Module 14 2022
21/03/2022
Biological Evaluation Report - 2
Quantitative Formulation
Ingredient /Chemical
% w/w
Quality Standard
CAS No Function
Petrolatum 15% Ph Eur 8012-95-1 Emollient
The Organisation for Professionals in Regulatory Affairs
21
Biological Evaluation Report - 3
• Exposure Assessment and Calculation of Margin of Safety • Describes exposure conditions: frequency, duration, quantities • Describes method of calculation of MoS
• Toxicological Assessment of Components • Toxicity profiles of individual ingredients/components, inc MoS • Toxicity assessment of leachables/degradants
The Organisation for Professionals in Regulatory Affairs
22
11
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