CPSC Statement On Mold And Mycotoxins Health Effects

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CPSC Staff Statement on Toxicology Excellence for Risk Assessment (TERA) Report “Reviewof the Health Risks of Mold, Health Effects of Molds and Mycotoxins” 1July 2015The report titled, “Review of the Health Risks of Mold, Health Effects of Molds andMycotoxins,” presents basic mold characteristics and was performed by TERA under ContractCPSC-D-12-0001, Task Order 0013. A second report, “Review of the Health Risk of Mold,Basic Mold Characteristics,” can be found under a separate cover. Consumer exposure to moldon a product may be more frequent and direct than exposures that might occur in a buildingsetting, making remediation even more important for products with mold contamination.Therefore, this contract was initiated for staff to gain a better understanding of these hazards andthe new information that has been developed over the past several years on mold characteristicsand toxicity.The available data on health effects associated with mold in each genus are reviewed in the firstsection. For each genus, the uptake and system spread and health effects in humans and/oranimals are discussed. Following that is a discussion of the health effects associated with keymycotoxins produced by the genera of interest. The physical and chemical characteristics,toxicokinetics, and animal and human hazard information are included in these discussions.Historically, much of the documented human exposure to molds and mycotoxins has been viafood. This means that most of the available experimental data for mycotoxins are for the oralroute, often in the context of dietary exposure; parenteral dosing studies are also often available.Generally speaking the data available for the inhalation and dermal routes are very limited. Incontrast to the mycotoxins, inhalation and dermal exposure to the mold (e.g., spores) may alsooccur.In this report, Table 1 summarizes the key information on the basic mold characteristics (see theBasic Mold Characteristics report for more details), together with the health effects associatedwith each genus. The summary of the toxin effects (irritation, kidney, liver, developmental,cancer) is based primarily on animal data, and human data were used when available.Information on irritant effects is from testing of the mycotoxins in animals, or reports fromhuman exposure to the mold or mycotoxins; controlled animal testing for irritancy was not donefor the molds themselves.1This statement was prepared by the CPSC staff, and the attached report was produced by TERA for CPSCstaff. The statement and report have not been reviewed or approved by, and do not necessarily representthe views of, the Commission.

Health effects associated with these different molds in humans include: allergic reactions,sensitization, asthma, neurotoxicity, sinusitis, otomycosis, onychomycosis, keratitis, respiratoryinfections, skin infections, and systemic infections.Determining which mycotoxins are produced by which genus is difficult. This reflectsdifferences in toxin production by different strains or species within a genus and data gaps, or thetendency of review articles to focus on primary toxins and classes of toxins, rather thanidentifying each toxin (or each major toxin) produced by a genus. Health effects associated withmycotoxins in humans include: hepatic toxicity, cancers (liver, esophageal, lymphoma, skin, andgastric), nephrotoxicity, hypertension, hyperlipidemia, immunosuppression, and nasal irritation.

Review of the Health Risks of MoldCompleted Under Contract CPSC-D-12-0001Task Order 0013Lead Scientists:Lynne Haber, TERABrandolyn Thran, Perspective Scientific ConsultingChris Chaisson, The Lifeline GroupHealth Effects of Molds and MycotoxinsFinal Report, July 13, 2015Lead Scientist, Lynne Haber

Table of Contents3Effects of the Mold as an Organism . 93.1Introduction . 93.2Alternaria. 173.2.1Uptake and Systemic Spread . 173.2.2Health Effects in Humans . 173.2.3References . 193.3Aspergillus . 213.3.1Uptake and Systemic Spread . 213.3.2Health Effects in Animals . 263.3.3References . 273.4Chaetomium . 303.4.1Uptake and Systemic Spread . 303.4.2Health Effects in Humans . 303.4.3Health Effects in Animals . 323.4.4References . 323.5Cladosporium . 333.5.1Uptake and Systemic Spread . 333.5.2Health Effects in Humans . 333.5.3Health Effects in Animals . 353.5.4References . 363.6Dicyma . 393.6.1Uptake and Systemic Spread . 393.6.2Health Effects in Humans . 393.6.3Health Effects in Animals . 393.6.4References . 403.7Epicoccum . 403.7.1Uptake and Systemic Spread . 403.7.2Health Effects in Humans . 404

3.7.3Health Effects in Animals . 423.7.4References . 423.83.8.1Uptake and Systemic Spread . 433.8.2Health Effects in Humans . 433.8.3Health Effects in Animals . 463.8.4References . 463.9Penicillium . 483.9.1Uptake and Systemic Spread . 483.9.2Health Effects in Humans . 483.9.3Health Effects in Animals . 503.9.4References . 513.10Phoma . 533.10.1Uptake and Systemic Spread . 533.10.2Health Effects in Humans . 533.10.3Health Effects in Animals . 553.10.4References . 563.11Stachybotrys . 583.11.1Uptake and Systemic Spread . 583.11.2Health Effects in Humans . 593.11.3Health Effects in Animals . 633.11.4References . 633.124Malassezia . 43Zygomycetes . 653.12.1Uptake and Systemic Spread . 653.12.2Health Effects in Humans . 653.12.3Health Effects in Animals . 683.12.4References . 68Effects of Mycotoxins . 704.1Aflatoxin. 714.1.1Physical and Chemical Characteristics . 715

4.1.2Toxicokinetics . 734.1.3Hazard Information - Human . 744.1.4Hazard Information - Animal. 764.1.5References . 844.2Alternaria Mycotoxins. 864.2.1Physical and Chemical Characteristics . 864.2.2Toxicokinetics . 864.2.3Hazard Information - Human . 884.2.4Hazard Information - Animal. 884.2.5References . 944.3Chaetomium Toxins . 944.3.1Physical and Chemical Characteristics . 954.3.2Toxicokinetics . 964.3.3Hazard Information - Human . 964.3.4Hazard Information - Animal. 964.3.5References . 984.4Ciclosporin/Cyclosporine . 994.4.1Physical and Chemical Characteristics . 994.4.2Toxicokinetics . 1004.4.3Hazard Information – Human . 1014.4.4Hazard Information - Animal. 1024.4.5References . 1104.5Citrinin . 1114.5.1Physical and Chemical Characteristics . 1114.5.2Toxicokinetics . 1124.5.3Hazard Information - Human . 1124.5.4Hazard Information - Animal. 1134.5.5Lowest Hazard Endpoints . 1194.5.6References . 1214.6Ochratoxin . 1226

4.6.1Physical and Chemical Characteristics . 1224.6.2Toxicokinetics . 1234.6.3Hazard Information- Human . 1244.6.4Hazard Information - Animal. 1254.6.5References . 1354.7Sterigmatocystin . 1374.7.1Physical and Chemical Characteristics . 1374.7.2Toxicokinetics . 1384.7.3Hazard Information- Human . 1394.7.4Hazard Information - Animal. 1404.7.5References . 1474.8Satratoxin . 1474.8.1Physical and Chemical Characteristics . 1474.8.2Toxicokinetics . 1494.8.3Hazard Information- Human . 1494.8.4Hazard Information - Animal. 1504.8.5References . 1547

List of TablesTable 1. Summary of Key Mold Characteristics and Health Effects . 11Table 2. Summary of Key Health Effects by Organism, Based on Animal and Human Data . 16Table 3. Summary of Toxins Associated with Organisms Addressed in this Document . 70Table 4. Physical and Chemical Characteristics of Aflatoxins . 71Table 5. Summary of Aflatoxin Toxicity Data . 81Table 6. Lowest Hazard Endpoints for Aflatoxin . 83Table 7. Summary of Alternaria Toxin Toxicity Data . 92Table 8. Physical and Chemical Characteristics of Chaetomium Toxins . 95Table 9. Summary of Toxicity Data of Chaetomium Toxins . 98Table 10. Physical and Chemical Characteristics of Cyclosporine . 99Table 12. Lowest Hazard Endpoints for Cyclosporine . 109Table 13. Physical and Chemical Characteristics of Citrinin . 111Table 14. Summary of Toxicity Data for Citrinin . 118Table 15. Lowest Hazard Endpoints for Citrinin . 120Table 16. Physical and Chemical Characteristics of Ochratoxin . 122Table 17. Summary of OTA Toxicity Data . 132Table 18. Lowest Hazard Endpoints for OTA . 135Table 19. Physical and Chemical Characteristics of Sterigmatocystin. 137Table 20. Summary of Toxicity Data of Sterigmatocystin . 144Table 21. Lowest Hazard Endpoints for STC . 146Table 22. Summary of Toxicity Data for Satratoxin . 1538

3Effects of the Mold as an Organism3.1 IntroductionThis volume reviews the key health effects associated with the molds and mycotoxins addressedin this report. The available data on health effects associated with the mold of each genus isreviewed in the first section. Following that is a discussion of the health effects associated withkey mycotoxins produced by the genera of interest. The approach utilized for this report is basedon a weight of evidence understanding of the relevant effects and should not be consideredexhaustive. The focus of the review is on a weight of evidence understanding of the relevanteffects and associated effect levels. There was no attempt to conduct an exhaustive review of theliterature, or to capture every effect that has b

The report titled, “Review of the Health Risks of Mold, Health Effects of Molds and Mycotoxins,” presents basic mold characteristics and was performed by TERA under Contract CPSC-D-12-0001, Task Order 0013. A second report, “Review of the Health Risk of Mold, Basic Mold Characteristics,” can be found under a separate cover.

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