The regulatory use of the Local Lymph Node Assay for the notification of new chemicals in Europe.

We have monitored the regulatory use of the LLNA for chemicals registration from the time of its adoption as stand alone method at the OECD to 2008. For this, we screened the New Chemicals Database (NCD) which was managed during this period by the former European Chemicals Bureau (ECB) at the European Commission Joint Research Centre (JRC). The NCD comprises chemicals notified after 1981, where registered data have been derived according to regulatory standards, including GLP and predominantly according to official test methods. The database was searched to extract records for which the information for skin sensitisation labelling was based on results derived with the LLNA. The details of these records were extracted and pooled, for a total of 545 entries, and evaluated with regards to the extent of use of the LLNA over time and countries, as well as analysing the information derived on critical aspects of the procedure e.g strain and amount of animals used, lymph node processing, solvent and doses selected, stimulation indices, and assessing their level of compliance to the OECD 429. Additional information on labelling was extracted, and its significance for the potential of the widespread use of the reduced version of the LLNA is discussed on the text.

ANGERS Alexandre;  TOSTI Luca;  CASATI Silvia; 

2012-01-17

ACADEMIC PRESS INC ELSEVIER SCIENCE

JRC61368

0273-2300,   

http://www.sciencedirect.com/science/article/pii/S0273230011000742,    https://publications.jrc.ec.europa.eu/repository/handle/JRC61368,   

10.1016/j.yrtph.2011.04.006,