United States regulatory requirements for skin and eye irritation testing

Author:

Choksi Neepa Y.1,Truax James1,Layton Adrienne2,Matheson Joanna3,Mattie David4,Varney Timothy5,Tao Jenny6,Yozzo Krystle6,McDougal Andrew J.7,Merrill Jill8,Lowther Donnie9,Barroso Joao10,Linke Brenda11,Casey Warren12,Allen David1

Affiliation:

1. Integrated Laboratory Systems, Inc, Morrisville, NC, USA;

2. Division of Pharmacology and Physiology Assessment, U.S. Consumer Product Safety Commission, Rockville, MD, USA;

3. U.S. Consumer Product Safety Commission, Rockville, MD, USA;

4. Bioeffects Division, Human Effectiveness Directorate, Air Force Research Laboratory, Wright-Patterson AFB, OH, USA;

5. Research Institute of Chemical Defense, U.S. Army, Aberdeen Proving Ground, MD, USA;

6. Office of Pesticide Programs, U.S. Environmental Protection Agency, Washington, DC, USA;

7. Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA;

8. Dermatologic and Dental Drug Products, U.S. Food and Drug Administration, Silver Spring, MD, USA;

9. Office of Cosmetics and Colors, U.S. Food and Drug Administration, University Station, MD, USA;

10. EU Reference Laboratory for Alternatives to Animal Testing, Institute for Health and Consumer Protection, Ispra, Italy;

11. Health Effects Division 1, Health Evaluation Directorate, Health Canada’s Pest Management Regulatory Agency, Ottawa, Canada;

12. National Toxicology Program, National Institutes of Environmental Health Sciences, Morrisville, NC, USA

Funder

National Institute of Environmental Health Sciences

National Institutes of Health

Publisher

Informa UK Limited

Subject

Toxicology,General Medicine

Reference76 articles.

1. U.S. Consumer Product Safety Commission. Definitions. 16 CFR 1500.3 (2015).

2. Improvement of the Bovine Corneal Opacity and Permeability (BCOP) assay as an in vitro alternative to the Draize rabbit eye irritation test

3. Retrospective analysis of the Draize test for serious eye damage/eye irritation: importance of understanding the in vivo endpoints under UN GHS/EU CLP for the development and evaluation of in vitro test methods

4. National Institute of Environmental Health Science. Strategic roadmap: New approaches to evaluate the safety of chemicals and medical products [Internet]. 2018. Available from: https://ntp.niehs.nih.gov/pubhealth/evalatm/natl-strategy/index.html [last accessed 8 Feb 2018].

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