Testing Chemicals under TSCA

As part of EPA’s comprehensive approach to enhance the Agency’s management of existing chemicals, EPA/OPPT identified a work plan of chemicals for further assessment under the Toxic Substances Control Act (TSCA) in March 2012. Chemical risk assessments will be conducted if, as a result of scoping and problem formulation, there are exposures of concern, identified hazards and sufficient data for quantitative analysis. If an assessment identifies unreasonable risks to humans or the environment, EPA will pursue risk reduction.

40 CFR Parts 796 CHEMICAL FATE TESTING GUIDELINES

Physical and Chemical Properties

§796.1050 Absorption in aqueous solution: Ultraviolet/visible spectra.
§796.1950 Vapor pressure.

Subpart D—Transformation Processes

§796.3100 Aerobic aquatic biodegradation.
§796.3500 Hydrolysis as a function of pH at 25 °C.

40 CFR Parts 797 ENVIRONMENTAL EFFECTS TESTING GUIDELINES

Aquatic Guidelines

§797.1050 Algal acute toxicity test.
§797.1300 Daphnid acute toxicity test.
§797.1330 Daphnid chronic toxicity test.
§797.1400 Fish acute toxicity test.
§797.1600 Fish early life stage toxicity test.

40 CFR Parts 798 HEALTH EFFECTS TESTING GUIDELINES

Genetic Toxicity

§798.5265 The salmonella typhimurium reverse mutation assay.
§798.5300 Detection of gene mutations in somatic cells in culture.
§798.5375 In vitro mammalian cytogenetics.

40 CFR Parts 79 PART 799—IDENTIFICATION OF SPECIFIC CHEMICAL SUBSTANCE AND MIXTURE TESTING REQUIREMENTS

Subpart E—Product Properties Test Guidelines

§799.6755 TSCA partition coefficient (n-octanol/water), shake flask method.
§799.6756 TSCA partition coefficient (n-octanol/water), generator column method.
§799.6784 TSCA water solubility: Column elution method; shake flask method.
§799.6786 TSCA water solubility: Generator column method.

Subpart H—Health Effects Test Guidelines

§799.9510 TSCA bacterial reverse mutation test.
§799.9530 TSCA in vitro mammalian cell gene mutation test.
§799.9537 TSCA in vitro mammalian chromosome aberration test.
§799.9538 TSCA mammalian bone marrow chromosomal aberration test.
§799.9539 TSCA mammalian erythrocyte micronucleus test.

In addition TSCA Section 4(h)(2)(C) requires EPA to develop a list of particular alternative test methods or strategies that do not require new vertebrate animal testing and are scientifically reliable and relevant. LAUS can support you with the following New Approach Methodologies (NAMs) presented in that list:

Source	Title	Information Gathered
OECD TG 431	In Vitro Skin Corrosion: Reconstructed Human Epidermis (Rhe) Test Method	Evaluates corrosivity (human skin as source)
OECD 435	In Vitro Membrane Barrier Test Method for Skin Corrosion	Evaluates corrosion using a synthetic membrane
OECD TG 437	Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage	Evaluates eye irritation / corrosivity in bovine eyes
OECD TG 439	In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method	Evaluates irritation (human skin as source)
OECD TG 442C	In Chemico Skin Sensitisation: Assays addressing the Adverse Outcome Pathway key event on covalent binding to proteins	No animal or human cells used, evaluates simple binding of a chemical to a synthetic peptide
OECD TG 442D	In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method	Skin sensitization evaluated – human cells used
OECD TG 442E	In Vitro Skin Sensitisation: In Vitro Skin Sensitisation assays addressing the Key Event on activation of dendritic cells on the Adverse Outcome Pathway for Skin Sensitisation	Skin sensitization evaluated – human cells used
OECD TG 476	In Vitro Mammalian Cell Gene Mutation	Tests using the Hprt and xprt genes Evaluates gene mutations in either human or rodent cells
OECD TG 487	In Vitro Mammalian Cell Micronucleus Test	Evaluates chromosomal effects in either human or rodent cells
OECD TG 490	In Vitro Mammalian Cell Gene Mutation	Tests Using the Thymidine Kinase Gene Evaluates gene mutations in either human or rodent cells
OECD TG 492	Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage	Evaluates eye irritation with reconstructed human cells (either eye or skin)