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EC number: 258-904-8
CAS number: 53988-10-6
An EOGRTS study (OECD 443) was performed to evaluate the pre- and
post-natal effects of Vulkanox ZMB2, an industrial chemical, when
administered orally, by gavage, to CD rats. The evaluation included
assessment of the integrity and performance of the adult male and female
reproductive tract, and systemic toxicity in pregnant and lactating
females and in young and adult offspring. In addition, developmental
neurotoxicity and developmental immunotoxicity assessments were
included, along with an evaluation of the maturing reproductive tract
and its integrity and function.
In the F0 generation, three groups of 25 male and 25 female CD rats
received Vulkanox ZMB2 at dose levels of 5, 15 or 40 mg/kg/day at a
volume dose of 5 mL/kg/day. Males were treated for two weeks before
pairing, up to necropsy after litters were weaned. Females were treated
for two weeks before pairing, throughout pairing up to necropsy on Day
28 of lactation. In the F1 generation, 70 males and 70 females were
treated from weaning to their scheduled termination (relevant to each
cohort) at the same dose levels and volume-dose as the F0 generation. A
similarly constituted Control group received the vehicle, dried corn
oil, at the same volume dose throughout the same period.
Clinical observations, body weight, food consumption (except Cohort 2B)
and macropathology examinations were performed on all animals for signs
of toxicity, with special emphasis on the integrity and performance of
the male and female reproductive system and the health (including
thyroid hormone analysis), growth, development and function of the
At weaning, five cohorts of selected males and females were assigned for
further investigations, including sexual maturation, reproductive organ
integrity and function, neurological and behavioural endpoints, and
Based on the results obtained in this study it was concluded that the
No-Observed-Adverse-Effect-Level (NOAEL) for reproductive performance of
the F0 and F1 Cohort 1B animals was 15 mg/kg/day due to the incidences
of prolonged parturition/dystocia in females of both generations
receiving 40 mg/kg/day.
As well as the above mentioned instances of prolonged
parturition/dystocia among females at 40 mg/kg/day, increased incidences
of liver hypertrophy, thyroid gland hypertrophy and involution/atrophy
of the thymus were observed at 40 mg/kg/day, therefore the NOAEL for
systemic toxicity in the F0 and F1 adult animals was concluded to be 15
The NOAEL for the F1 and F2 offspring up to weaning was concluded to be
15 mg/kg/day due to reduced early post-partum survival at 40 mg/kg/day
in both generations.
There was no evidence of developmental neurotoxicity or developmental
immunotoxicity on this study, therefore the NOAEL for these endpoints
was concluded to be 40 mg/kg/day.
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