Cardno ChemRisk LLC

Aliso Viejo, California, United States

Cardno ChemRisk LLC

Aliso Viejo, California, United States
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Cowan D.M.,Cardno ChemRisk LLC | Kingsbury T.,Cardno ChemRisk LLC | Perez A.L.,Cardno ChemRisk LLC | Woods T.A.,Cardno ChemRisk LLC | And 4 more authors.
Regulatory Toxicology and Pharmacology | Year: 2014

Chemistry enables more than 95% of products in the marketplace. Over the past 20. years, various entities began to generate inventories of chemicals ("chemical watch lists") potentially associated with human or environmental health risks. Some lists included thousands of chemicals, while others listed only a few chemistries with limited properties or toxicological endpoints (e.g., neurotoxicants). Enacted on October 1, 2013, the California Safer Consumer Products Regulation (SCP) utilized data from chemical inventory lists to create one master list. This paper aims to discuss the background and requirements of this regulation. Additionally, we wanted to understand the universe of Candidate Chemicals identified by the Regulation. Data from all 23 chemical lists identified in the SCP Regulation were entered into a database. The most prevalent chemicals among the ~2900 chemicals are identified, including the most prevalent chemical, lead, appearing on 65% of lists, followed by DEHP (52%), perchloroethylene (48%), and benzene (48%). Our results indicated that the most prevalent Candidate Chemicals were either persistent, bioaccumulative, carcinogenic, or reprotoxic. This regulation will have wide-ranging impact in California and throughout the global supply chain, which is highlighted through selected examples and case studies. © 2013 Elsevier Inc.

Perez A.L.,Cardno ChemRisk LLC | Nembhard M.,Cardno ChemRisk LLC | Monnot A.,Cardno ChemRisk LLC | Bator D.,University of Michigan | And 2 more authors.
Regulatory Toxicology and Pharmacology | Year: 2017

Costume cosmetics (lipstick, body paints, eyeshadow) were analyzed for metals using inductively coupled plasma mass spectrometry (ICP-MS). Sb was detected in all samples (range: 0.12–6.3 mg/kg; d.f. 100%), followed by Pb (<0.15–9.3 mg/kg), Ni (<0.20–6.3 mg/kg), Co (<0.5–2.0 mg/kg); with d.f. 80% each, Hg (<0.00015–0.0020 mg/kg; d.f. 50%) and As (0.53 mg/kg, d.f. 10%). Ingestion and dermal exposures were estimated for child- and adult-intermittent and adult-occupational users. Adult-occupational users exceeded the U.S. EPA Reference Dose (RfD) for Sb and the CA Proposition 65 maximum allowable dose level (MADL) for Pb was exceeded for all user scenarios. The Pb dose from body paint was sufficient to raise blood lead levels (BLL) in all user scenarios above baseline BLLs from 0.2 μg/dL to 1.9 μg/dL per the Adult Lead Model (ALM) and child Integrated Exposure Uptake Biokinetic (IEUBK) blood Pb models. Change in BLL was less than 1 μg/dL amongst the child and adult-intermittent users, the benchmark change in BLL developed for health risk assessments for children. Adult-occupational users exceeded the CA Proposition 65 NSRL intake value of 15 μg/day, which corresponds to an increase of 1.2 μg/dL above baseline levels using ALM. Exposure of occupational users of costume cosmetics should be evaluated further to prevent unnecessary metal exposure. © 2016 Elsevier Inc.

Paustenbach D.J.,Cardno ChemRisk LLC | Winans B.,Cardno ChemRisk LLC | Novick R.M.,Cardno ChemRisk LLC | Green S.M.,Eastman Chemical Company
Critical Reviews in Toxicology | Year: 2015

Crude 4-methylcyclohexanemethanol (MCHM) is an industrial solvent used to clean coal. Approximately 10 000 gallons of a liquid mixture containing crude MCHM were accidently released into the Elk River in West Virginia in January 2014. Because of the proximity to a water treatment facility, the contaminated water was distributed to approximately 300 000 residents. In this review, experimental data and computational predictions for the toxicity for crude MCHM, distilled MCHM, its other components and its putative metabolites are presented. Crude MCHM, its other constituents and its metabolites have low to moderate acute and subchronic oral toxicity. Crude MCHM has been shown not to be a skin sensitizer below certain doses, indicating that at plausible human exposures it does not cause an allergic response. Crude MCHM and its constituents cause slight to moderate skin and eye irritation in rodents at high concentrations. These chemicals are not mutagenic and are not predicted to be carcinogenic. Several of the constituents were predicted through modeling to be possible developmental toxicants; however, 1,4-cyclohexanedimethanol, 1,4-cyclohexanedicarboxylic acid and dimethyl 1,4-cyclohexanedicarboxylate did not demonstrate developmental toxicity in rat studies. Following the spill, the Centers for Disease Control and Prevention recommended a short-term health advisory level of 1 ppm for drinking water that it determined was unlikely to be associated with adverse health effects. Crude MCHM has an odor threshold lower than 10 ppb, indicating that it could be detected at concentrations at least 100-fold less than this risk criterion. Collectively, the findings and predictions indicate that crude MCHM poses no apparent toxicological risk to humans at 1 ppm in household water. © 2015 Cardno ChemRisk.

Tvermoes B.E.,Cardno ChemRisk LLC. | Paustenbach D.J.,Cardno ChemRisk LLC. | Kerger B.D.,Exponent, Inc. | Finley B.L.,Cardno ChemRisk LLC. | Unice K.M.,Cardno ChemRisk LLC.
Critical Reviews in Toxicology | Year: 2015

Cobalt (Co) can stimulate erythropoietin production in individuals at doses exceeding 25 mg CoCl2/day. Co has also been shown to exert effects on the thyroid gland, heart and nervous system at sufficient doses. The biological activity of Co is dictated by the concentration of free (unbound) ionic Co2+. Blood concentrations, as well as, urinary excretion rates of Co are reliable biomarkers for systemic Co exposure. A recent series of human volunteer Co-supplement studies simultaneously measured Co blood and urine concentrations, as well as, Co speciation in serum, and a number of biochemical and clinical parameters. It was found in these studies that peak Co whole blood concentration as high as 117 μg/L were not associated with changes in hematological parameters such as increased red blood cell (RBC) count, hemoglobin (Hgb) or hematocrit (Hct) levels, nor with changes in cardiac, neurological or, thyroid function. Using a Co biokinetic model, the estimated Co systemic tissue concentrations (e.g., liver, kidney, and heart) following 90-days of Co-dietary supplementation with ∼1 mg Co/day were found to be similar to estimated tissue concentrations in implant patients after 10 years of exposure at continuous steady state Co blood concentration of ∼10 μg/L. This study is the first to present modeled Co tissue concentrations at various doses following sub-chronic and chronic exposure. The modeled steady state tissue Co concentrations in combination with the data on adverse health effects in humans should help in the characterization of potential hazards associated with increased blood Co concentrations due to exposure to dietary supplements or cobalt-chromium (Co-Cr) containing implants. © 2015 Informa Healthcare USA, Inc.

Monnot A.D.,Cardno ChemRisk LLC | Christian W.V.,Cardno ChemRisk LLC | Paustenbach D.J.,Cardno ChemRisk LLC | Finley B.L.,Cardno ChemRisk LLC
Critical Reviews in Toxicology | Year: 2014

Chromium (Cr) (III) is a trace metal essential to human health and exposure typically occurs via the diet on a daily basis. Some groups of individuals, such as those consuming Cr(III) supplements or patients with Cr-containing implants, may have elevated blood Cr(III) concentrations. Although blood Cr(III) levels are thought to be an accurate metric of exposure, little is known about the relationship between these concentrations and possible adverse health risks. This study evaluated the various effects reported in animal and human epidemiological studies of Cr(III) exposure in an attempt to correlate them with blood Cr(III) concentrations. The target endpoints identified in this analysis included the hematological, hepatic, and renal systems. Animal and human physiological-based pharmacokinetic (PBPK) models were used to estimate steady state blood Cr(III) concentrations from a variety of dosing regimens. Based on the animal studies, our results suggest that blood Cr(III) concentrations as high as 480-580 μg/L are not associated with any responses. For each of the three health endpoints considered in this analysis (hematological, hepatic, and renal) no adverse effects were observed below 3,700 μg/L. Some hematological responses were observed at 3,700 μg/L, and adverse effects clearly occurred at 7,500 μg/L. These findings can be used to assess potential health risks to individuals with elevated blood Cr(III) concentrations. © 2014 Informa Healthcare USA, Inc.

Kerger B.D.,Cardno ChemRisk LLC | James R.C.,ToxStrategies | Galbraith D.A.,Cardno ChemRisk LLC
Frontiers in Genetics | Year: 2014

The diagnosis of mesothelioma is not always straightforward, despite known immunohistochemical markers and other diagnostic techniques. One reason for the difficulty is that extrapleural tumors resembling mesothelioma may have several possible etiologies, especially in cases with no meaningful history of amphibole asbestos exposure. When the diagnosis of mesothelioma is based on histologic features alone, primary mesotheliomas may resemble various primary or metastatic cancers that have directly invaded the serosal membranes. Some of these metastatic malignancies, particularly carcinomas and sarcomas of the pleura, pericardium and peritoneum, may undergo desmoplastic reaction in the pleura, thereby mimicking mesothelioma, rather than the primary tumor. Encasement of the lung by direct spread or metastasis, termed pseudomesotheliomatous spread, occurs with several other primary cancer types, including certain late-stage tumors from genetic cancer syndromes exhibiting chromosomal instability. Although immunohistochemical staining patterns differentiate most carcinomas, lymphomas, and mestastatic sarcomas from mesotheliomas, specific genetic markers in tumor or somatic tissues have been recently identified that may also distinguish these tumor types from asbestos-related mesothelioma. A registry for genetic screening of mesothelioma cases would help lead to improvements in diagnostic criteria, prognostic accuracy and treatment efficacy, as well as improved estimates of primary mesothelioma incidence and of background rates of cancers unrelated to asbestos that might be otherwise mistaken for mesothelioma. This information would also help better define the dose-response relationships for mesothelioma and asbestos exposure, as well as other risk factors for mesothelioma and other mesenchymal or advanced metastatic tumors that may be indistinguishable by histology and staining characteristics. © 2014 Kerger, James and Galbraith.

Monnot A.D.,Cardno ChemRisk LLC | Christian W.V.,Cardno ChemRisk LLC | Abramson M.M.,Cardno ChemRisk LLC | Follansbee M.H.,Syracuse Research Corporation
Food and Chemical Toxicology | Year: 2015

Lead (Pb) content in lipstick and other consumer products has become an increasing concern. In 2010, the United States Food and Drug Administration tested 400 lipstick samples and found a maximum Pb concentration of 7.19 ppm. To assess the safety of lipstick in adults that chronically apply lipstick as well as instances where children might incidentally ingest lipstick products, the United States Environmental Protection Agency's (US EPA) Adult Lead Model and Integrated Exposure Uptake Biokinetic Model for Lead in Children were used to determine the blood Pb concentrations of adults and children ingesting varying amounts of lipstick of different Pb concentrations. Modeled blood Pb concentrations were compared with oral ingestion guidelines and to the Centers for Disease Control and the US EPA's actionable blood Pb levels of 5 and 10 μg/dL. Background Pb exposure was the primary contributor to estimated blood Pb levels (BLLs) in children and adults, and Pb exposure from lipstick did not significantly increase estimated BLLs. These results suggest that the safety of consumer products and cosmetics should be assessed not only by the presence and amounts of hazardous contents, but also in conjunction with an assessment of estimated background exposures and comparison to health-based standards. © 2015 Elsevier Ltd.

Christian W.V.,Cardno ChemRisk LLC | Oliver L.D.,Cardno ChemRisk LLC | Paustenbach D.J.,Cardno ChemRisk LLC | Kreider M.L.,Cardno ChemRisk LLC | Finley B.L.,Cardno ChemRisk LLC
Journal of Applied Toxicology | Year: 2014

In this paper, quantitative methods were used to evaluate the weight of evidence regarding a causative relationship between cobalt-chromium (CoCr)-containing hip implants and increased cancer risk. We reviewed approximately 80 published papers and identified no-observed-adverse-effect level (NOAEL) and/or lowest-observed-adverse-effect level (LOAEL) values for specific endpoints of interest: genotoxic effects from in vitro studies with human cell lines as well as genotoxicity and tumor formation in animal bioassays. Test articles included Co particles and ions, Cr particles and ions, and CoCr alloy particles as well as CoCr alloy implants. The NOAEL/LOAEL values were compared with body burdens of Co/Cr particles and ions we calculated to exist in systemic tissues of hip implant patients under normal and excessive wear conditions. We found that approximately 40 tumor bioassays have been conducted with CoCr alloy implants or Co/Cr particles and ions at levels hundreds to thousands of times higher than those present in hip implant patients, and none reported a statistically significant increased incidence of systemic tumors. Results from in vitro and in vivo genotoxicity assays, which are relatively less informative owing to false positives and other factors, also indicated that DNA effects would be highly unlikely to occur as a result of wear debris from a CoCr implant. Hence, the toxicological weight of evidence suggests that CoCr-containing hip implants are unlikely to be associated with an increased risk of systemic cancers, which is consistent with published and ongoing cancer epidemiology studies involving patients with CoCr hip implants. © 2014 John Wiley & Sons, Ltd.

Tvermoes B.E.,Cardno ChemRisk LLC | Unice K.M.,Cardno ChemRisk LLC | Paustenbach D.J.,Cardno ChemRisk LLC | Finley B.L.,Cardno ChemRisk LLC | And 2 more authors.
American Journal of Clinical Nutrition | Year: 2014

Background: Over-the-counter cobalt supplements are available for sale in the United States, but little is known regarding their clinical effects and biokinetic distribution with long-term use. Objective: We assessed blood kinetics, biochemical responses, and clinical effects in 5 adult men and 5 adult women who voluntarily ingested ∼1.0 mg Co/d (0.080-0.19 mg Co · kg-1 · d-1) of a commercially available cobalt supplement over a 3-mo period. Design: Volunteers were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label. Blood samples were collected and analyzed for a number of biochemical variables before, during, and after dosing. Hearing, vision, cardiac, and neurologic functions were also assessed in volunteers before, during, and after dosing. Results : After ∼90 d of dosing, mean cobalt blood concentrations were lower in men than in women. Mean cobalt whole blood and serum concentrations in men were 20 μg/L (range: 12-33 μg/L) and 25 μg/L (range: 15-46 μg/L), respectively. In women, mean cobalt whole blood and serum concentrations were 53 μg/L (range: 6-117 μg/L) and 71 μg/L (range: 9-149 μg/L), respectively. Estimated red blood cell (RBC) cobalt concentrations suggested that cobalt was sequestered in RBCs during their 120-d life span, which resulted in a slower whole blood clearance compared with serum. The renal clearance of cobalt increased with the serum concentration and was, on average, lower in women (3.5 ± 1.3 mL/min) than in men (5.5 ± 1.9 mL/min). Sex-specific differences were observed in cobalt absorption and excretion. There were no clinically significant changes in biochemical, hematologic, and clinical variables assessed in this study. Conclusion: Peak cobalt whole blood concentrations ranging between 9.4 and 117 μg/L were not associated with clinically significant changes in basic hematologic and clinical variables. This study was registered at as NCT01990794. © 2014 American Society for Nutrition.

Perez A.L.,Cardno ChemRisk LLC | De Sylor M.A.,Cardno ChemRisk LLC | Slocombe A.J.,Cardno ChemRisk LLC | Lew M.G.,Cardno ChemRisk LLC | And 2 more authors.
Environmental Toxicology and Chemistry | Year: 2013

Recently, concern has grown regarding the presence of triclosan (TCS) in waters because of its potential for causing ecological and human health effects. The authors present a statistical analysis of TCS concentrations reported between 1999 and 2012 in freshwater environments in the United States and provide a comparison with available health-based and aquatic guidance values. Data from 46 peer-reviewed and unpublished investigations from 45 states and 1 US territory were included in the meta-analysis, encompassing the following coded water types: untreated (raw wastewater), effluent (wastewater treatment plant effluent), effluent-impacted environmental, environmental, and finished drinking water (total n=2305). Triclosan was most frequently detected in untreated waters (92% detection frequency; mean±standard error, 11270±2925ng/L; n=237), but concentrations were significantly reduced in effluent waters (83% detection frequency 775±311ng/L; n=192, α=0.05). Triclosan concentration in effluent-impacted environmental waters (62% detection frequency; 130±17ng/L; n=228) was not significantly reduced from effluent waters but was significantly greater than TCS in environmental waters not classified as effluent impacted (11% detection frequency; 13±3ng/L; n=1195). In finished drinking water, TCS was largely undetected (1% detection frequency; 4±2ng/L n=453), suggesting that for the United States, drinking water is not an appreciable source of TCS exposure. In posttreatment waters, average TCS concentrations were below part-per-billion levels. Although no US regulatory standard exists for TCS in aquatic systems, comparison of averages reported in the present study with a predicted-no-effect concentration (PNEC) of 500ng/L showed that 5.3% of effluent-impacted environmental waters were above the PNEC for changes in algal biomass, while only 0.25% of environmental waters surpassed this value. © 2013 SETAC.

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