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EC number: 252-161-3
CAS number: 34708-08-2
the key study conducted according to OECD Test Guideline 408 and in
compliance with GLP (Charles River Laboratories, 2022, reliability score
1), Wistar Han rats were administered
triethoxy(3-thiocyanatopropyl)silane (CAS No. 34708-08-2, EC No.
252-161-3) at 0, 30, 100, and 300 mg/kg bw/day via oral gavage (arachis
oil vehicle) for 7 days/week over 13 weeks. The systemic NOAEL for
triethoxy(3-thiocyanatopropyl)silane was 100 mg/kg bw/day, based on
effects in males (decreased body weight, body weight gain, and food
consumption) and females (increased renal organ weight and related
histopathological alterations) at 300 mg/kg bw/day. For local effects in
the non-glandular stomach, the NOAEL was 30 mg/kg bw/day.
has been evaluated in a study conducted according to OECD Test Guideline
408 and in compliance with GLP (Charles River Laboratories, 2022,
reliability score 1). Wistar Han rats were administered
triethoxy(3-thiocyanatopropyl)silane at 0, 30, 100, and 300 mg/kg bw/day
via oral gavage (arachis oil vehicle) for 7 days/week over 13 weeks. The
main study included 10 rats per sex per dose group, with 5 rats per sex
in the 28-day recovery (0 and 500 mg/kg bw/day) groups. Observations and
examinations were conducted per OECD Test Guideline 408, and included
cage-side observations, detailed clinical signs, body weights, food
consumption, ophthalmology, functional observation tests, oestrous stage
determination, clinical pathology parameters (haematology, coagulation
and clinical chemistry), organ weights, gross pathology, and
deaths occurred during the study. Clinical signs included hunched
posture and/or erected fur at 300 mg/kg bw/day in seven males and six
females, between Days 2 and 92. Other clinical findings were considered
not toxicologically relevant.
item-related and adverse lower body weight and body weight gain occurred
in males at 300 mg/kg bw/day, which recovered during the dosing-free
period. Test item-related and adverse lower food consumption was also
observed in males at 300 mg/kg bw/day, with this finding partially
recovering during the dosing-free period.
ophthalmology findings were noted that were considered related to
treatment with the test item. The nature and incidence of findings were
within the range considered normal for rats of this age and strain.
mg/kg bw/day, haematology effects (increased reticulocyte counts) were
observed in males and females at the end of the dosing period. In
addition, females at 300 mg/kg bw/day showed increased counts of large
unstained cells. Both findings normalized following recovery. In absence
of a histopathological correlation, the findings at this dose level were
considered non-adverse. The remaining findings were considered of no
toxicological significance. No effects were reported for 30 or 100 mg/kg
chemistry findings at 100 and/or 300 mg/kg bw/day at the end of the
dosing period were as follows:
Increased calcium concentrations in males and females
Decreased T4 and (at 300 mg/kg bw/day) increased TSH concentrations in
Decreased T3 and (at 100 mg/kg bw/day) T4 concentrations, and increased
TSH concentrations in females
Increased triglyceride concentrations (at 300 mg/kg bw/day) in males
were no corresponding gross pathology or histopathology findings in the
thyroid. In terms of the elevated triglyceride levels, see the renal
histopathology results at 300 mg/kg bw/day discussed below.
behavioural results were normal compared to controls (hearing ability,
hearing ability, pupillary reflex, static righting reflex, male grip
strength, female fore-leg grip strength, motor activity), or were
considered not toxicologically relevant (female hind-leg grip strength
at 100 and 300 mg/kg bw/day). Latter was within the range considered
normal for rats of this age and strain and lacked a clear dose-related
organ weights, test item-related lower absolute thymus weights in males,
higher relative kidney weights in females and higher relative liver
weights in males and females were observed at 300 mg/kg bw/day. Changes
in female kidney weight could be correlated with multifocal bilateral
tubular basophilia with mononuclear cell infiltrates and showed no
recovery following the treatment-free period. No microscopic correlates
were observed for the changes in thymus and liver weights.
item-related gross pathology was seen locally in the non-glandular
stomach of both sexes, and in the liver for two males. Dark purple/red
foci in the glandular stomach, dark grey/purple/red foci in the
non-glandular stomach and/or an irregular surface of the non-glandular
stomach was seen in one female at 30 mg/kg bw/day, six females at 100
mg/kg bw/day and five males and five females at 300 mg/kg bw/day at the
end of treatment. Microscopic correlates for the abnormalities in the
non-glandular stomach consisted of haemorrhage
epithelial hyperplasia, respectively. In addition, two males at 300
mg/kg bw/day showed enlarged livers (no corresponding histopathology).
The non-glandular stomach and liver findings were not seen at the end of
recovery. The remainder of the recorded macroscopic findings were within
the range of background gross observations encountered in rats of this
age and strain.
histopathologic examination, both systemic and local findings were
reported. In the kidney, tubular basophilia and mononuclear cell
infiltration were ascribed to treatment with the test item only when
scored as bilateral and multifocal at 300 mg/kg bw/day. These findings
correlated with increased kidney weight in females. These findings were
recorded in females at the end of the treatment as well as at the end of
the recovery at severities up to a moderate degree and were regarded to
be adverse. Minimal tubular basophilia and mononuclear cell infiltration
are common background pathology findings in the rat kidney. Accumulation
of hyaline droplets in the kidney in males also
seen in the study, which showed full recovery at the end of the recovery
period. Accumulation of hyaline droplets is caused by an increased
production of alpha-2-urinary-globulin which is a protein specific for
male rats. This is a well-known phenomenon and in absence of indicators
of tubular damage regarded to be non-adverse.
in the non-glandular stomach, histopathological findings in animals
treated at 300 mg//kg bw/day consisted of haemorrhage, epithelial
hyperplasia, ulceration, mixed cell infiltration, oedema and
hyperkeratosis in the non-glandular stomach in males and females, which
was regarded to be adverse. These findings correlated with
macroscopically dark grey/purple/red and/or an irregular surface
(interpreted as non-adverse) at necropsy.
systemic NOAEL for triethoxy(3-thiocyanatopropyl)silane was 100 mg/kg
bw/day, based on effects in males (decreased body weight, body weight
gain, and food consumption) and females (increased renal organ weight
and related histopathological alterations) at 300 mg/kg bw/day. For
local effects in the non-glandular stomach, the NOAEL was 30 mg/kg
a 14-day range finding study conducted in compliance with GLP (Charles
River Laboratories, 2022,
Appendix 3, reliability
score 2), Wistar Han rats (3 per sex
per dose group) were administered triethoxy(3-thiocyanatopropyl)silane
at 0, 100, 300, and 500 mg/kg bw/day via daily oral gavage (arachis oil
vehicle) for 14 days. These endpoints were assessed: mortality, cage
side clinical signs, body weight, food consumption, and gross pathology.
Except as noted in the study report,
the test system, procedures and techniques were identical to those used
during the main study. The systemic NOAEL for
triethoxy(3-thiocyanatopropyl)silane was 100 mg/kg bw/day, based on
clinical signs (prostrate, posture, gait, activity, erected fur, and/or
salivation) in both sexes at 300 mg/kg bw/day. Mortality (1/3 males on Day
1) and additional clinical signs occurred at 500 mg/kg bw/day. For local
effects in the non-glandular stomach, the NOAEL was 300 mg/kg bw/day,
based on gross pathology at 500 mg/kg bw/day (blood analysis and
histopathology not performed). The findings were used for dose selection
for the main repeated dose study.
on the available information related to systemic toxicity,
triethoxy(3-thiocyanatopropyl)silane does not require classification for
repeated dose toxicity according to Regulation (EC) No, 1272/2008.
Irritation effects were observed in the
stomach, but this local finding
does not trigger classification.
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