Department of Alternative Toxicological Methods

Tests performed by the Department of Alternative Toxicological Methods

Head: Kristina Kejlová, M.Sc., Ph.D.

cytotoxicity testing (test on extract, material, direct contact)

ISO 10993-5 Biological evaluation of medical devices – Part 5: Tests for cytotoxicity: in vitro methods.

phototoxicity testing – 3T3 Balb/c Neutral Red Uptake Photoxicity Test

Commission 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) (Method B.41)

OECD TG 432: In Vitro 3T3 NRU Phototoxicity Test (2004)

cytotoxicity assay for acute oral toxicity testing – 3T3 Balb/c Neutral Red Uptake Test

OECD Guidance Document No 129 on using Cytotoxicity Tests to Estimate Starting Doses for Acute Oral Systemic Toxicity Tests (2010)

phototoxicity testing – 3D skin model EpiDerm^TM

OECD TG 498: In Vitro Phototoxicity – Reconstructed Human Epidermis Phototoxicity Test Method (2021)

skin corrosion testing – 3D skin model EpiDerm^TM

COMMISSION 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) (Method B.40a)

OECD TG 431: In Vitro Skin Corrosion: Human Skin Model Test (2019)

skin irritation testing – 3D skin model EpiDerm^TM

Commission Regulation (EC) No. 761/2009 of 23 July 2009 amending, for the purpose of its adaptation to technical progress, Regulation (EC) No 440/2008 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) (Method B.46)

OECD TG 439: In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method (2021)

ISO 10993-23 Biological evaluation of medical devices – Part 23: Tests for irritation (2021)

eye irritation testing – 3D model EpiOcular^TM

OECD TG 492: Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage (2019)

eye irritation testing – Hen´s Egg Test on the Chorioallantoic Mebrane (HET-CAM)

DB-ALM Protocol n° 47: HET-CAM Test

https://jeodpp.jrc.ec.europa.eu/ftp/jrc-opendata/EURL-ECVAM/datasets/DBALM/LATEST/online/dbalm.html

genotoxicity testing of chemicals – in vitro chromosome aberration test
cytogenetic analysis of human lymphocytes of subjects professionally exposed to genotoxic agent

OECD TG 473: In Vitro Mammalian Chromosomal Aberation Test (2016)

mutagenicity testing of chemicals – reverse mutation test using bacteria (Ames Test)

OECD TG 471: Bacterial Reverse Mutation Test (2020)

sensitization – in chemico Direct Peptide Reactivity Assay – DPRA

OECD TG 442C: In Chemico Skin Sensitisation – Assays addressing the Adverse Outcome Pathway key event on covalent binding to proteins (2022)

sensitization – in vitro test LuSens

OECD TG 442D: In Vitro Skin Sensitisation – ARE-Nrf2 Luciferase Test Method (2022)

sensitization – in vitro test HCLAT

OECD TG. 442E: In Vitro Skin Sensitisation – In Vitro Skin Sensitisation assays addressing

the Key Event on activation of dendritic cells on the Adverse Outcome Pathway for Skin

Sensitisation

skin absorption in vitro

OECD TG 428: Skin Absorption: In Vitro Method (2004)

test for estrogenic and androgenic agonistic/antagonistic activity (potential of endocrine disruption)

Yeast based reporter gene assay (Xenoscreen® YES/YAS, Xenometrix, Switzerland)