nano-TAB v0.5 Specification Development Effort Weekly Meeting June 8, 2010

Agenda Review NTP Study and Example Files Follow-up on Actions Review Project Status and Discuss Next Steps

NTP Fullerene-C60 Study

Toxicology/Carcinogenicity Studies

13-Week Toxicity Study Protocol

DRAFT Investigation and Studies (1 of 2) INVESTIGATION TITLE: 90 Day Toxicity Study for Nanoscale material (Fullerene-C60) DESCRIPTION: Obtain toxicological data and determine the treatments for each strain and species to be used in the 2-year toxicology/carcinogenesis study STUDY #1: TITLE: Standard Toxicology and Carcinogenesis Studies DESCRIPTION: Analysis of rats and mice of both sexes exposed to concentrations of fullerene-C60 for a period of 13 weeks. DESIGN: exposure; time course; compound based treatment FACTORS: duration of exposure; dose; compound; strain; sex ASSAYS: ASSAY MEASUREMENTS: body weight ASSAY TECHNOLOGY TYPE: PROTOCOLS: PROTOCOL NAME: 13-Week Toxicity Study PROTOCOL PARAMETERS: duration of exposure; compound; dose; route of exposure; strain; sex; diet; cage group; sacrifice method

DRAFT Investigation and Studies (2 of 2) STUDY #2: TITLE: Genetic Toxicology Study DESCRIPTION: Analysis of the frequency of micronucleated erythrocytes in rats and mice of both sexes exposed to concentrations of fullerene-C60 for a period of 13 week as an in vivo measure of genotoxic potential DESIGN: exposure; time course; compound based treatment FACTORS: duration of exposure; dose; compound; strain; sex ASSAYS: ASSAY MEASUREMENTS: total MN cells, percent PCD, MC cells per 1000 ASSAY TECHNOLOGY TYPE: PROTOCOLS: PROTOCOL NAME: 13-Week Toxicity Study PROTOCOL PARAMETERS: duration of exposure; compound; dose; route of exposure; strain; sex; diet; cage group; sacrifice method

DRAFT NTP Investigation File (1 of 3)

DRAFT NTP Investigation File (2 of 3)

DRAFT NTP Investigation File (3 of 3)

Study Samples Nanomaterial SOURCE: SAMPLE NAME: MATERIAL TYPE: fullerene CHARACTERISTICS: description: fullerene C-60 number of carbons: 60 Diameter (?): 1 micron; 50 nanometers Biological Material SOURCE: B6C ; Wistar ; (Animal ID ) SAMPLE NAME: B6C ; Wistar ; (Animal ID ) MATERIAL TYPE: whole organism CHARACTERISTICS organism: mice; rats strain: B6C3F1; Wistar Han sex: male; female PROTOCOL REF PARAMETER VALUE compound: duration of exposure: 90 days FACTOR VALUE dose: vehicle control; 0.5; 2.0 unit: mg/m3

Study-Sample Files - Material

Study-Sample Files - Animals (1 of 2)

Study-Sample Files- Animals (2 of 2)

Standard Toxicology & Carcinogenesis Studies

Study Search Criteria

Body Weight Results

Body Weight Assay File (1 of 2)

Body Weight Assay File (2 of 2)

Micronucleus Study

Micronucleus Study Search

Summary Results

Detailed Results

Individual Animal Data

Micronucleus Assay File TBD

Agenda Review NTP Study and Example Files Follow-up on Actions Review Project Status and Discuss Next Steps

Follow-up on Actions ActionAssigned To Draft example files for the NTP dataSharon Gaheen Identify top ten (10) nanotechnology assays leveraging ASTM protocolsStacey Harper Marty Fritts Continue to update nano-TAB filesSharon Gaheen Stacey Harper Continue to update the NPO in support of nano-TAB termsDennis Thomas

Agenda Review NTP Study and Example Files Follow-up on Actions Review Project Status and Discuss Next Steps

Project Status

Next Steps Continue review/update of nano-TAB files Update files based on feedback from the 6/11 ISA-TAB discussion Create assay files for prioritized ASTM assays Continue drafting assays files for NTP nanomaterial studies and review with the NTP Continue collaborations with the ISA-TAB organization Schedule next meeting for early June (est. June 11) Obtain overview of ISA-TAB tools Continue updating NPO in support of nano-TAB ontology needs Begin drafting nano-TAB specification ( Specification Summary – Sharon Gaheen Section 1: Introduction – Stacey Harper Section 2: nano-TAB Structure – Sharon Gaheen, Stacey Harper, and Raul Cachua (Structures) Section 3: Relationships to Standards – Dennis Thomas, Nathan Baker (ASTM) Section 4: nano-TAB Details - Sharon Gaheen, Stacey Harper, Dennis Thomas, and Raul Cachua (Structures) Section 5: References – TBD Document Review – All Team Members Review/update nano-TAB timeline Next meeting: Tuesday, June 15, 11:00-12:00

References Nano-TAB &language_id=1http://gforge.nci.nih.gov/docman/index.php?group_id=69&selected_doc_group_id= 5653&language_id=1 LS DAM Nano Subdomain DAM%20R1_2.EAP?root=lsdamhttps://gforge.nci.nih.gov/plugins/scmsvn/viewcvs.php/*checkout*/requirements/LS DAM%20R1_2.EAP?root=lsdam caBIG ICR Nano Data Standards Document standards/data-sharing-standardshttp://sites.google.com/site/cabignanowg/data-sharing-and-nanotechnology- standards/data-sharing-standards MAGE-TAB ISA-TAB