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EC number: 239-701-3
CAS number: 15625-89-5
Analysis of dose preparations showed that no test substance was detected
in the Group 1 formulations (control group). The concentrations analysed
in the formulations of Groups 2, 3 and 4 prepared for use on 04 and 31
March 2015 were in agreement with the target concentrations (i.e. mean
accuracies between 90% and 110%). The formulations of Group 2 and Group
4 prepared for use on 04 and 31 March 2015 were homogeneous (i.e.
coefficient of variation ≤ 10%). Formulations at the entire range were
stable when stored at room temperature protected from light for at least
5 hours (i.e. relative difference ≤ 10%). The long term storage samples
were stable at ≤-70°C for at least 34 days. It should be noted that the
tested storage period was slightly shorter than the maximum storage
period in this study which was 37 days for the formulation samples taken
on treatment Day 28. Data from the accuracy measurement of these samples
showed no degradation of the test substance in formulation after storage
in the freezer, thereby supporting stability over the longer period.
Overall, formulation analysis showed that the formulations were prepared
accurately and homogenously, and were stable when stored at room
temperature protected from light for at least 5 hours.
The repeated dose toxicity (28-day) 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 parental toxicity at 100 and 300 mg/kg/day (both sexes). There
were only adverse local morphologic alterations in the non-glandular
part of the stomach, the forestomach, which represented a local
irritating effect of the test substance rather than a systemic effect.
No treatment-related toxicologically significant changes were noted in
any of the remaining parental parameters investigated in this study
(i.e. clinical appearance, functional observations, body weight, food
consumption, clinical laboratory investigations and organ weights).
Based on these results, a NOAEL of 30 mg/kg bw/day for local toxicity
and a NOAEL of 300 mg/kg bw/day for systemic toxicity could be derived
for parental toxicity (F0). No higher doses could be tested due to test
substance related local toxicity on the non-glandular part of the
stomach (i.e. the forestomach) at doses of 100 mg/kg/day and higher.
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