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EC number: 239-701-3
CAS number: 15625-89-5
There was one couple treated at 30 mg/kg bw/day (male 16 and female 56)
that was not pregnant. No abnormalities were seen in the reproductive
organs, which could account for their nonpregnancy.
There were no morphological findings in the reproductive organs of
either sex which could be attributed to the test item and spermatogenic
staging profiles were normal for all males examined using
PAS/haematoxylin staining methods.
The reproductive and developmental toxicity of TMPTA was evaluated in a
combined 28-day repeated dose toxicity study with the
reproduction/developmental toxicity screening test in accordance with
OECD 422. TMPTA was administered by daily oral gavage to male and female
Wistar Han rats at dose levels of 30, 100 and 300 mg/kg/day. Males were
exposed for 2 weeks prior to mating, during mating, and up to
termination (for 29 days). The females were exposed for 2 weeks prior to
mating, during mating, during gestation, and at least 4 days of
lactation (for 41-55 days).
Treatment with TMPTA at dose levels of 30, 100 and 300 mg/kg/day
revealed no treatment-related effects in relation to reproduction
(mating, fertility and conception indices, precoital time, number of
corpora lutea and implantation sites) and developmental toxicity
(gestation index and duration, parturition, maternal care and early
postnatal pup development i.e mortality, clinical signs, body weight and
macroscopy). Further, there were no morphological findings in the
reproductive organs of either sex which could be attributed to TMPTA and
spermatogenic staging profiles were normal for all males examined.
Based on these results, a NOAEL of 300 mg/kg bw/d for reproductive
toxicity and for developmental toxicity could be derived from this
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