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The Consortium for Environmental Risk Management, LLC. Elizabeth Becker, Ph.D. Manager of Technical Services Consortium for Environmental Risk Management (CERM) [email protected] With Peter Ranslow, Ph. D. (CERM) and Bernard Gadagbui, M. Sc., Ph. D., DABT (TERA).

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The Consortium for Environmental Risk Management, LLC

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The consortium for environmental risk management llc

The Consortium for Environmental Risk Management, LLC

Elizabeth Becker, Ph.D.

Manager of Technical Services

Consortium for Environmental Risk Management (CERM)

[email protected]

With Peter Ranslow, Ph. D. (CERM) and

Bernard Gadagbui, M. Sc., Ph. D., DABT (TERA)


The consortium for environmental risk management llc

Beyond Science and Decisions:

From Problem Formulation

to Dose-Response

Challenge: Evaluating Chemicals In The Absence Of Data

Case Study #6

Sustainable Futures™ Screening (Isodecyl Acrylate)


Sustainable futures approach

An Integrated Approach to Chemical Risk Screening

Phys/ChemProperties: EPI Suite

Environmental Fate: EPI Suite

Hazard

AIM (mammalian)

Exposure / Risk

ChemSTEER

Release amounts

Worker exposure

E-FAST Human Risk: Consumer dermal & inhalation exposure

SustainableFutures™ Approach


The consortium for environmental risk management llc

NONCANCER HAZARD ASSESSMENT

EVALUATE MAMMALIAN TOXICITY BASED ON EXPERIMENTAL DATA

NON-CANCER HEALTH EFFECTS

Acute Toxicity

Irritation

Skin Sensitizer

Reproductive Effects

Developmental Effects

Immune System Effects

Neurotoxicity

Genotoxicity

Mutagenicity

Systemic Effects

IF NO EXPERIMENTAL DATA, USE ANALOG IDENTIFICATION METHODOLOGY (AIM) TO SELECT ANALOG


The consortium for environmental risk management llc

AIM

(Analog Identification Methodology)

The AIM database contains 31,031 potential analogs with publicly available toxicity data

Enter chemical by CAS, SMILES, or Drawing structure

Uses a chemical fragment-based approach with 645 individual chemical fragments to identify potential analogs.


The consortium for environmental risk management llc

Uses a “three-pass” methodology to identify analogs:

Pass 1- Analogs are selected when a match of 645 possible chemical fragments occurs. If less than 7 analogs are identified, then:

Pass 2 - Analogs are selected when a match of 200 fragments occur and allows alkyl substitutions. If less than 7 analogs are identified again, then:

Pass 3 - Allows halogens (chlorine, bromine, or iodine) substitutions.

Results from first pass (search) are displayed in numerical order by CAS RN, followed by results from second, then third passes. First analog displayed may not be the closest analog with data.

AIM


E fast

HUMAN EXPOSURE

Considers human exposures due to

Industrial releases

Ingestion and inhalation

The use of consumer products

Inhalation and dermal

The disposal of consumer products

Ingestion

Estimates potential dose rates

For assessing cancer risk

Potential Lifetime Average Daily Dose (LADDpot) in mg/kg/day

For assessing chronic non-cancer risk

Potential Average Daily Dose (ADDpot) in mg/kg/day

For assessing acute non-cancer risk

Potential Acute Dose Rate (ADRpot) in mg/kg/day

E-FAST


Chemsteer

Chemical Screening Tool for Exposures and Environmental Releases

Estimates workplace exposures and releases to a chemical

in the absence of monitoring data

estimates are screening-level

uses EPA methods and models

uses EPA assumptions (worst case scenarios)

CHEMSTEER


Risk assessment

Risk = Hazard x Exposure

If Hazard = 0, (Low Toxicity Concern)

or

If Exposure = 0, (Minimal Exposure Expected)

Then LOW Potential for Risk!

Quantitative Measures of Risk:

HUMAN HEALTH

Calculate a “Margin of Exposure” (MOE) to evaluate risk to human health based on NOAEL or LOAEL In Toxicity Studies and Exposure Data From exposure models

Risk Assessment


The consortium for environmental risk management llc

Determining Human Health Risk

(Typical Non-Cancer Approach

For Calculation based on NOAEL (preferred)MOE ≤ 100 (Potential for Risk)MOE ≥ 100 (Low Concern for Risk)For Calculation based on LOAELMOE ≤ 1000 (Potential for Risk)MOE ≥ 1000 (Low Concern for Risk)Depending on philosophy and framework, these “Assessment Factors” may also be called: Safety Factor Application Factor Uncertainty FactorThe typically values used for these factors can vary dramatically depending on the framework you are operating under (EU vs. Canada vs. US vs. New Chemicals vs. Existing Chemicals, etc.)


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