2011 Health Risk Limits for Groundwater
Health Risk Assessment Unit, Environmental Health Division
651-201-4899
651-201-5797 TDD
Web Publication Date: March 21, 2011
Chemical Name: Perfluorobutane sulfonate
CAS: 375-73-5
Synonyms: PFBS, Nonafluorobutanesulphonic acid
Acute Noncancer Health Risk Limit (nHRLacute) = Not Derived (Insufficient Data)
Short-term Noncancer Health Risk Limit (nHRLshort-term) = Not Derived (Insufficient Data)
Subchronic* Noncancer Health Risk Limit (nHRLsubchronic) = 9 μg/L
= (Reference Dose, mg/kg/d) x (Relative Source Contribution) x (Conversion Factor)
(Subchronic Intake Rate, L/kg/d)
= (0.0042 mg/kg/d) x (0.5) x (1000 μg/mg)
(0.245** L/kg-d)
= 8.57 rounded to 9 μg/L
* Based on a mean human half-life of 27.7 days for PFBS the time to steady state is 2.7 - 4.5 months. Subchronic is defined as a
duration of more than 30 days, up to approximately 10% of a lifetime. Rather than the default subchronic period of 8 years a
chemical specific duration of 4 months was used.
** Intake rate used corresponds to the time-weighted average 95th% intake rate over first 4 months of life. Since a young infant
intake is used a RSC of 0.5, the default for non-volatiles, is utilized.
Reference Dose:
Source of toxicity value:
Point of Departure:
Human Equivalent Dose:
Total uncertainty factor:
UF allocation:
Critical effect(s):
Co-critical effect(s):
0.0042 mg/kg-d (laboratory animal)
MDH 2009
60 mg/kg-d (NOAEL, Leider et al 2009a and York 2003a)
0.42 mg/kg-d (Serum levels were not reported, therefore the
administered dose NOAEL, 60 mg/kg-d, was divided by a half-life
adjustment factor of 142 for extrapolation from male rats to
humans)
100
3 interspecies extrapolation for potential differences in
toxicodynamics, 10 intraspecies variability and 3 for database
insufficiencies (additional studies regarding neurological and
thyroid effects are warranted)
Decreased hemoglobin and hematocrit, histological changes in
kidney
Increased liver weight with increased incidence of hepatocellular
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hypertrophy
Additivity endpoint(s): Hematological (blood) system, Hepatic (liver) system, Renal
(kidney) system
Secondary effect(s): Decreased serum protein, albumin and red blood cell count,
increased serum chloride
Chronic Noncancer Health Risk Limit (nHRLchronic) = 7 μg/L
= (Reference Dose, mg/kg/d) x (Relative Source Contribution) x (Conversion Factor)
(Chronic Intake Rate, L/kg/d)
= (0.0014 mg/kg/d) x (0.2) x (1000 μg/mg)
(0.043 L/kg-d)
= 6.51 rounded to 7 μg/L
Reference Dose:
Source of toxicity value:
Point of Departure:
Human Equivalent Dose:
Total uncertainty factor:
UF allocation:
Critical effect(s):
Co-critical effect(s):
Additivity endpoint(s):
Secondary effect(s):
0.0014 mg/kg-d (laboratory animal)
MDH 2009
60 mg/kg-d (NOAEL, Leider et al 2009a and York 2003a)
0.42 mg/kg-d (Serum levels were not reported, therefore the
administered dose NOAEL, 60 mg/kg-d, was divided by a half-life
adjustment factor of 142 for extrapolation from male rats to
humans)
300
3 interspecies extrapolation for potential differences in
toxicodynamics, 10 intraspecies variability, 3 for database
insufficiencies (additional studies regarding neurological and
thyroid effects are warranted), and 3 for use of a subchronic study
(database does not contain a chronic study and additional effects
(decreased hemoglobin and hematocrit) were noted in the 90 day
study (Leider et al 2009a and York 2003a) that were not observed
following shorter exposure durations)
Decreased hemoglobin and hematocrit, histological changes in
kidney
Increased liver weight with increased incidence of hepatocellular
hypertrophy
Hematological (blood) system, Hepatic (liver) system, Renal
(kidney) system
Decreased serum protein, albumin and red blood cell count,
increased serum chloride
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Cancer Health Risk Limit (cHRL) = Not Applicable
Cancer classification:
Slope factor:
Source of slope factor:
Tumor site(s):
PFBS has not been classified regarding potential carcinogenicity.
Not available
Not applicable
Not applicable
Volatile: No
Summary of changes since 1993/1994 HRL promulgation:
There are no pre-existing guidance values for PFBS. The 2011HRLs above represent new values.
Summary of toxicity testing for health effects identified in the Health Standards Statute:
Endocrine
Immunotoxicity Development
Reproductive
Neurotoxicity
Tested?
No
No
Yes
Yes
Secondary
Observations
Effects?
--Yes1
Yes2
Unclear3
Note: Even if testing for a specific health effect was not conducted for this chemical, information about that effect might be
available from studies conducted for other purposes. Most chemicals have been subject to multiple studies in which researchers
identify a dose where no effects were observed, and the lowest dose that caused one or more effects. A toxicity value based on the
effect observed at the lowest dose across all available studies is considered protective of all other effects that occur at higher
doses.
Comments on extent of testing or effects:
1
An oral developmental study and a 2 generational study have been conducted in rats. Both studies
identified a NOAEL for developmental effects 5-fold higher than the critical study NOAEL.
2
An oral 2 generation study in rats has been conducted. No treatment related effects on female reproductive
parameters were noted. Decreased number of spermatids per gram testes and increased incidence of
abnormal sperm were noted at doses >15-fold higher than the critical study NOAEL. Mating and fertility
parameters were unaffected.
3
Neurological alterations were reported in the 28-day (Premedia Redfield 2001) but not the 90-day oral
study (Leider et al 2009a and York 2003a) in rats. The results from the 28-day study are difficult to
interpret. Treated males did differ from control males, however, the decreases in tail flick, rotorod
latency and foot splay did not exhibit a dose-response at the doses tested. In contrast, treated females
exhibited an increase in rotorod latency. The 90 day study, which included a FOB and motor activity
assessment but not a peripheral neuropathy assessment per se, did not report any treatment related
effects. A database UF was incorporated into the derivation of the subchronic and chronic RfDs, in part,
to address the need for additional neurological testing.
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