SCREENING-LEVEL HAZARD CHARACTERIZATION OF HIGH PRODUCTION VOLUME CHEMICALS SPONSORED CHEMICAL Hydroxybenzenesulfonic Acid (CAS No. 1333-39-7) [9th CI Name: Benzenesulfonic acid, hydroxy-] December 2007 INTERIM Prepared by High Production Volume Chemicals Branch Risk Assessment Division Office of Pollution Prevention and Toxics Environmental Protection Agency 1200 Pennsylvania Avenue, NW Washington, DC 20460-0001 ------- SCREENING-LEVEL HAZARD CHARACTERIZATION OF HIGH PRODUCTION VOLUME CHEMICALS The High Production Volume (HPV) Challenge Program1 is a voluntary initiative aimed at developing and making publicly available screening-level health and environmental effects information on chemicals manufactured in or imported into the United States in quantities greater than one million pounds per year. In the Challenge Program, producers and importers of HPV chemicals voluntarily sponsor chemicals; sponsorship entails the identification and initial assessment of the adequacy of existing toxicity data/information, conducting new testing if adequate data do not exist, and making both new and existing data and information available to the public. Each complete data submission contains data on 18 internationally agreed to "SIDS" (Screening Information Data Set1'2) endpoints that are screening-level indicators of potential hazards (toxicity) for humans or the environment. The Environmental Protection Agency's Office of Pollution Prevention and Toxics (OPPT) is evaluating the data submitted in the HPV Challenge Program on approximately 1400 sponsored chemicals. OPPT is using a hazard- based screening process to prioritize review of the submissions. The hazard-based screening process consists of two tiers described below briefly and in more detail on the Hazard Characterization website3. Tier 1 is a computerized sorting process whereby key elements of a submitted data set are compared to established criteria to "bin" chemicals/categories for OPPT review. This is an automated process performed on the data as submitted by the sponsor. It does not include evaluation of the quality or completeness of the data. In Tier 2, a screening-level hazard characterization is developed by EPA that consists of an objective evaluation of the quality and completeness of the data set provided in the Challenge Program submissions. The evaluation is performed according to established EPA guidance2'4 and is based primarily on hazard data provided by sponsors. EPA may also include additional or updated hazard information of which EPA, sponsors or other parties have become aware. The hazard characterization may also identify data gaps that will become the basis for a subsequent data needs assessment where deemed necessary. Under the HPV Challenge Program, chemicals that have similar chemical structures, properties and biological activities may be grouped together and their data shared across the resulting category. This approach often significantly reduces the need for conducting tests for all endpoints for all category members. As part of Tier 2, evaluation of chemical category rationale and composition and data extrapolation(s) among category members is performed in accord with established EPA2 and OECD5 guidance. The screening-level hazard characterizations that emerge from Tier 2 are important contributors to OPPT's existing chemicals review process. These hazard characterizations are technical documents intended to support subsequent decisions and actions by OPPT. Accordingly, the documents are not written with the goal of informing the general public. However, they do provide a vehicle for public access to a concise assessment of the raw technical data on HPV chemicals and provide information previously not readily available to the public. The public, including sponsors, may offer comments on the hazard characterization documents. The screening-level hazard characterizations, as the name indicates, do not evaluate the potential risks of a chemical or a chemical category, but will serve as a starting point for such reviews. In 2007, EPA received data on uses of and exposures to high-volume TSCA existing chemicals, submitted in accordance with the requirements of the Inventory Update Reporting (IUR) rule. For the chemicals in the HPV Challenge Program, EPA will review the IUR data to evaluate exposure potential. The resulting exposure information will then be combined with the screening-level hazard characterizations to develop screening-level risk characterizations4'6. The screening-level risk characterizations will inform EPA on the need for further work on individual chemicals or categories. Efforts are currently underway to consider how best to utilize these screening-level risk characterizations as part of a risk- based decision-making process on HPV chemicals which applies the results of the successful U.S. High Production Volume Challenge Program and the IUR to support judgments concerning the need, if any, for further action. 1 U.S. EPA. High Production Volume (HPV) Challenge Program; http://www.epa.gov/chemrtk/index.htm. 2 U.S. EPA. HPV Challenge Program - Information Sources; http://www.epa.gov/chemrtk/pubs/general/guidocs.htm. 3 U.S. EPA. HPV Chemicals Hazard Characterization website (http://www.epa.gov/hpvis/abouthc.html). 4 U.S. EPA. Risk Assessment Guidelines; http://cfpub.epa.gov/ncea/raf/rafguid.cfm. 5 OECD. Guidance on the Development and Use of Chemical Categories; http://www.oecd.org/dataoecd/60/47/1947509.pdf. 6 U.S. EPA. Risk Characterization Program; http://www.epa.gov/osa/spc/2riskchr.htm. 2 ------- SCREENING-LEVEL HAZARD CHARACTERIZATION Hydroxybenzenesulfonic Acid (CAS No. 1333-39-7) Introduction The sponsor, Aromatic Sulfonic Acids Association, submitted a Test Plan and Robust Summaries to EPA for hydroxybenzenesulfonic acid (CAS No. 1333-39-7, 9th CI name: benzenesulfonic acid, hydroxy-) on September 16, 2003. EPA posted the submission on the ChemRTK HPV Challenge website on October 23, 2003 (http://www.epa.gov/oppt/chemrtk/pubs/summaries/hYdrbnsa/cl4744tc.htm'). EPA comments on the original submission were posted to the website on March 8, 2004. Public comments were also received and posted to the website. The sponsor submitted updated/revised documents on May 20, 2004 which were posted to the ChemRTK website on August 27, 2004. This screening level hazard characterization is based primarily on the review of the test plan and robust summaries of studies submitted by the sponsor(s) under the HPV Challenge Program. In preparing the hazard characterization, EPA considered its own comments and public comments on the original submission as well as the sponsor's responses to comments and revisions made to the submission. A summary table of SIDS endpoint data with the structure(s) of the sponsored chemical(s) is included in the appendix. The screening-level hazard characterization for environmental and human health effects is based largely on SIDS endpoints and is described according to established EPA or OECD effect level definitions and hazard assessment practices. Justification for Supporting Chemical Hydroxybenzenesulfonic acid is sold as an aqueous commercial preparation containing the following three major components: 2-hydroxybenzenesulfonic acid (CAS No. 609-46-1), 4-hydroxybenzenesulfonic acid (CAS No. 98- 67-9) and benzenesulfonic acid (CAS No. 98-11-3). Data for some of the physical-chemical properties of the individual components are included in this hazard characterization; however, these compounds were not used as supporting chemicals for the environmental or human health effects endpoints. Summary-Conclusion The log Kow of hydroxybenzenesulfonic acid indicates that its potential to bioaccumulalc is expected to be low. The potential of hydroxybenzenesulfonic acid to persist in the environment cannot be characterized because no adequate biodegradalion data were provided. The potential hazard of hydroxybenzenesulfonic acid to aquatic organisms was not determined because no test data were provided for the aquatic toxicity endpoints. Acute oral toxicity of hydroxybenzenesulfonic acid lo rats and mice is moderate. Hydroxybenzenesulfonic acid is corrosive to rabbits" eyes. No adequate data were provided for the acute, repeated-dose, reproductive, developmental or genetic toxicity endpoints. EPA believes that, given the strong acidity of hydroxybenzenesulfonic acid, it is unlikely thai mammalian toxicity tests would provide meaningful systemic toxicity information. Testing was proposed for the genetic mutation and chromosomal aberrations endpoints. The potential health hazard of hydroxybenzenesulfonic acid is high based on the strong acidity/corrosivily of the chemical. Acute toxicity to fish and aquatic invertebrates, toxicity to aquatic plants, gene mutation and chromosomal aberrations were identified as data gaps under the HPV Challenge Program. 3 ------- 1. Physical-Chemical Properties and Environmental Fate A summary of physical-chemical and environmental fate data submitted is provided in the Appendix. For the purpose of the screening-level hazard characterization, the review and summary of these data were limited to the octanol-water partition coefficient and biodegradation endpoints as indicators of bioaccumulation and persistence, respectively. Octanol-Water Partition Coefficient LogKow: -1.65 (estimated) Ready Biodegradation The sponsor proposed testing for the biodegradation endpoint in 2004. Conclusion: The log Kow of hydroxybenzenesulfonic acid indicates that its potential to bioaccumulate is expected to be low. The potential of hydroxybenzenesulfonic acid to persist in the environment cannot be characterized because biodegradation data were not provided. 2. Environmental Effects - Aquatic Toxicity Acute Toxicity to Fish No measured data were provided for this endpoint. The sponsor provided an ECOSAR estimated 96-hour LC50 value of 45,329 mg/L. The sponsor's test plan proposed that two endpoints (acute toxicity to aquatic invertebrates and toxicity to aquatic plants) would be tested and that the results will be compared to ECOSAR predictions. If there is close agreement with the test results and ECOSAR predictions, then the acute toxicity to fish can be addressed with ECOSAR. EPA agreed with this approach. Acute Toxicity to Aquatic Invertebrates No measured data were provided for this endpoint. The sponsor provided an ECOSAR estimated 48-hour EC50 value of 2916 mg/L. Testing was proposed by the sponsor. Toxicity to Aquatic Plants No measured data were provided for this endpoint. The sponsor provided an ECOSAR estimated 96-hour EC50 value of 1.5xl06 mg/L. Testing was proposed by the sponsor. Conclusion: The potential hazard of hydroxybenzenesulfonic acid to aquatic organisms cannot be determined because no data were provided for the aquatic toxicity endpoints. 3. Human Health Effects Acute Oral Toxicity Two acute oral toxicity values for rat and mouse are 1900 and 1500 mg/kg-bw, respectively. Although these data are from the secondary sources with limited information to assess the data adequacy, it is unlikely that additional mammalian toxicity tests would provide meaningful systemic toxicity information because the chemical is a strong acid. 4 ------- Repeated-Dose Toxicity No data were provided for this endpoints. EPA believes that, given the strong acidity of hydroxybenzenesulfonic acid, it is unlikely that mammalian toxicity tests would provide meaningful systemic toxicity information. Reproductive/Developmental Toxicity No data were provided for these endpoints. EPA believes that, given the strong acidity of hydroxybenzenesulfonic acid, it is unlikely that mammalian toxicity tests would provide meaningful systemic toxicity information. Genetic Toxicity - Gene Mutation In vitro No data were provided for this endpoint. Testing was proposed by the sponsor. Genetic Toxicity - Chromosomal Aberrations In vitro No data were provided for this endpoint. Testing was proposed by the sponsor. Additional Information Eye Irritation Aliquots of 0.1 mL of hydroxybenzenesulfonic acid were instilled in the eyes of rabbits (3/group, strain and sex not specified) for exposure times of 5, 10 or 30 seconds. Eyes were rinsed with isotonic saline after the exposure and monitored for up to 14 days after exposure. After 5 seconds of exposure, copious discharge, swelling with the lids about half closed and severe redness of the conjunctivae were observed and opacity sufficient to render the iris invisible developed within a few minutes. After 14 days, there was moderate edema and discharge, moderately severe erythema and opalescent areas. The iris reacted to light. After 10 seconds of exposure, the results were the same as for 5 seconds, but the iris seemed to be damaged after 14 days. After 30 seconds of exposure, severe edema and congestion extending for a considerable distance around the eye was observed rapidly after exposure. Hydroxybenzenesulfonic acid was corrosive to rabbit eyes in this assay. Conclusion: Acute oral toxicity of hydroxybenzenesulfonic acid to rats and mice is moderate. Hydroxybenzenesulfonic acid is corrosive to rabbit eyes. No data were provided for the repeated-dose, reproductive, developmental or genetic toxicity endpoints. EPA believes that, given the strong acidity of hydroxybenzenesulfonic acid, it is unlikely that mammalian toxicity tests would provide meaningful systemic toxicity information. Testing was proposed for the genetic mutation and chromosomal aberrations endpoints. The potential health hazard of hydroxybenzenesulfonic acid is high based on the strong acidity/corrosivity of the chemical. 5 ------- 4. Hazard Characterization The log Kow of hydroxybenzenesulfonic acid indicates that its potential to bioaccumulate is expected to be low. The potential of hydroxybenzenesulfonic acid to persist in the environment cannot be characterized because no adequate biodegradation data were provided. The potential hazard of hydroxybenzenesulfonic acid to aquatic organisms was not determined because no test data were provided for the aquatic toxicity endpoints. Acute oral toxicity of hydroxybenzenesulfonic acid to rats and mice is moderate. Hydroxybenzenesulfonic acid is corrosive to rabbits' eyes. No adequate data were provided for the acute, repeated-dose, reproductive, developmental or genetic toxicity endpoints. EPA believes that, given the strong acidity of hydroxybenzenesulfonic acid, it is unlikely that mammalian toxicity tests would provide meaningful systemic toxicity information. Testing was proposed for the genetic mutation and chromosomal aberrations endpoints. The potential health hazard of hydroxybenzenesulfonic acid is high based on the strong acidity/corrosivity of the chemical. 5. Data Gaps Acute toxicity to fish and aquatic invertebrates, toxicity to aquatic plants, gene mutation and chromosomal aberrations were identified as data gaps under the HPV Challenge Program. 6 ------- APPENDIX Summary Tabic of the Screening Information Data Set as Submitted under the U.S. HPV Challenge Program Endpoints SPONSORED CHEMICAL Hydroxybcnzcncsulfonic Acid ' (1333-39-7) Structure OH 1 0=S=0 (^U Summary of Physical-Chemical Properties and Environmental Fate Data Melting Point (°C) 129 (estimated) Boiling Point (°C) 270 (estimated) Log K„w 4.4 x 10"7 (estimated) Indirect (OH) Photodegradation Half-life (t1/2) 1.4 days (estimated) Stability in Water (Hydrolysis) (t1/2) Not expected to undergo hydrolysis in the environment Fugacity (Level III Model) Air (%) Water (%) Soil (%) Sediment (%) < 1 99.8 < 1 < 1 Biodegradation at 28 days (%) No data. Testing proposed. Summary of Environmental Effects - Aquatic Toxicity Data Fish 96-h LCS0 (mg/L) No data. Technical discussion.1 Aquatic Invertebrates 48-h ECS0 (mg/L) No data. Testing proposed. Aquatic Plants 72-h ECS0 (mg/L) No data. Testing proposed. Summary of Human Health Data Acute Oral Toxicity LDS0 (mg/kg-bw) 1500 - 1900 (mice, rat)2 Repeated-Dose Toxicity NOAEL/LOAEL Oral (mg/kg-bw/day) No data. Technical discussion.3 Reproductive/Developmental Toxicity NOAEL/LOAL Oral (mg/kg-bw/day) No data. Technical discussion.3 Genetic Toxicity - Gene Mutation In vitro No data. Testing proposed. Genetic Toxicity - Chromosomal Aberrations In vitro No data. Testing proposed. Additional Information Eye Irritation Corrosive 7 ------- 1 EPA agreed with the sponsor's test plan, which stated that two endpoints (acute toxicity to aquatic invertebrates and toxicity to aquatic plants) will be tested and that the results will be compared to ECOSAR predictions. If there is close agreement with the test results and ECOSAR predictions, then the acute toxicity to fish endpoint can be addressed with ECOSAR. 2Although these data are from the secondary sources with limited information to assess the data adequacy, it is unlikely that additional mammalian toxicity tests would provide meaningful systemic toxicity information because the chemical is a strong acid. 3Because the chemical is a strong acid, EPA believes that it is unlikely that mammalian toxicity tests would provide meaningful systemic toxicity information. 8 ------- |