Clive Roper

Clive Roper

Director and Founder

Expert Witness in Toxicology with 35 years in vitro toxicology experience focussed on dermal & respiratory in pharmaceuticals, chemicals, agrochemicals, & cosmetics. I have Expert Witness insurance.

Pharmaceutical Development & Clinical Research Toxicology CRO Oversight Regulatory Submissions
📅 35+ years experience 📍 Edinburgh, Scotland

About

In 1996, after academia (PhD and post doc), Clive joined CRL performing in vitro skin penetration studies, then promoted to Director, In Vitro Toxicology, led a diverse in vitro testing services portfolio. In 2021, Clive started Roper Toxicology Consulting working with SMEs and multinationals with NAMs across geographies and industries. Clive is Chairperson of PeptiMatrix, a board member of 3RsC, NC3Rs and VP ESTIV, a Fellow of Royal Society of Biology, and European Registered Toxicologist.

Director, Roper Toxicology Consulting Limited (03/2021-present) Chairperson of the Board of Directors, PeptiMatrix (07/2023-present) Director, In Vitro Toxicology (10/2010-02/2021), Charles River Laboratories Edinburgh Limited (CRL), Tranent, UK Scientific Manager (01/2003 to 08/2010), CRL Study Director (07/1997 to 12/2002), CRL Research Officer (06/1996-06/1997), CRL

Methodology & Approach

I learn about the scientific issues from both perspectives. I read the available regulatory data and then search for epidemiology and non-regulatory testing, e.g., from academic manuscripts. I identify the strengths and weaknesses of the data, usually with regulatory GLP scientific reports having the highest confidence and data from an academic researcher as much lower. I maintain an ongoing literature search to see if there is new data generated and published. I listen to and follow the instructions of the legal team.

Expert Witness Experience

The project that I was involved in was settled out of court. This was a pesticide which was excessively used by consumers. I reviewed the regulatory toxicology package and supporting data, especially regarding dermal absorption and genetic toxicology. I also performed a literature search for information on epidemiology and non-regulated testing.

Case Types

I provided toxicology support to the solicitors representing the company being sued. This did not go to court.

Notable Matters

I have only so far worked n one case which did not go to court.

Education & Credentials

Education

BSc (Hons), Agricultural Biochemistry and Nutrition, Newcastle University, 1990 PhD, In Vitro Skin Absorption and Toxicology, Newcastle University, 1994 Postdoctoral Researcher, Newcastle University, 1996

Certifications & Licenses

European Registered Toxicologist Chartered Scientist (CSci) Chartered Biologist (CBiol)

Publications & Media

Additional Credentials

Abdallah et al (2026). ESTIV early career network: A growing initiative to support the next generation of NAMs-oriented toxicologists. TIV 106216. doi: 10.1016/j.tiv.2026.106216. Willett et al. (2025). The Decision Tree approach as a strategy for the global phase out of animal testing for acute and local toxicity for chemicals: recommendations from an expert workshop. RTP. https://doi.org/10.1016/j.yrtph.2025.105969. Ouedraogo et al. (2025). A call to action: advancing new approach methodologies (NAMs) in regulatory toxicology through a unified framework for validation and acceptance. RTP. doi: 10.1016/j.yrtph.2025.105904. Courtot et al. (2025). Panel discussions on the global regulatory acceptance and harmonisation of non-animal NAMs. NAMJ. doi: https://doi.org/10.1016/j.namjnl.2025.100027. Ward et al. (2025). Predicting acute oral toxicity using AcutoX: An animal product-free and metabolically relevant human cell-based test. ALTEX 42(1):39-55. doi: 10.14573/altex.2311142. Haber et al. (2024). New approach methodologies (NAMs) for the in vitro assessment of cleaning products for respiratory irritation: workshop report. Front Tox 6:1431790. doi: 10.3389/ftox.2024.1431790. Sharma et al. (2024). Minimum information for reporting on the TEER (trans-epithelial/endothelial electrical resistance) assay (MIRTA). Arch Tox. https://doi.org/10.1007/s00204-024-03879-z. Ejaz et al. (2024). A comparative study of the in vitro dermal absorption of radiolabeled benzophenone through human skin. TIV 98: 105835. doi: 10.1016/j.tiv.2024.105835. Sewell et al. (2024). New approach methodologies (NAMs): identifying and overcoming hurdles to accelerated adoption. Tox Res 13(2), tfae044. https://doi.org/10.1093/toxres/tfae044. Kandárová et al. 2024). ESTIV 2022: Key enabling non-animal technologies for research, education and testing. TIV 105779. https://doi.org/10.1016/j.tiv.2024.105779. Brackin et al. (2024). Skin barrier function for regulatory skin absorption tests and effects on testosterone and sucrose absorption. TIV 95; 105735. https://doi.org/10.1016/j.tiv.2023.105735. Page et al. (2024). Assessment of the utility of the novel Phenion® full thickness human skin model for detecting the skin irritation potential of antimicrobial cleaning products. TIV 94, 105726, https://doi.org/10.1016/j.tiv.2023.105726. Belsey et al. (2023). Visualisation of drug distribution in skin using correlative optical spectroscopy and mass spectrometry imaging. JCR 364; 79-89. https://doi.org/10.1016/j.jconrel.2023.10.026. Roper CS and Neill DR. (2023). Transitioning acute in vitro inhalation toxicology testing to chronic and repeat dose testing; the challenge of mucus depletion in upper airway test systems and use of sputum mimics. OAJT 5(4); 555669. DOI: 10.19080/OAJT.2023.05.555669. Wallace et al. (2023). Evaluation of in vitro rat and human airway epithelial models for acute inhalation toxicity testing. Tox Sci 194 (2); 178‑190. https://doi.org/10.1093/toxsci/kfad058. Naik et al. (2023). Advances in Animal Models and Cutting-Edge Research in Alternatives: Proceedings of the Third International Conference on 3Rs Research and Progress, Vishakhapatnam, 2022. ATLA 51(4); 263-288. DOI: 10.1177/02611929231180428. Turner et al. (2024). Corrigendum to Incorporating new approach methodologies into regulatory nonclinical pharmaceutical safety assessment. ALTEX 41(4): 674-675. doi: 10.14573/altex.2408291. Erratum for: ALTEX 40(3); 519-533. Turner et al. (2023). Incorporating new approach methodologies into regulatory nonclinical pharmaceutical safety assessment. ALTEX 40(3); 519-533. doi:10.14573/altex.2212081. Kluxen et al. (2022). Characterizing local acute irritation properties of captan and folpet with new approach methods. AIVT 8 (3); 83-101. DOI: 10.1089/aivt.2022.0004. Roper et al. (2022). Case study on the use of an Integrated Approach for Testing and Assessment (IATA) for New Approach Methodology (NAM) for refining inhalation risk assessment from point of contact toxicity of the pesticide, chlorothalonil. ENV/CBC/MONO(2022)31. OECD Environment, Health and Safety Publications Series on Testing and Assessment No. 367. https://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/cbc/mono(2022)31&doclanguage=en. Hummer et al. (2022). Optimization of topical formulations using a combination of in vitro methods to quantify the transdermal passive diffusion of drugs. IJP. https://doi.org/10.1016/j.ijpharm.2022.121737. Welch et al. (2021). Evaluation of the toxicity of sodium dodecyl sulphate (SDS) in the MucilAir™ human airway model in vitro. RTP 125; 105022. https://doi.org/10.1016/j.yrtph.2021.105022. Singh et al. (2021). Towards more predictive, physiological and animal-free in vitro models: advances in cell and tissue Culture 2020 conference proceedings. ATLA 49 (3); 93-110. https://doi.org/10.1177/02611929211025006. Plaza et al. (2021). Support for regulatory assessment of percutaneous absorption of retronecine-type pyrrolizidine alkaloids through human skin. Support for regulatory assessment of percutaneous absorption of retronecine-type pyrrolizidine alkaloids through human skin. Planta Medica 88 (2); 144-151. DOI 10.1055/a-1505-8524. Clippinger et al. (2018). Pathway‑based predictive approaches for non-animal assessment of acute inhalation toxicity. TIV 52; 131–145. https://doi.org/10.1016/j.tiv.2018.06.009. Rothe et al. (2017). Application of in vitro skin penetration measurements to confirm and refine the quantitative skin sensitization risk assessment of methylisothiazolinone. RTP 91; 197‑207. http://dx.doi.org/10.1016/j.yrtph.2017.10.024. Mitra et al. (2016). Use of an in vitro human skin permeation assay to assess bioequivalence of two topical cream formulations containing butenafine hydrochloride (1%, w/w). RTP 82; 14‑19. http://dx.doi.org/10.1016/j.yrtph.2016.11.008. Alépée et al. (2016). Multi-laboratory evaluatation of SkinEthic HCE test method for testing serious eye damage/eye irritation using solid chemicals and overall performance of the test method with regard to solid and liquid chemicals testing. TIV 34; 35-70. http://dx.doi.org/10.1016/j.tiv.2016.02.014. Alépée et al. (2016). Multi-laboratory validation of SkinEthic HCE test method for testing serious eye damage/eye irritation using liquid chemicals. TIV 31; 43-53. http://dx.doi.org/10.1016/j.tiv.2015.11.012. Williams et al. (2016). Assessing the safety of cosmetic chemicals: consideration of a flux decision tree to predict dermally delivered systemic dose for comparison with oral TTC (threshold of toxicological concern). RTP 76; 174-186. http://dx.doi.org/10.1016/j.yrtph.2016.01.005. White et al. (2013). Corrigendum to “On the correlation between single-frequency impedance measurements and human skin permeability to water.”. TIV 25 (2011) 2095-2104]. TIV 27; 993. http://dx.doi.org/10.1016/j.tiv.2012.12.008. White et al. (2011). On the correlation between single-frequency impedance measurements and human skin permeability to water. TIV 25 (8); 2095-2104. doi:10.1016/j.tiv.2011.09.011. Davies et al. (2011). Determining epidermal disposition kinetics for use in an integrated nonanimal approach to skin sensitization risk assessment. Tox Sci 119 (2); 308–318. doi:10.1093/toxsci/kfq326. Meidan and Roper (2008). Inter- and intra-individual variability in human skin barrier function: a large scale retrospective study. TIV 22; 1062–1069. doi:10.1016/j.tiv.2008.01.009. Pendlington et al. (2008). Development of a modified in vitro skin absorption method to study the epidermal/dermal disposition of a contact allergen in human skin. COT 27(4); 238-294. http://dx.doi.org/10.1080/15569520802327005 Roper et al. (2006). Absorption of [14C]‑tetrabromodiphenyl ether (TeBDE) through human and rat skin in vitro. Drug Chem Tox 29 (3); 289-301. DOI: 10.1080/01480540600652954 Chilcott et al. (2005). Interlaboratory variation of in vitro diffusion cell measurements: An international multi-centre study using quasi-standardised methods and materials. J Pharm Sci 94 (3); 632‑638. doi: 10.1002/jps.20229. Jones et al. (2004). CEFIC Workshop on methods to determine dermal permeation for human risk assessment. Research Report TM/04/07 December 2004. http://www.iom-world.org/pubs/IOM_TM0407.pdf Roper et al. (1998). A comparison of the absorption of a series of ethoxylates through rat skin in vitro. TIV 12; 57‑65. Lockley et al. (1998). Use of in vitro systems with viable skin to investigate dermal exposure to glycol ethers. PPP, STS Publishing, Cardiff Ed Brain, James and Waters, Volume 5B; 117‑120. Roper et al. (1997). Percutaneous penetration of 2‑phenoxyethanol through rat and human skin. Food & Chem Tox 35 (10-11); 1009‑1016. doi: 10.1016/s0278-6915(97)00109-9. Roper et al. (1995). Prediction of the percutaneous penetration and metabolism of dodecyl decaethoxylate in rats using in vitro models. Arch Tox 69; 649‑654.​ doi: 10.1007/s002040050227.

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