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TSCA SECTION 5 ORDER

View TSCA § 5 Order
  • Chemical Name: Quaternary ammonium salts (generic)
  • Chemical Identifier: P-16-0356
  • Effective Date: February 27, 2018
  • Chemical Category: Cationic (quanternary ammonium) surfactants
What type of TSCA Section 5 Order was developed for this chemical substance?
  • Exposure-based
  • Insufficient information and may present an unreasonable risk
TSCA Section 5 Order for: Quaternary ammonium salts (generic)
PMN Number: P-16-0356
Has the chemical been commenced?: No
Functional Use: Wellbore additive (generic)
What are the health or environmental toxicity concerns?
  • Aquatic and/or terrestrial toxicity
  • Dermal irritation
  • Lung effects (particulate overload, cationic binding, surfactancy, waterproofing)
  • Neurological
  • Ocular irritation
  • Respiratory irritation
What is the basis for the health or environmental toxicity concerns?
  • Analog data
  • Cationic (quanternary ammonium) surfactants
  • Physical/chemical properties
What is the exposure concern to the chemical?
  • Occupational settings: Worker exposures without workplace protection
  • Occupational settings: Worker exposures without hazard communication
  • The substance is expected to be produced in substantial quantities, there may be significant or substantial human exposure to the substance, and the substance may enter the environment in substantial quantities
  • Releases to the environment associated with commercial processing/use of the chemical Aquatic/Terrestrial Species exposure from releases to surface waters in concentrations that exceed 880 parts per billion (ppb) over a one day period
  • Releases to the environment associated with commercial processing/use of the chemical Aquatic/Terrestrial species from releases to surface waters in concentrations that exceed 31 parts per billion (ppb) over a period greater than 20 days per year
  • Releases to the environment associated with industrial processing/use of the chemical Aquatic/Terrestrial Species exposure from releases to surface waters in concentrations that exceed 880 parts per billion (ppb) over a one day period
  • Releases to the environment associated with industrial processing/use of the chemical Aquatic/Terrestrial species from releases to surface waters in concentrations that exceed 31 parts per billion (ppb) over a period greater than 20 days per year
  • Releases to the environment associated with manufacture of the chemical
Limitations on manufacture (including import), processing, distribution in commerce, use, or disposal pending submission and evaluation of information:
  • Distribute the PMN substance only: to a person who agrees to follow the same restrictions (except the testing requirements) and to not further distribute the PMN substances, other than for disposal, until after the PMN substances have been completely reacted (cured)
  • Hazard Communication (labeling, containers, SDS, precautionary statements, etc.)
  • Recordkeeping for all manufacturers and processors
  • Use in the following physical form of the chemical because other forms would result in exposures of concern: refrain from manufacturing, processing or using the PMN substances in a manner that generates a vapor, mist, or aerosol
  • Use of the PMN substance for the uses listed in the TSCA Section 5 Order
  • Workplace protection (gloves, respirators, etc.) to prevent dermal and/or inhalation exposure
Required Testing: The Company is prohibited from manufacturing(including import) the PMN substance beyond the limits or manufacturing volume limits specified in the TSCA Section 5 order, unless the company conducts the following:
  • No testing required
Potentially useful information: What additional information would be useful to evaluate the potential health or environmental effects associated with the PMN substance before EPA would make a modification to the TSCA Section 5 Order’s restriction on manufacture, processing, distribution in commerce, use, and disposal of the PMN substance? The order does not require submission of the listed testing at any specified time or production volume. However, the Order's restriciton on manufacture, processing, distribution in commerce, use, and disposal of the PMN substance will remain in effect until the Order is modified or revoked by EPA based on submission of appropriate testing or other relevant information:
  • Ecotoxicity testing :
    • OCSPP 850.4500 - Algal Toxicity Test (formerly OPPTS 850.5400)
    • OPPTS 850.1010 - Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids
    • OPPTS 850.1075 (OECD 203) - Fish Acute Toxicity Test, Freshwater and Marine
  • Surface Tension Decreases (capillary surface tension method with appropriate controls); Step 1; OECD Acute TG 4S3 featuring rats exposed for 4 hours and observed for 2 weeks (LOAEC < 2000 mg/m3, proceed to step 2); Step 2: 5-Day study to address toxicity progression (substantial decrease in the POD or increase in severity at the same concentration over time relative to the acute study, proceed to step 3); Step 3: OECD TG 412 (28-day inhalation study in rats with 14-day recovery period)
  • Physical/Chemical properties testing :
    • OPPTS 830.7520 (OECD 110) - Particle Size, Fiber Length, and Diameter Distribution
Has EPA modified or revoked the TSCA Section 5 Order based on submission of the listed testing?
  • No