A FRAME response to the European commission consultation on the draft report on alternative (nonanimal) methods for cosmetics testing: Current status and future prospects - 2010

Alternatives to Laboratory Animals

Volumn 38, Issue 5, 2010, Pages 345-353

  Balls, Michael ^a   Clothier, Richard ^a  

^a RUSSELL AND BURCH HOUSE   (United Kingdom)

Author keywords

Alternative methods; Animal tests; Carcinogenicity; Cosmetic ingredients; Cosmetics directive; In silico; In vitro; REACH system; Repeated dose testing; Reproductive toxicity; Skin sensitisation; Toxicokinetics

Indexed keywords

COSMETIC; HAIR DYE; SUNSCREEN;

ABSORPTION; ANIMAL EXPERIMENT; ANIMAL TESTING ALTERNATIVE; CARCINOGENICITY; CONSULTATION; EMBRYO; EUROPE; HEALTH HAZARD; HUMAN; HUMAN CELL; IN VITRO STUDY; METABOLISM; NONHUMAN; NOTE; ORGANIZATION; PATCH TEST; PRIORITY JOURNAL; REPRODUCTIVE TOXICITY; RISK ASSESSMENT; SAFETY; SKIN SENSITIZATION; SKIN TOXICITY; TOXICITY TESTING; TOXICOKINETICS; VALIDATION STUDY; ANIMAL; ARTICLE; DRUG EFFECT; METHODOLOGY; PHARMACOKINETICS; REPRODUCTION; SKIN;

ANIMALIA;

ANIMAL TESTING ALTERNATIVES; ANIMALS; COSMETICS; PHARMACOKINETICS; REPRODUCTION; SKIN;

EID: 79251473744     PISSN: 02611929     EISSN: None     Source Type: Journal    
DOI: 10.1177/026119291003800502     Document Type: Note

References (24)

1. Anon. (2004). Guidance Document on the Demarcation between the Cosmetic Products Directive 76/768 and the Medical Products Directive 2001/83 as agreed between the Commission Services and the Competent Authorities of the Member States. 11pp. Brussels, Belgium: European Commission.
2. OECD (2004). OECD Guidelines for the Testing of Chemicals. Section 4: Health Effects, No. 427. Skin Absorption: In Vivo Method, 8pp. Paris, France: OECD. Available at: http://titania.sourceoecd.org/vl=7565018/cl=29/nw=1/rpsv/cw/ vhosts/oecdjournals/1607310x/v1n4/contp1-1.htm (Accessed 30.09.10).
3. OECD (2004). OECD Guidelines for the Testing of Chemicals. Section 4: Health Effects, No. 428. Skin Absorption: In Vitro Method, 8pp. Paris, France: OECD. Available at: http://titania.sourceoecd.org/vl=7565018/cl=29/nw=1/rpsv/cw/ vhosts/oecdjournals/1607310x/v1n4/contp1-1.htm (Accessed 30.09.10).
4. Carmichael, P., Davies, M., Dent, M., Fentem, J., Fletcher, S., Gilmour, N., MacKay, C., Maxwell, G., Merolla, L., Pease, C., Reynolds, F. & Westmoreland, C. (2009). Non-animal approaches for consumer safety risk assessments: Unilever's scientific research programme. ATLA 37, 595-610.
5. Suuronen, E.J., Nakamura, M., Watsky, M.A., Stys, P.K., Muller, L.J., Munger, R., Shinozaki, N. & Griffith, M. (2004). Innervated human corneal equivalents as in vitro models for nerve-target cell interactions. FASEB Journal 18, 170-172.
6. Moore, P., Ogilvie, J., Horridge, E., Mellor, I.R. & Clothier, R.H. (2005). The development of an innervated epithelial barrier model using a human corneal cell line and ND7/23 sensory neurons. European Journal of Cell Biology 84, 581-592.
7. Clothier, R. & Sansom, R. (1996). Effects of surfactant retreatment in vitro: Changes in cell junctions and in cell viability. ATLA 24, 859-865.
8. Clothier, R.H., Beed, M., Sansom, R. & Ward, R. (1997). An in vitro approach to the evaluation of repeat exposure in the prediction of toxicity. Toxicology in Vitro 11, 679-682.
9. Gray, A.C., Malton, J. & Clothier, R.H. (2004). The development of a standardised protocol to measure squamous differentiation in stratified epithelia, by using the fluorescent cadaverine incorporation technique. ATLA 32, 91-100.
10. Gray, A.C., McLeod, J.C. & Clothier, R.H. (2007). A review of in vitro modelling approaches to the identification and modulation of squamous metaplasia in the human tracheobronchial epithelium. ATLA 35, 493-504.
11. Clothier, R.H. & Bourne, N. (2003). Effects of THz exposure on human primary keratinocyte differentiation and viability. Journal of Biological Physics 29, 179-185.
12. Ashikaga, T., Sakaguchi, H., Sono, S., Kosaka, N., Ishikawa, M., Nukada, Y., Miyazawa, M., Ito, Y., Nishiyama, N. & Itagaki, H. (2010). A comparative evaluation of in vitro skin sensitisation tests: The human cell-line activation test (h-CLAT) versus the local lymph node assay (LLNA). ATLA 38, 275-284.
13. Knight, A., Bailey, J. & Balcombe, J. (2006). Animal carcinogenicity studies: 1. Poor human predictivity. ATLA 34, 19-27.
14. Knight, A., Bailey, J. & Balcombe, J. (2006). Animal carcinogenicity studies: 2. Obstacles to extrapolation of data to humans. ATLA 34, 29-38.
15. OECD (2004). OECD Guidelines for the Testing of Chemicals. Section 4: Health Effects, No. 414. Prenatal Development Toxicity Study, 11pp. Paris, France: OECD. Available at: http://titania.sourceoecd. org/vl=7565018/cl=29/nw= 1/rpsv/cw/vhosts/oecdjournals/1607310x/v1n4/contp1-1.htm (Accessed 30.09.10).
16. West, P.R., Weir, A.M., Smith, A.M., Donley, E.L.R. & Cezar, G.G. (2010). Predicting human developmental toxicity of pharmaceuticals using human embryonic stem cells and metabolomics. Toxicology & Applied Pharmacology 247, 18-27.
17. Hartung, T. (2008). Toward a new toxicology - evolution or revolution. ATLA 36, 635-639.
18. Hartung, T. & Rovida, C. (2009). Chemical regulators have overreached. Nature, London 460, 1080-1081.
19. Spielmann, H. & Vogel, R. (2006). REACH testing requirements must not be driven by reproductive toxicity testing in animals. ATLA 34, 365-366.
20. Combes, R. (2007). Reproductive toxicity testing under the REACH System: Time for a paradigm shift. ATLA 35, 1-4.
21. Schaefer, C., Spielmann, H. & Vetter, K. (2006). Arzneiverordnung in Schwangerschaft und Stillzeit, 781pp. Jena, Germany: Urban & Fischer.
22. Bremer, S., Pellizzer, C., Hoffmann, S., Seidle, T. & Hartung, T. (2007). The development of new concepts for reproductive toxicity applicable to large scale programmes. Current Pharmaceutical Design 13, 3047-3058.
23. Bailey, J., Knight, A. & Balcombe, J. (2005). The future of teratology is in vitro. Biogenic Amines 19, 97-145.
24. Spielmann, H. (2009). The way forward in reproductive/development toxicity testing. ATLA 37, 641-656.