News Details
US EPA Revises Risk Threshold for Perfluorodecanoic Acid in Finalized IRIS Toxicological Review
On July 16, 2024, the US Environmental Protection Agency (EPA) finalized the Integrated Risk Information System (IRIS) Toxicological Review for perfluorodecanoic acid (PFDA) and related salts. The Agency has raised the acceptable reference dose (RfD) for PFDA. The final review tripled the proposed risk threshold for PFDA, indicating that any subsequent risk management measures will be less stringent.
Introduction:
Perfluorodecanoic acid (PFDA, CASRN 335-76-2) and its related salts, members of the per- and polyfluoroalkyl substances (PFAS) group, are known for their resistance to hydrolysis, photolysis, and biodegradation, resulting in persistent environmental contamination. EPA's Integrated Risk Information System (IRIS) review covers PFDA and its fully dissociating salts, such as ammonium perfluorodecanoate (CASRN 3108-42-7), and sodium perfluorodecanoate (CASRN 3830-45-3) which are expected to fully dissociate in aqueous solutions at pH ranging from 4 to 9 (e.g., in the human body).
Human studies indicate that PFDA exposure may cause liver, immune, developmental, and reproductive effects, with potential impacts on cardiometabolic and neurodevelopmental health. The IRIS program is developing a series of five PFAS assessments at the request of EPA to address these concerns.
Final Report:
The reference dose (RfD) for PFDA remains significantly lower than the RfDs for PFBA and PFHxA, which were finalized in last year's IRIS assessments. It is also comparable to the preliminary RfDs for PFHxS and PFNA, which are currently in the draft assessment stage. The final PFDA assessment used the same studies, hazard endpoints, points of departure (PODs) and uncertainty factors as the draft assessment to determine the overall RfD.
Organ-specific RfDs for health effects compared with the 2023 draft review of PFDA:
|
Organ/system |
Integration judgment |
Value (mg/kg-day) |
Value (mg/kg-day) 2023 Draft report |
|
Developmental |
Evidence indicates (likely) |
2 × 10−9 |
3 × 10−10 |
|
Liver |
Evidence indicates (likely) |
6 × 10−7 |
7 × 10−7 |
|
Male Reproductive |
Evidence indicates (likely) |
3 × 10−6 |
5 × 10−6 |
|
Female Reproductive |
Evidence indicates (likely) |
1 × 10−6 |
3 × 10−6 |
|
Immune/ developmental |
Evidence indicates (likely) |
2 × 10−9 |
4 × 10−10 |
|
Immune (developmental immune effects) |
Evidence indicates (likely) |
2 × 10−9 |
3-4 × 10−10 |
We acknowledge that the above information has been compiled from Environmental Protection Agency (US EPA).
Global Product Compliance (GPC) specializes in Global Regulatory Compliance Solutions across sectors
globally. SSS Europe, a familiar name in chemical regulatory and compliance services now formally belongs
under the umbrella of GPC Holding Sweden.
Since 2008, we have emerged as one of the leading names among Global Regulatory Compliance Service
Providers with Representation services in Europe, Asia and Middle East for respective chemical
regulations.
