How Our Toxicologists Make an Assessment

Our board-certified toxicology team assesses chemicals using the SciveraLENS GHS+ Chemical Assessment Framework. Our board-certified toxicologists and supporting research team research and evaluate chemicals across 23 Human and Environmental Endpoints to complete a comprehensive Chemical Hazard Assessment. This is an incredibly rigorous process. SciveraLENS GHS+ approach is based on the United Nations Globally Harmonized System (GHS) for Classification and Labelling of Chemicals. These GHS endpoints and criteria have been in use by toxicologists and chemical safety professionals for decades to assess and communicate the safety of chemicals used in processes and products.

The UN GHS framework is also the foundation for other well-known chemical assessment methods such as the US Environmental Protection Agency Design for Environment Alternatives Assessment Standard, and the US National Academy of Sciences “Green Book” describing the process for selection of safer alternative chemicals.

In 2018 the SciveraLENS GHS+ Assessment Framework received approval by the US Green Electronics Council for use by electronics companies seeking product certification under the EPEAT Standard.

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

Core Endpoints require conclusive data to generate a conclusive hazard assessment for the chemical.

Conclusive data for Supplemental Endpoints are not required except in the case of a Preferred or Acceptable Chemical overall assessment, but support the overall hazard assessment for the chemical.

Each chemical’s hazard assessment is based on a set of 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, performs a quality assurance step, and confirms the provisional hazard assessment for each chemical.

One example of a data point type in the Carcinogenicity endpoint is the International Agency for Research on Cancer (IARC) authoritative list. If the chemical is listed on the IARC list, that chemical will have an “IARC Group Classification” assigned to it. Each IARC Group Classification results in a corresponding hazard condition for the chemical with regard to carcinogenicity. The chemical formaldehyde has an IARC Group Classification of 1; “known to cause cancer in humans.” This IARC Group Classification corresponds to a Very High or Black color code hazard assessment in SciveraLENS.

What is the SciveraLENS Hazard Category?

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. Having a summary of the endpoint assessments can also be a very useful tool for comparing chemicals, evaluating alternatives, or prioritizing where additional review or consideration is warranted.

To simplify 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 makes use of some generally accepted principles in toxicology also used by other hazard assessment frameworks like the US EPA’s Safer Choice Program Alternatives Assessment among others. This process currently evaluates 20 of the endpoint-level hazard assessment conditions for a chemical to generate a Hazard Category result for each chemical.

The SciveraLENS Hazard Category rules divide the 23 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 — 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 high potential to cause developmental defects in unborn or young humans or other mammals?
4. Reproductive Toxicity — Does the chemical have high potential to cause damage to reproductive systems in humans or other mammals?

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

Here are the Core Endpoints for Environmental Health:

1. Persistence — Does the chemical stay persistent in the environment (ie 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 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 high potential to cause death to aquatic life if present in water over a long period of time?

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

Core Endpoints carry greater importance in categorizing a chemical for 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 or Chronic Aquatic Toxicity, or both

All of 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.

Here are the Supplemental Endpoints:

1. 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?
2. Acute Oral Toxicity — Does the chemical have a high potential to cause death in humans or other mammals when ingested?
3. Acute Dermal Toxicity — Does the chemical have a high potential to cause death in humans or other mammals when absorbed through the skin?
4. Acute Inhalation Toxicity — Does the chemical have a high potential to cause death in humans or other mammals when inhaled?
5. Respiratory Sensitization — Does the chemical have a high potential to cause a permanent allergy to inhalation by humans or other mammals?
6. Dermal Sensitization — Does the chemical have a high potential to cause a permanent allergy to skin contact in humans or other mammals?
7. Dermal Irritation — Does the chemical have a high potential to cause severe damage to the skin of humans or other mammals on contact?
8. Eye Irritation — Does the chemical have a high potential to cause severe damage to the eyes of humans or other mammals on contact?
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. Sensory Irritation — Does the chemical have a high potential to cause irritation of mucous membrane tissue?
12. Aspiration Potential — Does the chemical have a high potential to result in pulmonary edema (fluid in lungs) if inhaled?
13. Reactivity* — Does the chemical have a high potential to cause a chemical reaction with air, water, or other chemicals?
14. Flammability* — Does the chemical have a high potential to cause a fire at low temperature (i.e., low flash point)?
15. Environmental Transformation Products* — Does the chemical degrade into other substances with high potential to cause adverse effects for one or more endpoints?

*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. 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.

If you have any questions or suggestions about the SciveraLENS Hazard Category process or rules, please contact us at sustainablechemistry.toxteam@enhesacom. We look forward to hearing from you.

What is a Verified Hazard Assessment?

List screen and comprehensive hazard assessment results available in SciveraLENS® are the best available information known to our board-certified toxicologists. They assess each chemical that is entered into SciveraLENS by subscribers to deliver results quickly, accurately, and cost-effectively. Currently, SciveraLENS has assessed over 1 million individual endpoints across 10,000+ unique CAS RNs. As much as we would love to have every CAS RN fully assessed, we’re not quite there yet.

Individual endpoint hazard assessment results offer very useful insight into the human and environmental health characteristics of chemicals used in consumer products and processes. SciveraLENS presents an easy to understand traffic light summary of these results for the 23 most common toxicological endpoints as well as an overall assessment for each chemical. Multiple levels of assessment results enable objective comparison of alternatives or prioritizing where additional review or consideration is warranted.

In some cases, our team completes an initial assessment but we have not yet verified the hazard assessment for a particular CAS RN. An assessment is considered verified if all 23 endpoints are assessed. Within SciveraLENS, if an endpoint is not assessed yet, you will see a solid light blue light in your detailed assessment view.

If you are interested in certifying a product using SciveraLENS, all CAS RNs will need to be verified as part of the process. If you plan on exporting any information about the assessments in SciveraLENS, we highly recommend confirming that hazard assessment is verified before proceeding. There are over 4,500 CAS numbers with fully complete hazard assessments in SciveraLENS and the number grows on a daily basis. To accelerate an assessment for a small fee, please get in touch with any questions or to submit your request.

What Lists are Tracked in SciveraLENS?

Our Toxicologists review hundreds of lists that are created by regulatory agencies, organizations, NGOs, etc. We add the lists that matter most to our customers into SciveraLENS so that you can quickly see if any of your chemicals appear on a list of interest. In addition to monitoring these lists and making sure that 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.

In order to make it easier for you to find the lists that you are interested in, you can search through our roster of lists using the filter function:

Or when you’re creating a Formulation in SciveraLENS, you can quickly search for and scan the lists available:

You’ll notice that our lists have identifiers in their titles so you can quickly see what category each list is in. Let’s learn a bit more about types of lists we track and explain more about each:

• Authoritative: Authoritative lists come from recognized experts that identify known hazards and are considered reliable and high confidence sources.
  • Examples include: IARC – Cancer Monographs Carcinogen Groups, NTP-OHAT Lists
• Group: Group lists identify chemical groups, often these have known hazard characteristics but not all group lists indicate a particular hazard level.
  • Examples include: Aluminum, Azo Dyes, Mercury, Toluene Diisocyanates
• Hazard: Hazard lists identify known hazards but are considered less authoritative and comprehensive sources. These hazards are assigned with lower confidence.
  • Examples include: AOEC – Asthmagens, Lancet – Grandjean & Landrigan Neurotoxic Chemical, TEDX
• Inventory: Inventory lists do not indicate specific hazards, only that a CAS RN is present on a list of known chemicals generally by a regulatory body and/or country.
  • Examples include: Canada DSL
• Organization: Organization lists include non-governmental organizations and other sources, these are often sector-specific.
  • Examples include: AAFA, Afirm, BIFMA, ChemSec, Cradle to Cradle, Safer Chemicals Healthy Families, ZDHC MRSL
• Preferred: Preferred lists indicate low hazard, generally for a particular endpoint, but can also be for a chemical overall.
  • Examples include: EPA Safer Chemical Ingredient List
• Regulatory: Regulatory lists are those published by regulatory authorities, these include country lists and specific agencies within countries.
  • Examples include: California Proposition 65, ECHA, EU REACH, Oregon Health Authority, US EPA, US FDA, Washington State CHCC

To view all lists in SciveraLENS, click on the Lists menu item on the navigation bar. Don’t see a list that you’re interested in tracking your chemicals against? Let us know!

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 or not a chemical in your product or formulation appears in the RSL and identify next steps.

Often these lists reference general families of chemicals (e.g., “all mercury-containing compounds”), which requires the user of the list to be very diligent about the possible chemicals that might fit into that group. One example is the 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 all of our subscribers to see a full assessment of how chemicals of interest are regulated or restricted and identify any 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 available in SciveraLENS gives you a comprehensive list screen that can save on testing costs and product failures down the road. We also offer the base lists like the WA CHCC list that includes the 70 original CAS RNs so you have a quick scan to see what you need to report on.

When you select a list for screening in SciveraLENS, you’ll quickly see whether or not your chemical appears on a list of interest, if a concentration threshold is indicated, whether or not your concentration exceeds that threshold, and if the chemical appears on the list as part of a chemical group.

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