National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/40238

Past Test Method Nominations and Submissions to ICCVAM

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List of Nominations

Nominator Nominated Test Method Activity Activity
Status
Additional
Materials
NIOSH/CDC Nomination of the Electrophilic Allergic Screening Assay for the Detection of Substances Causing Allergic Contact Dermatitis
View Nomination Cover Letter
Validation study to begin April 2017 NICEATM Preliminary Evaluation (July 2012)
BioSentinel Pharmaceuticals Submission of the BoTest™, BoTest™ Matrix, and BoCell™ Botulinum Neurotoxin Activity assays for interlaboratory validation studies by ICCVAM and NICEATM.
View Nomination Cover Letter
Final ICCVAM priority: high

In conjunction with a review of other botulinum toxin test methods
-
MB Research Labs Nomination of the In Vitro Sensitivity Assay for Detection of Substances That Cause Dermal Sensitization
View nomination letter
Evaluation suspended View March 2013 letter to test method sponsor
Biotest AG Nomination of an in vitro test method for assessing pyrogenicity of pharmaceuticals and other products for further evaluation in order to expand its applicability domain to non-endotoxin pyrogens
View Nomination Cover Letter
Evaluation completed FDA Document:
"Guidance for Industry — Pyrogen and Endotoxins Testing: Questions and Answers"
CPSC CPSC Nomination : Request for Assessment of the Validation of the Local Lymph Node Assay for Classification of Sensitizers Evaluation Completed -
View Summaries of Evaluations
List of References
HSUS Alternative Methods to Replace the Mouse LD50 Assay for Botulinum Toxin Potency Testing

View HSUS Letter to Allergan, Inc.(Dec. 15, 2005)
Workshop Completed Workshop Report
CertiChem, Inc MCF-7 Estrogenic Activity Cell Proliferation Assay
View Nomination Cover Letter
View Documentation Provided with Nomination
Validation Study and Evaluation Completed Draft Validation Study Report
Xenobiotic Detection Systems LUMI-CELLTM Estrogen Receptor High-Throughput System for Screening Estrogen-Like Chemicals for Validation Studies
View Nomination Cover Letter
View Documentation Provided with Nomination
Validation Study and Evaluation Completed Test Method Evaluation Report
(Redacted at nominator's request) NTP Two-Year Toxicology and Carcinogenesis Rodent Studies(received Oct. 24, 2007)

Additional nominating material (received May 13, 2008)
Under Consideration Draft ICCVAM Recommended Priority

List of Submissions

Sponsor Test Method Evaluation
Status
Additional
Materials
Alternatives Testing Steering Committee:
Johnson Diversey
S.C. Johnson & Son, Inc.
The Procter & Gamble Company
The Accord Group
In Vitro Test Method for Assessment of the Eye Irritation Potential of Antimicrobial Cleaning Products

View Submission Cover Letter from IIVS, Inc.
Evaluation Completed ICCVAM Test Method Evaluation Report
ECVAM In Vitro Pyrogenicity Test Methods Peer Review Complete Pyrogenicity Test Methods
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