Carcinogenicity - GHS in Solvents
Definition
A chemical substance or a mixture of chemical substances which induce cancer or increase its incidence.

GHS places chemicals in one of five categories with respect to carcinogenicity:

  1. Category 1A: Known to have carcinogenic potential for humans
  2. Category 1B: Presumed to have carcinogenic potential for humans
  3. Category 2: Suspected human carcinogen
  4. Not classified as a carcinogen (weight of evidence or sufficient data is available to determine not a carcinogen)
  5. Classification unknown (due to insufficient data)
Rationale
The CleanGredients® database does not allow the listing of any solvent ingredients that are known human carcinogens.
Listing Requirements
As a prerequisite for being listed in CleanGredients, all solvents must have their carcinogenicity data evaluated by a third party. Solvents listed in CleanGredients cannot contain chemicals included on any of 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.
Data and Submission Guidance
Please report whether or not your solvent is present on any of the following regulatory lists:

  • California Proposition 65 List: http://oehha.ca.gov/prop65/prop65_list/Newlist.html
  • GHS Categorization: http://www.osha.gov/dsg/hazcom/ghs.html#6.0
  • IARC List: http://monographs.iarc.fr/ENG/Classification/crthalllist.php
  • NTP Lists: http://ntp.niehs.nih.gov/ntp/roc/toc11.html
  • US EPA Lists: http://www.epa.gov/iris/search_human.htm


  • Test data is only required on this endpoint if the solvent belongs to a class of chemicals that is suspected of carcinogenicity. The following are among the tests recommended for evaluating carcinogenicity:

    • OECD Test Guideline 451: Carcinogenicity Studies [5];
    • OECD Test Guideline 453: Combined Chronic Toxicity/Carcinogenicity Studies [6];
    • OPPTS Harmonized Guideline 870.4200: Carcinogenicity [7];
    • OPPTS Harmonized Guideline 870.4300: Combined Chronic Toxicity/Carcinogenicity [8];
    • NTP 2 Year Study Protocol: “Specifications for the conduct of studies to evaluate the toxic and carcinogenic potential of chemical, biological and physical agents in laboratory animals for the National Toxicology Program” [9].