Page 154 - CW E-Magazine (13-2-2024)

News from Abroad

CHEMICAL SAFETY ASSESSMENT
BASF and partners join ECHA’s quest to find alternatives

to animal testing

The European Chemicals Agency researchers can then draw conclusions
(ECHA) has contracted a consortium about changes to cells or organs. Meta-
that includes BASF to conduct scienti- bolomics technologies can be used to
fic studies on the reliability and rele- study metabolic products in cells, such as
vance of New Approach Methodo- amino acids, lipids or hormones. If these
logies (NAMs) as alternatives to animal change, the health of an organism can be
testing and to promote the use of such evaluated, much like a diagnostic blood
methods in the future. test at the doctor’s office.

The aim of the contract is to get ad- The research team aims to find out
ditional NAMs accepted by regulatory under which conditions the OMICS
authorities, focusing on molecular bio- technologies can reliably deliver rele-
logical technologies (OMICS and toxico- predictions. “This approach is already vant and reproducible findings for as-
kinetics), and thereby further reduce being used to close data gaps in regis- sessing the safety of chemical substances.
the number of animal studies conducted as trations under the EU chemicals regula- Regulatory authorities should then be
part of safety assessments for chemical tion REACH. We would like to expand able to consult these findings when as-
substances. The contract will run for six it further, for example, through the use sessing the substances. This could also
years and has a total value of €4.2-mn in of molecular biological methods. If further reduce the number of animal
ECHA funding. grouping and read-across is correctly studies needed in the future. The neces-
applied, there is no longer a need to sary regulatory guidelines also have to
The contract research project is led test every substance on animals. We be developed.
by the Fraunhofer Institute for Toxi- will therefore be able to further reduce
cology and Experimental Medicine the number of animal studies and the The project will also evaluate
(ITEM) in Hanover, Germany. ITEM, costs for safety assessments,” said the methods to predict the toxicokinetic
Michabo Health Science, based in toxicologist Professor Hennicke Kamp, behaviour of substances in an organism,
Coventry, England, and BASF Meta- Managing Director at BASF Meta- including how they are absorbed,
bolome Solutions in Berlin, Germany, bolome Solutions. distributed and excreted, as well as to
are coordinating the work. Other part- evaluate the accumulation and degra-
ners include the department for ex- Role of OMICS technologies dation of substances. These methods
perimental toxicology and ecology at A major focus of the research is comprise computational modelling
BASF in Ludwigshafen, Germany, the evaluating the informative value of approaches, so-called physiologically
University of Birmingham in England OMICS technologies in chemical safety based kinetic (PBK) models. To facili-
and the biotech companies BioClavis, assessments. These technologies can be tate the application and implementation
based in Glasgow, Scotland, and used to study, among other things, the of such PBK modelling data in regu-
Novogene Europe, based in Cambridge, activation of genes (transcriptomics) latory toxicology, the consortium will
England. or entire metabolic processes (meta- evaluate the applicability of PBK
bolomics) in cultured cells or a living models and their input parameters, in
The research partners will support organism. With OMICS technologies, particular the in silico (in computers)
ECHA in developing guidelines that researchers can measure numerous dif- and in vitro (experiments on cells, tissue
can be used to reliably predict the pro- ferent changes in a biological sample or organs and isolated under controlled
perties of substances for which there to extrapolate whether substances have conditions outside the body) toxico-
is not yet sufficient safety information. a potentially hazardous effect. Transcripto- kinetic parameters. A special focus is
The grouping and read-across approach mics can, for example, determine to better understand the performance
uses existing safety data from structur- how the activities of genes change and limitations of these methods, the
ally similar substances to make these after exposure to a certain substance. The current knowledge and data gaps.

154 Chemical Weekly February 13, 2024

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