Chemical Name: Perfluorobutane sulfonate CAS: Synonyms: PFBS, Nonafluorobutanesulphonic acid

Transcription

1 Chemical Name: Perfluorobutane sulfonate CAS: Synonyms: PFBS, Nonafluorobutanesulphonic acid 2011 Health Risk Limits for Groundwater Health Risk Assessment Unit, Environmental Health Division TDD Acute Noncancer Health Risk Limit (nhrl acute ) = Not Derived (Insufficient Data) Web Publication Date: March 21, 2011 Short-term Noncancer Health Risk Limit (nhrl short-term ) = Not Derived (Insufficient Data) Subchronic* Noncancer Health Risk Limit (nhrl subchronic ) = 9 μg/l = (Reference Dose, mg/kg/d) x (Relative Source Contribution) x (Conversion Factor) (Subchronic Intake Rate, L/kg/d) = ( 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 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 95 th % 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: mg/kg-d (laboratory animal) Source of toxicity value: MDH 2009 Point of Departure: 60 mg/kg-d (NOAEL, Leider et al 2009a and York 2003a) Human Equivalent Dose: 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) Total uncertainty factor: 100 UF allocation: 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) Critical effect(s): Decreased hemoglobin and hematocrit, histological changes in kidney Co-critical effect(s): Increased liver weight with increased incidence of hepatocellular PFBS - 1 of 6

2 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 (nhrl chronic ) = 7 μg/l = (Reference Dose, mg/kg/d) x (Relative Source Contribution) x (Conversion Factor) (Chronic Intake Rate, L/kg/d) = ( mg/kg/d) x (0.2) x (1000 μg/mg) (0.043 L/kg-d) = 6.51 rounded to 7 μg/l Reference Dose: mg/kg-d (laboratory animal) Source of toxicity value: MDH 2009 Point of Departure: 60 mg/kg-d (NOAEL, Leider et al 2009a and York 2003a) Human Equivalent Dose: 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) Total uncertainty factor: 300 UF allocation: 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) Critical effect(s): Decreased hemoglobin and hematocrit, histological changes in kidney Co-critical effect(s): Increased liver weight with increased incidence of hepatocellular 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 PFBS - 2 of 6

3 Cancer Health Risk Limit (chrl) = Not Applicable Cancer classification: PFBS has not been classified regarding potential carcinogenicity. Slope factor: Not available Source of slope factor: Not applicable Tumor site(s): 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? Yes 1 Yes 2 Unclear 3 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. PFBS - 3 of 6

4 References: Agency for Toxic Substances and Disease Registry (ATSDR). Minimal Risk Levels. ATSDR Draft Toxicological Profile for Perfluoroalkyls. May 2009 Australian Government, Department of Health and Aging, National Industrial Chemicals Notification and Assessment Scheme (NICNAS) Existing Chemical Hazard Assessment Report Potassium Perfluorobutane Sulfonate. Calafat AM, LY Wong, Z Kuklenyik, JA Reidy, LL Needham Polyfluoroalkyl Chemicals in the U.S. Population: Data from the National Health and Nutrition Examination Survey (NHANES) and Comparison with NHANES Env Health Perspec. 115(11) California Environmental Protection Agency, OEHHA Toxicity Criteria Database pdf Chen YM and LH Guo Fluorescence study on site-specific binding of perfluoroalkyl acids to human serum albumin. Arch Toxicol. Advanced access doi: /s x. Chengelis CP, JB Kirkpatrick, NR Myers, M Shinohara Comparison of the toxicokinetic behavior of perfluorohexanoic acid (PFHxA) and nonafluorobutane-1-sulfonic acid (PFBA) in cynomolgus monkeys and rats. Repro Toxicol 27: Environmental Protection Agency (EPA) Health Effects Assessment Summary Tables (HEAST). EPA Integrated Risk Information System. EPA Office of Drinking Water. Drinking Water Standards and Health Advisories (August, 2006) EPA Region 3. Risk Based Concentration. (click on RBC Tables PDF link) EPA Region 9. Preliminary Remediation Goal. (click on Region 9 PRGs 2004 Table link) Ericson, I, M Gomez, M Nadal, B van Baval, G Lindstrom, JL Domingo Perfluorinated chemicals in blood of residents in Catalonia (Spain) in relation to age and gender: A pilot study. Env Int 33: Ericson I, R Marti-Cid, M Nadal, R Van Bavel, G Lindstrom, JL Domingo. 2008a. Human Exposure to Perfluorinated Chemicals through the Diet: Intake of Perfluorinated Compounds in Foods from the Catalan (Spain) Market. J Agric Food Chem 56: PFBS - 4 of 6

5 Ericson I, M Nadal, B van Bavel, G Lindstrom, JL Domingo 2008b. Levels of perfluorochemicals in water samples from Catalonia, Spain: is drinking water a significant contribution to human exposure? Env Sci Pollut Res 15: Hickey NJ, D Crump, SP Jones, SW Kennedy Effects of eighteen perfluoroalkyl compounds (PFCs) on mrna expression in chick embryo hepatocyte cultures. Tox Sci. Advance Access. July 17, 2009 Holzer J, O Midasch, K Rauchfuss, M Kraft, R Reupert, J Angerer, P Kleeschulte, N Marschall, M Wilhelm Biomonitoring of Perfluorinated Compounds in Children and Adults Exposed to Perfluorooctanoate-Contaminated Drinking Water. Env Health Perspec 116(5): International Agency for Research on Cancer (IARC). Agents Reviewed by the IARC Monographs. Johansson N, Fredriksson A, Eriksson P, 2008 Neonatal exposure to perfluorooctane sulfonate (PFOS) and perfluorooctanoic acid (PFOA) causes neurobehavioural defects in adult mice. Neurotoxicology 29: Karrman A, KH Harada, K Inoue, T Takasuga, E Ohi, A Koizumi Relationship between dietary exposure and serum perfluorochemical (PFC) levels - A case study. Environ Int doi: /j.envint Leider PH, SC Chang, RG York, JL Butenhoff. 2009a. Toxicological evaluation of potassium perfluorobutanesulfonate in a 90-day oral gavage study with Spraque-Dawley rats. Toxicology 255: Leider PH, RG York, DC Hakes, JL Butenhoff. 2009b. A Two-Generation Oral Gavage Reproduction Study with Potassium Perfluorobutanesulfonate (K+PFBS) in Sprague Dawley Rats. Toxicology 259: Minnesota Department of Health (MDH) East Metro Perfluorochemical Biomonitoring Pilot Project. Olsen GW, SC Chang, PE Noker, GS Gorman, DJ Ehresman, PH Lieder, JL Butenhoff A comparison of the pharmacokinetics of perfluorobutanesulfonate (PFBS) in rats, monkeys and humans. Toxicology 256: Oak Ridge National Laboratory. Screening Levels for Chemical Contaminants. Premedica Redfield Report A Repeated Dose Range-Finding Toxicity Study of T-7485 in Sprague- Dawley Rats. Study Number Premedica Redfield Report A 28-Day Oral (Gavage) Toxicity Study of T-7485 in Sprague-Dawley Rats. Study Number Slotkin, TA, EA MacKillop, RL Melnick, KA Thayer, FJ Seidler Developmental Neurotoxicity of Perfluorinated Chemicals Modeled in Vitro. EHP 116(6) PFBS - 5 of 6

6 Syracuse Research PhysProp Database. Tao L, K Kannan, CM Wong, KF Arcaro, JL Butenhoff Perfluorinated Compounds in Human Milk from Massachusetts, U.S.A. Environ Sci Technol. Advance Access published March 7, 2008: /es702789k Weiss J, PL Andersson, MH Lamoree, PEG Leonards, SPJ van Leeuwen, T Hamers Competitive Binding of Poly- and Perfluorinated Compounds to the Thyroid Hormone Transport Protein Transthyretin. Tox Sci 109(2) Wolf CJ, ML Takacs, JE Schmid, C Lau, BD Abbott Activation of Mouse and Human Peroxisome Proliferator Activated Receptro Alpha by Perfluoroalkyl Acids of Different Functional Groups and Chain Lengths. Tox Sci 106(1) World Health Organization (WHO) Recommended Classification of Pesticides by Hazard World Health Organization. Guidelines for Drinking-Water Quality. Chapter 12 Chemical Fact Sheets. York RG Oral (Gavage) Developmental Toxicity Study of Potassium Perfluorobutane Sulfonate (PFBS) in Rats. Argus Research Protocol Number York RG 2003a. Oral (Gavage) Repeated Dose 90-Day Toxicity Study of Potassium Perfluorobutane Sulfonate (PFBS) in Rats. Argus Research Protocol Number York RG 2003b. Oral (Gavage) Two-Generation (One Litter per Generation) Reproduction Study of Perfluorobutane Sulfonate (PFBS) in Rats. Argus Research Protocol Number PFBS - 6 of 6