Non-animal approaches for consumer safety risk assessments: Unilever's scientific research programme

Alternatives to Laboratory Animals

Volumn 37, Issue 6, 2009, Pages 595-610

  Carmichael, Paul ^a   Davies, Michael ^a   Dent, Matt ^a   Fentem, Julia ^a   Fletcher, Samantha ^a   Gilmour, Nicola ^a   MacKay, Cameron ^a   Maxwell, Gavin ^a   Merolla, Leona ^a   Pease, Camilla ^a   Reynolds, Fiona ^a   Westmoreland, Carl ^a  

^a UNILEVER RESEARCH   (United Kingdom)

Author keywords

Cancer; Repeat dose toxicity; Risk assessment; Skin allergy

Indexed keywords

ARTICLE; CONSUMER; INHALATION; NEOPLASM; PRIORITY JOURNAL; RESEARCH; RISK ASSESSMENT; SAFETY; SCIENTIFIC LITERATURE; SKIN ALLERGY; SKIN IRRITATION; SKIN SENSITIZATION; TOXICITY TESTING;

ANIMALIA;

EID: 77749277515     PISSN: 02611929     EISSN: None     Source Type: Journal    
DOI: 10.1177/026119290903700605     Document Type: Article

References (73)

1. Fentem, J., Carmichael, P., Maxwell, G., Pease, C., Reynolds, F., Warner, G. & Westmoreland, C. (2008). Exploring new approaches to assess safety without animal testing. AATEX 14, 15-20.
2. Fentem, J. & Westmoreland, C. (2007). Risk Assessment & New Technologies: Opportunities to Assure Safety Without Animal Testing and Better Protect Public Health? Available at: http://www.alttox.org/ttrc/overarching- challenges/way-forward/fentem-westmoreland/ (Accessed 01.11.09).
3. US National Research Council (2007). Toxicity Testing in the 21st Century: A Vision and a Strategy, 216pp. Washington, DC, USA: The National Academies Press.
4. Fentem, J., Chamberlain, M. & Sangster, B. (2004). The feasibility of replacing animal testing for assessing consumer safety: a suggested future direction. ATLA 32, 617-623.
5. Maxwell, G., Aleksic, M., Aptula, A., Carmichael, P., Fentem, J., Gilmour, N., MacKay, C., Pease, C., Pendlington, R., Reynolds, F., Scott, D., Warner, G. & Westmoreland, C. (2008). Assuring consumer safety without animal testing: A feasibility case study for skin sensitisation. ATLA 36, 557-568.
6. Smith, C.K. & Hotchkiss, S.A. (2001). Allergic Contact Dermatitis, pp. 1-16. London, UK: Taylor & Francis.
7. Felter, S.P., Ryan, C.A., Basketter, D.A., Gilmour, N.J. & Gerberick, G.F. (2003). Application of the risk assessment paradigm to the induction of allergic contact dermatitis. Regulatory Toxicology & Pharmacology 37, 1-10.
8. OECD (2002). OECD Guideline for the Testing of Chemicals. No. 429. Skin Sensitisation: Local Lymph Node Assay, 7pp. Paris, France: Organisation for Economic Co-operation and Development. Available at: http://puck. sourceoecd.org/vl=4494207/cl=19/nw=l/rpsv/cw/vhosts/oecdjournals/1607310x/v1n4/ contp1-1.htm (Accessed 09.12.09).
9. Safford, R.J. (2008). The Dermal Sensitisation Threshold - a TTC approach for allergic contact dermatitis. Regulatory Toxicology & Pharmacology 51, 195-200.
10. Basketter, D., Pease, C., Kasting, G., Kimber, I., Casati, S., Cronin, M., Diembeck, W., Gerberick, F., Hadgraft, J., Hartung, T., Marty, J.P., Nikolaidis, E., Patlewicz, G., Roberts, D., Roggen, E., Rovida, C. & van de Sandt, J. (2007). Skin sensitisation and epidermal disposition: The relevance of epidermal disposition for sensitisation hazard identification and risk assessment. The report and recommendations of ECVAM Workshop 59. ATLA 35, 137-154.
11. Pendlington, R.U., Minter, H.J., Stupart, L., MacKay, C., Roper, C.S., Sanders, D.J. & Pease, C.K. (2008). Development of a modified in vitro skin absorption method to study the epidermal/dermal disposition of a contact allergen in human skin. Cutaneous & Ocular Toxicology 27, 283-294.
12. Aeby, P., Ashikaga, T., Diembeck, W., Estrich, D., Gerberick, F., Kimber, I., Marrec-Fairley, M., Maxwell, G., Ovigne, J.M., Sakaguchi, H., Tailhardat, M. & Tessier, S. (2008). The COLIPA strategy for the development of in vitro alternatives: Skin sensitisation. AATEX 14, 375-379.
13. Nitsche, J.M. & Kasting, G.B. (2008). Biophysical models for skin transport and absorption. In Dermal Absorption and Toxicity Assessment (ed. M.S. Roberts & K.A. Walters), pp. 251-269. New York, NY, USA: Informa Healthcare.
14. Maxwell, G. & MacKay, C. (2008). Application of a systems biology approach to skin allergy risk assessment. ATLA 36, 521-556.
15. Divkovic, M., Pease, C.K., Gerberick, G.F. & Basketter, D.A. (2005). Hapten protein binding: from theory to practical application in the in vitro prediction of skin sensitisation. Contact Dermatitis 54, 73-74.
16. Gerberick, G.F., Vassallo, J.D., Foertsch, L.M., Price, B.B., Chaney, J.G. & Lepoittevin, J.P. (2007). Quantification of chemical peptide reactivity for screening contact allergens: A classification tree model approach. Toxicological Sciences 97, 417-427.
17. Natsch, A., Gfeller, H., Rothaupt, M. & Ellis, G. (2007). Utility and limitations of a peptide reactivity assay to predict fragrance allergens in vitro. Toxicology in Vitro 21, 1220-1226.
18. Kato, H., Okamoto, M., Yamashita, K., Nakamura, Y., Fukumori, Y., Nakai, K. & Kaneko, H. (2003). Peptide-binding assessment using mass spectrometry as a new screening method for skin sensitization. Journal of Toxicological Sciences 28, 19-24.
19. Aleksic, M., Thain, E., Roger, D., Saib, O., Davies, M., Li, J., Aptula, A. & Zazzeroni, R. (2009). Reactivity profiling: Covalent modification of single nucleophile peptides for skin sensitization risk assessment. Toxicological Sciences 108, 401-411.
20. Aptula, N., Roberts, D.W., Schultz, T.W. & Pease, C. (2007). Reactivity assays for non-animal based prediction of skin sensitisation potential. Toxicology 231, 117-118.
21. Jowsey, I.R., Basketter, D.A., Westmoreland, C. & Kimber, I. (2006). A future approach to measuring relative skin sensitising potency: a proposal. Journal of Applied Toxicology 26, 341-350.
22. Flynn, T.J. & Ferguson, M.S. (2008). Multiendpoint mechanistic profiling of hepatotoxicants in HepG2/C3A human hepatoma cells and novel statistical approaches for development of a prediction model for acute hepatotoxicity. Toxicology in Vitro 22, 1618-1631.
23. Natsch, A., Emter, R. & Ellis, G. (2009). Filling the concept with data: integrating data from different in vitro and in silico assays on skin sensitizers to explore the battery approach for animal-free skin sensitization testing. Toxicological Sciences 107, 106-121.
24. Roberts, D.W. & Williams, D.L. (1982). The derivation of quantitative correlations between skin sensitisation and physiochemical parameters for alkylating agents, and their application to experimental data for sultones. Journal of Theoretical Biology 99, 807-825.
25. Maxwell, G. & MacKay, C. (2008). Application of a systems biology approach for skin allergy risk assessment. AATEX 14, 381-388.
26. Dearman, R.J., Wright, Z.M., Basketter, D.A., Ryan, C.A., Gerberick, G.F. & Kimber, I. (2001). The suitability of hexyl cinnamic aldehyde as a calibrant for the murine local lymph node assay. Contact Dermatitis 44, 357-361.
27. Basketter, D.A. & Cadby, P. (2004). Reproducible prediction of contact allergenic potency using the local lymph node assay. Contact Dermatitis 50, 15-27.
28. Basketter, D.A., McFadden, J.F., Gerberick, F., Cockshott, A. & Kimber, I. (2009). Nothing is perfect, not even the local lymph node assay: a commentary and the implications for REACH. Contact Dermatitis 60, 65-69.
29. Kennedy, M.C. (2009). Bayesian modelling of long-term dietary intakes from multiple sources. Food & Chemical Toxicology, 9 October 2009. [E-pub ahead of print].
30. Gerberick, G.F., Ryan, C.A., Kern, P.S., Schlatter, H., Dearman, R.J., Kimber, I., Patlewicz, G.Y. & Basketter, D.A. (2005). Compilation of historical local lymph node assay data for evaluation of skin sensitization alternative methods. Dermatitis 16, 157-202.
31. Basketter, D.A., Blaikie, L., Dearman, R.J., Kimber, I., Ryan, C., Gerberick, G.F., Harvey, P., Evans, P., White, I.R. & Rycroft, J.G. (2000). Use of the local lymph node assay for the estimation of relative contact allergenic potency. Contact Dermatitis 42, 344-348.
32. Basketter, D.A., Clapp, C., Jefferies, D., Safford, B., Ryan, C.A., Gerberick, G.F., Dearman, R.J. & Kimber, I. (2005). Predictive identification of human skin sensitisation thresholds. Contact Dermatitis 53, 260-267.
33. Basketter, D.A. & Kimber, I. (2007). Information derived from sensitisation test methods: test sensitivity, false positives and false negatives. Contact Dermatitis 56, 1-4.
34. Basketter, D.A., McFadden, J., Evans, P., Andersen, K.E. & Jowsey, I. (2006). Identification and classification of skin sensitisers: Identifying false positive and false negatives. Contact Dermatitis 55, 268-273.
35. Wilkinson, J.D., Shaw, S., Andersen, K.E., Brandao, F.M., Bruynzeel, D.P., Bruze, M., Camarasa, J.M., Diepgen, T.L., Ducombs, G., Frosch, P.J., Goossens, A., Lachappelle, J.M., Lahti, A., Menné, T., Seidenari, S., Tosti, A. & Wahlberg, J.E. (2002). Monitoring levels of preservative sensitivity in Europe: A 10-year overview (1991-2000). Contact Dermatitis 46, 207-210.
36. Schuch, A., Uter, W., Geier, J., Lessmann, H. & Frosch, P.J. (2007). Sensitisation to 26 fragrances to be labeled according to current European regulation. Contact Dermatitis 57, 1-10.
37. Jowsey, I.R. (2007). Proactive surveillance of contact allergies: an important component of the risk management strategy for skin sensitizers. Contact Dermatitis 56, 305-310.
38. Schnuch, A., Geier, J., Uter, W., Basketter, D.A. & Jowsey, I.R. (2007). The biocide polyhexamethylene biguanide remains an uncommon contact allergen. Contact Dermatitis 56, 235-239.
39. Tweats, D.J., Scott, A.D., Westmoreland, C. & Carmichael, P.L. (2007). Determination of genetic toxicology and potential carcinogenicity in vitro - challenges post the Seventh Amendment to the European Cosmetics Directive. Mutagenesis 22, 5-13.
40. Kirkland, D.J., Aardema, M., Banduhn, N., Carmichael, P., Fautz, R., Meunier, J.R. & Pfuhler, S. (2007). In vitro approaches to develop weight-of-evidence (WoE) and mode of action (MoA) discussions with positive in vitro genotoxicty results. Mutagenesis 22, 161-175.
41. Carmichael, P., Aardema, M., Diembeck, W., Fautz, R., Harvey, J., Hewitt, M., Latil, A., Marrec-Fairley, M., Pfuhler, S., Quedraogo, G. & Reisinger, K. (2009). The COLIPA strategy for animal-free genotoxicity testing. ALTEX 26, 150.
42. Fowler, P., Williams, K., Jeffrey, L., Young, J., Carmichael, P., Aardema, M., Diembeck, W., Fautz, R., Harvey, J., Hewitt, N.J., Latil, A., Pfuhler, S., Quedraogo, G., Reisinger, K., Marrec-Fairley, M. & Kirkland, D. (2009). Reduction of misleading ("false") positive results in mammalian cell genotoxicity assays. I: Choice of cell type. ALTEX 26, 190.
43. Williams, K., Fowler, P., Jeffrey, L., Young, J., Carmichael, P., Aardema, M., Diembeck, W., Fautz, R., Harvey, J., Hewitt., N.J., Latil, A., Pfuhler, S., Quedraogo, G., Reisinger, K., Marrec-Fairley, M. & Kirkland, D. (2009). Reduction of misleading ("false") positive results in mammalian cell genotoxicity assays. II: Importance of accurate toxicity measurement. ALTEX 26, 189.
44. Scott, A., Malcomber, S., Maskell, S., Moore, C., Windebank, S., Diaz, D. & Carmichael, P. (2007). An assessment of the performance of an automated scoring system (Cellomics) for the in vitro micronucleus assay in CHO-K1 cells. Toxicology 231, 111-112.
45. Windebank, S., Malcomber, S., Maskell, S., Scott, A. & Carmichael, P. (2006). Validation of a high-throughput bacterial screen for mutagenicity: Incorporation of Salmonella typhimurium strain TA102. [Proceedings of the British Toxicological Society & United Kingdom Environmental Mutagen Society Congress, Warwick, UK]. Toxicology 226, 72-73.
46. Kirsch-Volders, M., Gonzalez, L., Carmichael, P. & Kirkland, D. (2009). Risk assessment of genotoxic mutagens with thresholds: A brief introduction. Mutation Research 678, 72-75.
47. Carmichael, P., Kirsch-Volders, M. & Vrijhof, H. (2009). Thresholds for genotoxins and their application in risk assessment. Mutation Research 678, 71.
48. Maskell, S., Malcomber, S., Windebank, S., Carmichael, P. & Scott, A. (2006). Development of a human keratinocyte cell line that is up-regulated for the expression of Superoxide Dismutase 1 (SOD1). [Proceedings of the British Toxicological Society & United Kingdom Environmental Mutagen Society Congress, Warwick, UK]. Toxicology, 226, 74-75.
49. Pant, K., Sly, J.E., Bruce, S.W., Leung, C. & San, R.H. (2008). Syrian hamster embryo (SHE) cell transformation assay with conditioned media (without X-ray irradiated feeder layer) using 2,4-diaminotoluene, 2,6-diaminotoluene and chloral hydrate. Mutation Research 654, 108-113.
50. Walsh, M.J., Bruce, S.W., Pant, K., Carmichael, P.L., Scott, A.D. & Martin, F.L. (2009). Discrimination of a transformed phenotype in Syrian golden hamster embryo (SHE) cells using ATR-FTIR spectroscopy. Toxicology 258, 33-38.
51. Titman, C.M., Downs, J.A., Oliver, S.G., Carmichael, P.L., Scott, A.D. & Griffin, J.L. (2009). A metabolomic and multivariate statistical process to assess the effects of genotoxins in Saccharomyces cerevisiae. Molecular BioSystems 5, 1913-1924.
52. Billinton, N., Hastwell, P.W., Beerens, D., Birrell, L., Ellis, P., Maskell, S., Webster, T.W., Windebank, S., Woestenborghs, F., Lynch, A.M., Scott, A.D., Tweats, D.J., van Gompel, J., Rees, R.W. & Walmsley, R.M. (2008). Inter-laboratory assessment of the Green-Screen HC GADD45a-GFP genotoxicity screening assay: An enabling study for independent validation as an alternative method. Mutation Research 653, 23-33.
53. Knight, A.W., Billinton, N., Cahill, P.A., Scott, A., Harvey, J.S., Roberts, K.J., Tweats, D.J., Keenan, P.O. & Walmsley, R.M. (2007). An analysis of results from 305 compounds tested with the yeast RAD54-GFP genotoxicity assay (GreenScreen GC) - including relative predictivity of regulatory tests and rodent carcinogenesis and performance with autofluorescent and coloured compounds. Mutagenesis 22, 409-416.
54. Billinton, N., Beerens, D., Birrell, L., van Gompel, J., Hastwell, P.W., Rees, R., Scott, A., Walmsley, R.M., Webster, T.W., Windebank, S. & Woestenborghs, F. (2006). An international, 4 laboratory assessment of the robustness and reproducibility of the GADD45a genotoxicity assay, GreenScreenHC. Environmental & Molecular Mutagenesis 47, 434.
55. Whitworth, T., Scott, A. & Walmsley, R.M. (2006). Further development of a yeast genotoxicity assay to improve the spectrum of compound detection. Environmental & Molecular Mutagenesis 47, 471.
56. Vinken, M., Doktorova, T., Ellinger-Ziegelbauer, H., Ahr, H.J., Lock, E., Carmichael, P., Roggen, E., van Delft, J., Kleinjans, J., Castell, J., Bort, R., Donato, T., Ryan, M., Corvi, R., Keun, H., Ebbels, T., Athersuch, T., Sansone, S.A., Rocca-Serra, P., Stierum, R., Jennings, P., Pfaller, W., Gmuender, H., Vanhaecke, T. & Rogiers, V. (2008). The carcinoGENOMICS project: Critical selection of model compounds for the development of omics-based in vitro carcinogenicity screening assays. Mutation Research 659, 202-210.
57. Ellinger-Ziegelbauer, H., Fostel, J.M., Aruga, C., Bauer, D., Boitier, E., Deng, S., Dickinson, D., Le Fevre, A.C., Fornace, Jr, A.J., Grenet, O., Gu, Y., Hoflack, J.C., Shiiyama, M., Smith, R., Snyder, R.D., Spire, C., Tanaka, G. & Aubrecht, J. (2009). Characterization and interlaboratory comparison of a gene expression signature for differentiating genotoxic mechanisms. Toxicological Sciences 110, 341-352.
58. Quirós, L., Svensson, P., Wang, E., Fry, R. & Samson, L. (2008). Analysing genetic interactions to elucidate DNA damage responsive networks and toxicity mechanisms of environmental agents in yeast. [Abstract: Environmental Mutagen Society Conference, Puerto Rico.] Environmental & Molecular Mutagenesis 49, 578.
59. Shannon, P., Markiel, A., Ozier, O., Baliga, N.S., Wang, J.T., Ramage, D., Amin, N., Schwikowski, B. & Ideker, T. (2003). Cytoscape: a software environment for integrated models of biomolecular interaction networks. Genome Research 13, 2498-2504.
60. White, A., Donaldson, K., Gaiser, B., Daly, P., BéruBé, K., Hughes, T., Merolla, L., Carthew, P., Adeleye, Y. & Fletcher, S. (2009). A mechanistic comparison of in vitro and in vivo studies of lung toxicity using transcriptomic analysis. ALTEX 26, 74.
61. Carthew, P., Fletcher, S., White, A., Harries, H. & Weber, K. (2006). Transcriptomic and histopathology changes in rat lung after intratracheal instillation of polymers. Inhalation Toxicology 18, 227-245.
62. Grainger, C.I., Greenwell, L.L., Martin, G.P. & Forbes, B. (2009). Hydrophilic solute permeability following particle delivery to air-interfaced airway cells that model the respiratory mucosa. European Journal of Pharmaceutics & Biopharmaceutics, in press.
63. Grainger, C.I., Greenwell, L.L., Martin, G.P. & Forbes, B. (2009). The permeability of large molecular weight solutes following particle delivery to air-interfaced cells that model the respiratory mucosa. European Journal of Pharmaceutics & Biopharmaceutics 71, 318-324.
64. Grainger, C.I., Greenwell, L.L., Lockley, D.J., Martin, G.P. & Forbes, B. (2006). Culture of Calu-3 cells at the air interface provides a representative model of the airway epithelial barrier. Pharmaceutical Research 23, 1482-1490.
65. Hughes, T.G. (2009). The Use of In Vitro Human Tissue Equivalents of Respiratory Epithelia for Toxicological Applications [PhD Thesis], pp. 75-139. Cardiff, Wales: Cardiff University.
66. BéruBé, K., Aufderheide, M., Breheny, D., Clothier, R., Combes, R., Duffin, R., Forbes, B., Gaça, M., Gray, A., Hall, I., Kelly, M., Lethem, M., Liebsch, M., Merolla, L., Morin, J-P., Seagrave, J., Swartz, M., Tetley, T. & Umachandran, M. (2009). In vitro models of inhalation toxicity and disease: The report of a FRAME workshop. ATLA 37, 89-141.
67. Kimber, I., Agius, R., Basketter, D.A., Corsini, E., Cullinan, P., Dearman, R.J., Gimenez-Arnau, E., Greenwell, L., Hartung, T., Kuper, F., Maestrelli, P., Roggen, E. & Rovida, C. (2007). Chemical respiratory allergy: Opportunities for hazard identification and characterisation. The report and recommendations of ECVAM Workshop 60. ATLA 35, 243-265.
68. Carthew, P., Clapp, C. & Gutsell, S. (2009). Exposure-based waiving: The application of the toxicological threshold of concern (TTC) to inhalation exposure for aerosol ingredients in consumer products. Food & Chemical Toxicology 47, 1287-1295.
69. EPAA (2008). New Perspectives on Safety: Workshop Report, 16pp. Brussels, Belgium: The European Partnership for Alternative Approaches to Animal Testing. Available at: http://ec.europa.eu/enterprise/epaa/3-activities/3-3- research/new-perspectives.pdf (Accessed 10.12.09).
70. European Commission (2009). Call for proposals under the 2009 and 2010 work programmes of the 7th EC Framework Programme for Research, Technological Development and Demonstration Activities 2009/C 177/06: FP7-HEALTH-2010- Alternative-Testing. Official Journal of the European Union 52, 16.
71. Creton, S., Billington, R., Davies, W., Dent, M., Hawksworth, G., Parry, S. & Travis, K. (2009). Application of toxicokinetics to improve chemical risk assessment: Implications for the use of animals. Regulatory Toxicology & Pharmacology 55, 291-299.
72. Westmoreland, C. & Holmes, A.M. (2009). Assuring consumer safety without animals: Applications for tissue engineering. Organogenesis 5, 67-72.
73. EPAA (undated). Activities: Validation and Acceptance. Brussels, Belgium: The European Partnership for Alternative Approaches to Animal Testing. Available at: http://ec.europa.eu/enterprise/epaa/3-6-validation.htm (Accessed 10.12.09).