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EC number: 932-235-8
CAS number: -
Alchisor TAL 123 can be characterised according to three constituents: Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%), undecan-1-ol and dodecan-1-ol; however, it should also be noted that Sasol commissioned a 28-day repeated dose oral toxicity study using Alchisor TAL 123 as the test substance (Holalagoudar, 2013), the results of which are used to anchor the read-across approach. ORAL: The Alchisor TAL 123 oral toxicity study is the most reliable and relevant study, yielding an oral NOAEL for Alchisor TAL 123 of 1000mg/kg bw.DERMAL: A study result from Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) read across rat data will be used for the Alchisor TAL 123 repeat dose dermal endpoint. A systemic NOAEL in this instance is >495mg/kg/day.INHALATION: A reliable (Klimisch 1) repeat dose rat inhalation toxicity study attributed to the Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) provides the key study inhalation result from this constituent of Alchisor TAL 123. Consequently following the protective approach as detailed above, an inhalation NOAEC for Alchisor TAL 123 of 690ppm is provided.
TAL 123 can be characterised according to three constituents:
Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%),
undecan-1-ol and dodecan-1-ol. As defined in the Read-across
Justification Document in section 13, data provided for these
constituents when considered together is representative of Alchisor TAL
123 and suitable for assessment purposes. Study data for each
constituent has been evaluated. In a protective approach the most
sensitive study result from across the three constituents has been
identified and used to address the hazard endpoint in question; however,
it should also be noted that the registrant commissioned a 28-day
repeated dose oral toxicity study using Alchisor TAL 123 as the test
substance (Holalagoudar, 2013), the results of which are used to anchor
the read-across approach.
30 -day subchronic toxicity study report with Hydrocarbons C11-C14,
n-alkanes, isoalkanes, cyclics, aromatics (2-25%) along with a combined
repeat dose and reproductive/developmental toxicity screening test on
dodecan-1-ol is available to address the repeat dose oral toxicity
endpoint of Alchsior TAL 123. Key read across data is provided for
dodecan-1-ol in the form of a reliable (Klimisch 2) 90 day dietary study
with hexan-1-ol. Read across data is provided for undecan-1-ol based on
the combined repeat dose and reproductive/developmental toxicity
screening test with dodecan-1-ol (Hansen 1992). Adequate
reliable data is available for each constituent. Therefore using a
protective approach the dataset is a reliable adequate basis for
Alchisor TAL assessment purposes.
oral gavage study BP8313 (representing C9-C14 aliphatics (2-25%
aromatics)) was dosed to rats in a corn oil vehicle over 30 days. 5 male
and 5 female rats were exposed to dose levels of 0.14, 0.42 and 1.28
ml/kg/day. No mortality was reported. Clinical signs were observed in
the majority of rats at the top two dose levels from day 4 of dosing.
These clinical signs manifested in the form of salivation, normally for
a short period and brown facial staining, which resolved within 24hrs.
Plasma glucose levels were depressed in rats at the top dose level. Male
rats at this dose level exhibited elevated lymphocyte and platelet
numbers and depressed packed cell volume, haemoglobin concentration and
erythrocyte counts. Urinary protein concentrations were higher in all
male rats in the two higher dose groups, and in 2 males in the lowest
dose group. Male rats showed a dosage related increase in liver and
kidney weights. Female rats only showed higher liver weight at the
highest dose level. Organ specific changes were noted in the kidney.
However these kidney changes identified were isolated to 3 male rats in
the low dose group and 4 male rats in the mid and high dose groups.
These changes specifically related to a slight degeneration of the cells
lining the proximal tubules. Tubular cell degeneration, tubular dilation
with intra-tubular protein and regeneration were evident. These
male-only alterations of the kidneys at all dose levels are known to be
species specific and of no-relevance to human hazard assessment. In this
study the NOAEL is however restricted to female rats and determined to
be 1.28ml/kg/day (1056mg/kg).
repeat dose toxicity of Dodecanol was assessed in a combined repeats
dose reproductivity study; draft OECD 422 (Hansen 1992). Dose levels of
0, 1500, 7500 and 30,000 were selected and 12 rats/sex/dose were exposed
to these doses of Dodecanol in their diets. Dietary exposure was
continued for 41-45 days in the case of males and 54 days in the case of
females. No mortality or clinical signs were reported and food
consumption remained the same as controls throughout the study.
Haematology and clinical chemistry parameters were assessed in males
only. A dose related reduction in white blood cell counts which was
significant in top and mid dose males was reported. It should be noted
that there were no differences in differential white cell count that
explained these observations.
There was a significant reduction in plasma triglyceride
at the top dose level and a significant reduction in plasma free cholesterol at the intermediate dose level. This reduced cholesterol level was re-analysed after removing 2 outlying
values when the statistical significance was lost. These results may
confounded by the difference in dietary composition between groups. In
this reliable study a NOAEL for systemic toxicity of 2000 mg/kg/day
(highest dose tested) was determined in rats in the absence of
toxicologically significant effects at any dose level. In addition a 90d
dietary study was presented as read across from Alfol 6 (hexan-1-ol) to
dodecan-1-ol. In this reliable study, the NOAEL for Alfol 6 in rats
following 13 weeks dietary exposure was 1127 mg/kg bw/day for males and
1243 mg/kg bw/day for females (highest doses tested).
the scope of these studies, evidence of repeat dose organ toxicity is
restricted to the kidneys (DHC Solvent Chemie GmbH, 1984) in the case of
exposure to BP8313. Although being dose related this type of renal
pathology is specific to male rats due to an alpha2u-globulin-mediated
process that is not relevant to humans. A NOAEL has been reported in
this instance (for female rats) at 1.28ml/kg/day (equivalent to
registrant commissioned a 28-Day Repeated Dose Oral Toxicity study with
Alchisor TAL 123 (Holalagoudar, 2013) in male and female Wistar rats
with dose levels of 100, 500, and 1000 mg/kg/day to assess the possible
health hazards that could arise from repeated exposure via oral
administration. The test item was administered daily in graduated doses
to 3 groups of test animals, one dose level per group for a treatment
period of 28 days. Animals of an additional control group were handled
identically as the dose groups but received cotton seed oil, the vehicle
used in this study. The 4 groups were comprised of 5 male and 5 female
Wistar rats. Daily oral treatment with Alchisor TAL 123 did not lead to
mortality, did not affect body weight development or food consumption
and did not lead to alterations in parameters of clinical pathology.
Histopathological liver changes and associated thyroid gland changes
were minor in degree and restricted to the 1000 mg/kg/day dose group.
Kidney changes, reflecting α2-microglobulin nephropathy, do not have
relevance for man. Based on the type of histological liver changes and
their reversibility shown in 8/10 animals in the recovery group, in the
absence of clinical signs and clinical pathology changes, the liver
findings are considered as non-adverse and minor adaptive change. The no
observed adverse effect level (NOAEL) is therefore considered to be 1000
mg/ kg body weight /day.
reliable sub-chronic oral toxicity study with BP8313 (representing
C9-C14 aliphatics (2-25% aromatics)) provides the most sensitive study
result for constituents of Alchisor TAL 123; however, since the Alchisor
TAL 123 oral toxicity study is the most reliable and relevant study, the
oral NOAEL is determined to be 1000 mg/kg/day.
repeat dose inhalation studies are available for the C9-C14 aliphatics
(2-25% aromatics). In addition read across information is presented for
Stoddard solvent and mineral spirits in support of the C9-C14 aliphatic
(2-25% aromatics) constituent category. No repeat dose inhalation
studies were available for either undecan-1-ol or dodecan-1-ol.
Consequently the most sensitive study result from the C9-C14 aliphatics
(2-25% aromatics) study reports will be used for the Alchisor TAL 123
repeat dose inhalation endpoint.
repeated dose study (Shell Research Ltd 1980) where C9-12 Aliphatics
(2-25% Aromatics) were administered via inhalation, no signs of toxicity
were observed at the maximum concentration of 1293 ppm in female rats.
Female rats had significant body weight reduction at the highest dose
tested. Based on these observations, the repeat inhalation NOAEL is =
690 ppm for C9-14 Aliphatics (2-25% Aromatics). Similarly to the oral
findings, renal damage was observed in male rats at all dose levels.
This type of renal pathology is specific to male rats due to an
alpha2u-globulin-mediated process that is not relevant to humans.
second reliable guideline comparable (OECD 413) inhalation study was
conducted in rats (ExxonMobil 1979). Groups of 35 rats were exposed to a
test atmosphere containing 100 or 300ppm MRD-78-25 (C9-C12 aliphatics
(2-25% aromatics)) for 6hrs/day 5days per week for 12 weeks.10
rats/sex from each group were sacrificed at week 4 and week 8.No
mortality was reported throughout the study. Males in the 300ppm dose
group had increased mean total leukocyte values at week 12. Alterations
in haemocrit, haemoglobin levels and some clinical chemistry parameters
were recorded within the study but where disregarded as being unrelated
to treatment and having little biological significance. A NOAEC for
female rats was determined to be 300ppm.
study examined the subchronic toxicity of MRD-78-25 to rats via
inhalation. Groups of 35 rats per sex were exposed to 0, 100, or 300 ppm
of test substance vapors. Exposure was 6 hrs/day, 5 days/week, for 12
weeks. Animals were observed for clinical signs daily, and weighed
weekly. At the end of the study, all surviving animals were sacrificed.
After sacrifice, hematological, clinical chemistry, and
histopathological parameters were examined. There was no treatment
related mortality during the study, and no treatment related body weight
effects. For male rats, the LOAEC was 100 ppm via inhalation. This value
is based on kidney effects due to a alpha2u-globulin-mediated process
that is not regarded as relevant to humans that are not relevant to
humans. For female rats, the NOAEC was 300 ppm.
inhalation studies have been documented as read-across arguments based
on supporting substances (structural analogue or surrogate). In a repeat
dose inhalation study (Carpenter 1975) both beagle dogs and rats were
examined following exposure to atmospheres of Stoddard solvent (0, 84,
190, 330ppm). No statistically significant differences were reported in
beagle dogs between control and test groups. However, rats exposed to
1.9 mg/liter (330 ppm) level for 65 days exhibited slight pathological
changes in the kidney, which were related at least in part to the
inherent murine nephrosis of the Harlan-Wistar rats employed. This
observation is also likely due to a2u-globulin mediated
nephropathy. Since humans do not have this protein, this finding is not
toxicologically relevant. The NOAEC>330 ppm for male and female rats.
further inhalations study (Rector 1966) no mortality was reported in
test groups of dogs, monkeys, or rabbits following repeated exposures.
No outward signs of toxicity, significant alterations in weight or
haematologic values, or noteworthy in gross pathologic or
histopathologic findings were noted in dogs, monkeys, rabbits, or rats.
The guinea pig was found to be the most susceptible, with significant
mortality occurring at the 363 mg/m3continuous exposure
level. The mortality rate generally increased as the concentrations of
the mineral spirits were increased.
Jenkins, 1971 reported on a repeats dose inhalation study of mineral
spirits in the Guinea Pig. Test animals were exposed to an atmosphere of
mineral spirits at a concentration of 900mg/m3continuously
for 90 days. Test diets were fortified with ascorbic acid. The LOAEL for
this study was 900 mg/m3.
reliable (Klimisch 1) repeat dose inhalation toxicity study attributed
to the C9-C14 aliphatics (2-25% aromatics) provides the key study result
for constituents of Alchisor TAL 123. Consequently following the
protective approach as detailed above, an inhalation NOAEC for Alchisor
TAL 123 of 690ppm (3950mg/m3) is provided.
repeat dose dermal toxicity of C9-C14 aliphatics (2-25%
Aromatics) was evaluated by read across from a13-Week
subchronic dermal study with neurotoxicology evaluations of
hydrodesulfurized kerosene in rats. Groups of 12 rats were dermally
exposed to doses of the test material of 165, 330 and 495mg/kg. Dosing
continued for five days per week for a total of 13 weeks. There
were no systemic or neurological effects noted at any of the tested
doses. The systemic NOAEL was >495 mg/kg/day.No
repeat dose dermal studies were available for either undecan-1-ol or
dodecan-1-ol. Consequently the study result from the C9-C14 aliphatics
(2-25% aromatics) read across data will be used for the Alchisor TAL 123
repeat dose dermal endpoint. A systemic NOAEL in this instance is
On the basis
presented, Alchisor TAL123 and its components have a low order of
repeated dose toxicity. Kidney changes identified in male rats exposed
to Alchisor TAL 123 and C9-C14 aliphatics (2-25% aromatics) are known to
be species specific and of no known relevance to human hazard
assessment. Consequently these findings do not warrant the
classification of Alchisor TAL 123 as a repeated dose toxicant under the
new 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 for preparations.
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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