CleanGredients - Solvent Listing Requirements

Solvent Listing Requirements

Third-Party Review

You must submit full information on all of the components of your product (solvent) – including all CAS registry numbers for chemicals intentionally added or present at > 0.01% by mass – to NSF International for third-party review. Criteria for non-solvent ingredients such as denaturants and unexpected residuals that may be present in individual lots should be listed even though a de minimis has yet to be determined.

You may confidentially provide NSF with internal test data for Tier 1 attributes, which, for solvents, include: acute aquatic toxicity, acute mammalian toxicity, bioconcentration factor, carcinogenicity, developmental toxicity, fate and ecotoxicity, neurotoxicity, repeated exposure systemic toxicity, and reproductive toxicity.

Minimal Listing Requirements

In order to be listed in CleanGredients®, all solvents must pass a minimal set of requirements for fate, human health and environmental toxicity. The Solvents TAC recommended adoption of the Phase 1 DfE Solvent Screen as the CleanGredients solvents listing criteria. The criteria are summarized in the table below; the full document should be reviewed before applying the screen and can be found at http://www.epa.gov/dfe/pubs/projects/gfcp/index.htm. Phase 1 comprises alcohols, esters, ethylene glycol ethers, and propylene glycol ethers. At this time, only solvents in these four classes may be listed in CleanGredients. DfE is working on Phase 2 of their solvent screen, which we expect to include terpenes, amines, and amides. The CleanGredients Solvents TAC has requested that DfE also consider including hydrocarbons in Phase 2.

Attribute	A solvent can be listed in CleanGredients if...
Acute Mammalian Toxicity	Its acute mammalian toxicity testing falls within Acute Oral: LD50 > 2000mg/kg Acute Dermal: LD50 > 2000 mg/kg Acute Inhalation: Gas: LC50 > 5000 ppm/4hr Vapor: LC50 > 20 mg/L Dust/Mist: LC50 > 5 mg/L Using the most sensitive testing methodology
Carcinogenicity	It is not included on the following lists: NTP: "Known" or "Reasonably Anticipated" human carcinogens EPA: (2005/1999) "Carcinogenic to humans" or "Likely to be carcinogenic to humans" (1996) "Known/Likely" (1986) "Group A – Human Carcinogen" or "Group B – Probable Human Carcinogen" " or "Group C – Possible human carcinogen" * IARC: "Group 1: Agent is carcinogenic to humans" or "Group 2A: Agent is probably carcinogenic to humans" "Group 2B: Agent is possibly carcinogenic to humans" * GHS: Category 1 – Known or presumed human carcinogens Category 2 – Suspected human carcinogens * IARC Group 2B and EPA (1986) Group C chemicals may be accepted for listing if the supplier can demonstrate that the finding of possible carcinogenicity in rodents is not relevant or does not apply to humans (e.g., through results from mode-of-action studies). CleanGredients (GreenBlue®) will defer to EPA's expert judgment when deciding whether this burden of proof has been met.
Developmental Toxicity	Its developmental toxicity effect level is Oral: NOAEL/LOAEL > 250 mg/kg-bw/day Dermal: NOAEL/LOAEL > 200 mg/kg-bw/day Inhalation: Gas: NOAEL/LOAEL > 250 ppm/6hr/day Vapor: NOAEL/LOAEL > 1.0 mg/L/6hr/day Dust/Mist/Fumes: NOAEL/LOAEL > 0.2 mg/L/6hr/day The GHS criteria and data evaluation approach and EPA risk assessment guidance will inform professional judgment in the review of both NOAEL and LOAEL values.
Environmental Fate and Toxicity (PBT status)	Acute Aquatic Toxicity Value (L/E/IC50 )	Persistence (Measured in terms of rate of biodegredation)	Bioaccumulation Potential
	If ≤ 1 ppm...	...then may be acceptable if biodegradation occurs within 10-day window...	...and BCF <1000
	If > 1 ppm and ≤ 10 ppm...	...then biodegradation must occur within a 10-day window...	...and BCF <1000
	If > 10 ppm and < 100 ppm...	...then biodegradation must occur within 28 days without degradation products of concern...	...and BCF <1000
	If ≥ 100 ppm...	...then biodegradation need not occur within 28 days if there are no degradation products of concern and half-life < 180 days...	...and BCF <5000
Neurotoxicity	It does not require a GHS categorization of 1 or 2. Its neurotoxicity effect level is Oral: 90-day NOAEL/LOAEL > 100 mg/kg-bw/day Dermal: 90-day NOAEL/LOAEL > 200 mg/kg-bw/day Inhalation: Gas: 90-day NOAEL/LOAEL > 250 Vapor: 90-day NOAEL/LOAEL > 1.0 mg/L/6hr/day Dust/Mist/Fumes: 90-day NOAEL/LOAEL > 0.2 mg/L/6hr/day If there is insufficient data to characterize this endpoint, the solvent is still eligible to be listed on CleanGredients if it meets the remaining criteria. The GHS criteria and data evaluation approach and EPA risk assessment guidance will inform professional judgment in the review of both NOAEL and LOAEL values.
Repeated Exposure Systemic Toxicity	It does not require a GHS categorization of 1 or 2. Its repeated exposure systemic toxicity effect level is Oral: 90-day NOAEL/LOAEL > 100 mg/kg-bw/day Dermal: 90-day NOAEL/LOAEL > 200 mg/kg-bw/day Inhalation: Gas: 90-day NOAEL/LOAEL > 250 ppm/6hr/day Vapor: 90-day NOAEL/LOAEL > 1.0 mg/L/6hr/day Dust/Mist/Fumes: 90-day NOAEL/LOAEL > 0.2 mg/L/6hr/day The GHS criteria and data evaluation approach and EPA risk assessment guidance will inform professional judgment in the review of both NOAEL and LOAEL values.
Reproductive Toxicity	Its reproductive toxicity effect level is Oral: NOAEL/LOAEL > 250 mg/kg-bw/day Dermal: NOAEL/LOAEL > 200 mg/kg-bw/day Inhalation: Gas: NOAEL/LOAEL > 250 ppm/6hr/day Vapor: NOAEL/LOAEL > 1.0 mg/L/6hr/day Dust/Mist/Fumes: NOAEL/LOAEL > 0.2 mg/L/6hr/day The GHS criteria and data evaluation approach and EPA risk assessment guidance will inform professional judgment in the review of both NOAEL and LOAEL values.

Reporting Format – General Guidelines

Whenever feasible, use the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). See each attribute page for more information on the reporting format for that specific value.

If you have any questions, please contact us.