Assessments in SciveraLENS

We provide two types of chemical assessments in SciveraLENS to help you better understand the chemicals you are using and make safer chemical decisions:

1. List screening: Our Toxicologists review hundreds of lists that are created by regulatory agencies, organizations, NGOs, etc., so you can quickly identify and understand chemicals that are listed or identified by your clients, are included on regulatory lists, on authoritative or hazard-trait based lists, and more. We add the lists that matter most to our customers into SciveraLENS so you can quickly see if any of your chemicals appear on a list of interest. In addition to monitoring these lists and ensuring you always have the most complete and up-to-date list when screening your chemicals, our toxicologists also expand any lists that include chemical groups or families. This means that we identify all CAS numbers associated with a chemical group or family so that you get the most complete and accurate screening results. If anything changes on a list that you’re tracking, you’ll receive real-time alerts letting you know of the change.
2. Chemical Hazard Assessments: Our toxicology team assesses chemicals across 23 Human and Environmental Health Endpoints, providing you with the information you need to better understand the human and environmental health impacts of your chemicals and make safer, more proactive, and informed chemical decisions. We provide both detailed and summarized views of the assessment results for each endpoint as well as an overall “score” for each chemical (called a hazardous category or “HC” score). Our team of experts uses the SciveraLENS GHS+ Chemical Assessment Framework (LINK) to assess each chemical.

List Screening in SciveraLENS

SciveraLENS allows you to easily assign one, several, or all the hundreds of lists and sublists we track daily to help you stay current on regulatory, industry, authoritative, and corporate governance trends.

Keeping up with all these lists and their nuances and changes is time-consuming and challenging. In addition to monitoring these lists and ensuring you always have the most complete and up-to-date list when screening your chemicals, our toxicologists also expand any lists that include chemical groups or families. This means that we identify all CAS numbers associated with a chemical group or family so that you get the most complete and accurate screening results. If anything changes on a list that you’re tracking, you’ll receive real-time alerts letting you know of the change.

When assessing your chemicals in SciveraLENS, you can quickly see what type of list your chemical(s) appear on and (if applicable) whether your concentration exceeds any threshold levels for a particular list using our color-coded triangle icons:

Setting your List Favorites

Click into the List page in your left-hand navigation. Here you can view and search through all of the lists we manage and maintain in SciveraLENS. You can also set favorite lists to make if even more efficient to screen your chemicals against the lists that matter most to you.

Search through our roster of lists using the filter function in the top right of your screen (look for the little filter icon). Set up your “Favorite” lists here by clicking the checkbox next to each list of interest. Your Account Manager can also work with you to set up “Account Favorites,” which will be available for all your account members.

To set your Favorite Lists, visit the Lists library in your left-hand navigation.

You can search through the roster of lists using the filter icon in the top right of your screen.

When you find a list you would like to mark as a Favorite, check the Favorite box next to each list.

Assigning Lists for Screening Your Formulations

If you create a Formulation in SciveraLENS, you can quickly search for and scan the available lists and select the lists you want to screen each Formulation against. If you set up Favorite lists or have Account Favorite lists selected, you’ll see headers for each when selecting your lists for screening.

You’ll notice that our lists have identifiers in their titles, so you can quickly see what category each list is in.
Don’t see a list you’re interested in tracking your chemicals against? Let us know by emailing Sustainablechemistry.support@enhesa.com.

How We Expand RSLs for a More Comprehensive List Screening in SciveraLENS

When screening your products and Formulations against regulatory “restricted substance lists” (“RSLs”) manually or with other software tools, you can quickly match up whether a chemical in your product or Formulation appears in the RSL and identify the next steps.

Often, these lists reference general families of chemicals (e.g., “all mercury-containing compounds”), which requires the user to be very diligent about the possible chemicals that might fit into that group. One example is Washington State’s Chemicals of High Concern to Children (“WA CHCC”) RSL. This list includes anywhere from 70 chemicals to over 4,000, depending on how one interprets the requirements.

When we manage lists in our system, our team includes and flags the chemicals that fit into the families of chemicals referenced in these lists. This allows our subscribers to fully assess how chemicals of interest are regulated or restricted and identify potential problematic chemicals. For example, our expanded list for WA CHCC includes over 4,000 chemicals when all chemicals in each of the several referenced families of chemicals are included in the screening process.
This expanded list screen in SciveraLENS gives you a comprehensive list screen that can save on testing costs and product failures. We also offer base lists like the WA CHCC list, which includes the 70 original CAS RNs, so you can quickly scan them to see what you need to report on.
When you select a list for screening in SciveraLENS, you’ll quickly see whether your chemical appears on a list of interest, if a concentration threshold is indicated, whether your concentration exceeds that threshold, and if the chemical appears on the list as part of a chemical group.

What To Do When Your Chemical is on a Restricted Substances List (RSL)

As a chemical supplier, a raw material supplier, a manufacturer, or a brand, you need to ensure that the chemicals you are using are safe. Often, the first step to ensuring chemical safety is ensuring your chemical(s) are not regulated or restricted. There are hundreds of regulatory, authoritative, NGO, inventory, restricted substances, or preferred substances lists available, and you have a responsibility to make sure that your chemicals are on the right lists and not on any lists that they shouldn’t be on. Often, your downstream customer will identify the list(s) that they require you to comply with, and SciveraLENS can provide a quick and easy way to screen your chemicals against these lists and help you identify the next steps.

When you see that your chemical has appeared on a list of interest, you first need to identify the type of list it is to more accurately determine the next steps.

Some lists have concentration threshold values included. This means that different actions are required if your chemical of interest is under or over the concentration threshold. You can easily determine this by looking at the colored triangle next to your chemical and list of interest.

If you’re screening against a Regulatory, Authoritative, Organization, or Hazard List, the yellow triangle indicates your lists of interest were checked, and there are one or more list(s) hits, but the chemical concentration is below a set threshold for the list(s).
The red or orange triangle indicates that your lists of interest were checked for these same lists, and one or more hits are above a set concentration threshold.

Generally, if you have a “list hit” on a regulatory or restricted substances list (RSL), you need to report or replace that chemical.
This is where our Chemical Hazard Assessment information or CHA report can be very helpful. If you need to replace a chemical, how do you determine which chemical to replace it with? Obviously, you need to consider many things like cost, performance, properties, etc. You also need to make sure that you’re choosing a safer alternative that won’t be regulated or restricted in the future and avoid regrettable substitutions. The CHA report helps you ensure that your chemical ingredients are safer for your workers, consumers, your brand, and the planet.

1. Identify the alternative chemicals that you are considering
2. Quickly screen these chemicals in SciveraLENS
3. Review and compare the CHA for each
4. Select the safest chemical that meets your needs

If you need help identifying some alternative chemicals to consider, let us know! We have example chemicals across several functional groups that you can add to your SciveraLENS subscription for consideration.

Chemical Hazard Assessments (CHAs) in SciveraLENS

Our team of toxicologists creates a comprehensive Chemical Hazard Assessment (CHA) for each chemical and shares these assessments through your subscription to SciveraLENS so that you have the critical chemical ingredient information needed to make safer and more efficient chemical decisions.

We have published a summary of our hazard assessment methodology, and we invite you to learn more. If you would like more details, please visit our SciveraLENS GHS+ Hazard Assessment Framework for specifics on Hazard and Dose-Response Assessment criteria by endpoint.

To complete our CHAs, our toxicologists use a combination of authoritative lists, regulatory lists, experimental data, modeled data, analogous data, and expert judgment. Please keep in mind that these assessments are more than list screening. While some lists we look at are based on specific ways that chemicals impact humans and the environment, a CHA looks at specific characteristics for each chemical, including those that aren’t restricted or regulated.

As part of the assessment process, we use the following authoritative resources for chemical hazard data gathering:

• European Chemicals Agency (ECHA)
• US Environmental Protection Agency (EPA)
• US National Institutes of Health National Library of Medicine (NIH NLM)
• National Toxicology Program
• WHO International Agency for Research on Cancer (IARC)
• Academic Journals
• Many others

Our team also uses many sophisticated modeling platforms for closing data gaps including:

• OECD QSAR Toolbox
• UP EPA EpiSuite/EcoSAR/PBTProfiler
• Others

With this information, our team generates a hazard assessment at two levels for each chemical:

• Endpoint Level Hazard Assessment
• Chemical Level Hazard Assessment

Each chemical’s hazard assessment is based on conditions relative to each endpoint. SciveraLENS implements a matrix of criteria for each endpoint and data point type within each endpoint that results in an appropriate hazard condition.

SciveraLENS implements a rules algorithm to generate a provisional hazard assessment for each endpoint, category, and overall, for each chemical across its Core and Supplemental Endpoints using a combination of data from authoritative lists, data from experimental studies, modeled data, analogous data, and expert judgment. Modeled and analogous data help to close data gaps for chemicals with endpoints where experimental or authoritative data are lacking. Our team of toxicologists and researchers then review these provisional results, perform a quality assurance step, and confirm the provisional hazard assessment for each chemical.

SciveraLENS Endpoints and Hazard Category Scoring

Individual endpoint hazard assessment results can be a very useful level of detail for understanding what level and type of hazard exists for a chemical. A summary of the endpoint assessments can also be useful for comparing chemicals, evaluating alternatives, or prioritizing where additional review or consideration is warranted.

Endpoint Level Hazard Assessments
Chemical Hazard Assessments (CHAs) provide information about how each chemical impacts human health and the environment. Certified toxicologists complete these assessments by compiling many data points and providing a summary score or assessment for each “endpoint” or characteristic based on the research conducted. As part of our review, we evaluate each chemical against 24 human and environmental health endpoints. Where data and/or expert judgment enable an assessment, our toxicology team generates a hazard assessment for up to 16 Human Health, 5 Ecotox and Environmental Fate, and 3 Physical Hazard endpoints. (Core Endpoints are in bold).

Here are the SciveraLENS Endpoints for Human Health:

1. Carcinogenicity — Does the chemical have a high potential to cause cancer in humans or other mammals?
2. Mutagenicity — Does the chemical have a high potential to cause genetic mutations in humans or other mammals?
3. Developmental Toxicity — Does the chemical have a high potential to cause developmental defects in unborn or young humans or other mammals?
4. Reproductive Toxicity—Does the chemical have a high potential to damage the reproductive systems of humans or other mammals?
5. Endocrine Activity — Does the chemical have a high potential to mimic hormones or cause other adverse effects on the endocrine system in humans or other mammals?
6. Acute Dermal Toxicity — Does the chemical potentially cause death in humans or other mammals when absorbed through the skin?
7. Acute Oral Toxicity — Does the chemical potentially cause death in humans or other mammals when ingested?
8. Acute Inhalation Toxicity — Does the chemical potentially cause death in humans or other mammals when inhaled?
9. Systemic Toxicity (Single and Repeat Dose) — Does the chemical have a high potential to cause damage to specific internal organs (e.g., liver, kidneys, etc.) upon initial exposure (i.e., Single dose) or multiple exposures (i.e., Repeat dose)?
10. Neurotoxicity (Single and Repeat Dose) — Does the chemical have a high potential to cause neurological effects upon initial exposure (i.e., Single dose) or multiple exposures (i.e., Repeat dose)?
11. Dermal Sensitization — Does the chemical have a high potential to cause a permanent allergy to skin contact in humans or other mammals?
12. Respiratory Sensitization — Does the chemical have a high potential to cause a permanent allergy to inhalation by humans or other mammals?
13. Dermal Irritation—Does the chemical have a high potential to cause severe damage to the skin of humans or other mammals when in contact with it?
14. Eye Irritation — Does the chemical have a high potential to cause severe damage to the eyes of humans or other mammals on contact?
15. Aspiration Potential — Does the chemical have a high potential to result in pulmonary edema (fluid in lungs) if inhaled?
16. Sensory Irritation — Does the chemical have a high potential to irritate mucous membrane tissue?

And the SciveraLENS Endpoints for Environmental Health:

1. Persistence — Does the chemical stay persistent in the environment (i.e., it is not readily biodegradable)?
2. Bioaccumulation — Does the chemical accumulate in the tissue of mammals or other living creatures?
3. Acute Aquatic Toxicity — Does the chemical have a high potential to cause death to aquatic life if present in water over a short period of time?
4. Chronic Aquatic Toxicity — Does the chemical have a high potential to cause death to aquatic life if present in water over a long period of time?
5. Mobility — How likely is the chemical to move through environmental media (soil, water, or air) and potentially contaminate different parts of the environment?

In addition, we include 3 “other” or physical characteristics:

1. Environmental Transformation Products* — Does the chemical degrade into other substances with a high potential to cause adverse effects for one or more endpoints?
2. Reactivity* — Does the chemical have a high potential to cause a chemical reaction with air, water, or other chemicals?
3. Flammability* — Does the chemical have a high potential to cause a fire at low temperature (i.e., low flash point)?

(Tip: In each assessment Detail report, hover your pointer over the endpoint of interest. This will present the full name of the endpoint in a help bubble.)

SciveraLENS uses an easy-to-understand “traffic light” system to communicate assessment results for the human and environmental health attributes of specific endpoints and for a chemical overall.

A solid green, yellow, red, or black light indicates sufficient authoritative or experimental evidence for an unequivocal hazard assessment.

When half of the light is gray, this indicates limited evidence is currently available for the endpoint. Our Toxicology Team has used systems such as modeling software, quantitative structural activity relationship (“QSAR”) methods, or expert judgment to complete the assessment.

Green is good. Green lights signal an overall assessment of a chemical or a specific human or environmental health endpoint that shows evidence of low hazard.

Yellow is acceptable. Yellow lights signal an overall assessment for a chemical or a specific human or environmental health endpoint that shows evidence of moderate hazard.

Red indicates concern. Red lights signal an overall assessment for a chemical or a specific human or environmental health endpoint that shows evidence of high hazard.

Black indicates high concern. Black lights signal an overall assessment of a chemical or a specific human or environmental health endpoint that shows evidence of high hazard.

The light blue and gray light shows a data gap and that there is insufficient data for an assessment.

Within SciveraLENS, if an endpoint has not been fully assessed yet, you will see a solid light blue light in your detailed assessment view. In these cases, we have included critical authoritative list or hazard-trait-based list information but have not completed a manual review of the hazard detail.

You can click on an endpoint or light for a specific endpoint assessment. This will present the underlying references and explain how our team reached the specific conclusion indicated by the light.

Chemical-Level Hazard Assessments or the SciveraLENS Hazard Category (“HC”) score

We also provide summary assessments for human and environmental health screen results to provide a quick summary or determination for easy reference.
The “HC” or Hazard Category Score is based on an algorithm like EPA Safer Choice and other hazard assessment methodologies. To calculate this summary score, our team uses Core Endpoints (CMRD/PBT) and Supplemental Endpoints (all the rest) to summarize 23 human environmental health characteristics into a simple colored light and action:

• Red light – overall high concern, replace
• Yellow light – overall moderate concern
• Yellow/Green light – overall moderate/low concern, acceptable
• Green light – overall low concern, preferred
• Grey light – insufficient information to summarize, incomplete

We also provide a “✓” for each CAS RN to indicate the verification status of the Chemical Hazard Assessment and HC score.

To simplify the categorization of an overall hazard assessment for a chemical, our toxicology team developed a set of qualitative rules for automated implementation in SciveraLENS. This process uses some generally accepted principles in toxicology, which are also used by other hazard assessment frameworks, like the US EPA’s Safer Choice Program Alternatives Assessment. This process evaluates 24 endpoint-level hazard assessment conditions for a chemical to generate a Hazard Category result for each chemical.

The SciveraLENS Hazard Category rules divide the 24 human and environmental health endpoints into 2 groups: Core Endpoints and Supplemental Endpoints. Core Endpoints are the generally accepted most critical questions to ask about a chemical.

Here are the SciveraLENS Core Endpoints for Human Health:

1. Carcinogenicity (C)
2. Mutagenicity (M)
3. Developmental Toxicity (D)
4. Reproductive Toxicity (R)
5. Endocrine Activity (EA)

These endpoints are often abbreviated to “CMR.” Many chemical management strategies require a basic “CMR Screen” to better understand human chemical safety.

Here are the Core Endpoints for Environmental Health:

1. Persistence (P)
2. Bioaccumulation (B)
3. Acute Aquatic Toxicity (AAT)
4. Chronic Aquatic Toxicity (CAT)
5. Mobility (Mo)

These endpoints are often abbreviated to “PBT.” Many chemical management strategies require a basic “PBT Screen” to understand environmental chemical safety better.

Core Endpoints are of greater importance when categorizing a chemical for an overall hazard. A Hazard Category result of Yellow, Yellow/Green, or Green requires:

• a conclusive hazard assessment for all Human Health Core Endpoints (Carcinogenicity, Mutagenicity-Genotoxicity, Developmental Toxicity, and Reproductive Toxicity),
• a conclusive hazard assessment for the Environmental Health Core Endpoints (Persistence and Bioaccumulation) and
• a conclusive hazard assessment for either Acute Aquatic Toxicity, Chronic Aquatic Toxicity, or both

All the above Core Endpoint rules must be true to enable an overall Hazard Category result other than Gray, which indicates insufficient data to assess, or Red, which indicates high concern.

Certain conditions for one or more Human Health Core Endpoints will result in a Hazard Category result of Red (high concern) for the chemical. Those conditions and the corresponding Hazard Category results are presented below.

Non-core endpoints are referred to as Supplemental Endpoints. These endpoints ask a broader set of questions about a chemical and its potential to cause harmful effects.

1. Here are the Supplemental Endpoints:
2. Acute Dermal Toxicity (atd)
3. Acute Oral Toxicity (ato)
4. Acute Inhalation Toxicity (ati)
5. Systemic Toxicity (Single and Repeat Dose) (st)
6. Neurotoxicity (Single and Repeat Dose) (n
7. Dermal Sensitization (ds)
8. Respiratory Sensitization (rs)
9. Dermal Irritation (di)
10. Eye Irritation (ei)
11. Aspiration Potential (ap)
12. Sensory Irritation (si)
13. Environmental Transformation Products* (etp)
14. Reactivity* (r)
15. Flammability* (f)

* These Supplemental Endpoints do not currently impact the Hazard Category for a chemical.

The SciveraLENS system reviews the hazard conditions for each core and supplemental endpoint for a chemical and then applies a series of rules to determine the appropriate Hazard Category score. After applying the rules to the endpoint hazard assessment results for a chemical, SciveraLENS generates one of six possible Hazard Category results.

SciveraLENS Overall Chemical Hazard Category Rules and Results

 Green — Preferred Chemical: All hazard endpoints have low conclusive hazard assessment conditions—no Core or Supplemental Endpoint data gaps.

 Green/Yellow — Preferred Chemical: All hazard endpoint assessments have low or moderate conclusive assessment conditions. No more than three Supplemental Endpoint data gaps present. No Core Endpoint moderate hazard conditions. No Core Endpoint data gaps.

 Yellow — Conditional Chemical: One or more hazard assessments for Supplemental Endpoints have high or very high conclusive assessment conditions. No Core Endpoints with high or very high hazard conditions. No more than three Supplemental Endpoint data gaps present. No Core Endpoint data gaps.

 Red — Chemical of High Concern: One or more hazard assessments for Core Endpoints have high or very high conclusive assessment conditions.

 Grey — Unable to be Categorized: One or more Core Endpoints have data gaps. Four or more Supplemental Endpoints have data gaps.

 Light Blue — In Process: One or more Core Endpoints have not been fully assessed. Three or more Supplemental Endpoints have not been fully assessed.

What is a Verified Hazard Assessment?

The Chemical Hazard Assessment results available in SciveraLENS® are based on the best available information known to our toxicologists.

An assessment is considered verified if all 24 endpoints are assessed or if we have conclusive enough evidence to support a summary assessment. We will show you the verification status for a chemical-level assessment with a “” in the Verified or “V” column of your assessment results.

In some cases, our team completes an initial assessment, but we have not yet verified the hazard assessment for a particular CAS RN. We will provide you with our best estimated Hazard Category or summary-level score based on the data gathered so far. This is generally going to be a conservative estimate based on any assessment results we have compiled so far.

If you would like our team to complete the verification for a particular CAS RN, please let us know and we can provide a quote and an estimated timeline for the assessment.

If you are interested in certifying a product using SciveraLENS for Screened Chemistry, all CAS RNs will need to be verified as part of the process.

Notifications and alerts

One of the many benefits of your SciveraLENS subscription is that our team of experts manage and maintain each list and sublist as well as hundreds of thousands of Human and Environmental Health assessments. Our team keeps these up to date in our Chemical Data Repository so you can monitor any changes impacting your chemicals in real-time. You can keep an eye on your Notifications and Alerts for any assessment updates that impact your chemicals of interest. There are several different kinds of Notifications and Alerts that you might see depending on your subscription type:

• A new list has been added to SciveraLENS
  When we add a new list to SciveraLENS, we’ll notify you here. You can always update your “Favorite Lists”, work with your Account Manager to update your “Account Favorite Lists” or edit your “Formulations” to screen against the newly added list.
• A list has been updated in SciveraLENS
  As we update lists in our database, we want to make you’re notified if the change impacts any of your chemicals of interest either in your Library or in your Formulations.
• An Endpoint Assessment has been updated
  When our team adds data to a CAS RN for a specific endpoint, we want to make sure you’re notified if that update impacts a specific endpoint score for a chemical of interest.
• The Hazard Category (HC or summary score) for a chemical has been updated
  Like the endpoint notification, when our team updates Chemical Hazard Assessment information for a chemical of interest that impacts the summary or Hazard Category score, we’ll let you know.
• An assessment for a chemical of interest has been Verified
  Our team is constantly adding new information and assessing chemicals that are prioritized by our users. When we complete our verification process (cross review and quality check of all data for a chemical assessment) for a chemical of interest, we’ll let you know. If you need a verification completed for a chemical of interest, you can request those through our toxicology and expert services team.

As any of these changes are made, we’ll let you know so you can:
See what changes were made
See what chemicals or Formulations were impacted

Your Alerts and Notifications page includes 3 main columns:

• Alert – This section provides details on what has changed along with options to view impacted Formulations or impacted CAS RNs
• Type – This will provide you with a quick idea of whether the alert is related to a change to a List that you are tracking or the underlying human and environmental health characteristics for your Formulations or chemicals of interest.
• When – This date stamp shows you when the alert was generated.

You can sort your alerts on any of these columns by clicking the column header.

You can also filter your Alerts by clicking on the funnel icon in the top right of your screen by:

• Type of Alert
• Formulation
• Created since
• Created before
• Archive status (Your alerts look at archived Formulations as well as active Formulations. When viewing the Formulations impacted, make sure your filter includes archived Formulations to view all impacted Formulations.)