Toxicology Report

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Dry Extract Refined From Birch Bark

Drug Overview

What is Dry Extract Refined From Birch Bark?

Dry Extract Refined From Birch Bark is a botanical material or multicomponent preparation rather than one structurally defined molecule. Refined dry extract of birch bark (Betulae cortex, from Betula pendula/B. pubescens), standardized to betulin (approx. 72-88% w/w) together with other triterpenes (betulinic acid, lupeol, oleanolic acid, erythrodiol); this is the active pharmaceutical extract used in the licensed wound-healing gel Oleogel-S10 (birch bark extract, INN ‘birch bark extract’, e.g. Filsuvez).

Biological effects arise from the combined and sometimes interacting constituents of the material, so a single molecular mechanism cannot represent the whole preparation; activity varies with species, plant part, chemotype, extraction solvent, ratio, and manufacturing controls. Major applications include traditional or herbal products, research on constituent profiles and bioactivity, raw-material authentication, chromatographic fingerprinting, quality control, and regulatory safety assessment.

Masuu Global provides end-to-end Environmental Risk Assessment (ERA) support for pharmaceutical and healthcare products, covering Phase I environmental exposure assessment, Phase II environmental fate and effects assessment, data-gap analysis, testing strategy, laboratory coordination and final regulatory-ready reporting.

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What's included:
ERA Phase I Evaluation, ERA Phase II Evaluation, Consortium Testing Support (OECD Ecotoxicology Study)
1,500+
Environmental & Regulatory
Risk Assessments Supported
70+
Subject Matter Experts
across global operations
12
In-House Ex-Agency
Regulatory & Scientific Experts
3
Expert Credentials:
ERT · UKRT · DABT

Regulatory Framework

Assessment Methodology

Masuu Global follows a science-based, tiered and risk-based ERA methodology, aligned with applicable international regulatory requirements. For human medicinal products, our approach is primarily guided by the EMA Guideline EMEA/CHMP/SWP/4447/00 Rev. 1, effective 1 September 2024, together with relevant OECD Test Guidelines and regional regulatory requirements.

EMA
ERA

EMA — Environmental Risk Assessment

Assessment of potential environmental exposure associated with the use, manufacture and disposal of medicinal products, with a structured approach to determine whether further environmental assessment is required.

Phase
I

Phase I — Environmental Exposure Assessment

Initial screening to determine potential environmental exposure, covering PEC calculation, physicochemical properties, usage and dosage data, environmental entry pathways, and persistence and fate considerations.

Phase
II

Phase II — Environmental Fate & Effects Assessment

Where Phase I indicates further assessment is required, Phase II provides detailed evaluation of environmental fate, persistence and ecological effects — including biodegradation, bioaccumulation, aquatic toxicity, PNEC derivation and PEC/PNEC risk characterisation.

OECD
GLP

OECD & International Testing Principles

Where laboratory studies are required, testing strategies are designed with consideration of relevant OECD Test Guidelines, GLP expectations and applicable regulatory requirements.

Risk
Env

Risk-Based Environmental Assessment

Integration of physicochemical data, environmental fate information, ecotoxicological data, existing literature, published studies, regulatory databases, usage data, and environmental monitoring data.

WoE

Weight-of-Evidence (WoE) Approach

A scientifically justified WoE approach integrates existing data and avoids unnecessary testing wherever scientifically and regulatorily justified.

ERA Assessment Pathway

Phase I → Phase II → Risk Characterization

Each phase builds on the prior tier — screening first, escalating only when the evidence demands it.

Phase I Screening

Environmental Exposure Assessment

Initial screening to determine whether the substance requires progression to Phase II.

  • Product and substance information review
  • Indication, dose and usage assessment
  • PEC calculation and environmental exposure estimation
  • Physicochemical property review
  • Initial environmental risk screening
  • Determination of Phase II requirement
Phase II Evaluation

Environmental Fate & Effects

Detailed evaluation when Phase I triggers further assessment.

  • Biodegradation, hydrolysis & photolysis
  • Adsorption/desorption behaviour
  • Bioaccumulation potential
  • Algal, Daphnia and fish toxicity
  • Chronic ecotoxicity, where required
  • PEC/PNEC risk characterisation
Consortium Testing Model

Laboratory Coordination & Study Execution

When regulatory testing is mandatory, Masuu coordinates with qualified GLP/appropriate testing laboratories and specialized scientific partners — giving clients a single point of contact across the full testing lifecycle.

Study Selection→ Protocol Development→ Lab Coordination→ Sample Management→ Study Execution→ Data Review→ Regulatory Interpretation→ ERA Integration

Final ERA Report — Contents

  • Executive summary
  • Substance & product information
  • Environmental exposure assessment
  • Phase I evaluation
  • Phase II assessment (where applicable)
  • Environmental fate assessment
  • Ecotoxicological assessment
  • PEC/PNEC calculations
  • Risk characterisation
  • Data gap evaluation
  • Testing rationale
  • Risk mitigation considerations
  • References and supporting scientific evidence

How We Work

Report Preparation Process

Every ERA follows a structured, tiered workflow designed to deliver scientifically defensible and regulator-ready assessments.

01

Comprehensive Data Collection

Product, substance, usage, physicochemical, toxicological, environmental and regulatory information collected and reviewed.

02

Phase I Environmental Screening

Environmental exposure assessment and determination of whether the assessment can conclude at Phase I or requires progression.

03

Phase II Evaluation

Detailed environmental fate and ecotoxicological assessment when Phase II is triggered.

04

Data Gap & Testing Strategy

Missing information identified and available alternatives evaluated before recommending additional testing.

05

Consortium Testing Support

Where testing is mandatory, Masuu coordinates with qualified testing partners through its Consortium Model.

06

Scientific & Regulatory Review

Integration and critical review of generated and existing data by experienced scientific and regulatory experts.

07

Final ERA Delivery

Comprehensive ERA report with transparent methodology, scientific rationale, calculations, conclusions and regulatory recommendations.

Ex-Agency Advantage

Why Masuu Global?

Our experienced regulatory and scientific experts bring a practical regulatory perspective — helping clients understand not only what data are required, but why they are required and how regulators may evaluate them.

✓
Regulatory expectation-driven assessmentsAligned with applicable global ERA requirements.
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Tiered assessment strategyPhase I screening followed by Phase II only when scientifically and regulatorily justified.
✓
Data gap optimisationLiterature, databases, read-across and in-silico information evaluated before recommending new testing.
✓
Consortium testing coordinationManaged laboratory engagement when mandatory studies are required.
✓
Integrated scientific interpretationEnvironmental fate, ecotoxicity and risk characterisation connected into one coherent assessment.
✓
Regulatory-ready documentationDesigned to support submissions, authority queries and technical reviews.
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Reduced testing burdenStructured data-gap and weight-of-evidence approach minimises unnecessary study requirements.
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Single-point coordinationAssessment, testing strategy, laboratory engagement and final ERA integration — one team.
✓
Global regulatory supportERA services spanning pharmaceutical and healthcare products across multiple markets.

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