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EC number: 239-701-3
CAS number: 15625-89-5
CONCENTRATION AND HOMOGENEITY ANALYSIS
No test item was detected in the control group diet.
The mean accuracies for the concentrations in the formulations of the 300, 900 and 2500 ppm group (Week 1, Week 6 and Week 12 formulations) were between 92% to 100% and therefore in agreement with the target concentrations for suspensions (80% and 120%).
The coefficient of variation for the formulations of the 300 and 2500 ppm group (Week 1, Week 6 and Week 12 formulations) and 900 ppm (week 1 formulation) were between 0.51 and 1.7% and therefore the formulations were considered homogeneous (i.e. coefficient of variation ≤ 10%).
Stability in rat diet (powder, SM R/M-Z; supplier SSNIFF®) over the concentration range 500 to 15000 ppm was confirmed for at least 3 weeks in the freezer (≤-15°C) and for at least 4 days at room temperature (Test Facility Study No. 20265399 (method development and validation study)). In addition, stability in rat diet (powder, SM R/M-Z; supplier SSNIFF®) at 300 ppm is confirmed for at least 3 weeks in the freezer (≤-15°C) and for at least 4 days at room temperature (Test Facility Study No. 20265399 (method development and validation study)).
TEST ARTICLE INTAKE
Table 1: Test Article Intake
Nominal Dietary Inclusion Level [ppm]
Mean over Means Intake [mg test item/kg body weight]
(mean range indicated within brackets)
Table 2: Summary Test Item-Related Microscopic Findings – Stomach
Dose level (ppm)
STOMACH (non-glandular) a
Hyperplasia squamous cell
Infiltration mixed cell, submucosal
a = Number of tissues examined from each group. Bold values indicate a test item-related effect.
A 90-day dietary rat toxicity study was conducted according to OECD/EC guidelines and in accordance with GLP principles. Wistar Han rats were administered with 2-ethyl-2-[[(1-oxoallyl)oxy]methyl]-1,3-propanediyl diacrylate for 90 days by dietary administration at dose levels of 300, 900 and 2500 ppm. The animals of the control group received the standard rodent diet alone.
No test item-related effects were observed in males and females up to 900 ppm.
At clinical chemistry assessment, a test item-related increase in alanine aminotransferase activity and calcium concentration were observed in males at 2500 ppm. At the severity observed and in absence of a histopathological correlation, these findings were considered to be not adverse.
At histopathological assessment, test item-related findings in the non-glandular stomach were noted in males and females at 2500 ppm consisting of squamous cell hyperplasia and hyperkeratosis. These findings correlated macroscopically with irregular surface described in the same stomach region. In addition, some females at 2500 ppm presented a few other microscopic findings in the non-glandular stomach including mucosal erosion, submucosal edema and submucosal mixed cell infiltrates. The combination of these findings at the recorded incidences, severities and distribution are considered non-adverse. The recorded alterations in the non-glandular stomach were local test item effects and likely resulted from the slightly irritating properties of the test item.
No test item-related toxicologically significant changes were noted in any of the remaining parameters investigated in this study (i.e. mortality, clinical appearance, body weight, food consumption, functional observations, ophthalmoscopy, hematology, coagulation and organ weights).
Based on these results, the No Observed Adverse Effect Level was considered to be at least 2500 ppm (corresponding to an actual test article intake of 173 and 190 mg/kg body weight/day for males and females, respectively). Selecting higher dose levels for this 90-day dietary study was considered to be not justified, based on the toxicity observed in the 14-day dietary rat study (Test Facility Study No. 20265400).
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