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EC number: 232-566-1 | CAS number: 9000-91-3
It was concluded that oral administration of beta-amylase, batch PPY36295 to Sprague-Dawley rats at doses up to 100% of the beta-amylase batch (equivalent to 1.199 g TOS/kg/day) for 90 days was well-tolerated and did not cause any adverse change. The no-observed adverse-effect level (NOAEL) was considered to be 100% of the beta-amylase batch, equivalent to 1.199 g TOS/kg/day.
The objective of this study was to assess the systemic toxic potential of beta-amylase batch PPY36295 when administered orally by gavage to Sprague-Dawley (Crl:CD(SD)) rats for 90 days. Three groups, each comprising 10 males and 10 females, received doses of 10, 33 or 100% of the beta-amylase batch (equivalent to 0.120, 0.396 or 1.199 g TOS/kg/day). A similarly constituted control group received the vehicle (reverse osmosis water) at the same volume-dose (10 mL/kg body weight).
During the study, clinical condition, detailed physical and arena observations, sensory reactivity, grip strength, motor activity, body weight, food consumption, water consumption (by visual assessment), ophthalmic examination, haematology (peripheral blood), blood chemistry, organ weight, macropathology and histopathology investigations were undertaken.
General appearance and behaviour, sensory reactivity responses, grip strength and motor activity were not affected by treatment, there were no deaths during the treatment period and there was no effect of treatment on bodyweight gain or on food and water consumption. There were no treatment-related ophthalmic findings. The haematology and blood chemistry investigations during Week 13 did not identify any toxicologically significant differences from controls. Organ weights were unaffected and there were no treatment-related macroscopic or microscopic findings.
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