SciveraLENS® GHS+ Chemical Hazard Assessment Framework Overview

Understand the steps, data requirements, criteria, assumptions, and assessor qualifications we implement to generate and maintain a Chemical Hazard Assessment (CHA).

1. Introduction

Since SciveraLENS’s founding in 2008, our toxicologists have been performing comprehensive chemical hazard assessments using procedures and criteria established by government authorities, accreditation bodies, and general toxicology best practices.

This page presents the steps, data requirements, criteria, assumptions, and assessor qualifications that the Enhesa Sustainable Chemistry team of toxicologists and chemical assessors implement to generate and maintain a Chemical Hazard Assessment (CHA) to evaluate human and environmental health of industrial chemicals.

Our toxicologists implement a series of steps for the hazard assessment of chemicals that:

1) confirms the identity of the chemical for assessment,
2) makes efficient use of authoritative and regulatory lists of chemicals as an early indication of the chemical’s hazard characteristics,
3) implements a deep investigation of the chemical’s hazard characteristics across twenty-three human and environmental health endpoints and physical hazards, and
4) determines an overall hazard assessment category for the chemical based on the results of the List Review and the Endpoint Assessments.

Figure 1-1 :: SciveraLENS GHS+ Chemical Hazard Assessment Process Flow Diagram

We’ve built and updated the GHS+ Chemical Hazard Assessment Process (“GHS+”) on a foundation of the broadly-accepted approach, endpoints, and criteria from the following leading documented references for best practices in this discipline:

  1. US Environmental Protection Agency Design for Environment Program* “Alternatives Assessment Criteria for Hazard Evaluation” Version 2.0 (2011)
  2. National Academy of Sciences, “A Framework to Guide the Selection of Chemical Alternatives” (2014)
  3. United Nations, Globally Harmonized System (“GHS”) for the Classification and Labelling of Chemicals, Tenth Revised Edition (2023)

 

2. GHS+ Assessment Process Steps

The following section outlines the principal steps of the GHS+ process.

 

Step 1 – Identify the chemical of interest

In order to process a Chemical Hazard Assessment, Enhesa Sustainable Chemistry toxicologists first confirm the identity of the chemical of interest by a set of accepted methods. The main purpose of confirming the identity of the chemical of interest is to make a unambiguous connection between the chemical of interest and all available physical chemical property data as well as human and environmental health data.

  1. Chemical Abstract Service® Registry Number (CAS RN) :: The CAS RN is the most common unique identifier that connects a chemical to its various references to physical chemical properties, as well as toxicological data for human and environmental health.There are over 204 million CAS RNs established for chemicals used across commerce and science. A subset of these chemicals are relevant to consumer products and their industrial processes. We currently track around over 300,000 unique CAS RNs in the SciveraLENS Chemical Assessment Knowledge Base.
  2. Other identifiers :: In the case of a chemical that does not have a CASRN, or if we find multiple/conflicting CAS RNs for the same chemical, our toxicologists will confirm the identity of the chemical of interest by searching for other authoritative identifiers such the European Chemicals Agency (“ECHA”) number (“EC-number”), US EPA Pre-manufacturing Number (“PMN”), molecular structure (ie SMILES Notation), or other available means to confirm the identity of the chemical of interest.

An important aspect of gathering chemical identity information is for the purpose of the List Review step. Chemical Lists most often use the CAS RN as the identifier for listed chemicals. This reduces ambiguity that can occur when a chemical name is used and most chemicals have multiple names based on industry, language, or source of information.

Furthermore, chemical identifiers are important to the use of modelling software and the work to identify analogous chemicals by class or molecular structure in order to predict hazard characteristics where authoritative and experimental data are not available.

 

Step 2 – Review Lists

The next step in the Process is to screen the chemical of interest against applicable lists of chemicals that indicate specific concerns or characteristics relevant to the assessment process. Our toxicologists and chemical researchers monitor and keep updated in SciveraLENS over 400 lists across several types:

  • Regulatory Lists
  • Authoritative Lists
  • Organizational Lists
  • Inventory Lists
  • Preferred Lists

 

Of these list types, the Regulatory, Authoritative, or Organizational Lists tracked by our toxicologists can show an indication of a concern for a specific human or environmental health endpoint. We make note of that concern as part of the data gathering effort for the hazard assessment.

See Appendix A – Chemical Lists Monitored by and Available for Screening in SciveraLENS

An important part of our approach to List Screening is the handling of chemical groups. Many Regulatory (e.g., Washington State Chemicals of High Concern to Children) and Organizational Lists (e.g., American Apparel and Footwear Association Restricted Substance List) refer to general groups of chemicals (e.g., “mercury and its compounds’). These general statements shift the burden of understanding what chemicals fit into these groups to the user. Given lack of expertise and resources at many consumer products brands and suppliers, this can be a very challenging task. Our advanced support of List Screening as part of its process is unique in the industry.

Furthermore, some chemical screening processes and software systems confuse List Screening with a chemical hazard assessment. A list screening process or software tool that checks chemicals for their presence on one or more chemical lists connected to general health concerns or specific hazard characteristics can be a useful first step in screening chemicals, but it is not an acceptable substitute for a hazard assessment. There are important differences between a List Screen and a Hazard Assessment that our Chemical Hazard Assessment Process is working to inform consumer products companies, their suppliers, and the broader stakeholder community of these differences.

 

Step 3 – Endpoint Assessment

Our team of experienced toxicologists process Endpoint Hazard Assessments using a broad selection of accepted chemical hazard data resources:

  • Authoritative Lists
  • Regulatory Lists
  • Experimental Data
  • Modelled Data
  • Analogous Data
  • Expert Judgment

Our toxicology team gathers available data from a wide-range of public and proprietary sources including (but not limited to):

  • National Institutes of Health, National Library of Medicine Suite of Chemical Hazard Data Resources (e.g., PubChem)
  • European Chemicals Agency (ECHA) REACH Dossiers
  • US Environmental Protection Agency Databases
  • National Toxicology Program reports
  • International Agency for Research on Cancer monographs
  • ToxPlanet Toxicological Data Aggregator Service
  • Scientific Journal Articles

If authoritative or experimental data are not available for a chemical, our toxicologists will generate modelled data if appropriate for that endpoint. We use a number of computational toxicology software tools including:

  • OECD QSAR Toolbox
  • US EPA PBT Profiler*
  • US EPA EpiSuite
  • US EPA T.E.S.T.

*PBT Profiler is no longer an actively supported modelling tool by US EPA, but SciveraLENS still references some PBT Profiler data for Environmental Health endpoint assessments.

In addition to using sophisticated modelling tools to fill endpoint data gaps, our toxicology team makes use of best practices for Quantitative Structure-Activity Relationships (QSAR) strategies to find analogous chemicals where hazard data is available to draw “read-across” assessment conclusions for similar chemicals.

Once our team has compiled available authoritative, experimental, modeled, and analogous data for an endpoint, our toxicologists makes use of SciveraLENS GHS+ Hazard Assessment Framework matrix for Hazard and Dose-Response Assessment Criteria to determine the corresponding hazard condition.

See our web-based table by endpoint below.

 

Data reliability – When collecting Endpoint Hazard Data for a chemical, Scivera’s toxicology team checks the reliability of each data point. Scivera’s toxicology team requires high reliability of experimental data for inclusion in the assessment decision process for an endpoint. The most effective method for confirming data reliability is the expert judgment of the toxicologist. Our toxicology team uses data sources of high reliability and corroborates one data point with as many others as possible to arrive at a conclusion for an endpoint assessment. We also refer to objective data reliability indicators such as the Klimisch Score for a experimental data point, but ultimately expert judgment of our toxicologists is critical to the determination of a valid data point.

Weight-of-Evidence – When multiple data points are present for an endpoint assessment, our toxicologists use a cautious, weight-of-evidence approach to the assessment decision. For example, if two data points indicate a high hazard for a chemical, and 6 data points indicate moderate hazard, the resulting hazard assessment for the endpoint would be high hazard (assuming all data are of equivalent quality).

 

Human Health Endpoints include:

  • Carcinogenicity
  • Mutagenicity-Genotoxicity
  • Developmental Toxicity
  • Reproductive Toxicity
  • Endocrine Activity
  • Acute Oral Toxicity
  • Acute Dermal Toxicity
  • Acute Inhalation Toxicity
  • Respiratory Sensitization
  • Dermal Sensitization
  • Dermal Irritation
  • Eye Irritation
  • Systemic Toxicity (Single and Repeat Dose)
  • Neurotoxicity (Single and Repeat Dose)
  • Sensory Irritation
  • Aspiration Potential

Underlined endpoints in the above table indicate Core Endpoints. Core Endpoints carry greater emphasis in the subsequent step of categorizing a chemical for overall hazard. SciveraLENS’s overall chemical assessment category, Hazard Category, require a conclusive hazard assessment for all Human Health Core Endpoints to enable an overall Hazard Category other than “Gray,” or “Insufficient data to assess”.

Endpoints that are not underlined are Supplemental Endpoints. Supplemental Endpoints are a critical component of the overall assessment category, but due to limited data availability, some data gaps are allowed for these endpoints while still generating an overall hazard assessment category for a chemical.

 

Environmental Health (Ecotox and Environmental Fate) Endpoints include:

  • Persistence
  • Bioaccumulation
  • Acute Aquatic Toxicity
  • Chronic Aquatic Toxicity

Underlined Environmental Health endpoints in the above table indicate Core Endpoints. Core Endpoints carry greater emphasis in the subsequent step of scoring a chemical for overall hazard. SciveraLENS’s overall chemical assessment category, Hazard Category, require 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, to enable an overall Hazard Category category other than “Gray,” or “Insufficient data to assess”.

Endpoints that are not underlined are Supplemental Endpoints. Supplemental Endpoints are a critical component of the overall assessment category, but due to limited data availability, some data gaps are allowed for these endpoints while still generating an overall hazard assessment category for a chemical.

 

Our toxicology team also collects data and completes assessments for three additional endpoints that are specific to a chemical’s physical chemical properties – these are Supplemental Endpoints:

  • Flammability
  • Reactivity
  • Environmental Transformation Products

Supplemental Endpoints are a critical component of the overall assessment category, but due to limited data availability, some data gaps are allowed for these endpoints while still generating an overall hazard assessment category for a chemical.

Environmental Transformation products consider the feasibility and relevance (not transient, not naturally occurring) of formation through appropriate pathways – oxidation (combustion), hydrolysis, photolysis, reduction or biodegradation.  If an environmental transformation product of concern is identified, the score of the endpoint of concern (persistence, toxicity, etc), will be adjusted to reflect the level of concern (Very high, High or Moderate) and subsequent overall Hazard Category score.

 

We use a traffic light (i.e., green, yellow, red indicators) approach to communicating the hazard assessment results for each endpoint, and for a chemical assessment outcome overall. See Table 2-1 :: SciveraLENS GHS+ Hazard Assessment Conditions for an overview of endpoint hazard conditions and the corresponding traffic light symbol.

The hazard conditions during the endpoint assessment step include the following possible outcomes:

Green

 – Low Hazard – The data indicate low hazard for the specific endpoint or overall chemical.

Yellow

– Moderate Hazard – The data indicate moderate hazard for the specific endpoint or overall chemical.

Red

– High Hazard — The data indicate high hazard for the specific endpoint or overall chemical. Chemicals showing high hazard for one or more endpoints require a review of potential exposure and/or concentration threshold and subsequent screening-level risk assessment.

Black – Very High Hazard – The data indicate very high hazard for the specific endpoint.

Blue

/

Gray

– Insufficient Data – The endpoint has been assessed by our team of board-certified toxicologists but available data are not sufficient to enable an assessment for the endpoint.

Blue

– Assessment In Process – Our toxicology team has not completed the full data gathering and assessment process for this endpoint, and there is no current List evidence indicating a concern for the endpoint.

 

NOTE: When hazard symbols employ a half-color and half-gray combination, this indicates that our toxicology team used computer modeling, analogous data, and/or expert judgment in the assessment process for the endpoint, category or chemical.

 

Table 2-1 :: SciveraLENS GHS+ Endpoint-level Hazard Assessment Conditions

Hazard Condition Description SciveraLENS Symbol
Low Hazard The chemical shows evidence of concern for the endpoint of interest only at a high dose level. [green]
Low Hazard based on Limited Evidence The chemical shows evidence of concern for the endpoint of interest only at a high dose level. [half green-half gray]
Moderate Hazard The chemical shows evidence of concern for the endpoint of interest at a moderate dose level. [yellow]
Moderate Hazard based on Limited Evidence The chemical shows evidence of concern for the endpoint of interest at a moderate dose level. [half yellow-half gray]
High Hazard The chemical shows evidence of concern for the endpoint of interest at a low dose level. [red]
High Hazard based on Limited Evidence The chemical shows evidence of concern for the endpoint of interest at a low dose level. [half red-half gray]
Very High Hazard The chemical shows evidence of concern for the endpoint of interest at a very low dose level. [black]
Very High Hazard based on Limited Evidence The chemical shows evidence of concern for the endpoint of interest at a very low dose level. [half black-half gray]
Insufficient data to assess There are not sufficient hazard and dose-response data available for this endpoint to assess hazard. [half blue-half gray]
In process Hazard assessment process underway for this endpoint but conclusive assessment not yet complete. [blue]

 

SciveraLENS GHS+ Chemical Hazard Assessment Framework – Criteria by Endpoint

Human Health Endpoints – Chronic

Hazard GHS+ Criteria Very High High Moderate Low
Carcinogenicity GHS GHS Category 1A – Known human carcinogen (largely based on human evidence) GHS Category 1B – Presumed human carcinogen (largely based on animal evidence) GHS Category 2 – Suspected human carcinogen
GHS+ Qualitative Assessment of Available Data Experimental and modeling data may be used. Experimental and modeling data may be used. Experimental and modeling data may be used. Modeling data may not be used alone. Negative modeling with negative Mutagenicity/Genotoxicity and repeated dose Systemic Toxicity.
Mutagenicity/Genotoxicity GHS GHS Category 1A GHS Category 1B GHS Category 2
Known to induce heritable mutations in germ cells of humans Presumed to induce heritable mutations in germ cells of humans. Experimental and modeling data may be used. Suspected of inducing heritable mutations in the germ cells of humans. Experimental and modeling data may be used. Experimental and modeling data may be used. Modeling data may not be used alone.
Authoritative Lists EU Category 1 EU Category 2 EU Category 3
Developmental and Reproductive Toxicity (scored as separate endpoints) GHS GHS Category 1A GHS Category 1B GHS Category 2
Known human reproductive toxicant Presumed human reproductive toxicant Suspected human reproductive toxicant
Assessment of Available Quantitative Data (quantitative values are used for guidance only, considered in the context of maternal toxicity in relation with reproductive / developmental effects) NOAEL/LOAEL oral (mg/kg/day): <50 NOAEL/LOAEL oral (mg/kg/day): 50-250 NOAEL/LOAEL oral (mg/kg/day): >250
NOAEL/LOAEL dermal (mg/kg/day): <100 NOAEL/LOAEL dermal (mg/kg/day): 100-500 NOAEL/LOAEL dermal (mg/kg/day): >500
NOAEL/LOAEL inhalation (vapor/gas) (mg/L/day): <1 NOAEL/LOAEL inhalation (vapor/gas) (mg/L/day): 1-2.5 NOAEL/LOAEL inhalation (vapor/gas) (mg/L/day): >2.5
NOAEL/LOAEL inhalation (dust/mist/fume) (mg/L/day): <0.1 NOAEL/LOAEL inhalation (dust/mist/fume) (mg/L/day): 0.1-0.5 NOAEL/LOAEL inhalation (dust/mist/fume) (mg/L/day): >0.5
Qualitative Assessment of Available Data Experimental and modeling data may be used. Experimental and modeling data may be used. Experimental and modeling data may be used. Modeling data may not be used alone
Authoritative Lists EU Category 1 EU Category 2 EU Category 3
California Proposition 65 – listed
Endocrine Activity GHS+ Qualitative Assessment of Available Data Evidence of endocrine disrupting activity in appropriate assays. Evidence or endocrine activity and related human health effect. SVHC endocrine chemicals. When C, D, R and TOST are H and in vivo effect is endocrine-related. Evidence of endocrine activity. When D, R and/or TOST are M with in vivo endocrine-related effects (e.g., thymus, thyroid). Listed on relevant lists; indication of endocrine activity in studies (modeling and in vitro). Modeling indicates “active”. No evidence of activity (no binding, perturbation, or evidence of endocrine-related adverse effects) in appropriate assays and no structural alerts. Need negative data (modeled, in vitro, and in vivo) for key EATS (estrogenic, androgenic, thyroid, steroidogenic) endocrine pathways.
Authoritative Lists EU Category 1 EU Category 2
Hazard Lists ChemSec SIN Listed TEDX Listed

Human Health Endpoints – Acute

Hazard GHS+ Criteria Very High High Moderate Low
Acute Oral Toxicity (LD50, rat) GHS GHS Category 1 or 2 GHS Category 3 GHS Category 4 GHS Category 5 or “not classified”
Qualitative Assessment of Available Data (Experimental or modeled) LD50 ≤ 50 mg/kg 50 mg/kg< LD50 ≤ 300 mg/kg 300 mg/kg < LD50 ≤ 2000 mg/kg LD50 > 2000 mg/kg
Acute Dermal Toxicity (LD50, rabbit) GHS GHS Category 1 and 2 GHS Category 3 GHS Category 4 GHS Category 5 or “not classified”
Qualitative Assessment of Available Data. LD50 ≤ 200 mg/kg 200 mg/kg < LD50 ≤ 1000 mg/kg 1000 mg/kg < LD50 ≤ 2000 mg/kg LD50 > 2000 mg/kg
Acute Inhalation Toxicity (LC50, rat) GHS GHS Category 1 and 2 GHS Category 3 GHS Category 4 GHS Category 5 or “not classified”
Qualitative Assessment of Available Data. Vapor – < 2 mg/L; Dust/mist - LC50 ≤ 0.5 mg/L Vapor- 2 mg/L < LC50 ≤ 10mg/L; Dust/mist - 0.5 mg/L < LC50 ≤ 1.0 mg/L Vapor -10 mg/L < LC50 ≤ 20mg/L; Dust/mist - 1 mg/L < LC50 ≤ 5mg/L Vapor – LC50 > 20 mg/L; Dust/mist LC50 > 5mg/L
Dermal Irritation GHS GHS Category 1, 1A, B and C 2-Irritant 3-Mild irritant “Not Classified”
Qualitative Assessment of Available Data including Modeling Results (e.g., Toxtree “me” data cards) 1A – Evidence of irreversible damage to skin in human following exp of up to 3 min and up to 1 hr observation; or in animal experience or test data; pH extremes of ≤ 2 and ≥ 11.5. 1B,C-Evidence of irreversible damage to skin in human following exp of > 3 min and up to 4 hrs and observations of up to 14 days, or in animal experience or test data; pH extremes of ≤ 2 and ≥ 11.5 — NOTE: If only GHS Category 1 is specified (but not 1A or 1B or 1C) then descriptive data of the hazard will be used to determine score. Evidence of reversible damage to skin following exp of up to 4 hrs (human experience or data or animal experience or data). Modeling data may be used. Evidence of reversible damage to skin following exp of up to 4 hrs in animal experience or test data. Modeling data may be used. Adequate data available, and negative studies, no structural alerts, GHS not classified. Modeling data may not be used alone.
Acute Eye Irritation GHS GHS Category 1 GHS Category 2A GHS Category 2B
Qualitative Assessment of Available Data Damage to the eye which is not fully reversible within 21 days (human data/experience) or positive animal experience or test data in at least 1 animal Changes in the eye which are fully reversible within 21 days (human data/experience) or positive animal experience or test data in at least 2 animals — NOTE: If only GHS Category 2 is specified (but not 2A or 2B) then descriptive data of the hazard will be used to determine score. Modeling data may be used. Evidence of mild eye irritation in human experience or data or animal experience or test data indicating complete reversibility of lesions within 7 d — NOTE: If only GHS Category 2 is specified (but not 2A or 2B) then descriptive data of the hazard will be Adequate data available, and negative studies, no structural alerts, GHS not classified. Modeling data may not be used alone.
Sensory Irritation GHS+ Qualitative Assessment of Available Data RD50 ≤ 5 ppm 5 ppm < RD50 ≤ 1500 ppm RD50 > 1500 ppm
GHS STOT H335

Human Health Endpoints – Other

Hazard GHS+ Criteria Very High High Moderate Low
TOST – Single Exposure (Specific target organ systemic toxicity following single exposure) GHS GHS Category 1 GHS Category 2 GHS Category 3 GHS Category “Not Classified”
Qualitative Assessment of Available Data Reliable evidence of a significant adverse effect on specific organ/systems or systemic toxicity in humans or animals. Oral ≤ 300mg/kg; Dermal ≤ 1000 mg/kg; Inhalation -vapor/gas – ≤ 10 mg/L/4hr; dust/mist/fumes – ≤ 1.0mg/L/4hr Evidence of a harmful adverse effect on specific organ/systems or systemic toxicity from animal studies or humans. Oral – > 300 to ≤ 2000mg/kg; Dermal – > 1000 to ≤ 2000 mg/kg; Inhalation -vapor/gas – > 10 to ≤ 20mg/L/4hr; dust/mist/fume – > 1.0 to ≤ 5.0mg/L/4hr Evidence of transient (1) irritant effects on respiratory tract in humans or (2) transient narcotic effects from animal studies and in humans Adequate data available, and negative studies, no structural alerts, GHS not classified
TOST – Repeat Exposure (Specific target organ systemic toxicity following repeated exposure; based on 90 day exposures) GHS GHS Category 1 GHS Category 2 Not Classified
NOAEL/LOAEL oral (mg/kg/day): <10 NOAEL/LOAEL oral (mg/kg/day): 10-100 NOAEL/LOAEL oral (mg/kg/day): >100
NOAEL/LOAEL dermal (mg/kg/day): <20 NOAEL/LOAEL dermal (mg/kg/day): 20-200 NOAEL/LOAEL dermal (mg/kg/day): >200
NOAEL/LOAEL inhalation (vapor/gas) (mg/L/6h/day): <0.2 NOAEL/LOAEL inhalation (vapor/gas) (mg/L/6h/day): 0.2-1.0 NOAEL/LOAEL inhalation (vapor/gas) (mg/L/6h/day): >1.0
NOAEL/LOAEL inhalation (dust/mist/fume) (mg/L/6h/day): <0.02 NOAEL/LOAEL inhalation (dust/mist/fume) (mg/L/6h/day): 0.02-0.2 NOAEL/LOAEL inhalation (dust/mist/fume) (mg/L/6h/day): >0.2
Qualitative Assessment of Available Data including Modeling Alerts as needed Reliable evidence of a significant adverse effect on specific organ/systems or systemic toxicity in humans or animals Evidence of a harmful adverse effect on specific organ/systems or systemic toxicity from animal studies or humans. Adequate data available, and negative studies, no structural alerts, GHS not classified. Modeling data may not be used alone.
Aspiration Hazard GHS GHS Category 1 GHS Category 2
Qualitative Assessment of Available Data Human evidence; hydrocarbons with kinematic viscosity of 20.5 mm2/s or less, measured at 40° C Based on animal studies; kinematic viscosity of 14 mm2/s or less, measured at 40°C
Dermal Sensitization GHS GHS Category 1A GHS Category 1B
Substances showing a high frequency of occurrence in humans and/or a high potency in animals Substances showing a low to moderate frequency of occurrence in humans and/or a low to moderate potency in animals
Hazard Lists MAK Sensitizing Substances Sh (Skin) or Sah (Respiratory and Skin)
Qualitative Assessment of Available Data Positive responses in predictive Human Repeat Insult Patch Tests (HRIPT) or other human experience or analogy to chemical classes and/or positive, animal or LLNA data. Modeling data may be used. Modeling data may be used. Adequate data available, and negative studies, no structural alerts, GHS not classified. Modeling data may not be used alone.
Respiratory Sensitization GHS GHS Category 1A GHS Category 1B – Low to moderate sensitization rate in humans or probability thereof based upon animal or other tests
High sensitization rate in humans or probability thereof based upon animal or other tests
Hazard Lists MAK Sensitizing Substances Sa (Respiratory) or Sah (Respiratory and Skin) AOEC
Neurotoxicity See TOST, Single and Repeat see TOST see TOST see TOST
Hazard Lists Listed on Grandjean & Landrigan (ME)
Qualitative Assessment of Available Data Evidence of neurotoxicity in humans or positive results in appropriate animal tests assessing functional observational battery, motor activity, neuropathology Probable human neurotoxicant (some positive results in appropriate animal tests) No evidence for a neurotoxic hazard

Ecotox and E-Fate Endpoints

Hazard GHS+ Criteria Very High High Moderate Low
Eco Toxicity
Acute Hazards to the Aquatic Environment GHS GHS Category 1 GHS Category 2 GHS Category 3 GHS Category “Not Classified”
Qualitative Assessment of Available Data (modeling data may be used) LC/EC50 ≤ 1mg/L (fish 96hr LC50, crustacea 48hr EC/LC50, or aquatic plant 72 or 96hr ErC50). 1 mg/L < LC/EC50 ≤ 10 mg/L (fish 96hr LC50, crustacea 48hr EC/LC50, or aquatic plant 72 or 96hr ErC50) 10 mg/L < LC/EC50 ≤ 100 mg/L (fish 96hr LC50, crustacea 48hr EC/LC50, or aquatic plant 72 or 96hr ErC50) LC/EC50 > 100mg/L
Chronic Hazards to the Aquatic Environment GHS GHS Category 1 GHS Category 2 GHS Category 3 and 4 GHS Category “Not Classified”
Qualitative Assessment of Available Data (modeling data may be used) LC/EC50 ≤ 0.1 mg/L LC/EC50 > 0.1 to ≤ 1mg/L (fish 96hr LC50, crustacea 48hr EC/LC50, or aquatic plant 72 or 96hr ErC50) and BCF ≥ 500 or if absent log Kow ≥ 4 > 1 mg/L 1mg/L. Category 4 – Poorly soluble and no acute toxicity is observed upon water solubility and BCF≥ 500 or if absent log Kow ≥ 4, unless chronic NOECs > 1mg/L LC/EC50 >10 mg/L
Environmental Fate
Persistence Qualitative Assessment of Available Data
% Biodegradation in 28 days ≤10% in 28 days, or when less than 30% in >28 days greater than 10% to <30% in 28 days ≥30% to 70% in 28 days Rapidly degradable; Degradation >70% of dissolved organic carbon in 28 days (reached within a 10-day window); if not available BOD (5 days)/ COD ratio ≥0.5, considered indicative of rapid degradation
Biological Oxygen Demand (BOD)/Chemical Oxygen Demand (COD) ratio BOD (5 day)/COD ratio <0.2, not biodegradable BOD (5 day)/COD ratio 0.2-0.4, slowly biodegradable BOD (5 day)/COD ratio >0.4-0.5, moderately biodegradable BOD (5 day)/COD ratio >0.5, easily biodegradable
t 1/2 in days Persistence in soil or sediment: Half-life>180 days or recalcitrant; Persistence in water: Half-life>60 days or recalcitrant; Persistence in air: >5 days or recalcitrant Soil or Sediment: >60 to 180 days; Water: >40 to 60 days; Air 2 to 5 days Soil or Sediment: 16 to 60 days; Water: 16 to 40 days; Air: Half-life assessed as high or low Soil, Sediment, or Water<16 days; Air<2 days; GHS "Rapid degradability"; Meets 10-day "Ready Biodegradability"
Chemical Class Inorganic – Determined by compound characteristics under environmental conditions
Potential for Long-range Transport Evidence Suggestive Evidence
Potential for Actual Bioaccumulation Qualitative Assessment of Available Data (modeling data may be used) BCF or BAF >5000 or log Kow >5 BCF or BAF >1000 to 5000 or log Kow 4.5-5 BCF or BAF 500 to 1000 or log Kow 4-4.5 BCF or BAF >100 – 500 or log Kow <4.5
Environmental Transformation Products (ETPs)
Environmental Transformation Products (ETPs) Qualitative Assessment of Available Data (modeling data may be used) Experimental data indicating persistent and very highly toxic degradation products. Experimental or modeling data indicating persistent and highly toxic degradation products. Experimental or modeling data indicating persistent and moderately toxic degradation products. Data are available suggesting low concern for ETPs (e.g., low persistence, low toxicity).

Physical Hazard Endpoints

Hazard GHS+ Criteria Very High High Moderate Low
Flammability GHS: Flammable Liquids GHS Category 1 GHS Category 2 GHS Category 3 and 4 GHS Category “Not Classified”
GHS: Flammable Gases GHS Category 1 GHS Category 2 or GHS Category A GHS Category B or GHS Category “Not Classified”
GHS: Flammable Solids GHS Category 1 GHS Category 1 GHS Category 2 GHS Category 3 or GHS Category “Not Classified”
GHS: Aerosols LC/EC50 ≤ 0.1 mg/L GHS Category 1 GHS Category 2 GHS Category 3 or GHS Category “Not Classified”
GHS: Pyrophoric Liquids GHS Category 1 GHS Category “Not Classified”
GHS: Pyrophoric Solids GHS Category 1 GHS Category “Not Classified”
Qualitative Assessment of Available Data (modeling data may be used) Flashpoint: flammable liquids Flash point 35 ∘C Flash point 35 ∘C Flash point ≥ 23 ∘C and ≤ 93 ∘C Flash point > 93 ∘C
Reactivity GHS: Explosives GHS Unstable GHS Division 1.1, 1.2, or 1.3 GHS Division 1.4 or 1.5 GHS Division 1.6 or GHS Category “Not Classified”
GHS: Self-reactive Substances GHS Type A or B GHS Type C or D GHS Type E or F GHS Type G or GHS Category “Not Classified”
GHS: Substances which on contact with water emit flammable gases GHS Category 1 GHS Category 2 GHS Category 3 GHS Category “Not Classified”
GHS: Oxidizing Gases GHS Type A or B GHS Type C or D GHS Type E or F GHS Type G or GHS Category “Not Classified”
GHS: Oxidizing Liquids and Solids GHS Category 1 GHS Category 2 GHS Category 3 GHS Category “Not Classified”
GHS: Organic Peroxides GHS Type A or B GHS Type C or D GHS Type E or F GHS Type G or GHS Category “Not Classified”
GHS: Self-Heating Substances Experimental data indicating persistent and very highly toxic degradation products. GHS Category 1 GHS Category 2 GHS Category “Not Classified”
GHS: Substances Corrosive to Metal GHS Category 1 GHS Category “Not Classified”
Step 4 – Overall Chemical Hazard Categorization

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 enable a overall hazard assessment category for a chemical, Enhesa Sustainable Chemistry developed a set of rules for automated implementation in SciveraLENS that evaluates the individual endpoint hazard assessment categories to generate our Hazard Category category for each chemical.

 

SciveraLENS Overall Chemical Hazard Category Results and Rules

[Green] – Highly Preferred Chemical: (1) All hazard endpoints have low (conclusive) or low (limited evidence) hazard assessment conditions, and (2) No Core or Supplemental Endpoint data gaps.

[Green/Yellow] – Preferred Chemical: (1) All Human Health Core Endpoints have low assessment conditions and no Core Endpoint data gaps, and (2) One or more Human Supplemental Endpoints is moderate hazard (3) Or one Environmental Fate endpoint is high hazard but the other is low hazard (4) No endpoints with a very high hazard assessment condition, and (5) No more than three Supplemental Endpoint data gaps present.

[Yellow] – Acceptable Chemical: (1) One or more hazard assessments for Supplemental Endpoints have high or very high (conclusive) or high or very high (limited evidence) hazard assessment conditions, and (2) No Core Endpoints with high or very high hazard assessment conditions, (3) No Environmental Fate endpoints are high with one or more moderate hazard Human or Ecotoxicity endpoints (4) No more than three Supplemental Endpoint data gaps present, and (4) No Core Endpoint data gaps.

[Red] – Chemical of High Concern: (1) One or more Human Health Core Endpoint has a high or very high hazard assessment, or (2) Two or more Environmental Health Core Endpoints have a high or very high hazard assessment (i.e., Bioaccumulation and Persistence, Acute or Chronic Aquatic Toxicity and Bioaccumulation, or Acute or Chronic Aquatic Toxicity and Persistence), or (3) Very high Persistence or Bioaccumulation with very high acute human or high chronic human supplemental endpoints.

[Gray] – Unable to be Categorized: (1) One or more Core Endpoints have data gaps, or (2) Four or more Supplemental Endpoints have data gaps.

[Blue] – In Process: (1) One or more Core Endpoints have not been fully assessed, or (2) Three or more Supplemental Endpoints have not been fully assessed.

 

Step 5 – Enhesa Sustainable Chemistry Quality Assurance/Verification Process

Enhesa Sustainable Chemistry’s toxicology team generates GHS+ hazard assessments through our Chemical Data Repository (CDR), which is the backbone to SciveraLENS. The following attributes of the CDR provide quality control for the process:

  1. Quantitative values for relevant endpoints (such as Acute Oral, Dermal and Inhalation Toxicity and Acute and Chronic Aquatic Toxicity) are built into the system to systematically generate vH/vHE, H/HE, M/ME, L/LE scores, reducing potential for misclassification.
  2. The Generic Sources List is built into the system so that the toxicologist can check-off the sources that they have reviewed as they work through the process.
  3. The work-flow is divided into sections by assessment endpoint – CMRD, PBT and non-CMR, as well as assessment status – Research, Assess, QA and Complete.  The toxicologist starts with Research and when all of the data sources have been compiled for the endpoints, he/she moves to Assess stage to establish the final overall hazard condition for each endpoint. The chemical is then promoted to the QA step. At QA, a different, board-certified toxicologist reviews the work and addresses any needed changes prior to marking the assessment as Complete.

When a chemical has been completed and gone through this QA process, it is considered to be Verified to our GHS+ hazard assessment framework.

Enhesa Sustainable Chemistry has worked with various outside, board-certified toxicologists and authorities over the years to review, critique, validate, and improve the GHS+ Hazard Assessment Framework. The GHS+ framework is a constant work in progress of constant improvement.

 

Step 6 – Ongoing Maintenance of Existing GHS+ Hazard Assessments

Enhesa Sustainable Chemistry’s toxicology team implements a methodical, recurring approach to updating lists, tracking resources for new chemical hazard data, and checking specific chemicals on a periodic basis for any changes to available data that would impact the current hazard condition for one or more endpoints and potentially the assessment overall. These changes and updates automatically propagate to the applicable chemical(s). Our toxicologists will then update any related endpoint hazard assessments as needed. SciveraLENS users with an interest in an updated chemical will receive a notification of the change via an alerts system.

3. References

 

Appendix A

Chemical Lists Monitored by Enhesa Sustainable Chemistry and Available for Screening in SciveraLENS

[Authoritative] Association of Occupational and Environmental Clinics (AOEC)-Asthmagens

[Authoritative] California Safer Consumer Products Candidate Chemicals: Full Candidate Chemical List

[Authoritative] EU SCCS – Fragrance Allergens – Established fragrance contact allergens of special concern (single chemicals only)

[Authoritative] EU SCCS – Fragrance Allergens – Fragrance substances categorised as established contact allergens in animals

[Authoritative] EU SCCS – Fragrance Allergens – Fragrance substances categorised as possible contact allergens

[Authoritative] EU SCCS – Fragrance Allergens – Established contact allergens in humans

[Authoritative] EU SCCS – Fragrance Allergens – Fragrance substances categorised as likely contact allergens by combination of evidence

[Authoritative] European Commission – Ozone depletion substances

[Authoritative] IARC – Cancer Monographs Carcinogens (CARC)-Group 2A

[Authoritative] IARC – Cancer Monographs Carcinogens (CARC)-Group 1

[Authoritative] IARC – Cancer Monographs Carcinogens (CARC)-Group 2B

[Authoritative] NTP-OHAT–Some Evidence of Adverse Effects – Developmental Toxicity

[Authoritative] NTP-OHAT-Clear Evidence of Adverse Effects – Developmental Toxicity

[Authoritative] NTP-OHAT-Clear Evidence of Adverse Effects – Reproductive Toxicity

[Authoritative] NTP-OHAT-Limited Evidence of Adverse Effects- Developmental Toxicity

[Authoritative] NTP-OHAT-Limited Evidence of Adverse Effects- Reproductive Toxicity

[Authoritative] NTP-OHAT-Some Evidence of Adverse Effects – Reproductive Toxicity

[Authoritative] OSPAR Chemicals for Priority Action Part A

[Authoritative] Stockholm Convention on Persistent Organic Pollutants (POPs)

[Authoritative] US CDC – Occupational Carcinogens National Institute for Occupational Safety and Health (NIOSH-C)

[Authoritative] US NIH-National Toxicology Program (NTP) Report on Carcinogens Known To Be Human Carcinogens

[Authoritative] US NIH-National Toxicology Program (NTP) Report on Carcinogens Reasonably Anticipated To Be Human Carcinogens

[GHS Inventory] Japan-GHS-Full

[GHS Inventory] Korea-GHS-Full

[GHS Inventory] New Zealand-GHS-Full

[GHS Inventory] Quebec-WHMIS-Full

[Group] EU-Endocrine Disruptors-Category 3

[Group] Germany DFG Substances for which BAR can be derived

[Group] Germany DFG Substances for which BLW can be derived

[Group] Germany DFG Substances without BAR but have documentation referrences

[Group] Germany DFG Substances without BLW but have documentation referrences

[Group] Germany MAK Carcinogenic Substances Groups Requiring Special Consideration

[Group] Germany MAK Sensitizing Substances

[Group] Germany MAK metal‐working fluids, hydraulic fluids and other lubricants

[Group] IARC – Cancer Monographs Carcinogens (CARC)-Group 3 “not classifiable as to its carcinogenicity to humans”

[Hazard] EHP-San Antonio Statement-Full

[Hazard] EPA Safer Chemical Ingredient List – Gray Square

[Hazard] Germany FEA-Class 2 Hazard to Waters

[Hazard] Germany FEA-Class 3 Severe Hazard to Waters

[Hazard] Lancet – Grandjean & Landrigan Neurotoxic Chemicals

[Hazard] OSPAR Commission Substances of Possible Concern

[Hazard] OSPAR-Priority Action List

[Hazard] Pattys Toxicology – Boyes Neurotoxicants (Boyes-N)

[Hazard] Proposed REACH Restricted Dermal Sensitizers

[Hazard] Rotterdam Convention Prior Informed Consent (PIC) Annex III Chemicals

[Hazard] The Endocrine Disruption Exchange (TEDX)-Potential Endocrine Disruptors

[Inventory] Canada-DSL-Government of Canada Results for all Existing Substances

[Inventory] Canada-DSL-substances that meet human health categorization criteria

[Inventory] China – Existing Chemicals List

[Inventory] MCF Uniques 20180301

[Inventory] Taiwan GHS Inventory

[Inventory] US EPA non-confidential Toxic Substances Control Act (TSCA) Chemical Substance Inventory

[Inventory] US FDA Effective FCS Notifications – Individual Chemicals

[Inventory] US FDA Effective FCS Notifications – Mixtures

[Inventory] US FDA Indirect Additives Used in Food Contact Substances

[Organization] ANSI/BIFMA e3 Furniture Sustainability Standard (2017)

[Organization] American Apparel & Footwear Association (AAFA) Restricted Substance List

[Organization] Annex 2 ETAD heavy metal limits for dyes -ZDHC sublist

[Organization] Apparel & Footwear International RSL Management Group (AFIRM)

[Organization] Apple Regulated Substances Specification 069-0135-K –Reportable Substances and Future Restriction in Products

[Organization] Apple Regulated Substances Specification 069-0135-K –Reportable Substances and Future Restrictions in Manufacturing Processes

[Organization] Apple Regulated Substances Specification 069-0135-K –Restricted Substances in Products

[Organization] Apple Regulated Substances Specification 069-0135-K –Restrictions in Manufacturing Processes

[Organization] Bolt MRSL K

[Organization] Bolt RSL A

[Organization] Bolt RSL K

[Organization] Bolt RSL L

[Organization] Bolt RSL S

[Organization] C&A RSL (C&A specific requirements. Also select AFIRM & ZDHC lists)

[Organization] ChemSec – Substitute it Now List (SIN) All Chemicals by CAS RN

[Organization] ChemSec – Substitute it Now List (SIN) All Chemicals with 15 Chemical Groups (Scivera Expanded)

[Organization] ChemSec – Substitute it Now List (SIN) Carcinogenicity Health Concern

[Organization] ChemSec – Substitute it Now List (SIN) Endocrine Activity Health Concern

[Organization] ChemSec – Substitute it Now List (SIN)-Mutagenicity Health Concern

[Organization] ChemSec – Substitute it Now List (SIN)-PBT

[Organization] ChemSec The 32 to leave behind, high concern endocrine disrupting chemicals

[Organization] ChemSec-Substitute it Now List (SIN)-Toxic to Reproduction

[Organization] Costco CSS Protocol for Detergent_Washing and House Hold Care_Cleaning Product Supplemental Test V1

[Organization] Costco CSS Protocol for HABA V2 – Apr 12, 2019

[Organization] Costco CSS Protocol for Packaging Material-V6

[Organization] Cradle to Cradle Banned List of Chemicals for Biological Nutrients

[Organization] Cradle to Cradle Banned List of Chemicals for Technical Nutrients

[Organization] Demo-S2A

[Organization] EICS-RSL – pilot v1

[Organization] Global Automotive Declarable Substance List (GADSL) – Declarable and Declarable/Prohibited

[Organization] Global Automotive Declarable Substance List (GADSL) – Prohibited and Declarable/Prohibited

[Organization] Google RSS – Future Phase-Out for Manufacturing Process

[Organization] Google RSS – Restrictions for Manufacturing Processes

[Organization] Green Science Policy Institute – Six Classes – Antimicrobials

[Organization] Green Science Policy Institute – Six Classes – Bisphenols and Phthalates

[Organization] Green Science Policy Institute – Six Classes – Certain Metals

[Organization] Green Science Policy Institute – Six Classes – Flame Retardants

[Organization] Green Science Policy Institute – Six Classes – Highly Fluorinated Chemicals

[Organization] Green Science Policy Institute – Six Classes – Some Solvents

[Organization] GreenPeace – GreenPeace 11 – Full

[Organization] H&M MRSL – Combined – Groups 1 & 2

[Organization] H&M MRSL – Group 1

[Organization] H&M MRSL – Group 2

[Organization] H&M RSL – Combined

[Organization] H&M RSL Aerosol Dispensers

[Organization] H&M RSL Apparel Accessories Footwear Home Interior Textile Products

[Organization] H&M RSL Candles

[Organization] H&M RSL Chemical Products

[Organization] H&M RSL Cosmetic Products

[Organization] H&M RSL Electrical and Electronic Products and Batteries

[Organization] H&M RSL Food Contact Products

[Organization] H&M RSL Hardline

[Organization] H&M RSL Medical devices

[Organization] H&M RSL Packaging

[Organization] H&M RSL Toys

[Organization] Healthier Hospitals – Safer Chemicals Healthy Interiors Guidance (HHI)

[Organization] Healthy Building Network – Priority Asthmagens

[Organization] International Living Future Institute – Living Building Red List

[Organization] International Living Future Institute – Living Building Red List (Scivera Enhanced)

[Organization] Kaiser Permanente Chemicals of Concern – Chemical Groups (Contact Scivera for additional lists to select)

[Organization] Levi S & Co-RSL-Usage Banned

[Organization] Levi S & Co.-RSL-Full

[Organization] Nike Priority Chemicals for formulation cap

[Organization] Nike-Electronics RSL-Full

[Organization] Nike-Packaging Restricted Substances List

[Organization] Nike-Restricted Substance List for Toys

[Organization] Nike-Restricted Substances List Chemical Group Antimony

[Organization] Nike-Restricted Substances List Chemical Group Arsenic

[Organization] Nike-Restricted Substances List Chemical Group Barium

[Organization] Nike-Restricted Substances List Chemical Group Brominated and Chlorinated Flame Retardants

[Organization] Nike-Restricted Substances List Chemical Group Cadmium

[Organization] Nike-Restricted Substances List Chemical Group Chromium

[Organization] Nike-Restricted Substances List Chemical Group Cobalt

[Organization] Nike-Restricted Substances List Chemical Group Copper

[Organization] Nike-Restricted Substances List Chemical Group Fluorinated Greenhouse Gases

[Organization] Nike-Restricted Substances List Chemical Group Halogenated Diarylalkanes

[Organization] Nike-Restricted Substances List Chemical Group Lead

[Organization] Nike-Restricted Substances List Chemical Group Mercury

[Organization] Nike-Restricted Substances List Chemical Group Nickel

[Organization] Nike-Restricted Substances List Chemical Group Nonylphenol and ethoxylates

[Organization] Nike-Restricted Substances List Chemical Group Octylphenols and ethoxylates

[Organization] Nike-Restricted Substances List Chemical Group PFOA and salts and ester

[Organization] Nike-Restricted Substances List Chemical Group Perfluorooctane Sulfonate (PFOS) and related compounds

[Organization] Nike-Restricted Substances List Chemical Group Phthalates

[Organization] Nike-Restricted Substances List Chemical Group Polychlorinated Biphenyls

[Organization] Nike-Restricted Substances List Chemical Group Polychlorinated naphthalenes

[Organization] Nike-Restricted Substances List Chemical Group Polychorinated terphenyls

[Organization] Nike-Restricted Substances List Chemical Group Polycyclic Aromatic Hydrocarbons

[Organization] Nike-Restricted Substances List Chemical Group Selenium

[Organization] Nike-Restricted Substances List Chemical Group Tin

[Organization] Nike-Restricted Substances List Chemical Group Tin Organic

[Organization] Nike-Restricted Substances List Chemical Group Volatile Organic Compounds

[Organization] Nike-Restricted Substances List Core CASRNs

[Organization] Packaging Pilot Base RSL

[Organization] Perkins + Will Architects Precautionary List

[Organization] Perkins + Will Architects Watch List

[Organization] Quebec CSST Asthma Agents

[Organization] SCJ – Potential Skin Allergens

[Organization] Sephora Public Chemicals Policy–High-Priority Chemicals

[Organization] Silent Spring Institute Mammary Carcinogens Reviews Database

[Organization] Standard 100 by Oeko-Tex Appendix 5 individual substances for Appendix 4

[Organization] The Hazardous 100+ List of Chemicals of High Concern Safer Chemicals Healthy Families

[Organization] Toxics in Packaging Clearinghouse (TPCH) – Restricted Substances List

[Organization] USGBC-Substance to avoid to fulfill LEED Pilot Credit 54 Option 1 (also select Prop 65)

[Organization] Walmart High Priority Chemicals

[Organization] ZDHC MRSL V 1.1 -Azo Dyes Releasing Amines Through Reductive Cleavage and Banned Amines

[Organization] ZDHC MRSL V 1.1 -Chemical Group Alkylphenols & APEs

[Organization] ZDHC MRSL V 1.1 -Chemical Group Arsenic

[Organization] ZDHC MRSL V 1.1 -Chemical Group Brominated and Chlorinated flame retardants

[Organization] ZDHC MRSL V 1.1 -Chemical Group Cadmium

[Organization] ZDHC MRSL V 1.1 -Chemical Group Chlorobenzenes

[Organization] ZDHC MRSL V 1.1 -Chemical Group Chlorophenols

[Organization] ZDHC MRSL V 1.1 -Chemical Group Chlorotoluenes

[Organization] ZDHC MRSL V 1.1 -Chemical Group Chromium +6

[Organization] ZDHC MRSL V 1.1 -Chemical Group Lead

[Organization] ZDHC MRSL V 1.1 -Chemical Group Mercury

[Organization] ZDHC MRSL V 1.1 -Chemical Group PFOA and related compounds

[Organization] ZDHC MRSL V 1.1 -Chemical Group PFOS and related compounds

[Organization] ZDHC MRSL V 1.1 -Chemical Group Phthalates

[Organization] ZDHC MRSL V 1.1 -Chemical Group Tin Organic

[Organization] ZDHC-MRSL V 1.1 – Chapter 2 MRSL for Leather Processing (CASRNs + Groups)

[Organization] ZDHC-MRSL V 1.1 -Chapter 1 MRSL for Textiles and Coated Fabrics Processing core CASRNs (Nike)

[Organization] ZDHC-MRSL V 1.1 -Chapter 1 Textiles and Coated Fabrics Processing (CASRNs + Groups)

[Organization] ZDHC-MRSL V 1.1 -Chapter 2 MRSL for Leather Processing Core CASRNs (Nike)

[Organization] ZDHC-MRSLV2.0- Chapter 1 –Textile, Leather, and Polymers (CASRNs + Groups)

[Organization] ZDHC-MRSLV2.0- Chapter 2 –Candidate List (CASRNs + Groups)

[Organization] ZDHC-MRSLV2.0- Chapter 3 –Archived List

[Organization] adidas Policy for the Control and Monitoring of Hazardous Substances

[Preferred] EPA Safer Chemical Ingredient List – Full Green Circle

[Preferred] EPA Safer Chemical Ingredient List – Half Green Circle

[Preferred] EPA Safer Chemical Ingredient List – Yellow Triangle

[Preferred] European Food Safety Authority – Union list of authorised monomers, other starting substances, macromolecules obtained from microbial fermentation, additives and polymer production aids

[Preferred] Germany FEA-Class 0 Non-Hazardous to Water

[Preferred] Germany FEA-Class 1 Low Hazard to Waters

[Preferred] Germany MAK Carcinogenic Substances Categories 4

[Preferred] Germany MAK Carcinogenic Substances Categories 5

[Preferred] Japan-GHS Category 4 Acute dermal toxicity

[Preferred] Japan-GHS Category 4 Acute inhalation toxicity

[Preferred] Japan-GHS Category 4 Acute oral toxicity

[Preferred] Japan-GHS Category 5 Acute dermal toxicity

[Preferred] Japan-GHS Category 5 Acute inhalation toxicity

[Preferred] Japan-GHS Category 5 Acute oral toxicity

[Preferred] Japan-GHS Category Not classified Acute dermal toxicity

[Preferred] Japan-GHS Not Classified Respiratory Sensitization

[Preferred] Japan-GHS Not classified Serious eye damage/eye irritation

[Preferred] Japan-GHS Not classified Acute inhalation toxicity

[Preferred] Japan-GHS Not classified Acute oral toxicity

[Preferred] Japan-GHS-Carcinogenicity Not classified

[Preferred] US FDA Generally Regarded as Safe (GRAS) List of Food Additives

[Regulatory] Australia-GHS-Acute Dermal Toxicity-Category 1

[Regulatory] Australia-GHS-Acute Dermal Toxicity-Category 2

[Regulatory] Australia-GHS-Acute Dermal Toxicity-Category 3

[Regulatory] Australia-GHS-Acute Inhalation Toxicity-Category 1

[Regulatory] Australia-GHS-Acute Inhalation Toxicity-Category 2

[Regulatory] Australia-GHS-Acute Inhalation Toxicity-Category 3

[Regulatory] Australia-GHS-Acute Inhalation Toxicity-Category 4

[Regulatory] Australia-GHS-Acute Oral Toxicity-Category 1

[Regulatory] Australia-GHS-Acute Oral Toxicity-Category 2

[Regulatory] Australia-GHS-Acute Oral Toxicity-Category 3

[Regulatory] Australia-GHS-Acute Oral Toxicity-Category 4

[Regulatory] Australia-GHS-Acute Toxicity Category 4

[Regulatory] Australia-GHS-Aspiration Hazard-Category 1

[Regulatory] Australia-GHS-Carcinogenicity – Category 1A

[Regulatory] Australia-GHS-Carcinogenicity – Category 1B

[Regulatory] Australia-GHS-Carcinogenicity – Category 2

[Regulatory] Australia-GHS-Corrosive to metals-Category 1

[Regulatory] Australia-GHS-Explosives-H200

[Regulatory] Australia-GHS-Explosives-H201

[Regulatory] Australia-GHS-Explosives-H203

[Regulatory] Australia-GHS-Eye Damage Category 1

[Regulatory] Australia-GHS-Eye Damage/Irritation Category 2B

[Regulatory] Australia-GHS-Eye Irritation-Category 2A

[Regulatory] Australia-GHS-Flammable Gases-Category 1

[Regulatory] Australia-GHS-Flammable Gases-Category 2

[Regulatory] Australia-GHS-Flammable Liquids-Category 1

[Regulatory] Australia-GHS-Flammable Liquids-Category 2

[Regulatory] Australia-GHS-Flammable Liquids-Category 3

[Regulatory] Australia-GHS-Flammable Solid-Category 1

[Regulatory] Australia-GHS-Flammable Solid-Category 2

[Regulatory] Australia-GHS-Germ Cell Mutagenicity-Category 1B

[Regulatory] Australia-GHS-Germ Cell Mutagenicity-Category 2

[Regulatory] Australia-GHS-Hazardous to the Ozone Layer-Category 1

[Regulatory] Australia-GHS-Hazardous to the aquatic environment, acute hazard-Category 1

[Regulatory] Australia-GHS-Hazardous to the aquatic environment, acute hazard-Category 2

[Regulatory] Australia-GHS-Hazardous to the aquatic environment, acute hazard-Category 3

[Regulatory] Australia-GHS-Hazardous to the aquatic environment, long-term hazard-Category 1

[Regulatory] Australia-GHS-Hazardous to the aquatic environment, long-term hazard-Category 2

[Regulatory] Australia-GHS-Hazardous to the aquatic environment, long-term hazard-Category 3

[Regulatory] Australia-GHS-Hazardous to the aquatic environment, long-term hazard-Category 4

[Regulatory] Australia-GHS-Organic Peroxides-Type A

[Regulatory] Australia-GHS-Organic Peroxides-Type B

[Regulatory] Australia-GHS-Organic Peroxides-Type C

[Regulatory] Australia-GHS-Organic Peroxides-Type D

[Regulatory] Australia-GHS-Organic Peroxides-Type E

[Regulatory] Australia-GHS-Organic Peroxides-Type F

[Regulatory] Australia-GHS-Oxidizing Liquids/Solids-Category 1

[Regulatory] Australia-GHS-Oxidizing Liquids/Solids-Category 2

[Regulatory] Australia-GHS-Oxidizing Liquids/Solids-Category 3

[Regulatory] Australia-GHS-Oxidizing gases-Category 1

[Regulatory] Australia-GHS-Pyrophoric Liquids/Solids-Category 1

[Regulatory] Australia-GHS-Reproductive Toxicity-Additional Category

[Regulatory] Australia-GHS-Reproductive Toxicity-Category 1A

[Regulatory] Australia-GHS-Reproductive Toxicity-Category 1B

[Regulatory] Australia-GHS-Reproductive Toxicity-Category 2

[Regulatory] Australia-GHS-Respiratory Sensitisation-Category 1

[Regulatory] Australia-GHS-Self-heating Substances and Mixture-Category 1

[Regulatory] Australia-GHS-Self-heating Substances and Mixture-Category 2

[Regulatory] Australia-GHS-Self-reactive Substances and Mixtures-Type A

[Regulatory] Australia-GHS-Self-reactive Substances and Mixtures-Type B

[Regulatory] Australia-GHS-Self-reactive Substances and Mixtures-Type C

[Regulatory] Australia-GHS-Self-reactive Substances and Mixtures-Type D

[Regulatory] Australia-GHS-Skin Corrosion/Irritation-Category 1

[Regulatory] Australia-GHS-Skin Corrosion/Irritation-Category 1A

[Regulatory] Australia-GHS-Skin Corrosion/Irritation-Category 1B

[Regulatory] Australia-GHS-Skin Corrosion/Irritation-Category 1C

[Regulatory] Australia-GHS-Skin Corrosion/Irritation-Category 2

[Regulatory] Australia-GHS-Skin Corrosion/Irritation-Category 3

[Regulatory] Australia-GHS-Skin Sensitisation-Category 1

[Regulatory] Australia-GHS-Skin Sensitisation-Category 1A

[Regulatory] Australia-GHS-Skin Sensitisation-Category 1B

[Regulatory] Australia-GHS-Specific target organ toxicity, repeated exposure-Category 1

[Regulatory] Australia-GHS-Specific target organ toxicity, repeated exposure-Category 2

[Regulatory] Australia-GHS-Specific target organ toxicity, single exposure-Category 1

[Regulatory] Australia-GHS-Specific target organ toxicity, single exposure-Category 2

[Regulatory] Australia-GHS-Specific target organ toxicity, single exposure; Narcotic effects-Category 3

[Regulatory] Australia-GHS-Specific target organ toxicity, single exposure; Respiratory tract irritation-Category 3

[Regulatory] Australia-GHS-Substances which, in contact with water, emit flammable gases-Category 1

[Regulatory] Australia-GHS-Substances which, in contact with water, emit flammable gases-Category 2

[Regulatory] California Chemicals with OEHHA RELs

[Regulatory] California Drinking Water Chemicals with MCLs

[Regulatory] California Drinking Water Chemicals with Notification Levels

[Regulatory] California Priority Toxic Pollutants

[Regulatory] California Toxic Air Contaminants

[Regulatory] California-Prop 65-Carcinogenicity

[Regulatory] California-Prop 65-Developmental Toxicity

[Regulatory] California-Prop 65-Reproductive Toxicity Female

[Regulatory] California-Prop 65-Reproductive Toxicity Male

[Regulatory] Canada-DSL-substances that are Persistent, Bioaccumulative and Inherently Toxic to the environment (PBiT)

[Regulatory] Canadian Environmental Protection Act (CEPA) – Environmental Registry – Toxic Substances List (Schedule 1)

[Regulatory] China – Restricted Harmful Substances in Electrical and Electronic Products

[Regulatory] China – Priority Control List of Chemicals

[Regulatory] Danish Environmental Protection Agency (DKEPA) List of Undesirable Substances

[Regulatory] ECHA-Registry of SVHC intentions until outcome-Intentions

[Regulatory] ECHA-Submitted SVHC Intentions-Full

[Regulatory] EU – Cosmetics Regulation Annex II

[Regulatory] EU – Cosmetics Regulation Annex III

[Regulatory] EU – REACH Substances of High Concern (EU SVHC) Candidate List

[Regulatory] EU Persistent, bioaccumulative and toxic substances (PBT)-Full-Persistent, bioaccumulative and toxic substances (PBT), very Persistent and very Bioaccumulative (vPvB) and Persistent organic pollutants (POPs)

[Regulatory] EU Priority Substances Directive (Directive 2008/105/EC Annex II)

[Regulatory] EU REACH Annex XIV SVHC Authorisation list

[Regulatory] EU REACH Annex XVII – Substances restricted under REACH

[Regulatory] EU Reduction of Hazardous Substances Directive (“RoHS”) Restricted Substances

[Regulatory] EU- Endocrine Disrupters Priority-Category 1

[Regulatory] EU-Annex VI (CLP) – STOT Single Exposure Category 3

[Regulatory] EU-Annex VI (CLP) – Acute Toxicity Category 3

[Regulatory] EU-Annex VI (CLP) – All Health, Environmental, Physical Harmonized

[Regulatory] EU-Annex VI (CLP) – Aquatic Acute Category 1

[Regulatory] EU-Annex VI (CLP) – Aquatic Acute Category 2

[Regulatory] EU-Annex VI (CLP) – Aspiration Toxicity Category 1

[Regulatory] EU-Annex VI (CLP) – Carcinogenicity Category 1A

[Regulatory] EU-Annex VI (CLP) – Carcinogenicity Category 1B

[Regulatory] EU-Annex VI (CLP) – Carcinogenicity Category 2

[Regulatory] EU-Annex VI (CLP) – Eye Damage Category 1

[Regulatory] EU-Annex VI (CLP) – Eye Irritation Category 2

[Regulatory] EU-Annex VI (CLP) – Mutagenicity Category 1A

[Regulatory] EU-Annex VI (CLP) – Mutagenicity Category 1B

[Regulatory] EU-Annex VI (CLP) – Mutagenicity Category 2

[Regulatory] EU-Annex VI (CLP) – Reproductive Toxicity Category 1A

[Regulatory] EU-Annex VI (CLP) – Reproductive Toxicity Category 1B

[Regulatory] EU-Annex VI (CLP) – Reproductive Toxicity Category 2

[Regulatory] EU-Annex VI (CLP) – Respiratory Sensitization Category 1

[Regulatory] EU-Annex VI (CLP) – STOT Repeat Exposure Category 1

[Regulatory] EU-Annex VI (CLP) – STOT Single Exposure Category 1

[Regulatory] EU-Annex VI (CLP) – Skin Corrosion Category 1

[Regulatory] EU-Annex VI (CLP) – Skin Corrosion Category 1A

[Regulatory] EU-Annex VI (CLP) – Skin Corrosion Category 1B

[Regulatory] EU-Annex VI (CLP) – Skin Corrosion Category 1C

[Regulatory] EU-Annex VI (CLP) – Skin Irritation Category 2

[Regulatory] EU-Annex VI (CLP) – Skin Sensitization Category 1

[Regulatory] EU-Annex VI (CLP) – Skin Sensitization Category 1A

[Regulatory] EU-Annex VI (CLP) – Skin Sensitization Category 1B

[Regulatory] EU-Endocrine Disrupters -Priority -Category 2

[Regulatory] Environment Canada – Virtual Elimination List (CEPA)

[Regulatory] Germany BAT Carcinogenic Substances Categories 1

[Regulatory] Germany BAT Carcinogenic Substances Categories 2

[Regulatory] Germany MAK Carcinogenic Substances Categories 1

[Regulatory] Germany MAK Carcinogenic Substances Categories 2

[Regulatory] Germany MAK Carcinogenic Substances Categories 3A

[Regulatory] Germany MAK Carcinogenic Substances Categories 3B

[Regulatory] Health Canada – Cosmetic Ingredient Hotlist – Prohibited

[Regulatory] Health Canada – Cosmetic Ingredient Hotlist – Restricted

[Regulatory] Homeland Security: Appendix A: Chemicals of Interest (COI) List

[Regulatory] Japan-GHS Category 1 Acute dermal toxicity

[Regulatory] Japan-GHS Category 1 Acute inhalation toxicity

[Regulatory] Japan-GHS Category 1 Acute oral toxicity

[Regulatory] Japan-GHS Category 1 Aspiration

[Regulatory] Japan-GHS Category 1 Dermal Irritation

[Regulatory] Japan-GHS Category 1 Dermal Sensitization

[Regulatory] Japan-GHS Category 1 Flammable Liquids

[Regulatory] Japan-GHS Category 1 Respiratory Sensitization

[Regulatory] Japan-GHS Category 1 Serious eye damage/eye irritation

[Regulatory] Japan-GHS Category 1A Carcinogenicity

[Regulatory] Japan-GHS Category 1A Respiratory Sensitization

[Regulatory] Japan-GHS Category 1A-1B Carcinogenicity

[Regulatory] Japan-GHS Category 1B Carcinogenicity

[Regulatory] Japan-GHS Category 1B Respiratory Sensitization

[Regulatory] Japan-GHS Category 2 Acute dermal toxicity

[Regulatory] Japan-GHS Category 2 Acute inhalation toxicity

[Regulatory] Japan-GHS Category 2 Acute oral toxicity

[Regulatory] Japan-GHS Category 2 Aspiration

[Regulatory] Japan-GHS Category 2 Dermal Irritation

[Regulatory] Japan-GHS Category 2 Flammable Liquids

[Regulatory] Japan-GHS Category 2 Serious eye damage/eye irritation

[Regulatory] Japan-GHS Category 2A Serious eye damage/eye irritation

[Regulatory] Japan-GHS Category 2A-2B Serious eye damage/eye irritation

[Regulatory] Japan-GHS Category 2B Serious eye damage/eye irritation

[Regulatory] Japan-GHS Category 3 Acute dermal toxicity

[Regulatory] Japan-GHS Category 3 Acute inhalation toxicity

[Regulatory] Japan-GHS Category 3 Acute oral toxicity

[Regulatory] Japan-GHS Category 3 Dermal Irritation

[Regulatory] Japan-GHS-Category 1 Acute Dermal Toxicity

[Regulatory] Japan-GHS-Category 1 Carcinogenicity

[Regulatory] Japan-GHS-Category 1 Reproductive Toxicity

[Regulatory] Japan-GHS-Category 1B Germ Cell Mutagenicity

[Regulatory] Japan-GHS-Category 2 Carcinogenicity

[Regulatory] Japan-GHS-Category 2 Germ Cell Mutagenicity

[Regulatory] Japan-GHS-Category 2 Reproductive Toxicity

[Regulatory] Maine Safer Chemicals in Children’s Products –Regulated Priority Chemicals

[Regulatory] Minnesota Department of Health – Chemicals of High Concern and Priority Chemicals

[Regulatory] Oregon Department of Environmental Quality – Priority Persistent Pollutants P3 List

[Regulatory] Oregon Health Authority-high priority chemicals of concern to children’s health

[Regulatory] State of Maine Department of Environmental Protection – Chemicals of High Concern

[Regulatory] TSD | Directive 2009/48/EC | Allergenic Fragrances (Labeling List)

[Regulatory] TSD | Directive 2009/48/EC | EN 71-3 :: Safety of toys – Annex II – Migration Limits on Metal

[Regulatory] TSD | Directive 2009/48/EC | EN 71-4 :: Safety of toys – Part 4: Experimental sets for chemistry and related activities

[Regulatory] US ATSDR Neurotoxicants

[Regulatory] US CPSC Strong Sensitizers

[Regulatory] US CPSC Supplemental Precautionary Labeling Required Substances

[Regulatory] US EPA – Chemical Action Plans (EPA Action)

[Regulatory] US EPA – Clean Water Act Priority Pollutants

[Regulatory] US EPA – Exempt VOCs

[Regulatory] US EPA – Extremely Hazardous Substances

[Regulatory] US EPA – Hazardous Air Pollutants (HAPs)

[Regulatory] US EPA – IRIS Carcinogens (EPA-C) 1986-A

[Regulatory] US EPA – IRIS Carcinogens (EPA-C) 1986-B1

[Regulatory] US EPA – IRIS Carcinogens (EPA-C) 1986-B2

[Regulatory] US EPA – IRIS Carcinogens (EPA-C) 1986-C

[Regulatory] US EPA – IRIS Carcinogens (EPA-C) 1996-Known/Likely

[Regulatory] US EPA – IRIS Carcinogens (EPA-C) 1999 Carc

[Regulatory] US EPA – IRIS Carcinogens (EPA-C) 1999 Likely Carcinogenic

[Regulatory] US EPA – IRIS Carcinogens (EPA-C) 1999 Suggested Carcinogen

[Regulatory] US EPA – IRIS Carcinogens (EPA-C) 2005 Likely Carcinogenic

[Regulatory] US EPA – IRIS Carcinogens–All

[Regulatory] US EPA – IRIS Neurotoxicants

[Regulatory] US EPA – IRIS-2005 Carcinogenic

[Regulatory] US EPA – IRIS-2005 Suggested Carcinogenic

[Regulatory] US EPA – Ozone Depleting Substances (EPA-ODS)-Class 1

[Regulatory] US EPA – Ozone Depleting Substances (EPA-ODS): Class 2

[Regulatory] US EPA – Polycyclic Aromatic Hydrocarbons (PAHs)

[Regulatory] US EPA – Priority Persistent, bioaccumulative and toxic substances PBTs

[Regulatory] US EPA – Priority Persistent, bioaccumulative and toxic substances PBTs (National Waste Minimization Program (NWMP) Priority)

[Regulatory] US EPA – Toxics Release Inventory-Persistent, bioaccumulative and toxic substances (TRI PBT)

[Regulatory] US EPA Toxic Release Inventory (TRI) Program

[Regulatory] US EPA first 10 chemicals under TSCA

[Regulatory] US FDA – Antimicrobials Banned in Antiseptic Washes

[Regulatory] US OSHA-Carcinogens

[Regulatory] Vermont Chemicals of High Concern to Children

[Regulatory] Washington State Department of the Environment -PBT-Metals of Concern

[Regulatory] Washington State DoE: Chemicals of High Concern to Children (CCHC)

[Regulatory] Washington State DoE: Chemicals of High Concern to Children (CCHC) (Scivera Expanded)

[Regulatory] Washington State DoE: Persistent, bioaccumulative and toxic substances-Full

[SV] List AP & APE (SCP)

[SV] ODS (SCP)