National Toxicology Program

National Toxicology Program
http://ntp.niehs.nih.gov/go/dev-nonanimal

Non-animal Methods and Strategies for Developmental Toxicity

Request for Data and Information on Zebrafish Embryo Screening

NICEATM requests available data and information on zebrafish embryo screening tests and protocol design, including pharmacokinetics measurements. Submitted information will be used to assess the state of the science and determine technical needs for non-animal test methods used to evaluate the potential of chemicals to induce developmental effects in offspring.

Respondents to this data request should provide information on any activities relevant to the development or validation of zebrafish embryo screening assays. NICEATM is particularly interested in how study design may influence measures of toxicity/bioactivity and the kinetics associated with chemical uptake. For comparative purposes, NICEATM also requests any available data from in vivo developmental studies using the same chemicals.

NICEATM specifically requests information on efforts to optimize zebrafish embryo screening tests and protocol design including comparisons of (1) zebrafish strains; (2) embryos with and without an intact chorion; and (3) static and static renewal exposures. NICEATM is also interested in developing a better understanding of pharmacokinetics in the zebrafish embryo model and requests available data on chemical uptake.

Respondents to this request for information should include their name, affiliation (if applicable), mailing address, telephone, email, and sponsoring organization (if any) with their communications.  The deadline for receipt of the requested information is December 30, 2016. Responses to this notice will be posted on this page, therefore no proprietary, classified, confidential, or sensitive information should be included in responses. View NTP guidelines for public comments.

Federal Register notice announcing data request (November 3, 2016) — View as a webpage

Comments Received
  • Jyotshna Kanungo, U.S. Food and Drug Administration
    Relevant references:
    • Guo X, Dumas M, Robinson BL, Ali SF, Paule MG, Gu Q, Kanungo J. 2016. Acetyl L-carnitine targets adenosine triphosphate synthase in protecting zebrafish embryos from toxicities induced by verapamil and ketamine: an in vivo assessment [published online ahead of print 18 May 2016]. J Appl Toxicol.
    • Trickler WJ, Guo X, Cuevas E, Ali SF, Paule MG, Kanungo J. 2014. Ketamine attenuates cytochrome p450 aromatase gene expression and estradiol-17-beta levels in zebrafish early life stages. J Appl Toxicol 35(5):480-8.
  • Josh Butler, ExxonMobil Biomedical Sciences
    Relevant references:
    • Butler JD, Parkerton TF, Letinski DJ, Bragin GE, Lampi MA, Cooper KR. 2013. A novel passive dosing system for determining the toxicity of phenanthrene to early life stages of zebrafish. Sci Total Environ 463-464:952-958.
    • Butler JD, Parkerton TF, Redman AD, Letinski DJ, Cooper KR. 2016. Assessing aromatic-hydrocarbon toxicity to fish early life stages using passive-dosing methods and target-lipid and chemical-activity models. Env Sci Toxicol 50:8305-8315.

Request for Data and Information on Technologies Used for Identifying Potential Developmental Toxicants

In June 2016, NICEATM requested available data and information on approaches and/or technologies currently used for identifying potential developmental toxicants.  Submitted information is being used to assess the state of the science and determine technical needs for non-animal test methods used to evaluate the potential of chemicals to induce adverse effects in offspring.

Guidelines for Submission of Developmental and Reproductive Toxicity Data

Developmental toxicity tests evaluate the extent to which exposure to a chemical can interfere with normal development. Testing for a chemical’s potential to cause developmental toxicity is required by multiple regulatory agencies and uses large numbers of animals. NICEATM supports efforts to develop, validate, and implement alternative approaches for identifying potential developmental toxicants. The goal of these alternative approaches is to replace, reduce, or refine the use of animals in testing.

Federal Register notice announcing data request (June 30, 2016) — View as a webpage

Comments Received
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.