-
1
-
-
84888447587
-
-
ICH Expert Working Group London, UK: European Medicines Agency. Available at: Accessed 25. 05.11
-
ICH Expert Working Group (2009). ICH Topic M3 (R2): Non-clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals, Step 4, June 2009, CPMP/ICH/286/95, 25pp. London, UK: European Medicines Agency. Available at: http://www.ema. europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/09/WC500002720. pdf (Accessed 25. 05.11).
-
(2009)
ICH Topic M3 (R2): Non-clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals, Step 4, June 2009, CPMP/ICH/286/95
, pp. 25
-
-
-
2
-
-
0142177156
-
Directive 2003/15/EC of the European Parliament and of the Council of 27 February 2003 amending Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products
-
Anon. Text with EEA relevance 11.3.2003
-
Anon. (2003). Directive 2003/15/EC of the European Parliament and of the Council of 27 February 2003 amending Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products. (Text with EEA relevance.) Official Journal of the European Union L66, 11.3.2003, 26-35.
-
(2003)
Official Journal of the European Union
, vol.L66
, pp. 26-35
-
-
-
3
-
-
51849127476
-
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and
-
Anon. 30.12.2006
-
Anon. (2006). Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC. Official Journal of the European Union L396, 30.12.2006, 1-849.
-
(2006)
Official Journal of the European Union
, vol.L396
, pp. 1-849
-
-
-
4
-
-
77952881274
-
Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC
-
Anon. 24.11.2009
-
Anon. (2009). Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. Official Journal of the European Union L309, 24.11.2009, 1-50.
-
(2009)
Official Journal of the European Union
, vol.L309
, pp. 1-50
-
-
-
5
-
-
77955168444
-
Cross-sector review of drivers and available 3Rs approaches for acute systemic toxicity testing
-
Seidle, T., Robinson, S., Holmes, T., Creton, S., Prieto, P., Scheel, J. & Chlebus, M. (2010). Cross-sector review of drivers and available 3Rs approaches for acute systemic toxicity testing. Toxicological Sciences 116, 382-396.
-
(2010)
Toxicological Sciences
, vol.116
, pp. 382-396
-
-
Seidle, T.1
Robinson, S.2
Holmes, T.3
Creton, S.4
Prieto, P.5
Scheel, J.6
Chlebus, M.7
-
6
-
-
24944532948
-
-
Geneva, Switzerland: United Nations Economic Commission for Europe. Available at: Accessed 25.05.11
-
United Nations (2009). Globally Harmonized System of Classification and Labelling of Chemicals (GHS): Third revised edition. Geneva, Switzerland: United Nations Economic Commission for Europe. Available at: http://live.unece.org/ trans/danger/publi/ghs/ghs-rev03/03files-e.html (Accessed 25.05.11).
-
(2009)
Globally Harmonized System of Classification and Labelling of Chemicals (GHS): Third Revised Edition
-
-
-
7
-
-
0012997805
-
-
Paris, France: Organisation for Economic Co-operation and Development. Available at: Accessed 25.05.11
-
OECD (2001). OECD Guideline for the Testing of Chem icals. No. 423: Acute Oral Toxicity - Acute Toxic Class Method, 14pp. Paris, France: Organisation for Economic Co-operation and Development. Available at: http://titania.sourceoecd. org/ vl=30196851/cl=17/nw=1/rpsv/cw/vhosts/oecdjournals/1607310x/v1n4/contp1-1. htm (Accessed 25.05.11).
-
(2001)
OECD Guideline for the Testing of Chem Icals. No. 423: Acute Oral Toxicity - Acute Toxic Class Method
, pp. 14
-
-
-
9
-
-
0003479926
-
-
OECD deleted on 17th December 2002. Paris, France: Organisation for Economic Co-operation and Development
-
OECD (1984). OECD Guideline for the Testing of Chemicals. No. 401: Acute Oral Toxicity, deleted on 17th December 2002. Paris, France: Organisation for Economic Co-operation and Development.
-
(1984)
OECD Guideline for the Testing of Chemicals. No. 401: Acute Oral Toxicity
-
-
-
10
-
-
0038245040
-
The registry of cytotoxicity: Toxicity testing cultures to predict acute toxicity (LD50) and testing in animals
-
Halle, W. (2003). The registry of cytotoxicity: Toxicity testing cultures to predict acute toxicity (LD50) and testing in animals. ATLA 31, 89-198.
-
(2003)
ATLA
, vol.31
, pp. 89-198
-
-
Halle, W.1
-
11
-
-
0026681363
-
Evaluation of the human epidermal keratinocyte Neutral Red Release and Neutral Red Uptake Assay using the first 10 MEIC test materials
-
Wallace, K.A., Harbell, J.W., Accomando, N., Triana, A., Valone, S. & Curren, R.D. (1992). Evaluation of the human epidermal keratinocyte Neutral Red Release and Neutral Red Uptake Assay using the first 10 MEIC test materials. Toxicology in Vitro 6, 367-371.
-
(1992)
Toxicology in Vitro
, vol.6
, pp. 367-371
-
-
Wallace, K.A.1
Harbell, J.W.2
Accomando, N.3
Triana, A.4
Valone, S.5
Curren, R.D.6
-
12
-
-
0009615070
-
Cytotoxicity of 28 MEIC chemicals to rat hepatocytes using two viability end-points: Correlation with acute toxicity data in rat and man
-
Roguet, R., Cotovio, J., Gaetani, Q., Dossou, K.G. & Rougier, A. (1993). Cytotoxicity of 28 MEIC chemicals to rat hepatocytes using two viability end-points: Correlation with acute toxicity data in rat and man. ATLA 21, 216-224.
-
(1993)
ATLA
, vol.21
, pp. 216-224
-
-
Roguet, R.1
Cotovio, J.2
Gaetani, Q.3
Dossou, K.G.4
Rougier, A.5
-
13
-
-
0242330171
-
The benefits of the 3T3 NRU test in the safety assessment of cosmetics: Long-term experience from pre-marketing testing in the Czech Republic
-
DOI 10.1016/S0887-2333(03)00125-5
-
Jirova, D., Kejlova, K., Brabec, M., Bendova, H. & Kolarova, H. (2003). The benefits of the 3T3 NRU test in the safety assessment of cosmetics: Longterm experience from pre-marketing testing in the Czech Republic. Toxicology in Vitro 17, 791-796. (Pubitemid 37352695)
-
(2003)
Toxicology in Vitro
, vol.17
, Issue.5-6
, pp. 791-796
-
-
Jirova, D.1
Kejlova, K.2
Brabec, M.3
Bendova, H.4
Kolarova, H.5
-
14
-
-
0242266950
-
In-house assessment of a modified in vitro cytotoxicity assay for higher throughput estimation of acute toxicity
-
DOI 10.1016/S0887-2333(03)00100-0
-
King, A.V. & Jones, P.A. (2003). In-house assessment of a modified in vitro cytotoxicity assay for higher throughput estimation of acute toxicity. Toxicology in Vitro 17, 717-722. (Pubitemid 37352684)
-
(2003)
Toxicology in Vitro
, vol.17
, Issue.5-6
, pp. 717-722
-
-
King, A.V.1
Jones, P.A.2
-
15
-
-
44749094190
-
Estimation of human blood LC50 values for use in modeling of in vitro-in vivo data of the ACuteTox project
-
Sjöström, M., Kolman, A., Clemedson, C. & Clothier, R. (2008). Estimation of human blood LC50 values for use in modeling of in vitro-in vivo data of the ACuteTox project. Toxicology in Vitro 22, 1405-1411.
-
(2008)
Toxicology in Vitro
, vol.22
, pp. 1405-1411
-
-
Sjöström, M.1
Kolman, A.2
Clemedson, C.3
Clothier, R.4
-
16
-
-
43549107381
-
ICCVAM Test Method Evaluation Report (TMER): In Vitro Cytotoxicity Test Methods for Estimating Starting Doses for Acute Oral Systemic Toxicity Testing
-
Research Triangle Park, NC, USA: National Institute of Environmental Health Sciences Available at: Accessed 25.05.11
-
ICCVAM/NTP/NICEATM (2006). ICCVAM Test Method Evaluation Report (TMER): In Vitro Cytotoxicity Test Methods for Estimating Starting Doses For Acute Oral Systemic Toxicity Testing, NIH Publication No. 07-4519. Research Triangle Park, NC, USA: National Institute of Environmental Health Sciences. Available at: http://iccvam.niehs.nih.gov/methods/acutetox/inv-nru-tmer.htm (Accessed 25.05.11).
-
(2006)
NIH Publication No. 07-4519
-
-
-
17
-
-
43549114744
-
Alternative methods to safety studies in experimental animals: Role in the risk assessment of chemicals under the new European Chemicals Legislation (REACH)
-
Lilienblum, W., Dekant, W., Foth, H., Gebel, T, Hengstler, J.G., Kahl, R., Kramer, P.J., Schweinfurth, H. & Wollin, K.M. (2008). Alternative methods to safety studies in experimental animals: Role in the risk assessment of chemicals under the new European Chemicals Legislation (REACH). Archives of Toxicology 82, 211-236.
-
(2008)
Archives of Toxicology
, vol.82
, pp. 211-236
-
-
Lilienblum, W.1
Dekant, W.2
Foth, H.3
Gebel, T.4
Hengstler, J.G.5
Kahl, R.6
Kramer, P.J.7
Schweinfurth, H.8
Wollin, K.M.9
-
18
-
-
77951517715
-
Estimation of reliability of predictions and model applicability domain evaluation in the analysis of acute toxicity (LD50)
-
Sazonovas, A., Japertas, P. & Didziapetris, R. (2010). Estimation of reliability of predictions and model applicability domain evaluation in the analysis of acute toxicity (LD50). SAR & QSAR in Environmental Research 21, 127-148.
-
(2010)
SAR & QSAR in Environmental Research
, vol.21
, pp. 127-148
-
-
Sazonovas, A.1
Japertas, P.2
Didziapetris, R.3
-
19
-
-
73849128409
-
Quantitative structure-activity relationship modeling of rat acute toxicity by oral exposure
-
Zhu, H., Martin, T.M., Ye, L., Sedykh, A., Young, D.M. & Tropsha, A. (2009). Quantitative structure-activity relationship modeling of rat acute toxicity by oral exposure. Chemical Research in Toxicology 22, 913-1921.
-
(2009)
Chemical Research in Toxicology
, vol.22
, pp. 913-1921
-
-
Zhu, H.1
Martin, T.M.2
Ye, L.3
Sedykh, A.4
Young, D.M.5
Tropsha, A.6
-
20
-
-
70350702677
-
ECVAM's ongoing activities in the area of acute oral toxicity
-
Kinsner-Ovaskainen, A., Bulgheroni, A., Hartung, T. & Prieto, P. (2009). ECVAM's ongoing activities in the area of acute oral toxicity. Toxicology in Vitro 23, 1535-1540.
-
(2009)
Toxicology in Vitro
, vol.23
, pp. 1535-1540
-
-
Kinsner-Ovaskainen, A.1
Bulgheroni, A.2
Hartung, T.3
Prieto, P.4
-
21
-
-
67649399461
-
Council Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
-
Anon. (Text with EEA relevance.) Part B: Methods for the determination of toxicity and other health effects. Acute Oral Toxicity - Acute Toxic Class Method [pp.145-173]. 31.05.2008
-
Anon. (2008). Council Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). (Text with EEA relevance.) Part B: Methods for the determination of toxicity and other health effects. Acute Oral Toxicity - Acute Toxic Class Method [pp.145-173]. Official Journal of the European Union L142, 31.05.2008, 1-739.
-
(2008)
Official Journal of the European Union
, vol.L142
, pp. 1-739
-
-
-
23
-
-
84887758843
-
-
MAFF Tokyo, Japan: Agricultural Production Bureau, Ministry of Agriculture, Forestry and Fisheries of Japan. Available at: Accessed 25.05.11
-
MAFF (2000). The Guidelines Related to the Study Reports for the Registration Application of Pesticide. Appendix to the Director General Notification, No. 12-Nousan-8147, 24 November, 2000, 120pp. Tokyo, Japan: Agricultural Production Bureau, Ministry of Agriculture, Forestry and Fisheries of Japan. Available at: http://www.mhlw.go.jp/english/topics/foodsafety/residue/ dl/01.pdf (Accessed 25.05.11).
-
(2000)
The Guidelines Related to the Study Reports for the Registration Application of Pesticide. Appendix to the Director General Notification, No. 12-Nousan-8147, 24 November, 2000
, pp. 120
-
-
-
25
-
-
58749111973
-
Estimation of acute oral toxicity using the No Observed Adverse Effect Level (NOAEL) from the 28 day repeated dose toxicity studies in rats
-
Bulgheroni, A., Kinsner-Ovaskainen, A., Hoffmann, S., Hartung, T. & Prieto, P. (2009). Estimation of acute oral toxicity using the No Observed Adverse Effect Level (NOAEL) from the 28 day repeated dose toxicity studies in rats. Regulatory Toxicology & Pharmacology 53, 16-19.
-
(2009)
Regulatory Toxicology & Pharmacology
, vol.53
, pp. 16-19
-
-
Bulgheroni, A.1
Kinsner-Ovaskainen, A.2
Hoffmann, S.3
Hartung, T.4
Prieto, P.5
-
26
-
-
33747084103
-
High concordance of drug-induced human hepatotoxicity with in vitro cytotoxicity measured in a novel cell-based model using high content screening
-
DOI 10.1007/s00204-006-0091-3
-
O'Brien, P.J., Irwin, W., Diaz, D., Howard-Cofield, E., Krejsa, C.M., Slaughter, M.R., Gao, B., Kaludercic, N., Angeline, A., Bernardi, P., Brain, P. & Hougham, C. (2006). High concordance of drug-induced human hepatotoxicity with in vitro cytotoxicity measured in a novel cell-based model using high content screening. Archives of Toxicology 80, 580-604. (Pubitemid 44214526)
-
(2006)
Archives of Toxicology
, vol.80
, Issue.9
, pp. 580-604
-
-
O'Brien, P.J.1
Irwin, W.2
Diaz, D.3
Howard-Cofield, E.4
Krejsa, C.M.5
Slaughter, M.R.6
Gao, B.7
Kaludercic, N.8
Angeline, A.9
Bernardi, P.10
Brain, P.11
Hougham, C.12
-
27
-
-
36148931004
-
Acute and sub-chronic functional neurotoxicity of methylphenidate on neural networks in vitro
-
DOI 10.1007/s00702-007-0759-8
-
Gopal, K.V., Miller, B.R. & Gross, G.W. (2007). Acute and sub-chronic functional neurotoxicity of methylphenidate on neural networks in vitro. Journal of Neural Transmission 114, 1365-1375. (Pubitemid 350112281)
-
(2007)
Journal of Neural Transmission
, vol.114
, Issue.11
, pp. 1365-1375
-
-
Gopal, K.V.1
Miller, B.R.2
Gross, G.W.3
-
28
-
-
2542468975
-
Spike manager: A new tool for spontaneous and evoked neuronal networks activity characterization
-
DOI 10.1016/j.neucom.2004.01.180, PII S0925231204001857
-
Vato, A., Bonzano, L., Chiappalone, M., Cicero, S., Morabito, F., Novellino, A. & Stillo, G. (2004). Spike manager: A new tool for spontaneous and evoked neuronal networks activity characterization. Neurocomputing 58, 1153-1161. (Pubitemid 38691035)
-
(2004)
Neurocomputing
, vol.58-60
, pp. 1153-1161
-
-
Vato, A.1
Bonzano, L.2
Chiappalone, M.3
Cicero, S.4
Morabito, F.5
Novellino, A.6
Stillo, G.7
-
29
-
-
15444362827
-
In vitro methods to study chemically-induced hepatotoxicity: A literature review
-
DOI 10.2174/1389200053586118
-
Farkas, D. & Tannenbaum, S.R. (2005). In vitro methods to study chemically-induced hepatotoxicity: A literature review. Current Drug Metabolism 6, 111-125. (Pubitemid 40394340)
-
(2005)
Current Drug Metabolism
, vol.6
, Issue.2
, pp. 111-125
-
-
Farkas, D.1
Tannenbaum, S.R.2
-
30
-
-
77957021236
-
Mechanism-based selection of compounds for the development of innovative in vitro approaches to hepatotoxicity studies in the LIINTOP project
-
Gómez-Lechón, M.J., Tolosa, L., Castell, J.V. & Donato, M.T. (2010). Mechanism-based selection of compounds for the development of innovative in vitro approaches to hepatotoxicity studies in the LIINTOP project. Toxicology in Vitro 24, 1879-1889.
-
(2010)
Toxicology in Vitro
, vol.24
, pp. 1879-1889
-
-
Gómez-Lechón, M.J.1
Tolosa, L.2
Castell, J.V.3
Donato, M.T.4
-
31
-
-
67650678980
-
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/ 45/EC, and amending Regulation (EC) No. 1907/ 2006
-
Anon. (Text with EEA relevance.) Annex I, Section 3.3 [pp. 91-95]. 31.12.2008
-
Anon. (2008). Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/ 45/EC, and amending Regulation (EC) No. 1907/ 2006. (Text with EEA relevance.) Annex I, Section 3.3 [pp. 91-95]. Official Journal of the European Union L353, 31.12.2008, 1-1355.
-
(2008)
Official Journal of the European Union
, vol.L353
, pp. 1-1355
-
-
|