Author: Dziwenka, Margitta; Coppock, Robert; Alexander, McCorkle; Palumbo, Eddie; Ramirez, Carlos; Lermer, Stephen
Title: Safety Assessment of a Hemp Extract using Genotoxicity and Oral Repeat-Dose Toxicity Studies in Sprague-Dawley Rats Document date: 2020_2_20
ID: u9msvq70_32
Snippet: In the 14-day study there was a non-statistically significant (p > 0.05) decrease in body weights for the male and female rats in Groups 2-4. For the female rats in the 90-day study, there were no test article-related changes (p > 0.05) in mean weekly body weights, daily body weight gain, food consumption, or food efficiency. For the male rats in Groups 3 and 4, a statistically significant (p < 0.05) dose-dependent decrease in mean weekly body we.....
Document: In the 14-day study there was a non-statistically significant (p > 0.05) decrease in body weights for the male and female rats in Groups 2-4. For the female rats in the 90-day study, there were no test article-related changes (p > 0.05) in mean weekly body weights, daily body weight gain, food consumption, or food efficiency. For the male rats in Groups 3 and 4, a statistically significant (p < 0.05) dose-dependent decrease in mean weekly body weights was observed that correlated with significant decreases (p < 0.05) in mean daily body weight gain and food efficiency for Groups 3 and 4 as well as food consumption for Groups 2-4. At the end of the recovery period, dosedependent decrease in mean weekly body weights was still observed for Table 7 Effect of 90-Day oral administration of test article on clinical chemistry parameters in male and female rats (n = 60/sex). the male rats in Groups 6-8 with correlating significant decrease (p < 0.05) in mean daily body weight gain and food consumption for Groups 6-8 as well as food efficiency for the male rats in Group 8.
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