Alternative acute oral toxicity assessment under REACH based on sub-acute toxicity values

Altex

Volumn 34, Issue 3, 2017, Pages 353-361

  Gissi, Andrea ^a   Louekari, Kimmo ^a   Hoffstadt, Laurence ^a   Bornatowicz, Norbert ^a   Aparicio, Alberto Martin ^a  

^a EUROPEAN CHEMICALS AGENCY   (Finland)

Author keywords

Acute toxicity; Adaptation; Alternative methods; REACH; Weight of evidence

Indexed keywords

ACUTE ORAL TOXICITY; ACUTE TOXICITY; ARTICLE; DATA BASE; DATA EXTRACTION; DIAGNOSTIC ACCURACY; HYPOTHESIS; LD50; MATHEMATICAL PARAMETERS; MOUTH DISEASE; NONHUMAN; PHYSICAL CHEMISTRY; PRACTICE GUIDELINE; PREDICTIVE VALUE; QUALITY CONTROL; TOXICITY ASSAY; ANIMAL; ANIMAL TESTING ALTERNATIVE; DANGEROUS GOODS; FACTUAL DATABASE; NO-OBSERVED-ADVERSE-EFFECT LEVEL; PROCEDURES; TOXICITY; TOXICITY TESTING;

DANGEROUS GOODS;

ANIMAL TESTING ALTERNATIVES; ANIMALS; DATABASES, FACTUAL; HAZARDOUS SUBSTANCES; NO-OBSERVED-ADVERSE-EFFECT LEVEL; TOXICITY TESTS, ACUTE;

EID: 85026213374     PISSN: 1868596X     EISSN: 18688551     Source Type: Journal    
DOI: 10.14573/altex.1609121     Document Type: Article

References (15)

1. ASTM (2007). ASTM D5517-07, Standard Test Method for Determining Extractability of Metals from Art Materials, ASTM International, West Conshohocken, PA, 2007. https://www. astm.org
2. Bulgheroni, A., Kinsner-Ovaskainen, A., Hoffmann, S. et al. (2009). Estimation of acute oral toxicity using the no observed adverse effect level (NOAEL) from the 28 day repeated dose toxicity studies in rats. Regul Toxicol Pharmacol 53, 16-19. doi:10.1016/j.yrtph.2008.10.001
3. Chapman, K., Creton, S., Kupferschmidt, H. et al. (2010). The value of acute toxicity studies to support the clinical management of overdose and poisoning: A cross-discipline con sensus. Regul Toxicol Pharmacol 58, 354-359. doi:10.1016/j.yrtph.2010.07.003
4. Creton, S., Dewhurst, I. C., Earl, L. K. et al. (2010). Acute toxicity testing of chemicals - opportunities to avoid redundant testing and use alternative approaches. Crit Rev Toxicol 40, 50-83. doi:10.3109/10408440903401511
5. EURL ECVAM (2013). Recommendation on the 3T3 NRU Assay for Supporting the Identification of Substances Not Requiring Classification for Acute Oral Toxicity, April 2013, European Commission, Joint Research Centre, Report EUR 25946 EN. http://bit.ly/2pWCpFy
6. EU - European Union (2006). Regulation (EC) No 1907/2006 of The European Parliament and of The Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Off J Eur Union L396, 10.04.2014. http://bit.ly/1pDFG2I
7. EU (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 Regulation (EC) No 1907/2006. Off J Eur Union L353, 31.12.2008. http://bit.ly/1F3nLbO
8. Graepel, R., Asturiol, A., Prieto, P. and Worth, A. P. (2016). Exploring waiving opportunities for mammalian acute systemic toxicity tests. Altern Lab Anim 44, 271-279.
9. Indans, I., Fry, T., Parsons, P. and Evans, P. (1998). Classification and labelling of new industrial chemicals for acute toxicity, skin and eye irritation. Hum Exp Toxicol 17, 529.
10. Kinsner-Ovaskainen, A., Prieto, P., Stanzel, S. and Kopp-Schneider, A. (2013). Selection of test methods to be included in a testing strategy to predict acute oral toxicity: An approach based on statistical analysis of data collected in phase 1 of the ACuteTox project. Toxicol Vitro Int J Publ Assoc BIBRA 27, 1377-1394. doi:10.1016/j.tiv.2012.11.010
11. Luechtefeld, T., Maertens, A., Russo, D. P. et al. (2016). Analysis of public oral toxicity data from REACH registrations 2008-2014. ALTEX 33, 111-122. doi:10.14573/altex.1510054
12. Prieto, P., Cole, T., Curren, R. et al. (2013). Assessment of thepredictive capacity of the 3T3 neutral red uptake cytotoxicity test method to identify substances not classified for acute oral toxicity (LD50>2000 mg/kg): Results of an ECVAM validation study. Regul Toxicol Pharmacol 65, 344-365. doi:10.1016/j.yrtph.2012.11.013
13. Robinson, S., Delongeas, J.-L., Donald, E. et al. (2008). A European pharmaceutical company initiative challenging the regulatory requirement for acute toxicity studies in pharmaceutical drug development. Regul Toxicol Pharmacol 50, 345-352. doi:10.1016/j.yrtph.2007.11.009
14. Russell, W. M. S. and Burch, R. L. (1959). The Principles of Humane Experimental Technique. Johns Hopkins Bloom School of Public Health. http://altweb.jhsph.edu/pubs/books/humane-exp/het-toc
15. Seidle, T., Prieto, P. and Bulgheroni, A. (2011). Examining the regulatory value of multi-route mammalian acute systemic toxicity studies. ALTEX 28, 95-102. doi:10.14573/altex.2011.2.095