction was experienced for those rats
in the 25 and 8 mg/kg/day groups. No dose-related effects in any of the
other haematological , clinical chemical or urinalyses in any dose group
organ for LCO in both males and females treated at 500 mg/kg/day was the
thymus. The thymus of males and female animals was smaller than normal,
as determined by visual inspection and by weight. Relative thymus
weights were 41% and 20% less than the controls for males and females,
respectively, for the 500 mg/kg/day dose group, while in the 125
mg/kg/day group relative thymus weights were reduced in males only (17%
relative to controls). Microscopic examination of the thymus revealed
depletion of lymphocytes and a slight increase in the amount of
connective tissue present (more prevalent in the males than in the
females). Study authors attributed the reduced thymus size to have
resulted from the depletion of lymphocytes within the thymus. The liver
weights were increased in both males (35%) and females (27%) treated
with 500 mg/kg body weight/day and liver cells from males contained more
fat than did the controls.
NOAEL of 25 mg/kg body weight/day was obtained for males, and 125 mg/kg
body weight/day for females, based upon reductions in thymus weight. The
NOAEL for local skin effects was 125 mg/kg body weight/day, however this
information is of limited value for the purposes of risk
characterisation since the test area was not reported and the dose per
unit area is therefore unknown.
subchronic dermal toxicity study, Beaumont coker light gas oil was
applied to the shaved skin of Sprague-Dawley rats (10/sex/treatment) at
dose levels of 0, 30, 125, 500, or 2,000 mg/kg/day 5 days a week for 13
weeks (Mobil, 1991). Animals wore Elizabethan collars to minimize
ingestion. Skin was wiped each Saturday morning and collars were removed.
treated with 2000 or 500 mg/kg groups were sacrificed early (during
weeks 2 and 9, respectively) due to severe skin irritation and moribund
condition. Erythema and signs of chronic skin deterioration were
observed in all treatment groups and, in general, the degree of skin
irritation was severe. With
the exception of animals in the 500 and 2000 mg/kg/day groups, mean body
weights for the remaining treated animals increased normally, compared
to controls, throughout the study, although a slight statistically
significant decrease (5-10%) was present in the 125 mg/kg body
weight/day groups (both sexes) at week 13. There were no
treatment-related changes in urine analysis or sperm evaluations.
chemistry analyses revealed the presence of a number of statistically
significant changes at week 13, with glucose decreased 17-20% in both
sexes at 125 mg/kg body weight/day, and by 12% in males only at 30 mg/kg
body weight/day. ALAT was significantly increased (31-33%) in both
groups of surviving males (females unaffected), while serum calcium was
significantly decreased (5-6% reduction) in surviving females (males
unaffected). Alkaline phosphatase was increased (30-35%) in both sexes
treated with 125 mg/kg body weight/day while females only exhibited an
increase (22%) in urea nitrogen at this dose. Serum sorbital
dehydrogenase activity was statistically significantly increased (40%)
in females from the 30 mg/kg/day group and significantly decreased (30%)
in females at 125 mg/kg/day, suggesting effects unrelated to treatment.
The clinical chemistry changes of probable biological relevance are the
reductions in blood glucose, ALAT and calcium and the increases in
alkaline phosphatase. The
other differences appear of doubtful significance.
haematology parameters were significantly altered following dermal
exposure to coker light gas oil. White blood cell counts were increased
significantly at week 5 in the 500 mg/kg body weight/day groups (32-77%
increase for males and females, respectively), and at week 13 in the 125
mg/kg groups (increased 22-29% for males and females, respectively).
Lymphocyte counts at week 5 were decreased by 17-22% in both sexes
following treated with 125 mg/kg body weight/day, and by 29-35% in the
500 mg/kg/day group. Following 13 weeks treatment, lymphocyte counts
were decreased by 9% and 18% in males treated with 30 or 125 mg/kg body
weight/day, respectively and by 20% females from the 125 mg/kg group.
The number of segmented neutrophils was increased approximately
three-fold (significant) in both sexes following 5 or 13 weeks exposure
to 125 mg/kg body weight/day.
necropsy at week 13, absolute thymus weights were found to be
statistically significantly lower in males from the 125 and 30 mg/kg
body weight/day groups (decreased 34% and 25%, respectively) and in
females from the 125 mg/kg/day group (decreased 23%) however values for
other organs were unaffected. Several differences in relative organ
weights were apparent in animals from the 125 mg/kg body weight/day
groups, however only changes in females (kidneys +8%, heart +6%, liver
+22%, spleen +19%) appeared related to treatment, with effects in males
most likely secondary to a 10% reduction in terminal body weight.
examination found treatment-related changes in several organs. Skin at
the treatment site was severely affected in all treatment groups, with
extensive damage (including congestion, crust formation, degeneration,
dyskeratosis, oedema, hyperkeratosis, hyperplasia, inflammation, and
ulcer formation). In animals sacrificed early, adrenal hypertrophy was
present in both sexes at 500 mg/kg body weight/day only, with a severe
reduction in erythropoietic cells and megakaryocytes in bone marrow in
the 2000 mg/kg groups. At scheduled termination, megakaryocitic changes
(characterised by larger, vacuolated and/or nuclei darkened or clumped
cell effects) were also observed in bone marrow from animals treated
with 125 mg/kg body weight/day and greater. A range of changes were
present at week 13 in the kidneys from males and females at 30 and 125
mg/kg body weight/day, including, cysts, degeneration, fibrosis, and
inflammation, while haematopoiesis, leukocytosis, necrosis, and nodules
were present in livers from the 125 mg/kg body weight/day groups (both
sexes). Other sporadic histological changes were considered by the
authors to be secondary to reduced body weight gain, treatment-related
skin injury, slight septicaemia and stress.
could be determined for coker light gas oil, with changes in some
clinical parameters (glucose, ALAT, calcium), decreased lymphocyte
counts and histological alterations in kidney tissue reported following
sub-chronic dermal treatment at 30 mg/kg body weight/day. Marked
irritation of the treatment site was also present in all dose groups.
The LOAEL for systemic toxicity from this study is therefore 30 mg/kg
body weight/day. The LOAEL for local effects is also 30 mg/kg body
weight/day, based on macroscopic and microscopic changes at the
treatment site, however this information is of limited value for the
purposes of risk characterisation since the dose per unit area is not
Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
one of 8 repeat dose dermal toxicity studies
Repeated dose toxicity: dermal - systemic effects (target organ) cardiovascular / hematological: thymus
In a 90 day
repeat dose dermal study, the NOEL was 25 mg/kg/day, with a LOEL of 125
mg/kg/day. In another study the LOAEL is identified as 30 mg/kg/day.
Based on these data cracked gas oils are classified for repeat dose
toxicity as STOT (repeated exposure) Cat 2, H373 according to EU CLP
Regulation (EC No.1272/2008) criteria. The NOAEC of > 1710 mg/m3 derived
from the 90-day inhalation read-across study also does not indicate
classification under EU CLP Regulation (EC No. 1272/2008) criteria.
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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