Review of Halliburton Energy Services, Inc. (HESI)

Chemistry Scoring Index

Prepared for

Halliburton Energy Services, Inc.

P.O. Box 42806

Houston, TX 77242-2806

December 30, 2009

~ -~ Grad=ent

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Table of Contents

1 Introduction .............................................................................................................. 1

2 The CSI Approach is Scientifically Defensible ....................................................... 3

2.1 Review Criteria ................................................................................................................... 3

2.2 Description of the CSI ........................................................................................................ 4

2.3 Assessment of the Primary Review Criteria ....................................................................... 5

2.3.1 Selection of Hazard Categories: The CSI generally reflects a

comprehensive approach to hazard identification .................................................. 5

2.3.2 Selection of a Concentration Cut-Off Value: The CSI reflects an inclusive

approach to concentration cut-offs ......................................................................... 6

2.3.3 Assignment of Hazard Categories: The CSI reflects a comprehensive

approach to assigning hazards ............................................................................... 6

2.3.4 Data Sources: The CSI relies on a widely used and generally

comprehensive primary data source ....................................................................... 7

2.4 Assessment of the Secondary Review Criteria ................................................................... 7

2.4.1 Scoring of Chemicals with No Data Available: The CSI approach assigns

a higher hazard score when data are not available ................................................. 7

2.4.2 Weighting of Health vs. Environmental vs. Physical Safety Hazard

Criteria: The CSI’s approach to weighting its three hazard criteria is

appropriate for genetic hazard scoring .................................................................. 8

2.4.3 Weighting of Scores Between Hazard Categories Within a Criterion: The

CSI’s scoring is logical, and technically supportable ............................................. 8

2.4.4 Weighting Within a Hazard Category Based on Concentration: The CSI

scoring approach is logical, and technically supportable ....................................... 8

2.5 Summary ............................................................................................................................. 9

3

4

5

The CSI Approach is Comparable to Several Existing Ranking Systems ............. 10

3.1 Detailed Comparison ........................................................................................................ 11

3.1.1 Green Screen ........................................................................................................ 12

3.1.2 US EPA’s CHAMP ............................................................................................... 14

3.1.3 US EPA’s DIE General Screen for Safer Ingredients .......................................... 16

3.2 Summary ........................................................................................................................... 17

Implementation and Use of the CSI will Enhance HESI’s Corporate

Sustainability Strategies ......................................................................................... 18

Summary and Conclusions ..................................................................................... 19

References ......................................................................................................................... 20

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List of Tables

Table

Table

Table

Table

Table

Table

Table

Table

2.1a

2.1b

2.1c

2.2a

2.2b

2.2c

2.3

2.4

Table 3.1

Table 3.2

Table 3.3

CSI - Health Criterion

CSI - Physical Safety Criterion

CSI - Environmental Criterion

CSI Scoring Scheme - Health Criterion

CSI Scoring Scheme - Physical Safety Criterion

CSI Scoring Scheme - Environmental Criterion

Comparison of CSI and GHS Cut-Off Values

Total Possible Score per Hazard Criteria for a Single Chemical

CPA Green Screen for Safer Chemicals

US EPA CHAMP

US EPA DIE General Screen for Safer Ingredients

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List of Abbreviations

ACGIH

BCF

CEPA

CHAMP

CPA

CPSIA

CSI

DART

DIE

DSL

ECOSAR

E-FAST

EU

GHS

H

HAP

HBP

HESI

HPV

HSDB

HWP

IRCHS

IRIS

L

LOLI

M

MPV

MSDS

OECD

OPPT

OSHA

PBT

PVC

QSAR

RBP

REACH

RollS

RSEI

SCRAM

SIDS

TRI

TSCA

US

US EPA

V

VOCs

WMPT

American Conference of Industrial Hygienists

Bioconcentration Factor

Canada Environmental Protection Agency

Chemical Assessment and Management Program

Clean Production Action

Consumer Product Safety Improvement Act

Chemistry Scoring Index

Decision Analysis by Ranking Techniques

Design for the Environment

Domestic Substances List

Ecological Structure Activity Relationships

Exposure and Fate Assessment Screening Tool

Europe Union

Globally Harmonized System

High

Hazardous Air Pollutant

Hazard-Based Prioritization

Halliburton Energy Services, Inc.

High Production Volume

Hazardous Substances Data Bank

Hazardous Water Pollutant

Indiana Relative Chemical Hazard Score

Integrated Risk Information System

Low

List Of Lists

Moderate

Medium Production Volume

Material Safety Data Sheet

Organization for Economic Cooperation and Development

Office of Pollution Prevention and Toxics

Occupational Safety and Health Administration

Persistent, Bioaccumulative Toxics

Polyvinyl Chloride

Quantitative Structure Activity Relationship

Risk-Based Prioritization

Registration, Evaluation, Authorisation and Restriction of Chemical Substances

Restriction of Hazardous Substances

Risk-Screening Environmental Indicators

Scoring and Ranking Assessment Model

Screening Information Data Set

Toxics Release Inventory

Toxic Substances Control Act

United States

United States Environmental Protection Agency

Very High

Volatile Organic Compounds

Waste Minimization Prioritization Tool

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1 Introduction

Gradient was retained by Halliburton Energy Services, Inc. (HESI) to review a comprehensive

hazard evaluation system, which was developed by HESI, and is hereafter referred to as "the Chemistry

Scoring Index," or "CSI." HESI personnel described the CSI during several conference calls with

Gradient, and provided Excel spreadsheets to Gradient containing eight product use groups consisting of a

total of 127 products comprised of 300-400 chemicals. This information formed the basis for Gradient’s

evaluation of the CSI approach.

HESI formulates a variety of products with specific properties and performance characteristics,

which include various chemicals in a range of concentrations. The CSI compiles and ranks intrinsic

chemical hazard properties for products designed for the same use so that products can be compared

based on their relative potential health, physical safety, and environmental hazards. HESI undertook

development of the CSI primarily to satisfy internal needs that included a desire to:

Consider relative hazards in selecting products for use in operations;

Review and assess HESI’s current product portfolio; and

Consider relative hazards in formulating new products.

In addition to the internal drivers that led to its development, the CSI is responsive to certain

external influences, including a larger societal movement towards the use of "green products" and

legislative and regulatory changes. For example, various innovative retailers (e.g., Walmart, SC Johnson,

BASF) are adopting product and chemical management systems to better understand hazards associated

with chemical ingredients in the products they sell, and to find safer (e.g., less toxic or hazardous)

alternatives to chemicals of concern. These systems range from a reliance on restricted substance lists, to

proprietary evaluation systems, to product design strategies (Green Chemistry & Commerce Council,

2009). Further, legislation in the United States (US) and the European Union (EU) is increasingly

affecting industrial and consumer product and retailing companies. Two key pieces of legislation in the

EU are the 2006 Restriction of Hazardous Substances (RollS Directive, 2009), which restricts the use of

certain metals and flame retardants in electronic and electrical equipment imported into Europe, and the

2007 Registration, Evaluation, Authorisation and Restriction of Chemical Substances (REACH) Directive

(ECHA, 2009), which requires detailed information on each chemical’s uses and toxicity from

manufacturers and importers of chemicals into the EU. In the US, several states have passed legislation

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affecting chemical management (e.g., California’s Safe Drinking Water and Toxic Enforcement Act,

which requires labeling of products containing chemicals known to cause cancer, mutagenic, or

reproductive effects, and California’s Green Chemistry Program and draft Proposal for "Safer Alternatives

for Consumer Products" Rule). The most noticeable federal legislative initiatives in recent years have

been the 2008 Consumer Product Safety Improvement Act (CPSIA) (US Congress, 2008) and the United

States Environmental Protection Agency’s 2009 proposal to reform the 1976 Toxic Substances Control

Act (TSCA) (US EPA, 2009f). This general backdrop of increased interest in understanding more about

the safety and/or toxicity of chemical ingredients in products provides further impetus for development of

chemical management approaches such as that offered by the CSI.

Gradient’s review of the CSI began by the establishment of a set of driving principles:

The approach must be scientifically defensible;

The implementation must be transparent; and

The intended and actual use must be appropriate; that is, it must be consistent with the

goals of the CSI to identify and rank relative potential hazards for of products in the same

product use group.

The review of the CSI described here focuses on the CSI approach. Section 2 describes our

criteria and conclusions for assessing the scientific defensibility of the approach. Section 3 compares the

CSI to other similar ranking tools in the public domain. Section 4 focuses on expected implementation

and use of the CSI. Section 5 presents a summary and our conclusions.

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2 The CSI Approach is Scientifically Defensible

To review the scientific defensibility of the approach used by the CSI, Gradient considered a

number of components necessary for assessing relative hazards of chemicals or products. These include

the selection of hazard categories, the assignment of hazard categories to chemicals, and the data sources

that are relied upon. Gradient also reviewed the approach for evaluating chemicals with no data, and the

relative weighting of different types of hazards in assigning a total hazard score. In this section, we

describe the review criteria we selected to evaluate these components, the general approach of the CSI,

and how we evaluated the CSI against the review criteria.

2.1 Review Criteria

To review the scientific defensibility of the CSI approach, Gradient defined a set of primary and

secondary technical review criteria. Primary technical review criteria assess the approach for assigning

hazards to a chemical; that is, the appropriateness, adequacy, and accuracy of hazard assignment.

Secondary technical review criteria assess the scoring and ranking of products based on the chemical

hazards that have been assigned to its chemical components. Put differently, Gradient assumed that it was

primarily important for a hazard evaluation system to correctly and conservatively assign hazards to a

product (i.e., while a system might identify hazards too conservatively, we would not want it to

underestimate or fail to identify chemical hazards), while it was secondarily important for those hazards

to be combined into an appropriate product score/rank.

Our primary technical review criteria include the following:

Selection of hazard categories;

Selection of a concentration cut-off value for scoring of a chemical component;

Assignment of hazard categories to chemicals; and

Data sources.

Our secondary technical review criteria include the following:

Scoring of chemicals with no data available;

Weighting of health vs. environmental vs. physical safety hazard criteria;

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Weighting of scores between hazard categories within a criterion; and

Weighting within a hazard category based on concentration.

2.2 Description of the CSI

The CSI compiles and scores intrinsic chemical hazard properties for products designed for the

same use so that products can be compared to other products in the same product use group based on their

potential health, physical safety, and environmental hazards. A primary distinction between the CSI and

other available hazard ranking tools is that the CSI was developed to rank products (which may contain

one or more chemicals), while other tools are focused on individual chemicals. In the CSI, a health

hazard score, an environmental hazard score, and a physical safety hazard score are given to each of the

product chemical components and these scores are added together to compile a total hazard score for the

product. Products that score lowest within a product use group have a lower intrinsic hazard and can

potentially be considered as more environmentally responsible.

As a formulator, HESI relies on the chemical information provided by its suppliers. After

defining the component make-up of a product, to the extent practical, the CSI compiles information for

each chemical component of a product on three hazard criteria - health, environmental, and physical

salty. In contrast to some systems, the CSI defines the health hazard criterion as addressing worker

health, whereas the environmental hazard criterion addresses ecological health as well as populationbased human health. This is a broader definition of the environmental hazard criterion than found

elsewhere. Each criterion consists of several hazard categories, including those defined in the United

Nations’ Globally Harmonized System (GHS) of Classification and Labeling of Chemicals (UN, 2007)

system, supplemented with additional non-GHS hazard categories. The following hazard categories are

included within each criterion in the CSI:

Health Criterion: carcinogenicity, mutagenicity, reproductive toxicity, endocrine

disruptors, sensitizers, acute toxicity, corrosivity, acute target organ toxicity, chronic

target organ toxicity, and aspiration;

Environmental Criterion: acute aquatic toxicity, chronic aquatic toxicity, ozone

depletion, volatile organic compounds (VOCs), hazardous air pollutants (HAPs),

hazardous water pollutants (HWPs), biodegradation, and bioaccumulation; and

Physical Safety Criterion: explosive, pyrotechnic, flammable gas, oxidizing gas, gases

under pressure, flammable liquid, flammable solid, self-reactive substance, pyrophoric,

self-heating substance, emit flammable gas in contact with water, oxidizing liquid,

oxidizing solid, organic peroxide, corrosive to metals.

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Each of the hazard categories is associated with a set of definitions, shown in Tables 2. la-c. To

assign hazard categories consistent with these definitions, the CSI relies on the List Of Lists (LOLI)

Database,1 which contains over 3,100 regulatory lists from around the world, including those that

summarize environmental, health, and safety regulations, international regulations, chemical inventories,

and reference material necessary for Material Safety Data Sheet (MSDS) preparation. After hazard

categories are assigned to each of the product chemical components, hazard scores are assigned based on

the CSI’s scoring matrix (shown in Table 2.2a-c). The scoring matrix specifies maximum scores for each

hazard category and reflects the relative weighting between hazard categories within a hazard criterion as

well as between hazard criteria. Within each hazard category, hazard scores are assigned based on the

percentage of the chemical component in the product, i.e., higher percentage ranges of the chemical in the

product can result in a higher hazard score.

After assigning scores in each hazard category to each chemical product component, hazard

scores are added for each criterion. This results in a health hazard score, an environmental hazard score,

and a physical safety hazard score. The product hazard score is the sum of the three hazard criteria

scores, and is used to rank products within a product use group, as well as comparatively against each

other. In the CSI, a higher score implies a product with a greater intrinsic hazard.

2.3 Assessment of the Primary Review Criteria

This section describes the application of our primary review criteria to the CSI.

2.3.1 Selection of Hazard Categories: The CSI generally reflects a comprehensive approach to

hazard identification

Proper hazard category selection is a key component of total hazard ranking, requiring a balance

between comprehensiveness and redundancy. HESI has primarily based its hazard category selection on

the GHS, but has added several additional hazard categories, reflecting a more comprehensive approach

to hazard identification. Additional categories included in the CSI but not considered under the GHS are

endocrine disruptors, HAPs, HWPs, ozone depletors, VOCs, and two separate biodegradability hazard

1 The LOLI Database is the property of ChemADVISOR, Ine, and provides a pay-for-use service, including extensive GHSrelated regulatory data (http://www.chemadvisor.com/) (ChemADVISOR, Inc., 2009).

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categories. The inclusion of these additional hazard categories allows for a more inclusive identification

of potential hazards.

2.3.2 Selection of a Concentration Cut-Off Value: The CSI reflects an inclusive approach to

concentration cut-offs

The CSI assesses hazard potential, based, in part, on the concentration of each chemical in the

finished product. Use of a concentration cut-off value means that chemicals present in a product at

concentrations below the cut-off value would not be identified as hazardous, regardless of the chemical’s

intrinsic properties. Lower cut-off values allow for more chemicals to be "screened in" to the hazard

evaluation, while higher cut-off values mean that more chemicals are excluded. All of the cut-off values

currently used in the CSI are either equally or more stringent than the cut-offs used by GHS (i.e., more

compounds were screened into the CSI assessment). A comparison of the CSI and GHS cut-offs is

presented in Table 2.3.

While the CSI’s concentration cut-off criteria are more inclusive than those used in the GHS,

Gradient understands that the HESI will go a step further by requesting that its suppliers provide full

analytical disclosure of all product constituents in the future. This information will be used to include all

known chemicals in a product in future hazard evaluations, effectively as if there were no concentration

cut-off. This step will make the CSI far more comprehensive than the GHS approach in that many more

chemicals at low concentrations will potentially be included in the hazard assessment.

2.3.3 Assignment of Hazard Categories: The CSI reflects a comprehensive approach to assigning

hazards

The inclusion criteria used by the CSI to assign chemicals to a certain hazard category is also

largely based on the GHS. Departures from the GHS categories reflect a comprehensive approach aimed

at maximizing the number of identified hazards. This methodology was generally evident in the

evaluations of health, environmental, and physical safety hazards.

In the health criterion, for example, some of the GHS categories that had a tiered classification

(i.e., classification based on degrees of toxicity) were rolled up into one category in the CSI. Specifically,

while the GHS differentiated between Category I and II reproductive toxins, the CSI treated all

reproductive toxins as equally toxic. Similarly, mutagens were divided into two distinct classes under the

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GHS scheme, while the CSI assumed toxic equivalency for all identified mutagens. The CSI also

combined GHS-Class II and III irritants into one category.

In the environmental assessment, the cut-off for defining a chemical as bioaccumulative

[bioconcentration factor (BCF) > 500] in the CSI is set conservatively low. For instance, a BCF cut-off

of 1,000 is used in PBT Profiler, a tool developed for US EPA’s Office of Pollution Prevention and

Toxics (OPPT).2

In the physical safety hazards assessment, the categories evaluated by the CSI mirror those

defined by the GHS, with a single minor exception. The GHS considers explosives as a general category,

and includes pyrotechnic chemicals; the CSI evaluates these as separate categories.

2.3.4 Data Sources: The CSI relies on a widely used and generally comprehensive primary data

source

The accuracy of the hazard evaluation is highly dependent on the reliability of the data sources

and the consistent application of that information to the chemicals which comprise the product. The CSI

relies on the LOLl database (ChemAdvisor, 2009), which is a comprehensive source of worldwide

regulatory lists including environmental, health, and safety, international regulations, chemical

inventories, and reference material necessary for MSDS preparation. This is an acceptable primary data

source. HESI may choose to augment this source with additional data sources.

2.4 Assessment of the Secondary Review Criteria

This section describes the application of our secondary review criteria to the CSI.

2.4.1 Scoring of Chemicals with No Data Available: The CSI approach assigns a higher hazard

score when data are not available

The CSI approach documents lack of chemical information on a chemical-specific basis, and

assigns a numerical score that is added to the product’s total hazard score. This ensures that products will

not be identified as non-hazardous solely on the basis of a lack of chemical data.

2 PBT Profiler. Persistent, Bioaeeumulative, and Toxic Profiles Estimated for Organic Chemicals On-Line.

http://www.pbtprofiler.net/(ESC, 2006).

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2.4.2 Weighting of Health vs. Environmental vs. Physical Safety Hazard Criteria: The CSI’s

approach to weighting its three hazard criteria is appropriate for generic hazard scoring

Under the current scheme, a single chemical can potentially receive the highest total hazard score

in the environmental hazard criterion, followed by the physical safety and health hazard criteria (see

Table 2.4), in the unlikely event that the chemical receives the maximum possible score in every hazard

category within the criteria. We consider this acceptable given that the environmental hazard criterion

includes hazards to both the general population and to ecological systems. Other than the somewhat

uneven total possible score for each hazard criterion, all hazard criteria are weighted equally when added

together, i.e., no hazard criteria score is added in multiples. Situations may arise, however, where more

interest in a certain hazard may be warranted. Overall, the approach to weighting health vs.

environmental vs. physical hazards in the CSI is appropriate for generic hazard scoring (i.e., when no

hazard criterion is implicitly assumed to be of greater concern because of a specific use setting).

2.4.3 Weighting of Scores Between Hazard Categories Within a Criterion: The CSI’s scoring is

logical, and technically supportable

Within each hazard criterion, HESI made professional judgments about the relative importance of

certain hazard categories by assigning different maximum scores. For example, the maximum score

assigned to a known human carcinogen is 100, twice the maximum score assigned to a reproductive toxin

(see Table 2.2a-c). These same types of relative scoring judgments also extend across hazard criteria.

For example, a chemical assigned to the bioaccumulative environmental hazard category can receive a

maximum score of 50. This is twice the maximum score that can be received by a gas under pressure

under the physical safety criterion. Despite the professional judgment involved in assigning these relative

weights, the impact of alternative weightings on total hazard scores does not appear to be significant.

That is, it is unlikely that a different product would be identified as substantially less hazardous on the

basis of a change in the maximum score received by a human carcinogen from 100 to 200. Overall, we

agree that there is logic in prioritizing certain hazards above others.

2.4.4 Weighting Within a Hazard Category Based on Concentration: The CSI scoring approach

is logical, and technically supportable

The use of weighting within a hazard category implies a defined quantitative relationship between

chemical concentration and degree of hazard. For example, in the chronic aquatic toxin category, the CSI

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scoring approach assumes that a chemical present at 5-9.9% is four times more hazardous than a chemical

present at 0.001 to 0.09%. Although a defined quantitative relationship between chemical concentration

and degree of hazard is a function of chemical-specific toxicity information and properties, the generic

approach taken in the CSI is preferable to assuming that a chemical’s hazard is equal at all concentrations.

This approach allows for distinctions to be made between products that contain a high concentration of a

hazardous chemical and those containing a very low concentration of the same chemical.

2.5 Summary

The CSI approach is sufficiently based on existing chemical hazard identification systems.

Specifically, the choice to rely on the GHS approach is sound. The GHS system is globally recognized,

and the result of an extensive harmonization effort by a multitude of countries, international

organizations, and stakeholders. Furthermore, the CSI approach is more comprehensive than the GHS in

its hazard identification by inclusion of additional hazard categories (i.e., VOCs, HWPs, HAPs, ozone

depletors, endocrine disruptors, and a second biodegradability category), by using concentration cut-off

values that are set equal to or lower than those defined in the GHS, by striving to include all identified

chemicals without regard to a concentration cut-off, and by assigning hazard scores when data are not

available. We conclude that the CSI’s overall approach is scientifically defensible, and as comprehensive,

or more comprehensive, in its hazard identification step than the GHS on which it is based.

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3 The CSI Approach is Comparable to Several Existing Ranking

Systems

As a further approach to ascertaining the scientific defensibility of the CSI, Gradient identified

approximately 25 other existing hazard and/or risk-based ranking, scoring and assessment systems or

tools currently in development or use, from which we chose three for a detailed comparison with the CSI.

This list of assessment systems described below is not comprehensive.

Although the systems we identified exhibit many similarities to each other, they encompass

several different categories of approaches, including the following:

Guidance/decision tree approaches that provide a framework for chemical evaluation. In

general, these are transparent, fully-documented decision tree approaches to evaluating

chemicals that involve comparing chemical toxicity information to established criteria.

Due to their transparency and documentation, these systems are among the easiest to

compare to the CSI approach. Examples include:

US EPA’s Design for the Environment (DIE) General Screen for Safer

Ingredients (US EPA, 2009a);

US EPA’s Chemical Assessment and Management Program (CHAMP)

methodology (US EPA, 2009b);

US EPAAJniversity of Tennessee Method for Ranking and Scoring Chemicals

(Davis et al., 1994); and

Organization for Economic Cooperation and Development’s (OECD) High

Production Volume (HPV) Chemical Evaluation/Screening Information Data Set

(SIDS) Analysis (OECD 2000, 2003, 2005, 2006, 2008, 2009a, b).

Automated software/database ranking and scoring tools that provide chemical-specific

numerical ranking based on hazards. Most of these tools require some level of manual

data input/entry (e.g., chemical properties, toxicity information) into spreadsheets or

other data platforms, then automatically generate a chemical score or rank relative to

other chemicals. Some of the tools we identified include the following:

Canada Environmental Protection Agency’s (CEPA) Domestic Substances List

(DSL) search engine (CEPA, 2006);

Scoring and Ranking Assessment Model (SCRAM) (Snyder et al., 2000a, b,c,d);

Indiana Relative Chemical Hazard Score (IRCHS) (Whaley, 1996);

EU’s Decision Analysis by Ranking Techniques (DART) (Pavan and Worth,

2008); and

US EPA’s Waste Minimization Prioritization Tool (WMPT) (US EPA, 1997).

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"Green Chemistry" labeling and product/life cycle assessment tools’, which are used to

determine whether a chemical is safe or "green," and/or evaluate resource consumption

and environmental burdens associated with product chemicals at every point during the

product’s life. Some of the tools we identified implement automated processes, while

others are documented guidance or decision tree approaches.

following:

Examples include the

Green Screen (CPA, 2007);

EU’s Eco Label program (EP, 2000);

SC Johnson’s proprietary tool Green List (Five Winds International, Undated-a);

Cradle to Cradle Protocol (MBDC, 2009); and

Eco-Efficiency (BASK 2008; Five Winds International, Undated-b; Saling et al.,

2002).

Data generation tools’ that provide predictive and/or risk-based assessment for chemicals.

These tools also consider toxicity and other factors, but generate new information or data

for chemicals being assessed. For example:

US EPA’s PBT Profiler (ESC, 2006) estimates persistence, bioaccumulation, and

toxicity for chemicals that lack existing experimental data;

US EPA’s Exposure and Fate Assessment Screening Tool (E-FAST) (Versar,

Inc., 200) calculates human potential dose rates for a wide variety of chemical

exposure routes and estimates the number of days per year that a concentration

corresponding to an aquatic ecotoxicity concern will be exceeded for organisms

in the water column;

US EPA’s Ecological Structure Activity Relationships (ECOSAR) tool (US EPA,

2009c) estimates a chemical’s acute toxicity and chronic toxicity to aquatic

organisms such as fish, aquatic invertebrates, and aquatic plants by using

structure activity relationships;

CalTox (McKone and Enoch, 2002) is a risk assessment model that calculates the

emissions of a chemical, the concentration of a chemical in soil, and the risk of

an adverse health effect due to a chemical; and

US EPA’s Risk-Screening Environmental Indicators (RSEI) (US EPA, 2009e) is

a computer-based screening tool that analyzes risk factors to put Toxics Release

Inventory (TRI) release data into a chronic health context.

3.1 Detailed Comparison

Of the ranking/assessment systems identified, we selected three for a more detailed comparison to

the CSI to further evaluate overall soundness and scientific defensibility of the approach. The selected

systems are Clean Production Action’s (CPA) Green Screen (CPA, 2007), US EPA’s CHAMP (US EPA

2009b,e), and US EPA’s DfE General Screen for Safer Ingredients (US EPA, 2009a). In general, these

systems were selected because they consider hazard criteria similar to those evaluated by the CSI (i.e.,

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health, environmental, and physical safety) and include transparent documentation and/or guidance.

Gradient relied on the primary and secondary technical review criteria established above, as well as

several other attributes, to evaluate the ranking schemes and compare them, in general terms, to the CSI.

Tables 3.1 through 3.3 provide details regarding each of the systems.

Other systems were excluded from consideration for a detailed comparison for one or more

reasons. For example, a number of systems are proprietary and are not publicly available [e.g., SC

Johnson GreenList (2004), BASF EcoEfficiency (Lawson et al., 2002; Lee et al., 1998), Walmart

GreenWercs (The Wercs Ltd. Co., 2009)]; thus, a more detailed comparison with the CSI was not

possible. Other systems provided very limited information regarding approach and evaluation criteria;

thus, a more detailed comparison was not possible [e.g., the EU EcoLabel (EP, 2000)]. Finally, some of

the systems do not consider each of the three hazard criteria evaluated by the CSI (health, environmental,

and physical safety); thus, an in-depth comparison to the CSI would be less useful [for example, the

Offshore Chemical Notification Scheme (Cefas, 2009a,b) was not selected for comparison because the

system is focused primarily on ecological hazards].

3.1.1 Green Screen

CPA’s Green Screen (CPA, 2007) (see Table 3.1) is a publicly available, hazard-based screening

method used to evaluate individual chemicals (and their byproducts) in consumer/industrial products.

Green Screen was selected for comparison to the CSI because it defines a comprehensive list of categories

and criteria for health, environmental, and physical safety hazards; thus, it is very similar in approach to

the CSI. Also, like the CSI, hazard categories and evaluation criteria are largely based on the UN’s GHS

(UN, 2007), as well as US EPA’s DfE program (US EPA, 2009a), thus the approach may be considered

scientifically sound. Finally, the Green Screen is documented in a transparent written guidance, with

well-defined hazard categories, evaluation criteria, and data sources, facilitating a more detailed

comparison review.

Green Screen was developed recently (2007) and its use is not yet widespread. However, it has

been used by some prominent companies. For example, according to the CPA website (CPA, 2009),

Green Screen was used by Walmart to develop their "GreenWercs" software tool (this program analyzes

the composition of individual products from ingredient data entered by manufacturers, examining its

potential impact on human health and the environment and plotting its combined score). In addition,

Hewlett-Packard is using the Green Screen to assess alternatives to brominated flame retardants and

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polyvinyl chloride (PVC) plastics. The state of Washington has used the Green Screen as an alternatives

assessment tool to determine if safer alternatives to Deca-BDE, a flame retardant used in television

casings and upholstery, existed on the market.

Green Screen’s approach is based on US EPA’s DIE program (US EPA, 2009d), and defines four

Benchmarks to indicate whether chemicals used in products are safe. Green Screen defines "threshold

values" for all chemical hazards evaluated (e.g., carcinogenicity, bioaccumulation, flammability). Based

on a comparison to the threshold values, chemicals AND their breakdown products/metabolites are

categorized as Very High (V), High (H), Moderate (M), or Low (L) for each of the hazards evaluated.

Chemicals are then placed within one of the four Benchmarks based on their categorization for each of

the hazards and the standards or criteria established for each of the Benchmarks. These Benchmarks are

as follows:

Benchmark 1 - Avoid, Chemical of High Concern: chemicals categorized as high/very

high PBT and human toxicity hazards;

Benchmark 2 - Use, but search for safer substitutes: chemicals categorized as

moderate/high PBT, human toxicity, flammable, or explosive hazards;

Benchmark 3 - Use, but still opportunity for improvement: chemicals categorized as

moderate PBT, ecotoxicity, or flammable, or explosive hazards; or

Benchmark 4 - Prefer, Safer Chemical: encompasses those chemicals categorized as

having low inherent toxicity to humans and wildlife.

Thus, if a chemical and its breakdown products were characterized as Low for each of the hazards

evaluated, that chemical would be placed in Benchmark 4. However, if the chemical was categorized as

Moderate for one of the hazards, that chemical might be placed in Benchmark 3. One aspect of Green

Screen that differs from the CSI is that each chemical AND its breakdown products/metabolites are used

to assign a chemical to a Benchmark. For example, a chemical might fall into the Benchmark 4 category

based on its own properties, but into the Benchmark 3 category when its breakdown products are

considered. In addition, in contrast with the CSI, there is no actual "scoring" of chemicals.

Green Screen’s hazard evaluation categories and criteria are based largely on those defined in US

EPA’s DIE as well as the UN GHS (UN, 2007). The hazard categories evaluated during Green Screen are

similar to those evaluated by the CSI, with some discrete differences.

Health: Green Screen evaluates neurotoxicity and immunotoxicity as separate categories,

while the CSI considers select endpoints for these categories under chronic toxicity.

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Aspiration hazards are not considered in Green Screen, although they are a hazard

category under the GHS and are evaluated by the CSI.

Environmental: Green Screen and the CSI both consider acute and chronic aquatic

toxicity, persistence (biodegradation), and bioaccumulation. Green Screen does not

consider several CSI environmental categories, i.e., VOCs, HAPs, HWPs, and ozone

depletion.

Physical Safety Hazards’: Green Screen considers only flammability and explosivity as

part of the physical safety hazard screen. The CSI considers all GHS physical safety

hazard categories.

Regarding data gaps and resources, the Green Screen recommends several approaches. It favors

what is called a "Comprehensive Data Approach," using existing experimental data to identify levels of

concern for as many hazards as possible, then using Quantitative Structure Activity Relationship (QSAR)

analyses to fill as many data gaps as possible. Another approach defined by Green Screen assesses

"Common Sense Data Sources" such as MSDSs, the Hazardous Substances Data Bank (HSDB), the

Integrated Risk Information System (IRIS), etc. A third approach used in Green Screen is the "Limited

Set of Hazards Approach," by which chemicals would be benchmarked based on a few hazards for which

experimental and QSAR data are available. This approach is useful when one is concerned with only

certain types of hazards as might be appropriate in some use settings. Note that chemicals for which there

are insufficient data are flagged and, in certain cases, may not be evaluated/benchmarked.

3.1.2 US EPA’s CHAMP

US EPA’s CHAMP (US EPA, 2009b,e) outlines guidance for qualitative Risk-Based Prioritization

(RBP) of HPV chemicals, as well as Hazard-Based Prioritization (HBP) for Medium Production Volume

(MPV) chemicals (see Table 3.2). The RBP and HBP screening evaluate most of the same hazard

categories; however, the RBP evaluates environmental fate (mobility, volatility, hydrolysis, photo- and

bio-degradation), and physical properties. These are not evaluated during the HBP. CHAMP was selected

for comparison to the CSI because it is a publicly available approach to hazard screening, documented in

a fairly transparent written guidance, with defined hazard categories, evaluation criteria, and data sources.

For this evaluation we compare the CSI to the RBP because the RBP incorporates physical

properties of chemicals and environmental fate, while HBP does not. During an RBP, chemicals undergo

qualitative hazard, risk, and exposure screenings based on US EPA-defined evaluation criteria. RBPs are

developed for chemicals for which adequate hazard and exposure/use information is available, while

HBPs are developed for MPVs which are less likely to have information available to develop exposure

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and risk characterizations to support an RBP. The findings of the screenings are summarized in written

reports. US EPA’s OPPT uses the findings to prioritize chemicals as low (follow-up action not suggested

at this time), medium (available information suggests possible concerns that might be resolved if

additional data were available), or high priority (available information suggests that these chemicals

appear to have more serious potential risk concerns; US EPA will encourage voluntary actions to

understand/mitigate risk and will also determine if regulatory actions are needed).

The hazard categories defined in CHAMP are based on OECD SIDS. Although the overall

approach to CHAMP is different than the CSI, the hazard categories evaluated during CHAMP are quite

similar to those evaluated by the CSI. Comparing ChAMP’s categories to the CSI, we find the following:

Health: CHAMP evaluates neurotoxicity and immunotoxicity as separate categories,

while the CSI considers select endpoints for neurotoxicity and immunotoxicity under the

chronic toxicity category. Aspiration and corrosivity hazards are not considered in

ChAMP, although they are evaluated by the CSI.

Environmental: CHAMP includes several environmental fate criteria not specifically

considered by the CSI - these include mobility, hydrolysis, and photo degradation.

ChAMP also considers volatility, ready/environmental biodegradation, persistence,

bioaccumulation, and aquatic toxicity, which are considered by the CSI. CHAMP does

not consider several CSI environmental categories - i.e., HAPs, HWPs, ozone depletion -

as specific categories.

Physical Hazards’: CHAMP evaluates only two properties under physical hazards - vapor

pressure and water solubility. The CSI considers all GHS physical hazard categories.

For the "hazard" screening portion of the RBP, CHAMP relies upon the National Library of

Medicine Databases, which allow searches of numerous data sources and databases, including PubMed,

the Hazardous Substances Database Bank, Science Direct, etc. A primary difference between the CSI

approach and ChAMP is that CHAMP does not rely on a single database for information, and also

expands its searches/review beyond regulatory boundaries. CHAMP is thus more comprehensive in its

research/review of data sources. The ChAMP RBP guidance document outlines an extensive list of

public sources searched by US EPA to obtain physical/chemical properties, hazard, and

exposure/use/release information.

As discussed above, RBPs are developed for chemicals for which adequate hazard and

exposure/use information is available. While HBPs are not the focus of our detailed comparison, it is

important to point out that chemicals evaluated during an HBP are generally not as well-characterized,

therefore, the available data are flagged for data adequacy. For example, the data are summarized in

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tables, and "measured" data values are clearly flagged as such, while "experimental" data are flagged with

symbols indicating whether they are categorized as either a "value from guideline study, clear weight of

evidence, or evaluated database," a "value from non-guideline but reliable experimental study," or a

"value reported without supporting details." Estimated data are also flagged/identified. When data are

not available, OPPT uses expert judgment and may use one or more estimation approaches (e.g.,

QSARS). Lack of available data may influence the prioritization of a chemical - i.e., a chemical with

data gaps may be categorized as a medium, not low, priority.

3.1.3 US EPA’s DfE General Screen for Safer Ingredients

US EPA’s General Screen for Safer Ingredients (US EPA, 2009d) is a publicly-available system

developed under US EPA’s DfE Program that is designed to delineate the safer or "low-concern" end of

the ingredient spectrum for chemicals used in consumer products, and to guide and ensure best-in-class

ingredient choices for DfE-recognized products (see Table 3.3). The DfE was selected for comparison

with the CSI because it is an established US EPA program that is widely recognized, highly regarded, and

currently implemented. Many well known consumer product companies such as SC Johnson and

Colgate-Palmolive have established partnerships with US EPA’s DfE program, and numerous consumer

products meeting the screening process carry the DfE label. GreenBlue has partnered with US EPA DfE

to develop the "CleanGredients" software tool, which used the DfE approach as the basis for evaluating

and verifying the surfactant and solvent chemicals contained in its database. In addition, the DfE screen

has a fairly transparent written guidance with clearly-defined evaluation criteria for comparison,

facilitating a more detailed comparison. Finally, like the CSI, DfE uses toxicological thresholds defined

in the GHS (UN, 2007), but also uses some thresholds defined in CHAMP.

Determinations using the DfE General Screen distinguish safer chemicals, and are not

classifications. The DfE also calls on the expertise of US EPA’s OPPT. It differs from the CSI in that

DfE is a pass/fail approach - there is no "scoring" per se - and chemicals are either considered DfEapproved or not DfE-approved depending on whether they meet threshold criteria within all of the

categories evaluated. For example, a chemical classified as an IARC Group 1 carcinogen will not pass

the DfE General Screen. In addition to the DfE General Screen, customized screens and standards have

been developed for select industries and consumer products (e.g., household cleaning products).

The DfE’s hazard categories and evaluation criteria are based on CHAMP (US EPA, 2009d) and

the UN GHS (UN, 2007). The DfE General Screen also defines preferred and acceptable test methods for

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the categories evaluated. DIE’s General Screen considers health, environmental, and physical safety

hazard categories that overlap with the CSI approach. Comparing DIE to the CSI, we find the following:

Health: The DIE considers neurotoxicity as a separate category, while the CSI considers

select endpoints for neurotoxicity under the chronic toxicity category.

Environmental: Similar to the CSI, the DIE considers acute aquatic toxicity, persistence

(biodegradation), and bioaccumulation potential. While the CSI also considers chronic

aquatic toxicity, DIE does not. DIE also does not consider several HESI environmental

categories - i.e., HAPs, HWP, ozone depletion - as specific categories.

Physical Hazards’: Although physical safety hazards are not addressed in the General

Screen, several of the customized screening protocols and standards do include this as an

evaluation category. The CSI considers all GHS physical safety hazard categories.

3.2 Summary

Our general comparison of the CSI to other ranking and scoring systems demonstrates that most

existing systems are fairly consistent with regard to approach and the hazard categories evaluated. The

CSI shares many similarities with some of those systems, indicating that the overall approach is sound

and scientifically defensible.

Our detailed comparison of the CSI approach to three of these systems (Green Screen, US EPA’s

CHAMP, and US EPA’s DIE) also indicates significant similarities in approach, as well as some

differences. Some of the other systems we identified consider a broader suite of data sources to evaluate

and score hazards (i.e., they rely on data sources beyond what is compiled in the LOLI). It is unclear if

the reliance on these additional data sources would have a significant impact on the scoring of chemicals

contained within HESI’s current product portfolio. There are clear advantages in relying on a single broad

data compilation source such as the LOLI database in that it allows for quick hazard scoring and ranking,

the LOLI database is automatically updated, hazard scores can be more easily automated and

implemented, and the effort is less labor-intensive.

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4 Implementation and Use of the CSI will Enhance HESI’s

Corporate Sustainability Strategies

Final implementation of the CSI will include a manual that describes the development and

appropriate use of the system. This manual will describe the approach, and technical and professional

judgment decisions that led to the implemented hazard scoring matrix. Uncertainties will be disclosed

and described. Data sources relied upon by the CSI will be identified and prioritized, with a decision tree

that describes the hazard assignment process. The system will undergo a thorough quality control check.

Use of specialized software will ensure the consistent application of databases and assignment of hazard

categories and scores to chemicals. A protocol for revisions will be developed so that updates to chemical

information will be made as new data become available.

The CSI is a hazard ranking tool, and does not at this time provide risk ranking ability. Although

hazard and risk ranking may give similar results, one can imagine that a hazard ranking system might give

equal rank to two chemicals that are assigned to the same hazard category and have the same

concentration, while a risk ranking system might give different rank based on the relative toxicity of the

two chemicals. Documentation will describe to all potential users the differences between relative hazard

and relative risk and make clear that the CSI is a hazard ranking tool. The appropriate use of the CSI is to

identify the presence of a hazard, thus identifying the subsequent potential need to minimize exposure and

resulting risk.

Based on our review, we believe that the CSI will allow HESI to meet its original goals:

To assist in selecting less hazardous products for use in HESI’s operations;

To review and assess intrinsic hazards associated with HESI’s current chemical/product

portfolio; and

To assist in formulating new, less hazardous, products.

Consistent use of the CSI could enhance HESI’s product management and corporate sustainability

strategies.

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5 Summary and Conclusions

On the basis of our detailed review of the CSI approach, Gradient concludes that the CSI

approach is scientifically defensible and provides a very credible means of comparing the intrinsic

hazards of chemical products in a product use group. The CSI approach is sufficiently based on existing

chemical hazard identification systems, specifically, the GHS approach, which is globally recognized, and

the result of an extensive harmonization effort by a multitude of countries, international organizations,

and stakeholders. Furthermore, we believe the CSI is more comprehensive than the GHS in its hazard

identification because of its inclusion of additional hazard categories.

Comparison of the CSI to other ranking and scoring systems shows a general consistency with

regard to approach and the hazard categories chosen for evaluation. The CSI shares many similarities

with some of those systems, further augmenting our conclusion that the overall approach is sound and

scientifically defensible. Our detailed comparison of the CSI approach to three of these systems (Green

Screen, US EPA’s CHAMP, and US EPA’s DfE) indicated significant similarities, and a few differences,

in the approach to hazard identification. Gradient concludes that the CSI is more comprehensive than

these other systems in the areas of environmental and physical safety hazards because the CSI includes

more hazard categories in these criteria. While the other systems we evaluated included a few additional

health hazard categories not explicitly considered by HESI, the CSI does consider select endpoints for

these categories. We therefore conclude that the CSI is comprehensive in its health hazard analysis as

well.

Based on the scientific defensibility of the approach, and the comparability to other ranking

systems, we believe that the CSI will aid HESI in meeting its goals of selecting and developing less

hazardous products for use in its operations. Furthermore, consistent use of the CSI could enhance

HESI’s product chemicals management and corporate sustainability strategies.

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Accessed on October 29, 2009 at www.ecn.purdue.edu/CMTI/IRCHS/IPWRKHZ3.RPT.doc, 56p.,

February 18.

G:\Projects~209095 FracFluids~D eliverables\Shor tRepor t\Final\Shor

tRepor~ fiilul.docx 23 Gradient

HESI302009
Tables

HESI302010
Table 2.1a

CSI - Health Criterion

Hazard Category

Carcinogenicity Cat. 1

(Known Human

Carcinogen)

Carcinogenicity Cat. 2

(Suspected Human

Carcinogen)

Mutagenicity

I Definitions

According to criteria (weigbt of the evidence), the substance is known or presumed to have carcinogenic potential in

humaaas.

IARC Group 1 aaad Group 2A

ACGIH Categor~ A1

NTP - Known Human Caxcinogens

EU - Dangerous Substaaaces Directive - Carcinogens Category 1 and Category 2

Substance is present at > 0.1% in the product and is on one of these lists:

ACGIH - Threshold Limit Values - Carcinogens (Categor~ A1)

IARC - Group 1 (Carcinogenic to Humaaas)

IARC - Group 2A (Probably Carcinogenic to Humaaas)

NTP (National Toxicology Program) - Report on Carcinogens - Known Humaaa Carcinogens

EU - CLP (1272/2008) - Annex VI - Table 3.2 - Caxcinogens Category 1

EU - CLP (1272/2008) - Annex VI - Table 3.2 - Caxcinogens Categor~ 2

Australia - GHS - Carcinogenicity (Priority Existing Chemical Assessment Reports)

Japan - GHS - Carcinogenicity

US - California - Proposition 65 - Carcinogens List

US - OSHA - Specifically Regulated Carcinogens (1910.1001 to 1910.1096)

According to criteria (weight of evidence), the substaaace is suspected to have carcinogenic potential in humans.

IARC Group 2B

ACGIH Category A2 and A3

NTP - Reasonably Anticipated to be Humaaa Carcinogens

EU - Dangerous Substaaaces Directive - Carcinogens Cate~or~ 3

Substance is present at > 0.1% in the product and is on one of these lists:

ACGIH - Threshold Limit Values - Carcinogens (Categor~ A2 and A3;

IARC - Group 2B (Possibly Carcinogenic to Humaaas)

NTP (National Toxicology Program) - Report on Caxcinogens - Reasonably Anticipated to be Human Carcinogens

EU - CLP (1272/2008) - Annex VI - Table 3.2 - Caxcinogens Category 3

According to criteria (weight of evidence), the substaaace is known to induce or is suspected to induce heritable

mutations.

Cat 1A: Chemicals known to induce heritable mutations in germ cell of humans. Positive evidence from human

epidemiological studies

Cat 1B: Chemicals which should be regarded as if they induce heritable mutations in the germ cells of humaaas

(a) Positive result(s) from in vivo heritable germ cell mutagenicity tests in mammals; or

(b) Positive result(s) from in vivo somatic cell mutagenicity tests in mammals, in combination with some evidence that

the substance has potential to cause mutation to germ cells. This supporting evidence may, for example, be derived from

mutagenicity/genotoxic test in germ cells in vivo, or by demonstrating the ability of the substance or its metabolite(s) to

interact with the genetic material of germ cells; or

(c) Positive result(s) from test showing mutagenic effects in the germ cells of humaaas, without demonstration of

transmission to progeny; for example, an increase in the frequency of aneuploidy in sperm cells of exposed people

Cat 2: Chemicals which cause concern for humaaas owing to the possibility that they may induce heritable mutations in

the germ cells of humans

Positive evidence obtained from experiments in mammals and/or in some cases from in vitro experiments obtained

from:

(a) Somatic cell mutagenicity tests in vivo, in mammals; or

(c) Other in vivo somatic cell genotoxicity test which are supported by positive results from in vitro mutagenicity assays

NOTE: Chemicals which are positive in in vitro mammaliaaa mutagenicity assays, and which also show- chemical

structure activity relationship to known germ cell mutagens, should be considered for classification as Category 2

mutagens.

Mutagenicity Test Method in germ cells: OECD 483

Genotoxicity Test Methods in germ cells: Sister Chromatic Exchange SEC aaaalysis in spermatogonia and UDS in

testicular cells

Genotoxicity Test Methods in somatic cells: OECD 486 and Mammalian bone marrow- SCE

Mutagenicity Test Method in vitro : OECD 473, OECD 476, and OECD 471

Mutagenicity Test Method in vivo heritable germ cell: OECD 478 and OECD 485

Mutagenicity Test Method in vivo somatic cell: OECD 475, OECD 484, and OECD 474

G:\PROJECTS\209095 FlzcFluids\Deliverables\ShortReport\Tables\

Table 2 1.xlsx~Iealth Prhlted: 12/30/2009 Page 1 of 21 Gradient

HESI302011
Table 2.1a

CSI - Health Criterion

Hazard Category

Reproductive Toxicity

Endocrine Disruptors

I Definitions

Substance is present at > 0.1% in the product and is on one of these lists:

Australia - GHS - Mutagenicity (Priority Existing Chemical Assessment Reports)

Austria - Prohibited Chemicals - Mutagens

Bulgaria - Occupational Exposure Limits - Mutagens

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Germ Cell Mutagenicity

EU - CLP (1272/2008) - Annex VI - Table 3.2 - Mntagens Category 1

EU - CLP (1272/2008) - Annex VI - Table 3.2 - Mutagens Category 2

EU - CLP (1272/2008) - Annex VI - Table 3.2 - Mntagens Category 3

Japan - ISHL Mutagens - Existing Chemicals

Japan - GHS - Germ Cell Mntagenicity

Korea - MOL - GHS - Germ Cell Mutagenicit~

Norway - Occupational Exposure Limits - Mutagens

Switzerland - Occupational Exposure Limits - Mutagens

United Kingdom - Dangerous Substances and Preparations - Muta~ens Cate~or~ 2

According to criteria (weight of evidence), the substance is a known or suspected reproductive toxicant

Sexual Function and Fertility: Adverse effects on sexual function and fertility including alterations to the reproductive

systems, effects on the onset of puberty, gamete production and transport, reproductive cycle normality, sexual behavior,

fertility, parturition, pregnancy outcomes, premature reproductive senescence, or modifications in other functions that

are dependent on the integrity of the reproductive system. Adverse effects on orvia lactation are also included in

reproductive toxicity, but are treated separately.

Development of Ott~pring: Developmental toxicity includes any effect which interferes with normal development ofth~

conceptus, either before or after birth, and resulting from exposure of either parent prior to conception, or exposure of

the developing ott~pring during prenatal development, or postnatally, to the time of sexual maturation including death of

developing organism, structural abnormality, altered growth and functional deficiency.

Evidence Criteria includes maternal mortality, mating index, fertility index, gestation length, body weight and body

weight change, food and water consumption, clinical evaluations, post-mortem data, and aaaimal and experimental data

(e.~g., OECD 421 aaad OECD 422).

Substance is present at > 0.1% in the product and is on one of these lists:

Austria - Prohibited Chemicals - Reproductive Toxins

Bulgaria - Occupational Exposure Limits - Toxic to Reproduction

Canada - British Columbia - Occupational Exposure Limits - Substances with Reproductive Critical Effects

Czech Republic - Prohibited or Restricted Hazardous Substances - Reproductive Toxins

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Reproductive Toxicity

EU - CLP (1272/2008) - Annex VI - Table 3.2 - Reproductive Category 1

EU - CLP (1272/2008) - Annex VI - Table 3.2 - Reproductive Category 2

EU - CLP (1272/2008) - Annex VI - Table 3.2 - Reproductive Category 3

France - Occupational Exposure Limits - Reproductive Toxins

Germany - TRGS 905 - Reproductive Toxins

Japan - GHS - Toxic to Reproduction

Korea - MOL - GHS - Reproductive Toxicity

Netherlands - List of Reproductive Toxins

Norway - Occupational Exposure Limits - Reproductive Hazards

Peru - Occupational Exposure Limits - Toxic for Reproduction

Slovenia - Occupational Exposure Limits - Reproductive Toxins

US - California - Proposition 65 - Reproductive Toxicity - Female

US - California - Proposition 65 - Reproductive Toxicity - Male

United Kingdom - Dangerous Substances and Preparations - Toxic for Reproduction Category 1

United Kingdom - Dangerous Substances and Preparations - Toxic for Reproduction Cate~o~ 2

According to criteria (weight of evidence), the substance is a endocrine disruptor.

Disruption of the endocrine system can occur in various ways. Some chemicals mimic a natural hormone, fooling the

body into over-responding to the stimulus (e.g., a growth hormone that results in increased muscle mass), or responding

at inappropriate times (e.g., producing insulin when it is not needed). Other endocrine disrupting chemicals block the

effects of a hormone from certain receptors (e.g., growth hormones required for normal development). Still others

directly stimulate or inhibit the endocrine system and cause overproduction or underproduction of hormones (e.g., an

over or underactive thyroid). Certain drugs are used to intentionally cause some of these effects, such as birth control

pills. In many situations involving environmental chemicals, however, an endocrine effect is not desirable.

Substance is present at > 0.1% in the product and is on one of these lists:

Denmark - List of Substances with Documented Endocrine Disruption Effects

EU - Endocrine Disrupters - Raaaked Priority List - Human Health Categorizations

EU - Endocrine Disrupters - Raaaked Priority List - Overall Categorizations

EU - Endocrine Disrupters - Ranked Priority List - Wildlife Categorizations

G:\PROJECTS\209095 FlzcFluids\Deliverables\ShortReport\Tables\

Table 2 1.xlsxkHealth Prhlted: 12/30/2009 Page 2 of 21 Gradient

HESI302012
Table 2.1a

CSI - Health Criterion

Hazard Category

Sensitizers

Acute Toxicity Cat. 1

I Definitions

Human or animal evidence of respiratory or skin sensitization

A respiratory sensitizer is a substance that will lead to hypersensitivity of the airways following inhalation of the

substance.

A skin sensitizer is a substaaace that will lead to an allergic response following skin contact.

Human Experience

(a) size of population

(b) extent of exposure

(c) clinical history

(i) in vivo immunological test (e.g., skin prick test)

(ii) in vitro immunological test (e.g., serological analysis)

(iii) studies that may indicate other specific hypersensitivity reactions (e.g., repeated low-level irritation,

phaxmacologically mediated effects)

(d~ data from no~itive bronchial challenge te~t~

Animal Studies

(a) measurement of Immunoglobulin E (igE) and other specific immunological parameters

(b) specific pulmonary responses in guinea pigs

Substance is present at > 0.1% in the product and is on one of these lists:

ACGIH - Threshold Limit Values - Sensitization (SEN) Notations

Argentina - Occupational Exposure Limits - Sensitizers

Australia - GHS - Skin Sensitizers (Priority Existing Chemical Assessment Reports)

Austria - Occupational Exposure Limits - Respiratory Sensitizers

Austria - Occupational Exposure Limits - Sensitizers

Austria - Occupational Exposure Limits - Skin Sensitizers

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Respiratory or Skin Sensitization

Germany - TRGS 907 - Table of Sensitizers

Japan - GHS - Respiratory Sensitizers

Japan - GHS - Skin Sensitizers

Korea - MOL - GHS - Respiratory Sensitization

Korea - MOL - GHS - Skin Sensitization

Norway - Occupational Exposure Limits - Sensitizers

South Africa - Mine Safety - Occupational Exposure Limits - Sensitizers

South Africa - Occupational Exposure Limits - Sensitizers

Oral LD50 < 5 m~/k~

Dermal LD50 < 50 mg/kg

Inhalation (Gas) LC50 < 100 ppm

Inhalation (Vapor) LC50 < 0.5 mg/1

Inhalation (Dust/Mist) LC50 < 0.05 mg/1

Substance is present at > 0.1% in the product and is on one of these lists:

Australia - GHS - Acute Toxicity - Dermal (Priority Existing Chemical Assessment Reports)

Australia - GHS - Acute Toxicity - Inhalation (Priority Existing Chemical Assessment Reports/

Australia - GHS - Acute Toxicity - Oral (Priority Existing Chemical Assessment Reports)

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Acute Toxicity - Dermal

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Acute Toxicity - Inhalation

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Acute Toxicity - Oral

Japan - GHS - Acute Toxicity - Dermal

Japan - GHS - Acute Toxicity - Inhalation - Dust and Mist

Japan - GHS - Acute Toxicity - Inhalation - Gas

Japan - GHS - Acute Toxicity - Inhalation - Vapor

Japan - GHS - Acute Toxicity - Oral

Korea - MOL - GHS - Acute Toxicity - Dermal

Korea - MOL - GHS - Acute Toxicity - Inhalation - Dust and Mist

Korea - MOL - GHS - Acute Toxicity - Inhalation - Gas

Korea - MOL - GHS - Acute Toxicity - Inhalation - Vapor

Korea - MOL - GHS - Acute Toxicity - Oral

G:\PROJECTS\209095 Fi~cFluids\Deliverables\ShortReport\Tables\

Table 2 1.xlsx~Iealth Prhlted: 12/30/2009 Page 3 of 21 Gradient

HESI302013
Table 2.1a

CSI - Health Criterion

Hazard Category

Acute Toxicity Cat. 2

Acute Toxicity Cat. 3

Acute Toxicity Cat. 4

I Definitions

Oral LD50 > 5 < 50 m~/kg

Dermal LD50 > 50 < 200 mg/kg

Inhalation (Gas) LC50 > 100 < 500 ppm

Inhalation (Vapor) LC50 > 0.5 < 2.0 mg/1

Inhalation (Dust/Mist) LC50 > 0.05 < 0.5 mg/1

Substance is present at > 0.1% in the product and is on one of these lists:

Australia - GHS - Acute Toxicity - Dermal (Priority Existing Chemical Assessment Reports)

Australia - GHS - Acute Toxicity - Inhalation (Priority Existing Chemical Assessment Reports)

Australia - GHS - Acute Toxicity - Oral (Priority Existing Chemical Assessment Reports)

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Acute Toxicity - Dermal

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Acute Toxicity - Inhalation

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Acute Toxicity - Oral

Japan - GHS - Acute Toxicity - Dermal

Japan - GHS - Acute Toxicity - Inhalation - Dust and Mist

Japan - GHS - Acute Toxicity - Inhalation - Gas

Japan - GHS - Acute Toxicity - Inhalation - Vapor

Japan - GHS - Acute Toxicity - Oral

Korea - MOL - GHS - Acute Toxicity - Dermal

Korea - MOL - GHS - Acute Toxicity - Inhalation - Dust and Mist

Korea - MOL - GHS - Acute Toxicity - Inhalation - Gas

Korea - MOL - GHS - Acute Toxicity - Inhalation - Vapor

Korea - MOL - GHS - Acute Toxicity - Oral

Oral LD50 > 50 < 300 mg/kg

Dermal LD50 > 200 < 1000 mg/kg

Inhalation (Gas) LC50 > 500 < 2500 ppm

Inhalation (Vapor) LC50 > 2.0 < 10 mg/1

Inhalation (Dust/Mist) LC50 > 0.5 < 1 mg/1

Substance is present at > 0.1% in the product and is on one of these lists:

Australia - GHS - Acute Toxicity - Dermal (Priority Existing Chemical Assessment Reports)

Australia - GHS - Acute Toxicity - Inhalation (Priority Existing Chemical Assessment Reports)

Australia - GHS - Acute Toxicity - Oral (Priority Existing Chemical Assessment Reports)

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Acute Toxicity - Dermal

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Acute Toxicity - Inhalation

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Acute Toxicity - Oral

Japan - GHS - Acute Toxicity - Dermal

Japan - GHS - Acute Toxicity - Inhalation - Dust and Mist

Japan - GHS - Acute Toxicity - Inhalation - Gas

Japan - GHS - Acute Toxicity - Inhalation - Vapor

Japan - GHS - Acute Toxicity - Oral

Korea - MOL - GHS - Acute Toxicity - Dermal

Korea - MOL - GHS - Acute Toxicity - Inhalation - Dust and Mist

Korea - MOL - GHS - Acute Toxicity - Inhalation - Gas

Korea - MOL - GHS - Acute Toxicity - Inhalation - Vapor

Korea - MOL - GHS - Acute Toxicity - Oral

Oral LD50 > 300 < 2000 m~/kg

Dermal LD50 > 1000 < 2000 mg/kg

Inhalation (Gas) LC50 > 2500 < 20000 ppm

Inhalation (Vapor) LC50 > 10 < 20 mg/1

Inhalation (Dust/Mist) LC50 > 1 < 5 mg/1

Substance present at > 0.1% in the product and on one of these lists:

Australia - GHS - Acute Toxicity - Dermal (Priority Existing Chemical Assessment Reports)

Australia - GHS - Acute Toxicity - Inhalation (Priority Existing Chemical Assessment Reports)

Australia - GHS - Acute Toxicity - Oral (Priority Existing Chemical Assessment Reports)

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Acute Toxicity - Dermal

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Acute Toxicity - Inhalation

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Acute Toxicity - Oral

Japan - GHS - Acute Toxicity - Dermal

Japan - GHS - Acute Toxicity - Inhalation - Dust and Mist

Japan - GHS - Acute Toxicity - Inhalation - Gas

Japan - GHS - Acute Toxicity - Inhalation - Vapor

Japan - GHS - Acute Toxicity - Oral

G:\PROJECTS\209095 FlzcFluids\Deliverables\ShortReport\Tables\

Table 2 1.xlsx~Iealth Prhlted: 12/30/2009 Page 4 of 21 Gradient

HESI302014
Table 2.1a

CSI - Health Criterion

Hazard Category

Corrosivity Cat. 1

Corrosivity Cat. 2 (Irritant~

I Definitions

Korea - MOL - GHS - Acute Toxicity - Dermal

Korea - MOL - GHS - Acute Toxicity - Inhalation - Dust and Mist

Korea - MOL - GHS - Acute Toxicity - Inhalation - Gas

Korea - MOL - GHS - Acute Toxicity - Inhalation - Vapor

Korea - MOL - GHS - Acute Toxicity - Oral

)H< 2> 11.5

Irreversible daanage to skin or eyes.

Skin Corrosion - produces destruction of skin tissue, visible necrosis through the epidermis and into the dermis, in at

least 1 of 3 tested animals after exposure up to a 4 hour duration. Reactions include ulcers, bleeding, bloody scabs and,

by the end of observation at 14 days, by discoloration due to blanching of the tissue, complete area of alopecia and scars.

Eye Corrosion - produces destruction of eye tissue, or serious physical decay of vision, following application of a test

substance to the anterior surface of the eye, which is not fully reversible within 21 days of application.

(a) at least one animal effect on the cornea, iris or conjunctiva that are not expected to reverse or have not fully reversed

within an observation period normally 21 days; and/or

(b) at in 2 of 3 tested animals, a positive response of:

(i) corneal opacity > 3; and/or

(ii) iritis > 1.5

calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material

Corrosive to metals - corrosion rate on either steel or aluminum surfaces exceeding 6.25 mm per year at a test

temperature of 55 C when tested on both materials.

Substance is present at > 1% in the product and is on one of these lists:

Australia - GHS - Skin Corrosion/Irritation (Priority Existing Chemical Assessment Reports)

Australia - GHS - Serious Eye Damage/Eye Irritation (Priority Existing Chemical Assessment Reports;

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Serious Eye Damage/Eye Irritation

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Skin Corrosion/Irritation

Hong Kong - Dangerous Goods - Categor~ 3 - Corrosive Substances

Japan - GHS - Skin Corrosion/Irritation

Japan - GHS - Serious Eye Damage/Irritation

Japan - ISHL Corrosive Liquids

Korea - MOL - GHS - Serious Eye Damage or Irritatio~

Korea - MOL - GHS - Skin Corrosion or Irritation

Singapore - Corrosive and Explosive Substances - Corrosive Substances

Reversible damage to skin or eyes

Skin Irritation

(1) Mean value of > 2.3 < 4.0 for erythema/eschar or for oedema in at least 2 of 3 tested animals from gradings at 24,

48 and 72 hours after patch removal or, if reaction are delayed, form grades on 3 consecutive days after the onset of skin

reaction; or

(2) Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly

taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or

(3) In some cases where there is pronounced variability of response among animals, with very definitive positive effects

related to chemical exposure in a single animal but less than the criteria above.

Eye Irritation

(1) at least in 2 of 3 tested animals a positive response of:

(a) corneal opacity > 1; and/or

(b) iritis > 1; and/or

(c) conjunctival redness > 2; and/or

(d) conjunctival oedema (Chemosis) >2

calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which

[’ullv reverses within an observation neriod of normally 21 davs.

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Table 2 1.xlsx~Iealth Prhlted: 12/30/2009 Page 5 of 21 Gradient

HESI302015
Table 2.1a

CSI - Health Criterion

Hazard Category

Acute Target Organ

Toxicity

Chronic Target Organ

Toxicity

Aspiration Hazard

I Definitions

Substance is present at > 1% in the product and is on one of these lists:

Australia - GHS - Skin Corrosion/Irritation (Priority Existing Chemical Assessment Reports)

Australia - GHS - Serious Eye Damage/Eye Irritation (Priority Existing Chemical Assessment Reports’,

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Serious Eye Damage/Eye Irritation

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Skin Corrosion/Irritation

Japan - GHS - Skin Corrosion/Irritation

Japan - GHS - Serious Eye Damage/Irritation

Korea - MOL - GHS - Serious Eye Damage or Irritatio~

Korea - MOL - GHS - Skin Corrosion or Irritation

Following a single exposure, the substance can produce significant toxicity to humans or the substance can be presumed

to have potential for harm to human health based on experimental studies with animals.

Substance is present at > 1% in the product and is on one of these lists:

Australia - GHS - Specific Organ Systemic Toxicity Following Single Exposure (Priority Existing Chemical Assessment

Reports)

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Specific Target Organ Toxicity - Single Exposure

Korea - MOL - GHS - Specific Tay~et Organ Toxicity - Single Exposure

Following repeated exposures, the substance can produce significant toxicity to humans or the substance can be

)resumed to have potential for harm to human health based on experimental studies with animals.

Substance is present at > 1% in the product and is on one of these lists:

Australia - GHS - Specific Organ Systemic Toxicity Following Repeated Exposure (Priority Existing Chemical

Assessment Report)

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Specific Target Orga~a Toxicity - Repeated Exposure

Korea - MOL - GHS - Specific Tay~et Organ Toxicit~¢ - Repeated Exposure

Practical experience in humans from reliable and good quality evidence that the substance can produce aspiration

hazard.

Cat 1: Hydrocarbon with a kinematic viscosity < 20.5 mm2/s measured at 40 C.

Cat 2: On the basis of existing animal studies and expert judgment that takes into account surface tension, water

solubility, boiling point, and volatility, substances, other than those classified in Cat 1, which have a kinematic viscosity

< 14 mm2/s, measured at 40 C.

Substance is present at > 1% in the product and is on one of these lists:

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Aspiration Hazard

Japan - GHS - Aspiration Hazards

Korea - MOL - GHS - Aspiration Hazard

Note." All tabulated information provided to Gradient by HESL

The same list may be cited under different hazard categories, indicating that specific information in that list is used to

further assign the chemical to a specific hazard category.

G:\PROJECTS\209095 FlzcFluids\Deliverables\ShortReport\Tables\

Table 2 1.xlsx~Iealth Prhlted: 12/30/2009 Page 6 of 21 Gradient

HESI302016
Table 2.1b

CSI - Physical Safety Criterion

Hazard Category

Explosive

Pyrotechnic

Flammable Gas

Oxidizing Gas

Gases Under Pressure

Flammable Liquid Cat. 1

(Extremely Flammable

Liquid)

I Def’mitions

Solid or Liquid substance or mixture which, by chemical reaction, is in itself capable of producing gas at such a

temperature and pressure and at such a speed as to cause damage to surroundings

Part I of the UN Recommendation on the Transport of Dangerous Goods’, Manual of Tests and Criteria (Test Series 1-

8)

Substance is present at > 0.1% in the product and is on one of these lists:

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Explosive

Hong Kong - Dangerous Goods - Category 1 - Explosives and Blasting Agents

Indonesia - Explosives - Quantity Limit Values

Japan - GHS - Explosives

Korea - MOL - GHS - Explosives

Korea - NEMA - GHS - Explosives

Luxembourg - Explosives Convention - Powerful Explosives

New- Zealand - HSNO - Explosives - GHS Classifications

Singapore - Arms and Explosives Act - Detection Agents (First Schedule)

Singapore - Arms and Explosives Act - Explosive Precursors (Second Schedule)

South Africa - Explosives Act - High Explosives

South Africa - Mine Safety - Occupational Exposure Limits - Explosion Hazards

US - BATF - List of Explosive Materials

US - State Department - Munitions List Cate~o~ V - Explosives and Energetic Materials

Substance/mixture designed to produce an effect by heat, light, sound, gas or smoke or a combination of these as the

result ofnon-detonative self-sustaining exothermic chemical reaction.

Part I of the UN Recommendation on the Transport of Dangerous Goods’, Manual of Tests and Criteria (Test Series 1-

8)

Gas having a flammable range with air at 20 C and standaxd pressure of 101.3 kPa

Test Method: ISO 10156:1996

Substance is present at > 1% in the product and is on one of these lists:

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Flammable Gas

Japan - GHS - Flammable Gases

Korea - MOL - GHS - Flammable Gases

Korea - NEMA - GHS - Flammable Gases

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Flammable Aerosol

Any gas which may, generally by providing oxygen, cause or contribute to the combustion of other material more than

air does.

Test Method: ISO 10156:99 and ISO 10156-2:2005

Substance is present at > 1% in the product and is on one of these lists:

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Oxidizing Gas

Japan - GHS - Oxidizing Gases

Korea - MOL - GHS - Oxidizin~ Gases

Gases contained in a receptacle at a pressure of 200 kPa (gauge) or more, or which are liquefied or liquefied and

refrigerated.

Compressed Gas: A gas which when packaged under pressure is entirely gaseous at -50 ; including all gases with a

criticaltemperature* < -50C

Liquefied Gas: A gas which when packaged under pressure is partially liquid at temperature above -50 C

(a) High Pressure Liquefied Gas - a gas with a critical temperature* between -50 C and +65 C

(b) Low- Pressure Liquefied Gas - a gas with a critical temperature* above +65 C

Refrigerated Gas: A gas which when packaged is made partially liquefied because of its low- temperature

Dissolved Gas: A gas which when packaged under pressure is dissolved in a liquid phase solvent

*Critical temperature is the temperature above which a pure gas cannot be liquefied; regardless of the degree of

compression

Substance is present at > 1% in the product and is on one of these lists:

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Gases under Pressure

Japan - GHS - Gases Under Pressure

Korea - MOL - GHS - Gases Under Pressure

Korea - NEMA - GHS - Gases Under Pressure

Liquid with a Flash Point < 23 C and initial boilin~ point < 35C

Substance is present at > 1% in the product and is on one of these lists:

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Flammable Liquid

Japan - GHS - Flammable Liquids

Korea - MOL - GHS - Flammable Liquids

Korea - NEMA - Dangerous Substances - Class 4 Flammable Liquids

Korea - NEMA - GHS - Flammable Liquids

US - CAA (Cleaaa Air Act) - Accidental Release Prevention - Flammable Substaaaces

G:\PROJECTS\209095 Fi~cFluids\Deliverables\ShortReport\Tables\

Table 2 1.xlsxkPhysicalH~m-ds Prhlted: 12/30/2009 Page 7 of 21 Gradient

HESI302017
Table 2.1b

CSI - Physical Safety Criterion

Hazard Category

Flammable Liquid Cat. 2

(Highly Flaa~mable

Liquid)

Flammable Liquid Cat. 3

Flammable Liquid)

Flammable Liquid Cat. 4

Combustible Liquid)

Flammable Solid

Self-Reactive Substance

Pyrophoric (Liquids and

Solids)

I Def’mitions

Liquid with a Flash Point < 23 C and initial boilin~ point > 35C

Substance is present at > 1% in the product and is on one of these lists:

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Flammable Liquid

Japan - GHS - Flammable Liquids

Korea - MOL - GHS - Flammable Liquids

Korea - NEMA - Dangerous Substances - Class 4 Flammable Liquids

Korea - NEMA - GHS - Flammable Liquids

US - CAA (Clean Air Act) - Accidental Release Prevention - Flammable Substances

Liquid with a Flash Point > 23 C and < 60 C

Substance is present at > 1% in the product and is on one of these lists:

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Flammable Liquid

Japan - GHS - Flammable Liquids

Korea - MOL - GHS - Flammable Liquids

Korea - NEMA - Dangerous Substances - Class 4 Flammable Liquids

Korea - NEMA - GHS - Flammable Liquids

US - CAA (Clean Air Act) - Accidental Release Prevention - Flammable Substances

Liquid with a Flash Point > 60 C and < 93 C

Substance is present at > 1% in the product and is on one of these lists:

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Flammable Liquid

Japan - GHS - Flammable Liquids

Korea - MOL - GHS - Flammable Liquids

Korea - NEMA - Dangerous Substances - Class 4 Flammable Liquids

Korea - NEMA - GHS - Flammable Liquids

US - CAA (Clean Air Act) - Accidental Release Prevention - Flammable Substances

Solids which are readily combustible, or may cause or contribute to fire through friction.

Test method N. 1 : see Part III, sub-section 33.2.1 of UNManual of Test and Criteria

Cat. 1 Burning Rate Test:

Substance or mixture other than metal powders:

(a) wetted zone does not stop fire; and

(b) burning time < 45 s or burning rate > 2.2 mm/s

Metal powders: burnin~ time < 5 min

Cat. 2 Burning Rate Test:

Substance or mixture other than metal powders:

(a) wetted zone stops fire for at least 4 min.; and

(b) burning time < 45 s or burning rate > 2.2 mm/s

Metal powders: burning time > 5 min and < 10 min

Substance is present at > 1% in the product and is on one of these lists:

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Flammable Solid

Japan - GHS - Flammable Solids

Korea - MOL - GHS - Flammable Solids

Korea - NEMA - Dangerous Substances - Class 2 Flammable Solids

Korea - NEMA - GHS - Flammable Solids

Thermally unstable liquid or solid substance or mixture liable to undergo a strongly exothermic decomposition even

without participation of oxygen (air). Excludes explosives, organic peroxides, and oxidizers.

Part II of the UN Recommendation on the Transport of Dangerous Goods’, Manual of Tests and Criteria (Test Series

A-H)

Substance present at > 1% in the product and on one of these lists:

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Self-Reactive Substance or Mixture

Japan - GHS - Self-Reactive Substamces and Mixtures

Korea - MOL - GHS - Self-Reactive Substances and Mixtures

Korea - NEMA - Dangerous Substances - Class 5 Self-Reactive Substances

Korea - NEMA - GHS - Self-Reactive Substances and Mixtures

Liquids/solids which, even in small quantities ~e liable to ignite within five minutes after coming into contact with air.

Liquids: Test method N.3 (Paxt III, sub-section 33.3.1.5 of UNManual of Test and Criteria)

Solids: Test method N.4 (Part III, sub-section 33.3.1.6 of UNManual qfTest and Criteria)

Substance is present at > 1% in the product and is on one of these lists:

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Pyrophoric Liquid

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Pyrophoric Solid

Japan - GHS - Pyrophoric Liquids

Japan - GHS - Pyrophoric Solids

Korea - NEMA - GHS - Pyrophoric Liquids

Korea - NEMA - GHS - Pyrophoric Solids

G:\PROJECTS\209095 Fi~cFluids\Deliverables\ShortReport\Tables\

Table 2 1.xlsxkPhysicalH~m-ds Prhlted: 12/30/2009 Page 8 of 21 Gradient

HESI302018
Table 2.1b

CSI - Physical Safety Criterion

Hazard Category

Self-Heating Substance

Emit Flammable Gases in

Contact with Water

Oxidizing Liquid

Oxidizing Solid

Organic Peroxide

Corrosive to Metals

Note."

I Def’mitions

A solid or liquid substance or mixture, other than pyrophoric liquid or solid, which, by reaction with air and without

energy supply, is liable to self-heat. These substances will ignite only when in large amounts (kg) and after long

3eriods of time (hours or days).

Test method N.4 (Part III, sub-section 33.3.1.6 of UNManual of Test and Criteria)

Substance is present at > 1% in the product and is on one of these lists:

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Self-Heating Substance or Mixture

Japan - GHS - Self-Heating Substances aaad Mixtures

Korea - MOL - GHS - Self-Heatin~ Substances and Mixtures

Substances or mixtures which, in contact with water, emit flammable gases are solid or liquid substances or mixtures

which, by interaction with water, are liable to become spontaneously flammable or to give off flammable gases in

dangerous quantities.

Test method N.5 (Part III, sub-section 33.4.1.4 of UNManual of Test and Criteria)

Substance is present at > 1% in the product and is on one of these lists:

EU - CLP (1272/2008) -Annex VI-Table 3.1-Classifications-Substance or Mixture which in Contact with Water Emits

Flammable Gas

Japan - GHS - Substances and Mixtures Which in Contact with Water Emit Flammable Gases

Korea - MOL - GHS - Substances and Mixtures which in Contact with Water Emit Flammable Gases

Korea - NEMA - GHS - Substances and Mixtures Which in Contact with Water Emit Flammable Gases

A liquid which, while in itself nor necessarily combustible, may, generally by yielding oxygen, cause, or contribute to,

the combustion of other material.

Test method 0.2 (Part III, sub-section 34.4.2 of UNManual of Test and Criteria)

Substance is present at > 1% in the product and is on one of these lists:

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Oxidizing Liquid

Japan - GHS - Oxidizing Liquids

Korea - MOL - GHS - Oxidizing Liquids

Korea - NEMA - Dangerous Substances - Class 6 Oxidizing Liquids

Korea - NEMA - GHS - Oxidizing Liquids

A solid which, while in itself nor necessarily combustible, may, generally by yielding oxygen, cause, or contribute to,

the combustion of other material.

Test method O. 1 (Part III, sub-section 34.4.1 of UNManual of Test and Criteria)

Substance is present at > 1% in the product and is on one of these lists:

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Oxidizing Solid

Japan - GHS - Oxidizing Solids

Korea - MOL - GHS - Oxidizing Solids

Korea - NEMA - Dangerous Substances - Class 1 Oxidizing Solids

Korea - NEMA - GHS - Oxidizin~ Solids

Liquid or solid organic substances which contain the bivalent -O-O- structure and may be considered derivative of

hydrogen peroxide, where one or both of the hydrogen atoms have been replaced by orgaaaic radicals.

Test series A to H (Part II of UNManual of Test and Criteria)

Substance is present at > 1% in the product and is on one of these lists:

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Organic Peroxide

Japan - GHS - Organic Peroxides

Korea - MOL - GHS - Organic Peroxides

Korea - NEMA - GHS - Organic Peroxides

US - DOT (Department of Traaasportation) - Organic Peroxides Table

Substance of a mixture which by chemical action will materially damage, or even destroy, metals at a rate exceeding

6.25 mm/year at a temperature of 55 C.

Tests in Part II, sub-section 37.4 of UNManual q[’Test and Criteria)

Substance is present at > 1% in the product and is on one of these lists:

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Substance or Mixture Corrosive to Metals

Japan - GHS - Corrosive to Metals

Korea - MOL - GHS - Corrosive to Metals

Korea - NEMA - GHS - Corrosive to Metals

All tabulated information provided to Gradient by HESL

The same list may be cited under different hazard categories, indicating that specific information in that list is used to

further assign the chemical to a specific hazard category

G:\PROJECTS\209095 Fi~cFluids\Deliverables\ShortReport\Tables\

Table 2 1.xlsxkPhysicalH~m-ds Prhlted: 12/30/2009 Page 9 of 21 Gradient

HESI302019
Table 2.1c

CSI - Environmental Criterion

Hazard Category

Acute Aquatic Toxicity

Cat. 1

Acute Aquatic Toxicity

Cat. 2

Acute Aquatic Toxicity

Cat. 3

Chronic Aquatic Toxicity

Cat. 1

Chronic Aquatic Toxicity

Cat. 2

Chronic Aquatic Toxicity

Cat. 3

I Def’mitions

96 hr LCs0 (fish) < 1 mg/1

48 hr ECs0 (crustacea) < 1 mg/1

72 or 96 hr ErCs0 (algae or other aquatic plants) < 1 rag/1

Substance is present at > 1% in the product and is on one of these lists:

Australia - GHS - Acute Hazards to the Aquatic Environment (Priority Existing Chemical Assessment Reports)

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Hazardous to the Aquatic Environment

Japan - GHS - Acute Hazards to the Aquatic Environment

Korea - MOL - GHS - Hazardous to the Aquatic Environment - Acute

96 hr LCs0 (fish) > 1 rag/1 a~d < 10 rag/1

48 hr ECs0 (crustacea) > 1 rag/1 and < 10 rag/1

72 or 96 hr ErCs0 (algae or other aquatic plants) > 1 rag/1 and < 10 rag/1

Substance is present at > 1% in the product and is on one of these lists:

Australia - GHS - Acute Hazards to the Aquatic Environment (Priority Existing Chemical Assessment Reports)

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Hazardous to the Aquatic Environment

Japan - GHS - Acute Hazards to the Aquatic Environment

Korea - MOL - GHS - Hazardous to the Aquatic Environment - Acute

96 hr LCs0 (fish) > 10 rag/1 and < 100 rag/1

48 hr ECs0 (crustacea) > 10 rag/1 and < 100 rag/1

72 or 96 hr ErCs0 (algae or other aquatic plants) > 10 rag/1 and < 100 rag/1

Substance is present at > 1% in the product and is on one of these lists:

Australia - GHS - Acute Hazards to the Aquatic Environment (Priority Existing Chemical Assessment Reports)

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Hazardous to the Aquatic Environment

Japan - GHS - Acute Hazards to the Aquatic Environment

Korea - MOL - GHS - Hazardous to the Aquatic Environment - Acute

96 hr LCs0 (fish) < 1 rag/1

48 hr ECs0 (crustacea) < 1 rag/1

72 or 96 hr ErCs0 (algae or other aquatic plants) < 1 rag/1

Lacks the potential to rapidly degrade (OECD 306 or 301 Biodegradation < 20%)

Has the potential to bioaccumulate (BCF > 500 or if absent, log Kow > 4)

Chronic NOEC(s) is < 1 rag/1

Substance is present at > 0.1% in the product and is on one of these lists:

Australia - GHS - Chronic Hazards to the Aquatic Environment (Priority Existing Chemical Assessment Reports)

Japan - GHS - Chronic Hazards to the Aquatic Environment

Korea - MOL - GHS - Hazardous to the Aquatic Environment - Chronic

96 hr LCs0 (fish) > 1 rag/1 a~d < 10 rag/1

48 hr ECs0 (crustacea) > 1 rag/1 and < 10 rag/1

72 or 96 hr ErCs0 (algae or other aquatic plants) > 1 rag/1 and < 10 rag/1

Lacks the potential to rapidly degrade (OECD 306 or 301 Biodegradation < 20%)

Has the potential to bioaccumulate (BCF > 500 or if absent, log Kow > 4)

If Chronic NOEC(s) is < 1 rag/1 then it is Chronic Aquatic Toxicity Cat. 1

Substance is present at > 0.1% in the product and is on one of these lists:

Australia - GHS - Chronic Hazards to the Aquatic Environment (Priority Existing Chemical Assessment Reports)

Japan - GHS - Chronic Hazards to the Aquatic Environment

Korea - MOL - GHS - Hazardous to the Aquatic Environment - Chronic

96 hr LCs0 (fish) > 10 rag/1 and < 100 rag/1

48 hr ECs0 (crustacea) > 10 rag/1 and < 100 rag/1

72 or 96 hr ErCs0 (algae or other aquatic plants) > 10 rag/1 and < 100 rag/1

Lacks the potential to rapidly degrade (OECD 306 or 301 Biodegradation < 20%)

Has the potential to bioaccumulate (BCF > 500 or if absent, log Kow > 4)

If Chronic NOEC(s) is < 1 rag/1 then it is Chronic Aquatic Toxicity Cat. 1

Substance is present at > 0.1% in the product and is on one of these lists:

Australia - GHS - Chronic Hazards to the Aquatic Environment (Priority Existing Chemical Assessment Reports)

Japan - GHS - Chronic Hazards to the Aquatic Environment

Korea - MOL - GHS - Hazardous to the Aquatic Environment - Chronic

G:\PROJECTS\209095 FlzcFluids\Deliverables\ShortReport\Tables\

Table 2 1.xlsx~Envh-omnent Prhlted: 12/30/2009 Page 10 of 21 Gradient

HESI302020
Table 2.1c

CSI - Environmental Criterion

Hazard Category

Chronic Aquatic Toxicity

Cat. 4

Ozone Depletion

I Def’mitions

Poorly soluble with no acute toxicity

Lacks the potential to rapidly degrade (OECD 306 or 301 Biodegradation < 20%)

Has the potential to bioaccumulate (BCF > 500 or if absent, log Kow > 4)

If Chronic NOEC(s) is < 1 m~/1 then it is Chronic Aquatic Toxicity Cat. 1

Substance is present at > 0.1% in the product and is on one of these lists:

Australia - GHS - Chronic Hazards to the Aquatic Environment (Priority Existing Chemical Assessment Reports)

Korea - MOL - GHS - Hazardous to the Aquatic Environment - Chronic

A substance which, on the basis of the available evidence concerning its properties and its predicted or observed

environmental fate and behavior, may present a danger to the structure aa~d/or the functioning of the stratospheric ozone

layer. Ozone Depletors are determined from regulatory lists.

Substance is present at > 0.1% in the product and is on one of these lists:

Australia - Ozone Protection Act - Scheduled Substances

Brazil - Prohibited Ozone Depleting Substances

Brazil - Restricted Commercial Use of Ozone Depleting Substances

Canada - Ozone Depleting Substances - Schedule 2

Canada - Ozone Depleting Substances - Schedule 3

Canada - Ozone Depleting Substances - Schedule 4

China - Ozone Depleting Substances - First Schedule

China - Ozone Depleting Substances - Fourth Schedule

China - Ozone Depleting Substances - Second Schedule

China - Ozone Depleting Substances - Third Schedule

Croatia - Ozone Depleting Substances - Annex A, Group I

Croatia - Ozone Depleting Substances - Annex A, Group II

Croatia - Ozone Depleting Substances - Annex B, Group I

Croatia - Ozone Depleting Substances - Annex B, Group II

Croatia - Ozone Depleting Substances - Annex B, Group III

Croatia - Ozone Depleting Substances - Annex C, Group I

Croatia - Ozone Depleting Substances - Annex C, Group II

Croatia - Ozone Depleting Substances - Annex C, Group III

Croatia - Ozone Depleting Substances - Annex E, Group I

Djibouti - Ozone Depleting Substances - Importation Restrictions

E1 Salvador - List of Ozone Depleting Substances

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Hazardous for the Ozone Layer

EU - Ozone Depleting Substances Regulation (2037/2000)

GCC - Ozone Depleting Substances - Annex A - Group I

GCC - Ozone Depleting Substances - Annex A - Group II

GCC - Ozone Depleting Substances - Annex B - Group I

GCC - Ozone Depleting Substances - Annex B - Group II

GCC - Ozone Depleting Substances - Annex B - Group IIl

GCC - Ozone Depleting Substances - Annex C - Group I

GCC - Ozone Depleting Substances - Annex C - Group II

GCC - Ozone Depleting Substances - Annex C - Group IIl

GCC - Ozone Depleting Substances - Annex E - Group I

Hong Kong - Ozone Depleting Substances

India - Ozone Depleting Substances - Schedule I

Indonesia - Ozone Depleting Substances - Annex I

Indonesia - Ozone Depleting Substances - Annex II

Indonesia - Ozone Depleting Substances - Annex IIl

Indonesia - Prohibition on the Production of Ozone Depleting Substances

Japan - Ozone Depleting Substances - Annex A Group I

Japan - Ozone Depleting Substances - Annex A Group II

Japan - Ozone Depleting Substances - Annex B Group I

Japan - Ozone Depleting Substances - Annex B Group II

Japan - Ozone Depleting Substances - Annex B Group IIl

Japan - Ozone Depleting Substances - Annex C Group I

Japan - Ozone Depleting Substances - Annex C Group II

Japan - Ozone Depleting Substances - Annex C Group IIl

Japan - Ozone Depleting Substances - Annex E

Japan - Prevention of Marine Pollution and Disaster - Ozone Depleting Substances

Latvia - Ozone Depleting Substances

New- Zealand - Ozone Depleting Substances

Norway - Ozone Depleting Substances

Oman - Ozone Depleting Substances

Philippines - Ozone Depleting Substances - Annex A - Group I

G:\PROJECTS\209095 Fl~cFluids\Deliverables\ShortReport\Tables\

Table 2 1.xlsxkEnvh-omnent Prhlted: 12/30/2009 Page 11 of 21 Gradient

HESI302021
Table 2.1c

CSI - Environmental Criterion

Hazard Categor.~

VOCs

Hazardous Air Pollutants

(HAPs)

I Def’mitions

Philippines - Ozone Depleting Substances - Annex

Philippines - Ozone Depleting Substances - Annex

Philippines - Ozone Depleting Substances - Annex

Philippines - Ozone Depleting Substances - Annex

Philippines - Ozone Depleting Substances - Annex

Philippines - Ozone Depleting Substances - Annex

Philippines - Ozone Depleting Substances - Annex

Singapore - Ozone Depleting Substances - Annex

Singapore - Ozone Depleting Substances - Annex

Singapore - Ozone Depleting Substances - Annex

Singapore - Ozone Depleting Substances - Annex

Singapore - Ozone Depleting Substances - Annex

Singapore - Ozone Depleting Substances - Annex

Singapore - Ozone Depleting Substances - Annex

Singapore - Ozone Depleting Substances - Annex

Singapore - Ozone Depleting Substances - Annex

Switzerland - Chemical Risk Reduction Ordinance

Taiwan - Ozone Depleting Substances

Turkey - Ozone Depleting Substances - Group I

Turkey - Ozone Depleting Substances - Group II

Turkey - Ozone Depleting Substances - Group II]

Turkey - Ozone Depleting Substances - Group IV

Turkey - Ozone Depleting Substances - Group V

Turkey - Ozone Depleting Substances - Group VI

Turkey - Ozone Depleting Substances - Group VII

B

B

C

C

C

E

A - Group II

B - Group I

B - Group II

B - Group IIl

C - Group I

C - Group II

E

A - Group I

A - Group II

B - Group I

- Group II

- Group IIl

- Group I

- Group II

- Group IIl

- Ozone Depleting Substances

Turkey - Ozone Depleting Substances - Substaaaces under Control

US - CAA (Cleaaa Air Act) - Class I Ozone Depletors

US - CAA (Cleaaa Air Act) - Class II Ozone Depletors

US - California - Ozone Depleting Compounds Prohibited in Antiperspirants and Deodorants

UNEP - Montreal Protocol Ozone Depletors - Annex A - Group ]

UNEP - Montreal Protocol Ozone Depletors - Annex A - Group I]

UNEP - Montreal Protocol Ozone Depletors - Annex B - Group 1

UNEP - Montreal Protocol Ozone Depletors - Annex B - Group I]

UNEP - Montreal Protocol Ozone Depletors - Annex B - Group II]

UNEP - Montreal Protocol Ozone Depletors - Annex C - Group 1

UNEP - Montreal Protocol Ozone Depletors - Annex C - Group I]

UNEP - Montreal Protocol Ozone Depletors - Annex C - Group II]

UNEP - Montreal Protocol Ozone Depletors - Annex E

VOCs are chemicals that evaporate easily at room temperature. VOCs have a high vapor pressure and low- water

solubility. The term "organic" indicates that the compounds contain carbon. VOC compounds are determined from

regulatory lists

Substance is present at > 0.1% in the product and is on one of these lists:

Cyprus- Air Quality- Ozone Precursors (VOCs)

Korea - MOE - Substaaaces Regulated as VOCs

Switzerland - VOCs

US - CAA (Clean Air Act) - VOCs in SOCMI

Toxic air pollutants, also known as HAPs, are those pollutants that are known or suspected to cause cancer or other

serious health effects, such as reproductive efl’ects or birth defects, or adverse environmental efl’ects. HAPs are

determined by regulatory lists.

Substance is present at > 0.1% in the product and is on one of these lists:

Cambodia - Pollutants in Ambient Air - Maximum Allowable Concentrations Emitted from Stationary Sources

Japan - Air Pollution Control Law- - Emission Standards for Air Pollutants

Japan - Air Pollution Control Law- - HAPs

Korea - MOE - Cleaaa Air Conservation Act - Air Pollutants

Korea - MOE - Cleaaa Air Conservation Act - Specified HAPs

Philippines - Air Quality - Source Specific Air Pollutants

Saudi Arabia - Royal Commission - HAPs

US - CAA (Cleaaa Air Act) - 1990 HAPs

US - CAA (Cleaaa Air Act) - High Risk HAPs

US - CAA (Clean Air Act) - HON Rule - Organic HAPs

G:\PROJECTS\209095 FlzcFluids\Deliverables\ShortReport\Tables\

Table 2 1.xlsx~Envh-omnent Prhlted: 12/30/2009 Page 12 of 21 Gradient

HESI302022
Table 2.1c

CSI - Environmental Criterion

Hazard Category

Hazardous Water

Pollutants (HWPs)

Biodegradation -

Persistent

Biodegradation - Inherent

Bioaccumulation

Note."

I Def’mitions

Pollutants that reduce the usefulness of water to humans and other organisms in nature. HWPs are determined by

regulatory lists.

Substance is present at > 0.1% in the product and is on one of these lists:

EU - Groundwater Directive (2006/118/EC) - Minimum List of Pollutants aaad Indicators

Japan - Environmental Quality Standards - Water Pollutants - Public Water - Monitored Substances & Guideline Values

Japan - Environmental Quality Standards - Water Pollutants - Public Water - Protection of Human Health

US - California - Priority Toxic Pollutants - Freshwater Criteria

US - California - Priority Toxic Pollutants - Human Health Criteria

US - California - Priority Toxic Pollutants - Saltwater Criteria

US - CWA (Cleaaa Water Act) - Priority Pollutants

US - DOT (Department of Traaasportation) - Severe Maxine Pollutants (regulated at 1% or greater) - (Appendix B)

Lacks the potential to rapidly degrade (OECD 306 or 301 Biodegradation < 20%)

Substance is present at > 1% in the product and is on one of these lists:

Canada - Saskatchewaaa - Dangerous Goods - Environmental Persistent or Chronic Hazardous Substances

EU - Persistent Organic Pollutants (850/2004) - Annex I - Substances Subject to Prohibitions

EU - Persistent Organic Pollutants (850/2004) - Annex III- Substances Subject to Release Reduction Provisions

EU - Persistent Organic Pollutants (Decision 2006/507/EC) - Stockholm Convention

India - Persistent Organic Pollutants (POPs)

Thailand - Banned Persistent Organic Pollutants (POPs)

US - Washington - Persistent Bioaccumulative Toxins

UNEP - Persistent Organic Pollutants (POP)

Lacks the potential to rapidly degrade (OECD 306 or 301 Biodegradation > 20 <60 %)

Has the potential to bioaccumulate (BCF > 500 or if absent, log Kow > 4)

Substance is present at > 1% in the product and is on one of these lists:

US - California - 22 CCR - Total Threshold Conc. (TTLC)-Persistent Bioaccumulative Substances - Extremely

Hazardous Wastes

US - California - 22 CCR-Total Threshold Limit Conc. (TTLC) Values-Persistent and Bioaccumulative Toxic

Substances

US - CWA (Cleaaa Water Act) - Bioaccumulative Chemicals of Concern (BCCs)

US - Washington - Persistent Bioaccumulative Toxins

All tabulated information provided to Gradient by HESL

The same list may be cited under different hazard categories, indicating that specific information in that list is used to

further assign the chemical to a specific hazard category.

G:\PROJECTS\209095 FlzcFluids\Deliverables\ShortReport\Tables\

Table 2 1.xlsx~Envh-omnent Prhlted: 12/30/2009 Page 13 of 21 Gradient

HESI302023
HESI302024
HESI302025
HESI302026
Table 2.3

Comparison of CSI and GHS Cut-Off Values

CSI Hazard Categories CSI Cut-Offs (%) GHS Cut-Offs (%)

Environmental Hazard

Acute Aquatic Toxicity Cat. 1 0.001 1 [1]

Acute Aquatic Toxicity Cat. 2 0.1 1 [1]

Acute Aquatic Toxicity Cat. 3 1 1 [1]

Chronic Aquatic Toxicity Cat. 1 0.001 1 [1]

Chronic Aquatic Toxicity Cat. 2 0.001 1 [1]

Chronic Aquatic Toxicity Cat. 3 0.001 1 [1]

Chronic Aquatic Toxicity Cat. 4 0.1 1 [1]

Ozone Depletion 0.001 NA

VOCs 0.001 NA

HAPs 0.001 NA

HWPs 0.001 NA

Biodegradation - Persistent 0.001 --

Biodegradation - Inherent 0.001 NA

Bioaccumulation 0.001 --

Physical Safety Hazard

Explosive 0.001 --

Pyrotechnic 0.001 --

Flammable Gas 0.001 --

Oxidizing Gas 0.001 --

Gases Under Pressure 0.001 --

Flammable Liquid Cat. 1 (Extremely Flammable Liquid)

Flammable Liquid Cat. 2 (Highly Flammable Liquid)

Flammable Liquid Cat. 3 (Flammable Liquid)

Flammable Liquid Cat. 4 (Combustible Liquid)

Flammable Solid

Self-Reactive Substance

Pyrophoric (Liquids and Solids)

Self-Heating Substance

Emit Flammable Gases in Contact with Water

Oxidizing Liquid

Oxidizing Solid

Organic Peroxide

Corrosive to Metals

Health Hazard

0.001 --

0.1 --

0.001 --

0.1 --

0.001 --

0.001 0.5 or 1 I21

Carcinogenicity Cat. 1 (Known Human Carcinogen) 0.001 0.1

Carcinogenicity Cat. 2 (Suspected Human Carcinogen) 0.001 0.1

Mutagenicity 0.001 0.1 or 1.0 [3]

Reproductive Toxicity 0.001 0.1

Endocrine Disruptors 0.001 NA

Sensitizers 0.001 0.1

Acute Toxicity Cat. 1 0.001 1

Acute Toxicity Cat. 2 0.001 --

Acute Toxicity Cat. 3 0.1 --

Acute Toxicity Cat. 4 1 --

Corrosivity Cat. 1 0.1 3 (eye), 5 (skin)

Corrosivity Cat. 2 (Irritant) 1 1

Acute Target Organ Toxicity 0.001 1

Chronic Target Organ Toxicity 0.001 1

Aspiration Hazard 5 --

Notes:

All tabulated CSI criteria and cutoffs provided to Gradient by HESL

NA: Not applicable. The UN GHS (2007) does not consider this hazard category.

-- Cut-offs are not defined by GHS for this hazard category.

[1] The GHS defines a generic cut-off of >_ 1.0%for chemicals that are ’Hazardous to the aquatic environment.

[2] < 1% available 0 2 from organic peroxides when >_ 1.0% H 2 0 ~ or < 0.5% available 0 ~ from organic peroxide

when > 1.0% to < 7% H~0 ~.

[3] > O. 1% for Category 1 mutagen; > 1.0% for Category 2 mutagen.

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Table 2.4

Total Possible Score per Hazard Criteria for a Single Chemical

Hazard Criteria Total Possible Score12

Environmental 635

Physical Safety 5503

Health 510

Notes:

1Assumes the highest possible score in each hazard category, and uses the highest

score value when there are multiple classes within a category (e.g., scored acute

toxicity as Category 1 acute toxin).

:Total possible score information derived from CSI scores presented in Tables 2.2a-c

of this report.

3The total score for physical safety hazards is dependent upon the phase of the

chemical. Thus, the highest possible score for liquid chemicals is 550, and the

highest possible score for solids and gases is 475, and 350, respectively.

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Table 3.1

CPA Green Screen for Safer Chemicals

Parameter Comments

General Overview Hazard-based screening method, based on US EPA’s DfEI21 program, that defines criteria for four (4)

Benchmark levels to indicate whether chemicals used in products are safe. Differs from the CSI in

that criteria are defined for each Benchmark that each chemical AND its breakdown

products/metabolites must pass.

Publicly Available? Yes.

Use/applicability? Individual chemicals (and their byproducts) in consumer/industrial products

Used by? State of Washington Department of Ecology, Walmart (in developing their internal tool, GreenWercs),

Hewlett-Packard

Primary Review Criteria

Hazard Categories Evaluated Health, Environmental, and Physical safety hazards (limited)

Hazard Category Comparison Health: Green Screen includes two categories not explicitly considered by the CSI, however, the CSI

considers select endpoints for these categories under chronic toxicity.

Environmentah Green Screen and the CSI both consider acute and chronic aquatic toxicity,

persistence (biodegradation), and bioaccumulation. Green Screen does not consider several CSI

environmental categories - i.e., VOCs, fLAPs, HWPs, and ozone depletion.

Physical Safety Hazards: Green Screen considers only flammability and explosivity as part of the

physical hazards screen, while CSI considers all GHS categories.

Based largely on those defined in US EPA’s DIE[21 as well as the UN GHS. Hazard Category [31

Resources/Databases Used

Secondary Review Criteria

Scoring/~Veighting of Chemicals Chemicals are not assigned hazard scores, but based on presence of chemical and its byproducts/metabolites, chemicals are assigned to a particular Green Screen Benchmark.

Are Data Gaps Addressed? Yes. Data are qualified/flagged if data are not available. Green Screen also recommends the use of

QSARs to fill data gaps.

Other Attributes

Platform Process (software, Traaasparent written guidance document that is not automated. Chemicals undergoing Green Screen

flowchart, etc. ) assessment are summarized in a comprehensive written report.

Are Data Qualifiers Used? Yes. For example, Green Screen will identify aaad flag chemicals when Benchmarks are based on

actual experimental data versus estimated/predicted results. Also, when data are unavailable for a

particular endpoint/category, this will be flagged during the Green Screen assessment.

Chemical Identifier (i e., CAS CAS number

number?)

Is there a "No Hazard Category"? No. However, Green Screen defines criteria for "low- hazards." Chemicals passing Benchmark 4 are

How is it Defined? considered "Safer Chemicals."

Notes: CAS - Chemical Abstract Service Number

]~@reFices:

[1] CPA, 2007.

[2] US EPA, 2009a.

[31 UN, 200Z

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Table 3.2

US EPA CHAMPIll

Parameter Comments

General Overview CHAMP outlines guidaaace for qualitative RBP of HPV chemicals, as well as HBP for MPV

chemicals. During RBP, chemicals undergo qualitative hazard, risk and exposure screenings based on

US EPA-defined evaluation criteria (the RBP hazard screening is most relevaaat for our comparison).

Publicly Available? Yes.

Use/applicability? Prioritization of individual HPV and MPV chemicals for further assessment.

Used by? US EPA, for purposes of chemical prioritization. Will be superseded by another program, but CHAMP

reports have been published as recently as September 2009.

Primary Review Criteria

Hazard Categories Evaluated Health, Environmental (Toxicity and Fate Characterization), aaad Physical Safety Hazards (limited)

Hazard Category Comparison Health: CHAMP considers two categories not explicitly considered by the CSI, however, the CSI

considers select endpoints for these categories under chronic toxicity.

Environmental: CHAMP includes several environmental hazard categories not specifically

considered by the C SI, while CHAMP does not consider several C SI environmental categories -i.e.,

HAPs, HWPs, ozone depletion.

Physical Safet~ Hazards: CHAMP evaluates only two properties under physical hazards - vapor

pressure and water solubility; the CSI evaluates all GHS categories.

Hazard Category

Resources/Databases Used

Hazard categories are based on OECD SIDS. For the "hazard" screening portion of RBP (considered

most relevant to the CSI comparison because the RBP approach also considers physical properties),

CHAMP relies upon the National Library of Medicine Databases which allows searches of numerous

data sources and databases, including PubMed, the Hazardous Substances Database Ba~k, etc.

Secondary Review Criteria

Scoring/~Veighting of Chemicals Chemicals undergoing CHAMP RBP are not scored, but are assigned low-, medium, or high priority

based on qualitative evaluation of hazard criteria.

Are Data Gaps Addressed? When data are not available, expert judgment aaad one or more estimation approaches (i. e., QSARS)

may be used. Lack of data may influence the prioritization of a chemical.

Other Attributes

Platform Process (software, Outlined in a fairly traaasparent written guidance document and is not automated. OPPT professional

flowchart, etc. ) judgment is used to evaluate data quality aaad endpoint information. Output is a comprehensive written

report (HBP) or reports (RBP, for the various screening aaaalysis reports and final decision).

Are Data Qualifiers Used? Yes, data are flagged for data adequacy. "Measured" data values are clearly flagged as such, while

"experimental" data are flagged with symbols indicating they are categorized as either a "value from

guideline study, clear weight of evidence, or evaluated database," a "value from non-guideline but

reliable experimental study," or a "value reported without supporting details." Estimated data are also

flagged/identified.

Chemical Identifier (i e., CAS CAS number and chemical formula/structure

number?)

Is there a "No Hazard Category"? No; however, there are low- priority chemicals for which "follow-up action not suggested at this time."

How is it Defined?

Notes:

CAS - Chemical Abstract Service Number

J~@rences:

[1] US EPA, 2009b, d

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Table 3.3

US EPA DfE General Screen for Safer Ingredients [11

Parameter

General Overview

Comments

The DIE is a screening system developed under US EPA’s Design for the Environment (DIE) Program.

Differs from the CSI in that DIE is a pass/fail approach - there is no "scoring" perse - mad chemicals

are screened out if they do not meet certain threshold criteria within any of the categories evaluated.

Customized screens and stmadards have been developed for select industries and consumer products

(e .g., household cleaning products).

Publicly Available? Yes.

Use/applicability? Designed to delineate the safer or "low-concern" end of the ingredient spectrum for chemicals used in

consumer products, to guide and ensure best-in-class ingredient choices for DIE-recognized products.

Products meeting the DIE screening process may be labeled with the DIE symbol.

Used by? Mmay well-known consumer product companies such as SC Johnson and Colgate-Palmolive have

established partnerships with US EPA’s DIE program. In addition, GreenBlue’s CleanGredients[4]

database was developed based on the DIE.

Primary Review Criteria

Hazard Categories Evaluated Health, Environmental, and Physical Safety Hazards (limited)

Hazard Category Comparison Health: The DIE considers an additional category not explicitly considered by the CSI; however, the

CSI considers select endpoints for this category under chronic toxicity.

Environmental: Similar to the CSI, the DIE considers acute aquatic toxicity, persistence

(biodegradation), and bioaccumulation potential. While the CSI also considers chronic aquatic

toxicity, DIE does not. DIE also does not consider several CSI environmental categories - i.e., HAPs,

HWPs, ozone depletion - as specific categories.

Physical Safety Hazards: Although physical hazards are not addressed in the General Screen,

several of the customized screening protocols mad standards do include this as an evaluation category,

but for limited categories. The CSI considers all GHS physical hazards.

The DIE’s categories and evaluation criteria are based on CHAMPI21 and the UN GHS.[3] The DIE

General Screen also defines preferred and acceptable test methods for the categories evaluated.

Hazard Category

Resources/Databases Used

Secondary Review Criteria

Scoring/~Veighting of Chemicals The DIE does not score chemicals, rather, chemicals are screened out based on hazard evaluation

criteria.

Are Data Gaps Addressed? QSAR mad other estimation models are used when data are unavailable.

Other Attributes

Platform Process (software, The DIE General Screen is documented in a fairly transparent written guidance. The output is a

, [4] flowchart, ete ) written report. Note that GreenBlue s software tool CleanGredients lists chemicals that have been

approved via use of the DIE screen (the database includes solvents and surfactmats only at this time,

but will be expanded to include fragrmaces and chelating agents).

Are Data Qualifiers Used? No.

Chemical Identifier (i e., CAS CAS number

number?)

Is there a "No Hazard Category"? No, however, chemicals that pass the screen are considered to be of "low- concern."

How is it Defined?

Notes:

CAS - Chemical Abstract Service Number

J~@reHcesJ

[1] US EPA, 2009a.

[2] US EPA, 2009b, d

[3] UN, 2007.

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