According to REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals), testing for acute inhalation toxicity is required for chemicals manufactured or imported at tonnages ≥ 10 tons per year. Three OECD test guidelines for acute inhalation toxicity in vivo are adopted (TG 403, TG 436, and TG 433). Since animal testing is ethically, scientifically and economically questionable, adoption of alternative methods by the European Union and the OECD is needed. An in vitro system based on the study of lung surfactant function is introduced.
Get full access to this article
View all access options for this article.
References
1.
European Commission.. Report from the Commission to the Council and the European Parliament—Seventh Report on the Statistics on the Number of Animals Used for Experimental and Other Scientific Purposes in the Member States of the European Union. Brussels, European Commission; 2013.
2.
European Chemicals Agency.. Guidance on Registration. Report No.: Version 3.0.Helsinki, Finland: European Chemical Agency; 2016.
3.
European Chemicals Agency.. Guidance on Information Requirements and Chemical Safety Assessment—Chapter R.7a: Endpoint specific guidance. Report No.: Version 6.0.Helsinki, Finland: European Chemical Agency; 2017.
4.
OECD.. Guideline 433 on Acute Inhalation Toxicity testing—Fixed Dose Procedure. Paris, France: Organisation for Economic Co-operation and Development (OECD); 2017.
5.
OECD.. Guideline 403 on Acute Inhalation Toxicity testing. Paris, France: Organisation for Economic Co-operation and Development (OECD); 2009.
6.
OECD.. Guideline 436 on Acute Inhalation Toxicity testing—Acute Toxic Class Method. Paris, France: Organisation for Economic Co-operation and Development (OECD); 2009.
7.
European Chemicals Agency.. Practical Guide for SME Managers and REACH Coordinators—How to Fulfil Your Information Requirements at Tonnages 1–10 and 10–100 Tonnes per Year. Report No.: Version 1.0.Helsinki, Finland: European Chemical Agency; 2016.
8.
EU. Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2020 on the Protection of Animals Used for Scientific Purposes. 2010.
9.
The Ministry of Environment and Food of Denmark.. Animal Testing Regulations. BEK number 88; January30, 2013.
10.
EnhorningG. Pulmonary surfactant function studied with the pulsating bubble surfactometer (PBS) and the capillary surfactometer (CS). Comp Biochem Physiol A Mol Integr Physiol, 2001:129; 221–226.
11.
SørliJB, Da SilvaE, BäckmanP, et al.A proposed in vitro method to assess effects of inhaled particles on lung surfactant function. Am J Respir Cell Mol Biol, 2016:54; 306–311.
12.
ValleRP, WuT, ZuoYY. Biophysical influence of airborne carbon nanomaterials on natural pulmonary surfactant. ACS Nano, 2015:9; 5413–5421.
13.
ZuoYY, DingM, LiD, et al.Further development of Axisymmetric Drop Shape Analysis-Captive Bubble for pulmonary surfactant related studies. Biochim Biophys Acta, 2004:1675; 12–20.
14.
SørliJ, HuangY, Da SilvaE, et al.Prediction of acute inhalation toxicity using in vitro lung surfactant inhibition. ALTEX, 2018; 35:26–36.
