Scivera GHS+ Chemical Hazard Assessment Framework

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 used to determine score. Modeling data may be used.	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 2	GHS Category 3 or GHS Category "Not Classified"
	GHS: Aerosols		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		GHS Category 1	GHS Category 2	GHS Category "Not Classified"
	GHS: Substances Corrosive to Metal			GHS Category 1	GHS Category "Not Classified"

Scivera GHS+ Chemical Hazard Assessment Framework

Human Health Endpoints – Chronic

Human Health Endpoints – Acute

Human Health Endpoints – Other

Ecotox and E-Fate Endpoints

Physical Hazard Endpoints

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