What I do

With a background in environmental toxicology, I decipher the intricate dance of molecules. I've served various teams and learned much about the rapidly evolving regulatory landscape. I understand the need to innovate and deliver safe and compliant products is complex and essential for brand trust, regulatory approval, and the environment.

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• TSCA Registration support: Interface with the EPA to address concerns and work with the business to resolve issues or concerns; develop testing strategies if the EPA requests additional tox data or needs to determine relevance to humans.

• Participate in consortia: Collaborate with internal/external tox colleagues with diverse expertise to recommend additional tox testing to ensure commercial success.

• Business R&D: Determine potential hazards of new substances using computational models, read across to similar substances, or testing as needed.

• Safety Oversight: Provide toxicology-related expertise to resolve and determine complex GHS classifications based on available toxicology data,  provide up-to-date safety assessments for raw materials, ingredients, formulations and finished products, review/sign-off on safety reports.

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Qualifications:

• Excellent knowledge in human health and environmental risk assessment methodology, interpretation of human health toxicology and ecotoxicology studies

• Experience in GLP toxicity studies in both in-vitro and in-vivo animal models

• Knowledgeable in US (TSCA), Canada and global chemical management regulations (e.g., EU, China) and Fundamental understanding of requirements for biocompatibility and safety testing

• Experience conducting QSAR modeling, using industrial and consumer exposure models

• Experience collaborating with key cross-functional partners including Product Development, ESG, Regulatory, and Clinical Safety to provide safety-related support.

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Publications:

• C.R. Kirman, B.R. Sonawane, J.G. Seed, N.O. Azu, W.T. Barranco, W.R. Hamilton, T.J. Stedeford, S.M. Hays, An evaluation of reproductive toxicity studies and data interpretation of N- methyl pyrrolidone for risk assessment: An expert panel review, Regulatory Toxicology and Pharmacology, Volume 138, 2023, ISSN 0273-2300, https://doi.org/10.1016/j.yrtph.2023.105337 

• Nkem Azu, Anne Chappelle, Toluene diisocyanate, Reference Module in Biomedical Sciences, Elsevier, 2022, ISBN 9780128012383, https://doi.org/10.1016/B978-0-12-824315-2.00271-2.

• Nkem O. Azu, Diphenylmethane diisocyanate (MDI), 4,4′-, Reference Module in Biomedical Sciences, Elsevier, 2023, ISBN 9780128012383, https://doi.org/10.1016/B978-0-12-824315-2.00639-4.

• Nkem O. Azu, Tetrahydrofuran, Reference Module in Biomedical Sciences, Elsevier, 2022, ISBN 9780128012383, https://doi.org/10.1016/B978-0-12-824315-2.00249-9