2002
DOI: 10.1016/s0940-2993(04)70074-3
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Distinguishing between adverse and non-adverse effects – Session summarySession Report from the Joint STP/IFSTP International Symposium “Toxicologic Pathology in the New Millenium” June 24–28, 2001, in Orlando, Florida

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“…However, these changes were not regarded to be adverse effects because they were not dose-dependent nor accompanied by an increase in the absolute organ weight of livers, or alterations of serum chemical markers of liver injury, and not associated with histopathological alterations in the liver ( 8 ). Furthermore, if liver weight caused by hypertrophy and hyperplasia does not involve an increase up to 20%, and is not accompanied by histopathological changes, it is not considered as an adverse effect in rodents ( 10 ). Finally, the increase of liver organ weight can be regarded as an adverse effect only if accompanied by alterations in parameter of hepatobiliary damage or dysfunction ( 11 , 12 ).…”
Section: Discussionmentioning
confidence: 99%
“…However, these changes were not regarded to be adverse effects because they were not dose-dependent nor accompanied by an increase in the absolute organ weight of livers, or alterations of serum chemical markers of liver injury, and not associated with histopathological alterations in the liver ( 8 ). Furthermore, if liver weight caused by hypertrophy and hyperplasia does not involve an increase up to 20%, and is not accompanied by histopathological changes, it is not considered as an adverse effect in rodents ( 10 ). Finally, the increase of liver organ weight can be regarded as an adverse effect only if accompanied by alterations in parameter of hepatobiliary damage or dysfunction ( 11 , 12 ).…”
Section: Discussionmentioning
confidence: 99%