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EC number: 938-875-4
CAS number: -
The available repeat dose studies gave rise to no significant adverse systemic toxicity by either the oral, inhalation or dermal routes. Male rat specific alpha 2u globulin effects were seen in several studies however this is not relevant to man.
The LOAEL for male rats was 0.14 ml/kg/day based on renal damage. This
type of renal damage is specific to male rats, and is not relevant to
humans. The NOAEL for female rats was 1.28 ml/kg/day.
This study examined the oral 30 -day subchronic toxicity of BP 8313 to
rats. Groups of 5 rats of each sex were given doses of 0.14 (116 mg/kg),
0.42 (347 mg/kg), or 1.28 (1056 mg/kg) mL/kg of test substance in corn
oil for 30 days. Animals were examined for clinical signs, mortality,
body weight, food consumption, water consumption, and food conversion.
After sacrifice clinical chemistry, hematology, clinical chemistry,
urinalysis, organ weights, histopathology, and gross pathology were
examined. There was no mortality during the experiment. Renal damage was
observed in male rats at all dose levels. This type of renal pathology
is specific to male rats due to a alpha2u-globulin-mediated process that
is not relevant to humans. Female rats exhibited adaptive liver changes
at the highest dosage. The LOAEL for male rats was 0.14 ml/kg/day based
on renal damage. The female NOAEL was 1.28 (1056 mg/kg) mL/kg.
Mean Body Weights of Male Rats (g)
Standard Deviation of a Single Observation
20.9 (cage effect)
34.2 (cage effect)
Mean Body Weights of Female Rats (g)
13.5 (cage effect)
12.9 (cage effect)
13.8 (cage effect)
This study evaluated the subchronic toxicity of low aromatic white
spirits to rats when exposed via inhalation. Groups of 18 rats per sex
were exposed to 345, 690, or 1293 ppm of test substance for 6 hrs/day, 5
days/week, for 13 weeks. The highest concentration, 1293 ppm, was near
the saturation point for test substance vapor. Rats were observed for
clinical signs, mortality, food consumption, water consumption, and body
weight. At the end of the exposure period, the animals were sacrificed,
and clinical chemistry, hematology, gross pathology, and histopathology
parameters were examined. Male rats at all exposure levels had
degenerative effects of the as a result of an alpha2u-globulin-mediated
process that is not regarded as relevant to humans. The LOAEC was
established at 1293 ppm (7400 mg/m3) due to a significant body weight
reduction. No other effects were noted. The LOAEC for female rats was
690 ppm (3950 mg/m3).
Test material was applied at concentrations of 165, 330 or 495
mg/kg/day. Dosing was continued daily for five consecutive days each
week, five days a week for 13 weeks. In addition a group of 12 male and
12 female rats of similar age were administered mineral oil as vehicle
controls and an additional high dose group was maintained for a 4-week
recovery period following dosing for 13 weeks. At the 14 week necropsy,
blood samples were collected from 12 animals/sex/group and at the week
18 necropsy from the recovery rats (vehicle and high dose groups). There
were no systemic or neurological effects noted at any of the tested
doses. The systemic NOAEL was >495 mg/kg/day.
The repeated dose toxicity assessment of Alchisor TAL 111 is based
on read-across data from C9-C14 aliphatics (2-25% aromatics).
In a 30 day oral study on C9-C14 aliphatics (2-25% aromatics) the
NOAEL was 1056 mg/kg.
In a 90 day inhalation study on C9-C14 aliphatics (2-25%
aromatics) the NOAEC was 3950 mg/m3.
In a 90 day dermal study on C9-C14 aliphatics (2-25% aromatics)
the NOAEL was >495 mg/kg.
Male rat specific renal pathology was seen in the oral and several
of the inhalation studies. However this type of renal pathology is
specific to male rats due to an alpha2u-globulin-mediated process that
is not relevant to humans.
Based on the available read-across
data, the substance does not meet the criteria for classification. Kidney
changes identified in male rats exposed to C9-C14 aliphatics (2-25%
aromatics) are known to be species specific and of no relevance to human
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