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EC number: 923-908-7 | CAS number: 1187204-08-5
The purpose of this repeat dose toxicity study was to assess the systemic toxicity potential of the test item, Acetalization product between glucose and C16/18 (even numbered)-alcohol in Wistar rats when administered orally by gavage for 90 consecutive days and to assess the reversibility of any effects following 28-days recovery period. This study was intended to provide information on major systemic toxic effects, target organs, the possibility of accumulation, additional parameters (clinical pathology and histopathological evaluations to evaluate effects of the test item on male reproductive organs) and an estimate of a No Observed Adverse Effect Level (NOAEL).
A total of 50 males and 50 female rats were randomly allocated to four main groups and two recovery groups, each main group comprised of 10 rats/sex and recovery groups 5 rats/sex as described below:
Number of Animals
Dose volume (mL/kg)
10M + 10F
5M + 5F
M: Males; F: Females; * The vehicle was Olive oil
The vehicle or test item suspensions were not administered to the recovery groups (G1R and G4R) for 28 days following the 90-days dosing period. All rats were observed for clinical signs and mortality daily. Body weights and food consumption were measured during the course of in-life phase of the experiment. The functional observation tests were performed during 13thweek of in-life phase. The blood samples were collected for clinical pathology at termination. All the rats were sacrificed at the end of the treatment for main groups and at the end of recovery groups for recovery groups and subjected to gross examination. The study plan specified organs were collected, weighed and preserved.
Histopathological examination was restricted to the preserved organs from vehicle control (G1) and high dose (G4) group animals (with qualitative assessment of stages of spermatogenesis), as there were no identifiable target organs/tissues in the high dose group rats. In addition, all the gross lesions from all the animals were examined microscopically.
Detailed testicular histopathological examination was conducted in order to identify possible treatment-related effects such as retained spermatids, missing germ cell layers or types, multinucleated giant cells or sloughing of spermatogenic cells into the lumen. Intact epididymis was also examined to include the caput, corpus, and cauda, which was accomplished by evaluation of a longitudinal section. The epididymis was evaluated for possible leukocyte infiltration, change in prevalence of cell types, aberrant cell types, and phagocytosis of sperm.As described in paragraphs 41 to 44 (OECD n°416).
The identity of the Acetalization product between glucose and C16/18 (even numbered)-alcohol was provided by the study Sponsor by a Certificate of Analysis. The correct identity and purity of the test item are the responsibility of the Sponsor. The test item was not authenticated at the test facility.
Summary of Results:
· No mortalities were observed in males and females of main toxicity and recovery groups at all dose levels.
· The salivation (slight to moderate) was observed in both sexes at all the test item treated groups during the course of the treatment period. This clinical sign of salivation was observed at 5-10 minutes post-dose and was persisted up to approximately 45 minutes post-dose only. The incidences of salivation were more in the high dose group rats (1000 mg/kg/day) and these were not observed consistently in same rats.The observed clinical sign of salivation was considered as transient andtest item-related non-adverse effect. There were no other clinical signs observed in any of the test item treated groups.
· Body weights, net body weight gains and food consumption were unaffected by the treatment at all dose levels.
· No eye abnormalities were found in the ophthalmological examination conducted at the end of the treatment and recovery period.
· There were no test item-related neurological abnormalities observed at at the end of the treatment and recovery period.
· There were no test item-related changes in hematology, coagulation, clinical chemistry, urinalysis, terminal fasting body weights, organ weights/ratios and sperm parameters.
· There were no test item-related gross and microscopic changes among the doses tested.
The repeated administration of test item Acetalization product between glucose and C16/18 (even numbered)-alcohol to Wistar rats through oral gavage for 90 consecutive days at the dose levels of 100, 300 and 1000 mg/kg Bwt/day did not cause any toxicological effects on general health, mortality, functional observational battery, growth and food consumption. No test item-related changes were observed in haematology, coagulation, clinical chemistry, urinalysis, terminal fasting body weights, organ weights/ratios and sperm parameters and gross and histopathological changes.The salivation (slight/moderate) which was observed in all rats at all the doseswas considered transient andtest item-related non-adverse effect. Hence, under the test conditions, the evaluated “No Observed Adverse Effect Level (NOAEL)” for test item Acetalization product between glucose and C16/18 (even numbered)-alcohol is 1000 mg/kg Body weight/day under the test conditions and doses employed.
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